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Anal sphincter injury at childbirth

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Anal sphincter injury at childbirth

There is a crisis of confidence in vaginal delivery. Women are aware of the potential for devastating consequences, and many ask for elective cesarean solely to avoid any possibility of incontinence or other problems linked to vaginal delivery.

Many obstetricians also have misgivings, though they are well aware that a cesarean is far more likely to cause maternal morbidity.1 In a survey of female obstetricians, 31% chose elective cesarean as their preferred mode of delivery—80% of whom gave fear of perineal trauma as their reason.2

We cannot dispute the risks. The incidence of anal incontinence following recognized obstetric anal sphincter injury (OASI) is estimated at over 60%,3 and the true incidence may be much higher,4 particularly when injury goes unrecognized at the time of delivery.

OASI—any 3rd- or 4th-degree perineal tear—causes far more morbidity than episiotomy alone or 1st- or 2nd-degree tears ( FIGURE 1). It is the most common cause of postpartum anal incontinence. Anal incontinence is defined by the International Continence Society as involuntary loss of flatus or feces that becomes a social or hygienic problem.5 What’s more, incontinence due to OASI causes very high cumulative health service costs.13

Lack of uniform classification, insufficient training, and limited evidence from randomized controlled trials all contribute to the notoriously poor outcomes of obstetric anal sphincter injury.

To improve the outcome and reestablish confidence in vaginal delivery, more training is needed, as is more research directed toward identifying how to prevent, identify, and manage anal sphincter injury following vaginal delivery.

Taboos, embarrassment, and mistaken thinking

Even though anal incontinence may be both physically and psychologically devastating, many women do not seek medical attention due to embarrassment.6-10 One study, for instance, found that only a third of women with fecal incontinence had ever discussed the problem with a physician.11

Wood et al10 reported that most women with anal sphincter injury were either unaware that they had the injury, or felt they did not receive an adequate explanation of their injury.

Some women chose not to speak with their doctors because they believed that anal incontinence was a normal consequence of childbirth.6,12

The scope of life-disrupting morbidities

Perineal pain and dyspareunia may persist for years

Perineal pain can be so distressing for the new mother that it may interfere with her ability to breast feed and cope with the daily tasks of motherhood.14 Short-term perineal pain is associated with reactionary edema, bruising, tight sutures, infection, and wound dehiscence. Persistent pain and discomfort from perineal trauma may also cause urinary retention and defecation problems.

Perineal pain and dyspareunia, which greatly impair sexual and social life, may last for many years after childbirth.6,15-17 Wheeless,18 for instance, reported that some women refrained from sexual intercourse for up to 14 years because of dyspareunia following sphincter injury.

Abscess formation, wound breakdown, rectovaginal fistulae

Following primary repair of OASI, Venkatesh et al19 noted a 10% wound disruption rate.

Price of missed injury could be colostomy. Most rectovaginal fistulae occur when the physician fails to recognize the true extent of sphincter injury at the time of repair, resulting in inadequate sphincter reconstruction and wound breakdown.17 Once rectovaginal fistulae have occurred, treatment is difficult and may ultimately require permanent colostomy.17,20

6 Risk factors for perineal trauma

1. Nulliparity

Because nulliparous women have a relatively inelastic perineum,21 time for perineal stretching during the second stage of labor is often inadequate, and perineal trauma is therefore more likely. Further, compared to the multipara, nulliparous women undergo more episiotomies to prevent perineal trauma, and are more likely to have instrumental delivery. This combination of factors increases their risk of OASI.

2. Macrosomia

Birth weight of more than 4 kg imposes risk of perineal injury, especially 3rd- and 4th-degree tears,8,22,23 due to larger head circumference, prolonged labor, and difficult delivery, especially if instrumental delivery is used. Even after safe delivery of the head, shoulder dystocia—more common in macrosomic infants—may contribute to perineal and anal sphincter trauma. A large baby is also likely to disrupt the fascial supports of the pelvic floor and cause a stretch injury to the pelvic and pudendal nerves.

 

 

3. Malposition, malpresentation

Occipito-posterior position incurs increased incidence of sphincter injury, for these reasons:8,22,24

  • Incomplete flexion of fetal head increases the presenting diameter.
  • Prolonged second stage of labor results in persistent pressure on the perineum, leading to edematous and friable tissues, which are more vulnerable to laceration, than during occipito-anterior labor.
  • Instrumental delivery is more likely than with occipito-anterior position.

Malpresentations such as face and brow presentations are also reported as risk factors for anal sphincter injury.22

Breech delivery does not appear to increase risk, but this may be due to stringent selection criteria and a low threshold for cesarean section during labor.

4. Precipitate labor

Cervical, perineal, labial, and urethral injury, all notable complications of precipitate labor, are largely due to inadequate time for maternal tissues to adjust to delivery forces. And delivery in unfavorable circumstances such as in transit to the hospital or in a standing position, without experienced assistance, allows no opportunity for management.

5. Prolonged second stage

Several studies have reported that a second stage of more than 60 minutes increases the incidence of anal sphincter injury.22,25,26 Evidence suggests that a prolonged active second stage causes pudendal nerve damage; however, if damage occurs in the first stage, as one report indicates, then a cesarean performed after onset of labor during which the cervix dilates more than 8 cm would not avert pudendal nerve damage.27

THE EVIDENCE ON EPISIOTOMY

Routine versus restrictive

A Cochrane review38 recommends restrictive use of episiotomy, based on an analysis of 6 randomized controlled trials, which concluded that there was no difference, in terms of severe vaginal or perineal trauma, between routine and restrictive episiotomy groups.

Compared to routine use, restrictive episiotomy had a lower incidence of posterior perineal trauma (relative risk 0.88; 95% confidence interval, 0.84-0.92), but a higher incidence of anterior perineal trauma (relative risk 1.02; 95% confidence interval, 0.90-1.16).

Mediolateral versus median

The reviewers also concluded that results for mediolateral versus median episiotomy were similar to the overall comparison, and recommended that, until further research is available, obstetricians should choose the technique with which they are most familiar.

Other data, however, have implied that mediolateral is superior to midline episiotomy. A retrospective study by Bodner-Adler and colleagues,25 for instance, reported a 6-fold increase in anal sphincter injury with midline episiotomy compared to mediolateral episiotomy. And a prospective nonrandomized controlled study by Combs et al21 reported an adjusted odds ratio of 5.92 for anal sphincter injury with midline episiotomy compared to mediolateral episiotomy.

As the Cochrane review noted, “There is a pressing need to evaluate which episiotomy technique (mediolateral or midline) provides the best outcome.”

We still don’t know Anal sphincter following vaginal delivery is a major cause of maternal morbidity worldwide, yet at present its management is based on limited evidence and expert opinion. Future research directed towards prevention and management of obstetric anal sphincter injury, and management of subsequent delivery, is needed.

It has been suggested that a passive second stage, particularly with an epidural, should be accelerated with oxytocics, rather than resorting to instrumental delivery, which itself may cause trauma.

6. Operative delivery

Though operative delivery is integral to obstetrics and reduces the cesarean rate, maternal morbidity is more likely, compared to unassisted delivery. Injuries caused by instrumental delivery include cervical laceration, as well as anal sphincter injury.

Forceps delivery. The operator needs to be skilled in use of both forceps and vacuum extraction, since some circumstances preclude use of the vacuum extractor (prematurity, face presentation, potential fetal bleeding tendency, delivery of the aftercoming head at breech presentation, lift out at cesarean section, and equipment failure). However, it is well established that maternal injury is more likely with forceps than vacuum extraction. The reasons:

  • The forceps occupy almost 10% more space in the pelvis.
  • The shanks of the forceps stretch the perineum and can cause injury. The anal sphincter is particularly vulnerable when the physician pulls in the posterolateral direction to encourage flexion of the head.
  • Unlike the vacuum extractor, which can detach, the forceps has no fail-safe mechanism, and therefore excessive force can be applied, particularly under epidural anaesthesia.
  • Forceps delivery always requires an episiotomy, but it is not an absolute necessity with the vacuum extractor.

Vacuum delivery. A Cochrane review28 of 10 trials concluded that vacuum-assisted vaginal delivery had significantly less maternal trauma (odds ratio [OR] 0.41; 95% confidence interval [CI], 0.33 to 0.50) and less general and regional anesthesia than forceps delivery.

A reduction in cephalhematoma and retinal hemorrhages with forceps might be considered a compensatory benefit; however, a 5-year follow-up of a randomized controlled trial comparing forceps with vacuum extraction found no significant differences in visual problems or child development.

 

 

Which cup for which position? Metal cups appear to be more suitable for occipitoposterior, transverse, and difficult occipitoanterior position deliveries.28

Soft cups seem appropriate for straightforward deliveries, as they are significantly more likely to fail to achieve vaginal delivery (OR 1.65; 95% CI, 1.19 to 2.29). Though scalp injury was less likely with soft cups (OR 0.45; 95% CI, 0.15 to 0.60), the 2 groups did not differ in maternal injury.

Let mother choose position—it’s not critical

Women should be encouraged to deliver in whichever position is most comfortable. Though some evidence suggests that perineal injury is more likely with a standing position delivery, a Cochrane review found that, with the possible exception of increased blood loss, there were no deleterious effects to the mother or fetus.29

The current evidence on various delivery positions is inconclusive.

Tactics for management of anal sphincter injury

Recognition and proper classification. Examination of perineal injury under adequate analgesia and light, and a combined vaginal and rectal examination are essential to assess the degree of anal sphincter injury.

If any doubt exists about the extent of the injury, a second opinion must be sought. It has been reported that the presence of an experienced person at the time of perineal assessment has increased the detection rate of anal sphincter injury.

Immediate repair of the perineal injury is advisable compared to delayed repair, as the immediate repair will reduce the bleeding and pain associated with the injury, which may in turn affect early breastfeeding and bonding. Immediate repair also prevents the development of edema (which may hinder subsequent recognition of structures involved) and reduces the possibility of infection.

Careful examination of the labia, clitoris, and urethra is essential to identify any injury. These structures need repair prior to the perineal repair.

Only a doctor experienced in anal sphincter repair or a trainee under supervision should perform a repair.

I prefer to repair the injury in the operating theater, where there is access to good lighting, appropriate equipment, and aseptic conditions.

General or regional (spinal, epidural, caudal) anesthesia is an important prerequisite—particularly for overlap repair, as the inherent tone in the sphincter muscle can cause the torn muscle ends to retract within the sheath. Muscle relaxation is necessary to retrieve the ends and overlap without tension.

The woman is placed in the lithotomy position and the full extent of the injury is evaluated by careful vaginal and rectal examination.

In the presence of a 4th-degree tear, the torn anal epithelium is repaired with interrupted 3/0 polyglactin (Vicryl, Ethicon, Somerville, NJ) sutures, with the knots tied in the anal lumen. Another option: A subcuticular repair of the anal epithelium using 3/0 polyglactin via the transvaginal approach has been used with equal success.

The sphincter muscles are repaired with 3/0 polydioxanone sulphate (PDS) clear sutures. Compared to a braided suture, these monofilamentous sutures are less likely to precipitate infection.

The internal anal sphincter should be identified and any tear repaired separately from the external sphincter, with interrupted 3/0 PDS. I advocate primary surgical repair of the internal sphincter, which has been shown to be beneficial in patients with established anal incontinence.

The external anal sphincter should be repaired with 3/0 PDS sutures, with either end-to-end or overlapping technique. No published randomized studies at present suggest that primary overlap technique is better than primary end-to-end technique. However the secondary overlapping techniques carried out by coloproctologists have shown better continence rates compared to secondary end-to-end technique.

Extra attention should be directed to reconstructing the perineal muscles, to provide support to the sphincter repair and maintain the vaginoanal distance. This may offer some protection in subsequent vaginal delivery and may prevent suture migration.

A vaginal and rectal examination must be performed and swabs and needles should be checked.

Intravenous antibiotics should be commenced intraoperatively and continued orally for 1 week.

A stool softener (lactulose 10 mL, 3 times daily) and a bulking agent should be prescribed for at least 2 weeks post-operatively, as passage of a large bolus of hard stool may disrupt the repair.

A comprehensive record should be documented, together with a diagram to demonstrate the injury.

The woman should be informed of the injury and the possible sequelae.

It is usual to ensure that a bowel action has occurred prior to discharge.

A hospital follow-up by an experienced doctor is essential.

Obstetric anal sphincter injury by the numbers

0.5%–5%Incidence in centers performing mediolateral episiotomy15,34
Up to 50%Incidence for forceps delivery with midline episiotomy35
At least 1 in 20Number of women with anal incontinence up to 1 year after childbirth36,37
Over 60%Incidence of anal incontinence following recognized anal sphincter injury3
One thirdNumber of women with anal incontinence who have discussed the problem with a doctor11
 

 

Future pregnancies: Set course by symptoms

Consider subsequent vaginal delivery only under these circumstances (FIGURE 2):

  • The woman is asymptomatic.
  • She has no evidence of anal sphincter defects detected by endoanal scan or low pressures on manometry.
  • Delivery will be carried out by an experienced midwife or doctor.

Since no evidence suggests that an elective prophylactic episiotomy will prevent another tear, perform episiotomy only if clinically indicated (ie, if the perineum is thick and inelastic, and an episiotomy will prevent multiple radial tears).

Asymptomatic women with low squeeze pressures and a defect greater than 1 quadrant are at increased risk of developing anal incontinence following another vaginal delivery; therefore, counseling should include the option of cesarean section.

Symptomatic women with severe injuries. Offer a secondary sphincter repair, and deliver future pregnancies by cesarean.

Women with mild symptoms can be managed conservatively with:

  • dietary advice to avoid gas-producing foods,
  • regulation of bowel action,
  • bulking agents,
  • constipating agents such as loperamide and codeine phosphate,
  • pelvic floor exercises, and
  • biofeedback.

This group of women is at risk of deterioration with a subsequent vaginal delivery, and should therefore be offered cesarean section. The risk of developing a repeat 3rd-degree tear is low, but no randomized studies have been performed to evaluate the benefit of routine cesarean section.

The author reports no financial relationships relevant to this article.

FIGURE 2 Pregnancy after sphincter injury: How to manage delivery30


References

1. Sultan AH, Stanton SL. Preserving the pelvic floor and perineum during childbirth—elective CS?. Br J Obstet Gynaecol. 1996;103:731-734.

2. Al-Mufti R, McCarthy A, Fisk NM. Obstetricians’ personal choice and mode of delivery. Lancet. 1996;347:544.-

3. Nazir M, Stein R, Carlsen E, Jacobsen AF, Nesheim B. Early evaluation of bowel symptoms after primary repair of obstetric perineal rupture is misleading—an observational cohort study. Dis Colon Rectum. 2003;46:1245-1250.

4. Goffeng AR, Andersch B, Andersson M, Berndtsson I, Hulten I, Oresland T. Objective methods cannot predict anal incontinence after primary repair of extensive anal tears. Acta Obstet Gynecol Scand. 1998;77:439-443.

5. Sultan AH, Kamm MA. Faecal incontinence after childbirth. Br J Obstet Gynaecol. 1997;104:972-982.

6. Haadam K, Ohrlander S, Lingman G. Long term ailments due ASR caused by delivery—a hidden problem. Eur J Obste Gynecol Reprod Biol. 1988;27:27-32.

7. Browning GG, Motson RW. Results of Parks operation for faecal incontinence after anal sphincter repair. BMJ. 1983;286:1873-1875.

8. Sultan AH, Kamm MA, Hudson CN, Bartrum CI. 3rd degree obstetric anal sphincter tears: risk factors & outcome of primary repair. BMJ. 1994;308:887-891.

9. Gjessing H, Backe B, Sahlin Y. Third degree obstetric tears; outcome after primary repair. Acta Obstet Gyaecol Scand. 1998;77:736-740.

10. Wood J, Amos L, Rieger N. Third degree anal sphincter tears—risk factors and outcome. Aust NZ J Obstet Gynaecol. 1998;38:3:414-417.

11. Johanson JF, Lafferty J. Epidemiology of faecal incontinence: the silent affliction. Am J Gastroenterol. January 1996;91:33-36.

12. Walsh CJ, Mooney EF, Upton GJ, Motson RW. Incidence of third degree perineal tears in labour and outcome after primary repair. Br J Surg. 1996;83:218-221.

13. Mellgren A, Jensen LL, Zetterstrom JP, Wong WD, Hofmeister JH, Lowry AC. Long-term cost of faecal incontinence secondary to obstetric injuries. Dis Colon Rectum. 1999;42:857-867.

14. Sleep J. Perineal care: a series of five randomized controlled trials. In: Robinson S, Thomson A, eds. Midwives, Research and Childbirth. Vol. 2. 1st ed. London, England: Chapman and Hall; 1991;199-251.

15. Sorensen SM, Bondesen H, Istre O, Vilmann P. Perineal rupture following vaginal delivery. Acta Obstet Gynecol Scand. 1988;67:315-318.

16. Sultan AH, Kamm MA, Bartrum CI, Hudson CN. Perienal damage at delivery. Contemp Review Obstet Gynaecol. 1994;6:18-24.

17. Giebel GD, Mennigen R, Chalabi K. Secondary anal reconstruction after obstetric injury. Coloproctology. 1993;1:55-58.

18. Wheeless CR, Jr. Ten steps to avoid FI secondary to 4th-degree obstetrical tear [Guest Editorial]. Obstet Gynecol Surv. March 1998;53:131-132.

19. Venkatesh KS, Ramanujam PS, Larson DM, Haywood MA. Anorectal complications of vaginal delivery. Dis Colon Rectum. 1989;32:1039-1041.

20. Pezim ME, Spencer RJ, Stanhope CR, Beart RW, Jr, Ready RL, Ilstrup DM. Sphincter repair for faecal incontinence after obstetrical or iatrogenic injury. Dis Colon Rectum. 1987;30:521-525.

21. Combs CA, Robertson PA, Laros RK. Risk factors in 3rd-and 4th-degree perineal lacerations in forceps and vacuum deliveries. Am J Obstet Gynecol. 1990;163:100-104.

22. de Leeuw JW, Sruijk PC, Vierhout ME, Wallenburg HCS. Risk factors for third-degree perineal ruptures during delivery. Br J Obstet Gynaecol. 2001;108:383-387.

23. Green JR, Soohoo SL. Factors associated with rectal injury in spontaneous delivery. Obstet Gynecol. 1989;73:732-738.

24. Pearl ML, Roberts JM, Laros RK, Hurd WW. Vaginal delivery from persistent occipito posterior position. Influence on maternal and neonatal morbidity. J Reprod Med. 1993;38:955-961.

25. Bodner-Adler B, Bodner K, Kaider A, et al. Risk factors for third degree perineal tears in vaginal delivery with an analysis of episiotomy types. J Reprod Med. 2001;46:752-756.

26. McLeod NL, Gilmour DT, Joseph KS, Farrell SA, Luther ER. Trends in major risk factors for anal sphincter lacerations: a 10 year study. J Obstet Gynaecol Can. 2003;25:586-593.

27. Sultan AH, Kamm MA, Hudson CN. Pudendal nerve damage during labour: prospective study before and after childbirth. Br J Obstet Gynaecol. 1994;101:22-28.

28. Johanson RB, Menon BKV. Vacuum extraction versus forceps for assisted vaginal delivery. Cochrane Database Syst Rev. 2000;(2):CD000224.-

29. Gupta JK, Hofmeyr GJ. Position for women during second stage of labour. Cochrane Database Syst Rev. 2004;(1):CD002006.-

30. Sultan AH, Thakar R. Lower genital tract and anal sphincter trauma. Best Pract Res Clin Obstet Gynecol. February 2002;16:99-115.

31. Sultan AH. Obsteric perineal injury and anal incontinence [editorial]. Clin Risk. 1999;5:193-196.

32. Adams EJ, Fernando RJ. Royal College of Obstetrics and Gynecology Green Top Guidelines. Guideline #29: Management of third- and fourth-degree perineal tears following vaginal delivery. RCOG; 2001.

33. Fernando RJ, Sultan AH, Radley S, Jones PW, Johanson RB. Management of obstetric anal sphincter injury: a systematic review and national practice survey. Biomed Cent Health Serv Res. 2002;2:9.-

34. Handa VL, Danielsen BH, Gilbert WM. Obstetric anal sphincter lacerations. Obstet Gynecol. 2001;98:225-230.

35. Kammerer-Doak DN, Wesol AB, Rogers RG, Dominguez CE, Dorin MH. A prospective cohort study of women after primary repair of obstetric anal sphincter laceration. Am J Obstet Gynecol. 1999;181:1317-1322.

36. Macarthur C, Lewis M, Knox EG. Health after childbirth: an investigation of long-term health problems beginning after childbirth in 11,701 women. London, England: HMSO; 1991;83-103.

37. Glazener CMA, Abdalla M, Stroud P, Naji S, Templeton A, Russell IT. Postnatal maternal morbidity: extent, causes, prevention and treatment. Br J Obstet Gynaecol. 1995;102:282-287.

38. Carroli G, Belizan J. Episiotomy for vaginal birth. Cochrane Database Syst Rev. 2000;(2):CD000081.-

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There is a crisis of confidence in vaginal delivery. Women are aware of the potential for devastating consequences, and many ask for elective cesarean solely to avoid any possibility of incontinence or other problems linked to vaginal delivery.

Many obstetricians also have misgivings, though they are well aware that a cesarean is far more likely to cause maternal morbidity.1 In a survey of female obstetricians, 31% chose elective cesarean as their preferred mode of delivery—80% of whom gave fear of perineal trauma as their reason.2

We cannot dispute the risks. The incidence of anal incontinence following recognized obstetric anal sphincter injury (OASI) is estimated at over 60%,3 and the true incidence may be much higher,4 particularly when injury goes unrecognized at the time of delivery.

OASI—any 3rd- or 4th-degree perineal tear—causes far more morbidity than episiotomy alone or 1st- or 2nd-degree tears ( FIGURE 1). It is the most common cause of postpartum anal incontinence. Anal incontinence is defined by the International Continence Society as involuntary loss of flatus or feces that becomes a social or hygienic problem.5 What’s more, incontinence due to OASI causes very high cumulative health service costs.13

Lack of uniform classification, insufficient training, and limited evidence from randomized controlled trials all contribute to the notoriously poor outcomes of obstetric anal sphincter injury.

To improve the outcome and reestablish confidence in vaginal delivery, more training is needed, as is more research directed toward identifying how to prevent, identify, and manage anal sphincter injury following vaginal delivery.

Taboos, embarrassment, and mistaken thinking

Even though anal incontinence may be both physically and psychologically devastating, many women do not seek medical attention due to embarrassment.6-10 One study, for instance, found that only a third of women with fecal incontinence had ever discussed the problem with a physician.11

Wood et al10 reported that most women with anal sphincter injury were either unaware that they had the injury, or felt they did not receive an adequate explanation of their injury.

Some women chose not to speak with their doctors because they believed that anal incontinence was a normal consequence of childbirth.6,12

The scope of life-disrupting morbidities

Perineal pain and dyspareunia may persist for years

Perineal pain can be so distressing for the new mother that it may interfere with her ability to breast feed and cope with the daily tasks of motherhood.14 Short-term perineal pain is associated with reactionary edema, bruising, tight sutures, infection, and wound dehiscence. Persistent pain and discomfort from perineal trauma may also cause urinary retention and defecation problems.

Perineal pain and dyspareunia, which greatly impair sexual and social life, may last for many years after childbirth.6,15-17 Wheeless,18 for instance, reported that some women refrained from sexual intercourse for up to 14 years because of dyspareunia following sphincter injury.

Abscess formation, wound breakdown, rectovaginal fistulae

Following primary repair of OASI, Venkatesh et al19 noted a 10% wound disruption rate.

Price of missed injury could be colostomy. Most rectovaginal fistulae occur when the physician fails to recognize the true extent of sphincter injury at the time of repair, resulting in inadequate sphincter reconstruction and wound breakdown.17 Once rectovaginal fistulae have occurred, treatment is difficult and may ultimately require permanent colostomy.17,20

6 Risk factors for perineal trauma

1. Nulliparity

Because nulliparous women have a relatively inelastic perineum,21 time for perineal stretching during the second stage of labor is often inadequate, and perineal trauma is therefore more likely. Further, compared to the multipara, nulliparous women undergo more episiotomies to prevent perineal trauma, and are more likely to have instrumental delivery. This combination of factors increases their risk of OASI.

2. Macrosomia

Birth weight of more than 4 kg imposes risk of perineal injury, especially 3rd- and 4th-degree tears,8,22,23 due to larger head circumference, prolonged labor, and difficult delivery, especially if instrumental delivery is used. Even after safe delivery of the head, shoulder dystocia—more common in macrosomic infants—may contribute to perineal and anal sphincter trauma. A large baby is also likely to disrupt the fascial supports of the pelvic floor and cause a stretch injury to the pelvic and pudendal nerves.

 

 

3. Malposition, malpresentation

Occipito-posterior position incurs increased incidence of sphincter injury, for these reasons:8,22,24

  • Incomplete flexion of fetal head increases the presenting diameter.
  • Prolonged second stage of labor results in persistent pressure on the perineum, leading to edematous and friable tissues, which are more vulnerable to laceration, than during occipito-anterior labor.
  • Instrumental delivery is more likely than with occipito-anterior position.

Malpresentations such as face and brow presentations are also reported as risk factors for anal sphincter injury.22

Breech delivery does not appear to increase risk, but this may be due to stringent selection criteria and a low threshold for cesarean section during labor.

4. Precipitate labor

Cervical, perineal, labial, and urethral injury, all notable complications of precipitate labor, are largely due to inadequate time for maternal tissues to adjust to delivery forces. And delivery in unfavorable circumstances such as in transit to the hospital or in a standing position, without experienced assistance, allows no opportunity for management.

5. Prolonged second stage

Several studies have reported that a second stage of more than 60 minutes increases the incidence of anal sphincter injury.22,25,26 Evidence suggests that a prolonged active second stage causes pudendal nerve damage; however, if damage occurs in the first stage, as one report indicates, then a cesarean performed after onset of labor during which the cervix dilates more than 8 cm would not avert pudendal nerve damage.27

THE EVIDENCE ON EPISIOTOMY

Routine versus restrictive

A Cochrane review38 recommends restrictive use of episiotomy, based on an analysis of 6 randomized controlled trials, which concluded that there was no difference, in terms of severe vaginal or perineal trauma, between routine and restrictive episiotomy groups.

Compared to routine use, restrictive episiotomy had a lower incidence of posterior perineal trauma (relative risk 0.88; 95% confidence interval, 0.84-0.92), but a higher incidence of anterior perineal trauma (relative risk 1.02; 95% confidence interval, 0.90-1.16).

Mediolateral versus median

The reviewers also concluded that results for mediolateral versus median episiotomy were similar to the overall comparison, and recommended that, until further research is available, obstetricians should choose the technique with which they are most familiar.

Other data, however, have implied that mediolateral is superior to midline episiotomy. A retrospective study by Bodner-Adler and colleagues,25 for instance, reported a 6-fold increase in anal sphincter injury with midline episiotomy compared to mediolateral episiotomy. And a prospective nonrandomized controlled study by Combs et al21 reported an adjusted odds ratio of 5.92 for anal sphincter injury with midline episiotomy compared to mediolateral episiotomy.

As the Cochrane review noted, “There is a pressing need to evaluate which episiotomy technique (mediolateral or midline) provides the best outcome.”

We still don’t know Anal sphincter following vaginal delivery is a major cause of maternal morbidity worldwide, yet at present its management is based on limited evidence and expert opinion. Future research directed towards prevention and management of obstetric anal sphincter injury, and management of subsequent delivery, is needed.

It has been suggested that a passive second stage, particularly with an epidural, should be accelerated with oxytocics, rather than resorting to instrumental delivery, which itself may cause trauma.

6. Operative delivery

Though operative delivery is integral to obstetrics and reduces the cesarean rate, maternal morbidity is more likely, compared to unassisted delivery. Injuries caused by instrumental delivery include cervical laceration, as well as anal sphincter injury.

Forceps delivery. The operator needs to be skilled in use of both forceps and vacuum extraction, since some circumstances preclude use of the vacuum extractor (prematurity, face presentation, potential fetal bleeding tendency, delivery of the aftercoming head at breech presentation, lift out at cesarean section, and equipment failure). However, it is well established that maternal injury is more likely with forceps than vacuum extraction. The reasons:

  • The forceps occupy almost 10% more space in the pelvis.
  • The shanks of the forceps stretch the perineum and can cause injury. The anal sphincter is particularly vulnerable when the physician pulls in the posterolateral direction to encourage flexion of the head.
  • Unlike the vacuum extractor, which can detach, the forceps has no fail-safe mechanism, and therefore excessive force can be applied, particularly under epidural anaesthesia.
  • Forceps delivery always requires an episiotomy, but it is not an absolute necessity with the vacuum extractor.

Vacuum delivery. A Cochrane review28 of 10 trials concluded that vacuum-assisted vaginal delivery had significantly less maternal trauma (odds ratio [OR] 0.41; 95% confidence interval [CI], 0.33 to 0.50) and less general and regional anesthesia than forceps delivery.

A reduction in cephalhematoma and retinal hemorrhages with forceps might be considered a compensatory benefit; however, a 5-year follow-up of a randomized controlled trial comparing forceps with vacuum extraction found no significant differences in visual problems or child development.

 

 

Which cup for which position? Metal cups appear to be more suitable for occipitoposterior, transverse, and difficult occipitoanterior position deliveries.28

Soft cups seem appropriate for straightforward deliveries, as they are significantly more likely to fail to achieve vaginal delivery (OR 1.65; 95% CI, 1.19 to 2.29). Though scalp injury was less likely with soft cups (OR 0.45; 95% CI, 0.15 to 0.60), the 2 groups did not differ in maternal injury.

Let mother choose position—it’s not critical

Women should be encouraged to deliver in whichever position is most comfortable. Though some evidence suggests that perineal injury is more likely with a standing position delivery, a Cochrane review found that, with the possible exception of increased blood loss, there were no deleterious effects to the mother or fetus.29

The current evidence on various delivery positions is inconclusive.

Tactics for management of anal sphincter injury

Recognition and proper classification. Examination of perineal injury under adequate analgesia and light, and a combined vaginal and rectal examination are essential to assess the degree of anal sphincter injury.

If any doubt exists about the extent of the injury, a second opinion must be sought. It has been reported that the presence of an experienced person at the time of perineal assessment has increased the detection rate of anal sphincter injury.

Immediate repair of the perineal injury is advisable compared to delayed repair, as the immediate repair will reduce the bleeding and pain associated with the injury, which may in turn affect early breastfeeding and bonding. Immediate repair also prevents the development of edema (which may hinder subsequent recognition of structures involved) and reduces the possibility of infection.

Careful examination of the labia, clitoris, and urethra is essential to identify any injury. These structures need repair prior to the perineal repair.

Only a doctor experienced in anal sphincter repair or a trainee under supervision should perform a repair.

I prefer to repair the injury in the operating theater, where there is access to good lighting, appropriate equipment, and aseptic conditions.

General or regional (spinal, epidural, caudal) anesthesia is an important prerequisite—particularly for overlap repair, as the inherent tone in the sphincter muscle can cause the torn muscle ends to retract within the sheath. Muscle relaxation is necessary to retrieve the ends and overlap without tension.

The woman is placed in the lithotomy position and the full extent of the injury is evaluated by careful vaginal and rectal examination.

In the presence of a 4th-degree tear, the torn anal epithelium is repaired with interrupted 3/0 polyglactin (Vicryl, Ethicon, Somerville, NJ) sutures, with the knots tied in the anal lumen. Another option: A subcuticular repair of the anal epithelium using 3/0 polyglactin via the transvaginal approach has been used with equal success.

The sphincter muscles are repaired with 3/0 polydioxanone sulphate (PDS) clear sutures. Compared to a braided suture, these monofilamentous sutures are less likely to precipitate infection.

The internal anal sphincter should be identified and any tear repaired separately from the external sphincter, with interrupted 3/0 PDS. I advocate primary surgical repair of the internal sphincter, which has been shown to be beneficial in patients with established anal incontinence.

The external anal sphincter should be repaired with 3/0 PDS sutures, with either end-to-end or overlapping technique. No published randomized studies at present suggest that primary overlap technique is better than primary end-to-end technique. However the secondary overlapping techniques carried out by coloproctologists have shown better continence rates compared to secondary end-to-end technique.

Extra attention should be directed to reconstructing the perineal muscles, to provide support to the sphincter repair and maintain the vaginoanal distance. This may offer some protection in subsequent vaginal delivery and may prevent suture migration.

A vaginal and rectal examination must be performed and swabs and needles should be checked.

Intravenous antibiotics should be commenced intraoperatively and continued orally for 1 week.

A stool softener (lactulose 10 mL, 3 times daily) and a bulking agent should be prescribed for at least 2 weeks post-operatively, as passage of a large bolus of hard stool may disrupt the repair.

A comprehensive record should be documented, together with a diagram to demonstrate the injury.

The woman should be informed of the injury and the possible sequelae.

It is usual to ensure that a bowel action has occurred prior to discharge.

A hospital follow-up by an experienced doctor is essential.

Obstetric anal sphincter injury by the numbers

0.5%–5%Incidence in centers performing mediolateral episiotomy15,34
Up to 50%Incidence for forceps delivery with midline episiotomy35
At least 1 in 20Number of women with anal incontinence up to 1 year after childbirth36,37
Over 60%Incidence of anal incontinence following recognized anal sphincter injury3
One thirdNumber of women with anal incontinence who have discussed the problem with a doctor11
 

 

Future pregnancies: Set course by symptoms

Consider subsequent vaginal delivery only under these circumstances (FIGURE 2):

  • The woman is asymptomatic.
  • She has no evidence of anal sphincter defects detected by endoanal scan or low pressures on manometry.
  • Delivery will be carried out by an experienced midwife or doctor.

Since no evidence suggests that an elective prophylactic episiotomy will prevent another tear, perform episiotomy only if clinically indicated (ie, if the perineum is thick and inelastic, and an episiotomy will prevent multiple radial tears).

Asymptomatic women with low squeeze pressures and a defect greater than 1 quadrant are at increased risk of developing anal incontinence following another vaginal delivery; therefore, counseling should include the option of cesarean section.

Symptomatic women with severe injuries. Offer a secondary sphincter repair, and deliver future pregnancies by cesarean.

Women with mild symptoms can be managed conservatively with:

  • dietary advice to avoid gas-producing foods,
  • regulation of bowel action,
  • bulking agents,
  • constipating agents such as loperamide and codeine phosphate,
  • pelvic floor exercises, and
  • biofeedback.

This group of women is at risk of deterioration with a subsequent vaginal delivery, and should therefore be offered cesarean section. The risk of developing a repeat 3rd-degree tear is low, but no randomized studies have been performed to evaluate the benefit of routine cesarean section.

The author reports no financial relationships relevant to this article.

FIGURE 2 Pregnancy after sphincter injury: How to manage delivery30


There is a crisis of confidence in vaginal delivery. Women are aware of the potential for devastating consequences, and many ask for elective cesarean solely to avoid any possibility of incontinence or other problems linked to vaginal delivery.

Many obstetricians also have misgivings, though they are well aware that a cesarean is far more likely to cause maternal morbidity.1 In a survey of female obstetricians, 31% chose elective cesarean as their preferred mode of delivery—80% of whom gave fear of perineal trauma as their reason.2

We cannot dispute the risks. The incidence of anal incontinence following recognized obstetric anal sphincter injury (OASI) is estimated at over 60%,3 and the true incidence may be much higher,4 particularly when injury goes unrecognized at the time of delivery.

OASI—any 3rd- or 4th-degree perineal tear—causes far more morbidity than episiotomy alone or 1st- or 2nd-degree tears ( FIGURE 1). It is the most common cause of postpartum anal incontinence. Anal incontinence is defined by the International Continence Society as involuntary loss of flatus or feces that becomes a social or hygienic problem.5 What’s more, incontinence due to OASI causes very high cumulative health service costs.13

Lack of uniform classification, insufficient training, and limited evidence from randomized controlled trials all contribute to the notoriously poor outcomes of obstetric anal sphincter injury.

To improve the outcome and reestablish confidence in vaginal delivery, more training is needed, as is more research directed toward identifying how to prevent, identify, and manage anal sphincter injury following vaginal delivery.

Taboos, embarrassment, and mistaken thinking

Even though anal incontinence may be both physically and psychologically devastating, many women do not seek medical attention due to embarrassment.6-10 One study, for instance, found that only a third of women with fecal incontinence had ever discussed the problem with a physician.11

Wood et al10 reported that most women with anal sphincter injury were either unaware that they had the injury, or felt they did not receive an adequate explanation of their injury.

Some women chose not to speak with their doctors because they believed that anal incontinence was a normal consequence of childbirth.6,12

The scope of life-disrupting morbidities

Perineal pain and dyspareunia may persist for years

Perineal pain can be so distressing for the new mother that it may interfere with her ability to breast feed and cope with the daily tasks of motherhood.14 Short-term perineal pain is associated with reactionary edema, bruising, tight sutures, infection, and wound dehiscence. Persistent pain and discomfort from perineal trauma may also cause urinary retention and defecation problems.

Perineal pain and dyspareunia, which greatly impair sexual and social life, may last for many years after childbirth.6,15-17 Wheeless,18 for instance, reported that some women refrained from sexual intercourse for up to 14 years because of dyspareunia following sphincter injury.

Abscess formation, wound breakdown, rectovaginal fistulae

Following primary repair of OASI, Venkatesh et al19 noted a 10% wound disruption rate.

Price of missed injury could be colostomy. Most rectovaginal fistulae occur when the physician fails to recognize the true extent of sphincter injury at the time of repair, resulting in inadequate sphincter reconstruction and wound breakdown.17 Once rectovaginal fistulae have occurred, treatment is difficult and may ultimately require permanent colostomy.17,20

6 Risk factors for perineal trauma

1. Nulliparity

Because nulliparous women have a relatively inelastic perineum,21 time for perineal stretching during the second stage of labor is often inadequate, and perineal trauma is therefore more likely. Further, compared to the multipara, nulliparous women undergo more episiotomies to prevent perineal trauma, and are more likely to have instrumental delivery. This combination of factors increases their risk of OASI.

2. Macrosomia

Birth weight of more than 4 kg imposes risk of perineal injury, especially 3rd- and 4th-degree tears,8,22,23 due to larger head circumference, prolonged labor, and difficult delivery, especially if instrumental delivery is used. Even after safe delivery of the head, shoulder dystocia—more common in macrosomic infants—may contribute to perineal and anal sphincter trauma. A large baby is also likely to disrupt the fascial supports of the pelvic floor and cause a stretch injury to the pelvic and pudendal nerves.

 

 

3. Malposition, malpresentation

Occipito-posterior position incurs increased incidence of sphincter injury, for these reasons:8,22,24

  • Incomplete flexion of fetal head increases the presenting diameter.
  • Prolonged second stage of labor results in persistent pressure on the perineum, leading to edematous and friable tissues, which are more vulnerable to laceration, than during occipito-anterior labor.
  • Instrumental delivery is more likely than with occipito-anterior position.

Malpresentations such as face and brow presentations are also reported as risk factors for anal sphincter injury.22

Breech delivery does not appear to increase risk, but this may be due to stringent selection criteria and a low threshold for cesarean section during labor.

4. Precipitate labor

Cervical, perineal, labial, and urethral injury, all notable complications of precipitate labor, are largely due to inadequate time for maternal tissues to adjust to delivery forces. And delivery in unfavorable circumstances such as in transit to the hospital or in a standing position, without experienced assistance, allows no opportunity for management.

5. Prolonged second stage

Several studies have reported that a second stage of more than 60 minutes increases the incidence of anal sphincter injury.22,25,26 Evidence suggests that a prolonged active second stage causes pudendal nerve damage; however, if damage occurs in the first stage, as one report indicates, then a cesarean performed after onset of labor during which the cervix dilates more than 8 cm would not avert pudendal nerve damage.27

THE EVIDENCE ON EPISIOTOMY

Routine versus restrictive

A Cochrane review38 recommends restrictive use of episiotomy, based on an analysis of 6 randomized controlled trials, which concluded that there was no difference, in terms of severe vaginal or perineal trauma, between routine and restrictive episiotomy groups.

Compared to routine use, restrictive episiotomy had a lower incidence of posterior perineal trauma (relative risk 0.88; 95% confidence interval, 0.84-0.92), but a higher incidence of anterior perineal trauma (relative risk 1.02; 95% confidence interval, 0.90-1.16).

Mediolateral versus median

The reviewers also concluded that results for mediolateral versus median episiotomy were similar to the overall comparison, and recommended that, until further research is available, obstetricians should choose the technique with which they are most familiar.

Other data, however, have implied that mediolateral is superior to midline episiotomy. A retrospective study by Bodner-Adler and colleagues,25 for instance, reported a 6-fold increase in anal sphincter injury with midline episiotomy compared to mediolateral episiotomy. And a prospective nonrandomized controlled study by Combs et al21 reported an adjusted odds ratio of 5.92 for anal sphincter injury with midline episiotomy compared to mediolateral episiotomy.

As the Cochrane review noted, “There is a pressing need to evaluate which episiotomy technique (mediolateral or midline) provides the best outcome.”

We still don’t know Anal sphincter following vaginal delivery is a major cause of maternal morbidity worldwide, yet at present its management is based on limited evidence and expert opinion. Future research directed towards prevention and management of obstetric anal sphincter injury, and management of subsequent delivery, is needed.

It has been suggested that a passive second stage, particularly with an epidural, should be accelerated with oxytocics, rather than resorting to instrumental delivery, which itself may cause trauma.

6. Operative delivery

Though operative delivery is integral to obstetrics and reduces the cesarean rate, maternal morbidity is more likely, compared to unassisted delivery. Injuries caused by instrumental delivery include cervical laceration, as well as anal sphincter injury.

Forceps delivery. The operator needs to be skilled in use of both forceps and vacuum extraction, since some circumstances preclude use of the vacuum extractor (prematurity, face presentation, potential fetal bleeding tendency, delivery of the aftercoming head at breech presentation, lift out at cesarean section, and equipment failure). However, it is well established that maternal injury is more likely with forceps than vacuum extraction. The reasons:

  • The forceps occupy almost 10% more space in the pelvis.
  • The shanks of the forceps stretch the perineum and can cause injury. The anal sphincter is particularly vulnerable when the physician pulls in the posterolateral direction to encourage flexion of the head.
  • Unlike the vacuum extractor, which can detach, the forceps has no fail-safe mechanism, and therefore excessive force can be applied, particularly under epidural anaesthesia.
  • Forceps delivery always requires an episiotomy, but it is not an absolute necessity with the vacuum extractor.

Vacuum delivery. A Cochrane review28 of 10 trials concluded that vacuum-assisted vaginal delivery had significantly less maternal trauma (odds ratio [OR] 0.41; 95% confidence interval [CI], 0.33 to 0.50) and less general and regional anesthesia than forceps delivery.

A reduction in cephalhematoma and retinal hemorrhages with forceps might be considered a compensatory benefit; however, a 5-year follow-up of a randomized controlled trial comparing forceps with vacuum extraction found no significant differences in visual problems or child development.

 

 

Which cup for which position? Metal cups appear to be more suitable for occipitoposterior, transverse, and difficult occipitoanterior position deliveries.28

Soft cups seem appropriate for straightforward deliveries, as they are significantly more likely to fail to achieve vaginal delivery (OR 1.65; 95% CI, 1.19 to 2.29). Though scalp injury was less likely with soft cups (OR 0.45; 95% CI, 0.15 to 0.60), the 2 groups did not differ in maternal injury.

Let mother choose position—it’s not critical

Women should be encouraged to deliver in whichever position is most comfortable. Though some evidence suggests that perineal injury is more likely with a standing position delivery, a Cochrane review found that, with the possible exception of increased blood loss, there were no deleterious effects to the mother or fetus.29

The current evidence on various delivery positions is inconclusive.

Tactics for management of anal sphincter injury

Recognition and proper classification. Examination of perineal injury under adequate analgesia and light, and a combined vaginal and rectal examination are essential to assess the degree of anal sphincter injury.

If any doubt exists about the extent of the injury, a second opinion must be sought. It has been reported that the presence of an experienced person at the time of perineal assessment has increased the detection rate of anal sphincter injury.

Immediate repair of the perineal injury is advisable compared to delayed repair, as the immediate repair will reduce the bleeding and pain associated with the injury, which may in turn affect early breastfeeding and bonding. Immediate repair also prevents the development of edema (which may hinder subsequent recognition of structures involved) and reduces the possibility of infection.

Careful examination of the labia, clitoris, and urethra is essential to identify any injury. These structures need repair prior to the perineal repair.

Only a doctor experienced in anal sphincter repair or a trainee under supervision should perform a repair.

I prefer to repair the injury in the operating theater, where there is access to good lighting, appropriate equipment, and aseptic conditions.

General or regional (spinal, epidural, caudal) anesthesia is an important prerequisite—particularly for overlap repair, as the inherent tone in the sphincter muscle can cause the torn muscle ends to retract within the sheath. Muscle relaxation is necessary to retrieve the ends and overlap without tension.

The woman is placed in the lithotomy position and the full extent of the injury is evaluated by careful vaginal and rectal examination.

In the presence of a 4th-degree tear, the torn anal epithelium is repaired with interrupted 3/0 polyglactin (Vicryl, Ethicon, Somerville, NJ) sutures, with the knots tied in the anal lumen. Another option: A subcuticular repair of the anal epithelium using 3/0 polyglactin via the transvaginal approach has been used with equal success.

The sphincter muscles are repaired with 3/0 polydioxanone sulphate (PDS) clear sutures. Compared to a braided suture, these monofilamentous sutures are less likely to precipitate infection.

The internal anal sphincter should be identified and any tear repaired separately from the external sphincter, with interrupted 3/0 PDS. I advocate primary surgical repair of the internal sphincter, which has been shown to be beneficial in patients with established anal incontinence.

The external anal sphincter should be repaired with 3/0 PDS sutures, with either end-to-end or overlapping technique. No published randomized studies at present suggest that primary overlap technique is better than primary end-to-end technique. However the secondary overlapping techniques carried out by coloproctologists have shown better continence rates compared to secondary end-to-end technique.

Extra attention should be directed to reconstructing the perineal muscles, to provide support to the sphincter repair and maintain the vaginoanal distance. This may offer some protection in subsequent vaginal delivery and may prevent suture migration.

A vaginal and rectal examination must be performed and swabs and needles should be checked.

Intravenous antibiotics should be commenced intraoperatively and continued orally for 1 week.

A stool softener (lactulose 10 mL, 3 times daily) and a bulking agent should be prescribed for at least 2 weeks post-operatively, as passage of a large bolus of hard stool may disrupt the repair.

A comprehensive record should be documented, together with a diagram to demonstrate the injury.

The woman should be informed of the injury and the possible sequelae.

It is usual to ensure that a bowel action has occurred prior to discharge.

A hospital follow-up by an experienced doctor is essential.

Obstetric anal sphincter injury by the numbers

0.5%–5%Incidence in centers performing mediolateral episiotomy15,34
Up to 50%Incidence for forceps delivery with midline episiotomy35
At least 1 in 20Number of women with anal incontinence up to 1 year after childbirth36,37
Over 60%Incidence of anal incontinence following recognized anal sphincter injury3
One thirdNumber of women with anal incontinence who have discussed the problem with a doctor11
 

 

Future pregnancies: Set course by symptoms

Consider subsequent vaginal delivery only under these circumstances (FIGURE 2):

  • The woman is asymptomatic.
  • She has no evidence of anal sphincter defects detected by endoanal scan or low pressures on manometry.
  • Delivery will be carried out by an experienced midwife or doctor.

Since no evidence suggests that an elective prophylactic episiotomy will prevent another tear, perform episiotomy only if clinically indicated (ie, if the perineum is thick and inelastic, and an episiotomy will prevent multiple radial tears).

Asymptomatic women with low squeeze pressures and a defect greater than 1 quadrant are at increased risk of developing anal incontinence following another vaginal delivery; therefore, counseling should include the option of cesarean section.

Symptomatic women with severe injuries. Offer a secondary sphincter repair, and deliver future pregnancies by cesarean.

Women with mild symptoms can be managed conservatively with:

  • dietary advice to avoid gas-producing foods,
  • regulation of bowel action,
  • bulking agents,
  • constipating agents such as loperamide and codeine phosphate,
  • pelvic floor exercises, and
  • biofeedback.

This group of women is at risk of deterioration with a subsequent vaginal delivery, and should therefore be offered cesarean section. The risk of developing a repeat 3rd-degree tear is low, but no randomized studies have been performed to evaluate the benefit of routine cesarean section.

The author reports no financial relationships relevant to this article.

FIGURE 2 Pregnancy after sphincter injury: How to manage delivery30


References

1. Sultan AH, Stanton SL. Preserving the pelvic floor and perineum during childbirth—elective CS?. Br J Obstet Gynaecol. 1996;103:731-734.

2. Al-Mufti R, McCarthy A, Fisk NM. Obstetricians’ personal choice and mode of delivery. Lancet. 1996;347:544.-

3. Nazir M, Stein R, Carlsen E, Jacobsen AF, Nesheim B. Early evaluation of bowel symptoms after primary repair of obstetric perineal rupture is misleading—an observational cohort study. Dis Colon Rectum. 2003;46:1245-1250.

4. Goffeng AR, Andersch B, Andersson M, Berndtsson I, Hulten I, Oresland T. Objective methods cannot predict anal incontinence after primary repair of extensive anal tears. Acta Obstet Gynecol Scand. 1998;77:439-443.

5. Sultan AH, Kamm MA. Faecal incontinence after childbirth. Br J Obstet Gynaecol. 1997;104:972-982.

6. Haadam K, Ohrlander S, Lingman G. Long term ailments due ASR caused by delivery—a hidden problem. Eur J Obste Gynecol Reprod Biol. 1988;27:27-32.

7. Browning GG, Motson RW. Results of Parks operation for faecal incontinence after anal sphincter repair. BMJ. 1983;286:1873-1875.

8. Sultan AH, Kamm MA, Hudson CN, Bartrum CI. 3rd degree obstetric anal sphincter tears: risk factors & outcome of primary repair. BMJ. 1994;308:887-891.

9. Gjessing H, Backe B, Sahlin Y. Third degree obstetric tears; outcome after primary repair. Acta Obstet Gyaecol Scand. 1998;77:736-740.

10. Wood J, Amos L, Rieger N. Third degree anal sphincter tears—risk factors and outcome. Aust NZ J Obstet Gynaecol. 1998;38:3:414-417.

11. Johanson JF, Lafferty J. Epidemiology of faecal incontinence: the silent affliction. Am J Gastroenterol. January 1996;91:33-36.

12. Walsh CJ, Mooney EF, Upton GJ, Motson RW. Incidence of third degree perineal tears in labour and outcome after primary repair. Br J Surg. 1996;83:218-221.

13. Mellgren A, Jensen LL, Zetterstrom JP, Wong WD, Hofmeister JH, Lowry AC. Long-term cost of faecal incontinence secondary to obstetric injuries. Dis Colon Rectum. 1999;42:857-867.

14. Sleep J. Perineal care: a series of five randomized controlled trials. In: Robinson S, Thomson A, eds. Midwives, Research and Childbirth. Vol. 2. 1st ed. London, England: Chapman and Hall; 1991;199-251.

15. Sorensen SM, Bondesen H, Istre O, Vilmann P. Perineal rupture following vaginal delivery. Acta Obstet Gynecol Scand. 1988;67:315-318.

16. Sultan AH, Kamm MA, Bartrum CI, Hudson CN. Perienal damage at delivery. Contemp Review Obstet Gynaecol. 1994;6:18-24.

17. Giebel GD, Mennigen R, Chalabi K. Secondary anal reconstruction after obstetric injury. Coloproctology. 1993;1:55-58.

18. Wheeless CR, Jr. Ten steps to avoid FI secondary to 4th-degree obstetrical tear [Guest Editorial]. Obstet Gynecol Surv. March 1998;53:131-132.

19. Venkatesh KS, Ramanujam PS, Larson DM, Haywood MA. Anorectal complications of vaginal delivery. Dis Colon Rectum. 1989;32:1039-1041.

20. Pezim ME, Spencer RJ, Stanhope CR, Beart RW, Jr, Ready RL, Ilstrup DM. Sphincter repair for faecal incontinence after obstetrical or iatrogenic injury. Dis Colon Rectum. 1987;30:521-525.

21. Combs CA, Robertson PA, Laros RK. Risk factors in 3rd-and 4th-degree perineal lacerations in forceps and vacuum deliveries. Am J Obstet Gynecol. 1990;163:100-104.

22. de Leeuw JW, Sruijk PC, Vierhout ME, Wallenburg HCS. Risk factors for third-degree perineal ruptures during delivery. Br J Obstet Gynaecol. 2001;108:383-387.

23. Green JR, Soohoo SL. Factors associated with rectal injury in spontaneous delivery. Obstet Gynecol. 1989;73:732-738.

24. Pearl ML, Roberts JM, Laros RK, Hurd WW. Vaginal delivery from persistent occipito posterior position. Influence on maternal and neonatal morbidity. J Reprod Med. 1993;38:955-961.

25. Bodner-Adler B, Bodner K, Kaider A, et al. Risk factors for third degree perineal tears in vaginal delivery with an analysis of episiotomy types. J Reprod Med. 2001;46:752-756.

26. McLeod NL, Gilmour DT, Joseph KS, Farrell SA, Luther ER. Trends in major risk factors for anal sphincter lacerations: a 10 year study. J Obstet Gynaecol Can. 2003;25:586-593.

27. Sultan AH, Kamm MA, Hudson CN. Pudendal nerve damage during labour: prospective study before and after childbirth. Br J Obstet Gynaecol. 1994;101:22-28.

28. Johanson RB, Menon BKV. Vacuum extraction versus forceps for assisted vaginal delivery. Cochrane Database Syst Rev. 2000;(2):CD000224.-

29. Gupta JK, Hofmeyr GJ. Position for women during second stage of labour. Cochrane Database Syst Rev. 2004;(1):CD002006.-

30. Sultan AH, Thakar R. Lower genital tract and anal sphincter trauma. Best Pract Res Clin Obstet Gynecol. February 2002;16:99-115.

31. Sultan AH. Obsteric perineal injury and anal incontinence [editorial]. Clin Risk. 1999;5:193-196.

32. Adams EJ, Fernando RJ. Royal College of Obstetrics and Gynecology Green Top Guidelines. Guideline #29: Management of third- and fourth-degree perineal tears following vaginal delivery. RCOG; 2001.

33. Fernando RJ, Sultan AH, Radley S, Jones PW, Johanson RB. Management of obstetric anal sphincter injury: a systematic review and national practice survey. Biomed Cent Health Serv Res. 2002;2:9.-

34. Handa VL, Danielsen BH, Gilbert WM. Obstetric anal sphincter lacerations. Obstet Gynecol. 2001;98:225-230.

35. Kammerer-Doak DN, Wesol AB, Rogers RG, Dominguez CE, Dorin MH. A prospective cohort study of women after primary repair of obstetric anal sphincter laceration. Am J Obstet Gynecol. 1999;181:1317-1322.

36. Macarthur C, Lewis M, Knox EG. Health after childbirth: an investigation of long-term health problems beginning after childbirth in 11,701 women. London, England: HMSO; 1991;83-103.

37. Glazener CMA, Abdalla M, Stroud P, Naji S, Templeton A, Russell IT. Postnatal maternal morbidity: extent, causes, prevention and treatment. Br J Obstet Gynaecol. 1995;102:282-287.

38. Carroli G, Belizan J. Episiotomy for vaginal birth. Cochrane Database Syst Rev. 2000;(2):CD000081.-

References

1. Sultan AH, Stanton SL. Preserving the pelvic floor and perineum during childbirth—elective CS?. Br J Obstet Gynaecol. 1996;103:731-734.

2. Al-Mufti R, McCarthy A, Fisk NM. Obstetricians’ personal choice and mode of delivery. Lancet. 1996;347:544.-

3. Nazir M, Stein R, Carlsen E, Jacobsen AF, Nesheim B. Early evaluation of bowel symptoms after primary repair of obstetric perineal rupture is misleading—an observational cohort study. Dis Colon Rectum. 2003;46:1245-1250.

4. Goffeng AR, Andersch B, Andersson M, Berndtsson I, Hulten I, Oresland T. Objective methods cannot predict anal incontinence after primary repair of extensive anal tears. Acta Obstet Gynecol Scand. 1998;77:439-443.

5. Sultan AH, Kamm MA. Faecal incontinence after childbirth. Br J Obstet Gynaecol. 1997;104:972-982.

6. Haadam K, Ohrlander S, Lingman G. Long term ailments due ASR caused by delivery—a hidden problem. Eur J Obste Gynecol Reprod Biol. 1988;27:27-32.

7. Browning GG, Motson RW. Results of Parks operation for faecal incontinence after anal sphincter repair. BMJ. 1983;286:1873-1875.

8. Sultan AH, Kamm MA, Hudson CN, Bartrum CI. 3rd degree obstetric anal sphincter tears: risk factors & outcome of primary repair. BMJ. 1994;308:887-891.

9. Gjessing H, Backe B, Sahlin Y. Third degree obstetric tears; outcome after primary repair. Acta Obstet Gyaecol Scand. 1998;77:736-740.

10. Wood J, Amos L, Rieger N. Third degree anal sphincter tears—risk factors and outcome. Aust NZ J Obstet Gynaecol. 1998;38:3:414-417.

11. Johanson JF, Lafferty J. Epidemiology of faecal incontinence: the silent affliction. Am J Gastroenterol. January 1996;91:33-36.

12. Walsh CJ, Mooney EF, Upton GJ, Motson RW. Incidence of third degree perineal tears in labour and outcome after primary repair. Br J Surg. 1996;83:218-221.

13. Mellgren A, Jensen LL, Zetterstrom JP, Wong WD, Hofmeister JH, Lowry AC. Long-term cost of faecal incontinence secondary to obstetric injuries. Dis Colon Rectum. 1999;42:857-867.

14. Sleep J. Perineal care: a series of five randomized controlled trials. In: Robinson S, Thomson A, eds. Midwives, Research and Childbirth. Vol. 2. 1st ed. London, England: Chapman and Hall; 1991;199-251.

15. Sorensen SM, Bondesen H, Istre O, Vilmann P. Perineal rupture following vaginal delivery. Acta Obstet Gynecol Scand. 1988;67:315-318.

16. Sultan AH, Kamm MA, Bartrum CI, Hudson CN. Perienal damage at delivery. Contemp Review Obstet Gynaecol. 1994;6:18-24.

17. Giebel GD, Mennigen R, Chalabi K. Secondary anal reconstruction after obstetric injury. Coloproctology. 1993;1:55-58.

18. Wheeless CR, Jr. Ten steps to avoid FI secondary to 4th-degree obstetrical tear [Guest Editorial]. Obstet Gynecol Surv. March 1998;53:131-132.

19. Venkatesh KS, Ramanujam PS, Larson DM, Haywood MA. Anorectal complications of vaginal delivery. Dis Colon Rectum. 1989;32:1039-1041.

20. Pezim ME, Spencer RJ, Stanhope CR, Beart RW, Jr, Ready RL, Ilstrup DM. Sphincter repair for faecal incontinence after obstetrical or iatrogenic injury. Dis Colon Rectum. 1987;30:521-525.

21. Combs CA, Robertson PA, Laros RK. Risk factors in 3rd-and 4th-degree perineal lacerations in forceps and vacuum deliveries. Am J Obstet Gynecol. 1990;163:100-104.

22. de Leeuw JW, Sruijk PC, Vierhout ME, Wallenburg HCS. Risk factors for third-degree perineal ruptures during delivery. Br J Obstet Gynaecol. 2001;108:383-387.

23. Green JR, Soohoo SL. Factors associated with rectal injury in spontaneous delivery. Obstet Gynecol. 1989;73:732-738.

24. Pearl ML, Roberts JM, Laros RK, Hurd WW. Vaginal delivery from persistent occipito posterior position. Influence on maternal and neonatal morbidity. J Reprod Med. 1993;38:955-961.

25. Bodner-Adler B, Bodner K, Kaider A, et al. Risk factors for third degree perineal tears in vaginal delivery with an analysis of episiotomy types. J Reprod Med. 2001;46:752-756.

26. McLeod NL, Gilmour DT, Joseph KS, Farrell SA, Luther ER. Trends in major risk factors for anal sphincter lacerations: a 10 year study. J Obstet Gynaecol Can. 2003;25:586-593.

27. Sultan AH, Kamm MA, Hudson CN. Pudendal nerve damage during labour: prospective study before and after childbirth. Br J Obstet Gynaecol. 1994;101:22-28.

28. Johanson RB, Menon BKV. Vacuum extraction versus forceps for assisted vaginal delivery. Cochrane Database Syst Rev. 2000;(2):CD000224.-

29. Gupta JK, Hofmeyr GJ. Position for women during second stage of labour. Cochrane Database Syst Rev. 2004;(1):CD002006.-

30. Sultan AH, Thakar R. Lower genital tract and anal sphincter trauma. Best Pract Res Clin Obstet Gynecol. February 2002;16:99-115.

31. Sultan AH. Obsteric perineal injury and anal incontinence [editorial]. Clin Risk. 1999;5:193-196.

32. Adams EJ, Fernando RJ. Royal College of Obstetrics and Gynecology Green Top Guidelines. Guideline #29: Management of third- and fourth-degree perineal tears following vaginal delivery. RCOG; 2001.

33. Fernando RJ, Sultan AH, Radley S, Jones PW, Johanson RB. Management of obstetric anal sphincter injury: a systematic review and national practice survey. Biomed Cent Health Serv Res. 2002;2:9.-

34. Handa VL, Danielsen BH, Gilbert WM. Obstetric anal sphincter lacerations. Obstet Gynecol. 2001;98:225-230.

35. Kammerer-Doak DN, Wesol AB, Rogers RG, Dominguez CE, Dorin MH. A prospective cohort study of women after primary repair of obstetric anal sphincter laceration. Am J Obstet Gynecol. 1999;181:1317-1322.

36. Macarthur C, Lewis M, Knox EG. Health after childbirth: an investigation of long-term health problems beginning after childbirth in 11,701 women. London, England: HMSO; 1991;83-103.

37. Glazener CMA, Abdalla M, Stroud P, Naji S, Templeton A, Russell IT. Postnatal maternal morbidity: extent, causes, prevention and treatment. Br J Obstet Gynaecol. 1995;102:282-287.

38. Carroli G, Belizan J. Episiotomy for vaginal birth. Cochrane Database Syst Rev. 2000;(2):CD000081.-

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Gynecologic laparoscopy in the obese? What was once the purview of the very talented or the foolhardy may now be the preferred surgical approach.

Obese women who undergo laparoscopy recover faster, with less pain, fewer wound infections, and shorter hospital stays than with laparotomy. Though it is true that obesity increases operative time and the risk for conversion to laparotomy, little evidence supports the theory that a body mass index (BMI) of 30 kg/m2 or higher should exclude laparoscopy.

Preoperative management

Unique elements of the physical

It is important to identify central obesity, which is more difficult to accommodate than distribution around the hips. Unfortunately, the roughly 40 million obese Americans tend to have central fat distribution.1,2

In central obesity, the subcutaneous tissue is thick, often requiring extra long ports to attain peritoneal access.

The relationship of the umbilicus to the underlying aortic bifurcation also shifts more caudally. This relationship should be noted and planned for before going to the operating room (FIGURE).

Abdominal obesity in particular confers additional risks during all types of surgery: higher rates of atelectasis, thromboembolism, cardiovascular dysfunction, and wound infection.

Closely inspect the skin and panniculus after a routine examination. Obesity predisposes patients to dark, moist, anoxic spaces beneath folds of skin that need to be identified and inspected for evidence of fungal or bacterial infection. To optimize postoperative wound healing, treat any preexisting infections before surgery.

Cigarette smoking further burdens pulmonary mechanics and oxygenation during surgery, so it is important to encourage smokers to kick the habit at least 8 weeks before elective surgery.3

In general, use the history and physical examination to focus on the recognized risk factors of obesity, with specific emphasis on hypertension, coronary artery disease, arrhythmia, pulmonary obstructive disease, peripheral vascular disease, diabetes, gastric reflux, and arthritis.4

Special tests and laboratory studies

EKG and chest x-ray. In morbidly obese patients (BMI >40), preoperative evaluation includes an electrocardiogram (EKG) and chest x-ray to identify any cardiomegaly, arrhythmias, and occult ischemia or conduction blockage.

Arterial blood gas sampling. Given the higher risk of postoperative thrombotic events in obese patients, it can be helpful to assess preoperative oxygenation and ventilation/perfusion status via arterial blood gas sampling. The obese may have elevated baseline Aa gradients, which, if not noted prior to surgery, can confuse later management of suspected pulmonary emboli.

During testing, assess venous access and counsel the patient if central venous line placement may be possible at surgery. Though central line placement is not routinely recommended, it may be warranted in patients with particularly difficult peripheral venous access.

Skip pulmonary function testing because the results rarely change surgical management. We consider its routine use to be wasteful.

Laboratory evaluation should include betahuman chorionic gonadotropin (in premenopausal patients), complete blood count, electrolytes, glucose, renal function, and type and screen.

Spell out risks at informed consent

The preoperative appointment is your chance to answer questions the patient may have and clearly delineate the risks and benefits of surgery. During this discussion, spell out the increased risks of conversion to laparotomy, prolonged anesthesia, postoperative thrombosis, wound infection, and pulmonary complications, and make sure all are listed on the written consent form.

Operative management

Prophylactic measures

Complete bowel preparation is recommended the evening prior to surgery, since intraabdominal visualization can be difficult and conversion to laparotomy may be necessary. Bowel prep decompresses the lumen, improving visualization and the outcome of any bowel injury.

Preoperative histamine receptor blockade is recommended for optimal results, since higher body mass can lead to increases in low pH gastric volume and difficulties with intubation.5 A typical regimen is 50 mg intravenous (IV) ranitidine 20 minutes prior to surgery.

Beta blockade. All patients with hypertension or a history of coronary artery disease should receive preoperative beta blockade, assuming there are no contraindications such as reactive airway disease or cardiac conduction block. Atenolol 10 mg IV 20 minutes prior to surgery is a standard initial dose. All patients already taking beta blockers should simply continue their home regimen through the day of surgery with small sips of water.

 

 

INTEGRATING EVIDENCE AND EXPERIENCE

Zeroing in on pneumoperitoneum

What are the effects of pneumoperitoneum and posture in obese women undergoing gynecologic laparoscopy? A recent study13 compared 8 morbidly obese patients with 9 normal-weight controls and confirmed previous evidence that morbidly obese, supine, anesthetized patients have a 68% increase in inspiratory resistance and a 30% decrease in static pulmonary compliance, compared with controls. Pneumoperitoneum further increases this resistance and diminishes compliance.

Oxygenation is not affected

Somewhat surprisingly, this study did not detect significant changes in respiratory mechanics with head down or up positioning, and despite the exacerbation of pulmonary mechanics with pneumoperitoneum, there was no significant change in oxygenation.

The conclusion: While pneumoperitoneum impairs respiratory mechanics during anesthesia in the obese, body mass is the only variable that significantly affects oxygenation. If an obese patient can tolerate anesthesia and supine positioning—necessary for both laparoscopy and laparotomy—she is likely to tolerate changes in position and pneumoperitoneum as well.

These findings also hold true in patients undergoing bariatric surgery,14 with no significant differences in respiratory mechanics or arterial oxygenation during either laparoscopic or laparotomic surgery.

Virtually all procedures are safe

In gynecology alone, practically all of the procedures commonly performed in women of normal weight have been studied and found to be safe in obese patients. They include adnexal surgery, myomectomy, total laparoscopic hysterectomy,15-18 management of tubal ectopic pregnancy,19 endometrial cancer,20 and pelvic/periaortic lymph node dissection.20,21

Two ways of comparing outcomes

Well-designed studies tend to fall into 2 camps: those that compare laparoscopy in obese patients with laparoscopy in nonobese patients, and those that compare laparoscopy in obese patients with laparotomy in obese patients.

  1. A review of the gynecologic literature in the first camp15-18,22-24 reveals little to no difference between cohorts with respect to estimated blood loss, operative and postoperative complications, and hospital stay. The nongynecologic literature on laparoscopy in obese versus nonobese patients tends to corroborate these findings, with an overall trend toward increased operating times and conversion rates.25-30
  2. In comparing laparoscopy with laparotomy, researchers found that total operative time tends to rise with laparoscopy.20,21,31 Otherwise, laparoscopy confers benefit or no difference with respect to hospital stay, postoperative pain, estimated blood loss, lymph node counts, postoperative complications (fever, ileus, wound infection), convalescence, and total medical cost.32,33
Antibiotics. The high rate of postoperative wound infection in obese patients makes preoperative antibiotic treatment logical. Although we were unable to find any studies demonstrating the benefit of routine antibiotic prophylaxis in obese patients undergoing laparoscopy, data do show a benefit when laparotomy is performed.

If no allergies or contraindications exist, give 1 to 2 g of a first-or second-generation cephalosporin intravenously 20 to 30 minutes prior to anesthesia induction.

Sequential compression devices. Since both obesity and gynecologic surgery are risk factors for deep venous thrombosis, use large sequential compression devices on the lower extremities, beginning before induction of anesthesia.

Position the patient for optimal access

Only 1 recent publication explores this issue in obese laparoscopy patients. Lamvu et al5 advocate the armstucked (“military”), low lithotomy position, with liberal padding on the legs and arms and a gel pad under the lower back. They also recommend stationary shoulder blocks to help maintain positioning in the Trendelenburg (head down) position, and they use clamps, gauze, weights, and tape to maintain the panniculus in its caudad position.

Novel technique realigns umbilical axis. We, too, use padding liberally on all pressure points, but do not weight the panniculus. In fact, we prefer its cephalad migration in the Trendelenburg position. Pelosi and Pelosi6 describe a useful technique to realign the umbilical axis cephalad before placing the first trocar (FIGURE). Once the Trendelenburg position is attained (after initial trocar placement), this cephalad position eases ancillary port placement.

Tucking 1 arm facilitates surgery, anesthesia access. Tucking both arms is ideal but not always feasible. It is especially problematic when adipose tissue surrounding the biceps makes the military position impossible. Further, anesthesiologists may be unwilling to abandon access to the peripheral intravenous site, since placement and emergency replacement can be difficult.

Central venous access is always an option but is not without risk and should be avoided, if possible. A creative alternative: Tuck the nonaccessed arm at the patient’s side and place the other arm over the chest. Maintain this position by tucking a sheet over the chest. This gives the anesthesia team access to 1 arm while facilitating ideal surgeon positioning.

Do not use shoulder blocks when the patient’s arms are extended, as this increases the risk of brachial plexus injury should the patient slide.

Success hinges on port placement, pneumoperitoneum

The success or failure of most laparoscopic surgeries is determined in the initial minutes during placement of the operative ports. This is especially true in obese patients. No single variable is more important to successful laparoscopy in obese patients than the establishment of pneumoperitoneum.

 

 

Entry variables of 3 body types. Obesity increases the distance between skin and fascia, and can increase the distance between fascia and peritoneum. The difficulty of placing the Veress needle or trocar into the peritoneal cavity increases with this distance. Preperitoneal insufflation of gas exacerbates the problem. In addition, dissection to the level of the fascia for an open (Hasson) approach sometimes requires incision extension and increases the risk of postoperative wound infection.

Obesity also changes the relationship of the umbilicus to the aortic bifurcation. Utilizing computed tomography, Hurd et al7 demonstrated that the umbilicus migrates caudally in relation to the aortic bifurcation as the BMI increases. In nonobese patients (BMI 30) patients, the umbilicus had a median location 2.4 and 2.9 cm caudal to the aortic bifurcation, respectively. However, in both groups, the umbilicus was directly over the aortic bifurcation in 30% of patients.

The same group of researchers, again using computed tomography, demonstrated that the distance between the umbilicus and peritoneum at a 45° angle from the umbilicus into the pelvis, in both nonobese and overweight patients, was only 2 cm. In obese patients, this distance increased to a median of 12 cm. Hurd et al8 also noted that the distance between the umbilicus and the underlying vessels was only 6 cm at a 90° angle in nonobese patients, but averaged 13 cm in obese patients.

To optimize intraperitoneal Veress needle and trocar placement while minimizing risk to the underlying vasculature, Hurd and colleagues recommend a 45° angle from the umbilicus toward the pelvis in nonobese patients and a 90° approach in obese patients. In overweight patients, the approach should range between 45° and 90° (TABLE 1).

TABLE 1

Instrument placement in laparoscopy: Anatomic distances and suggested angles

 DISTANCE FROM THE UMBILICUS (CM) 
GROUPTO BIFURCATIONTO PERITONEUMTO VESSELS AT 90°RECOMMENDED PLACEMENT ANGLE
Nonobese (BMI 0.4 ± 1.62 ± 26 ± 345°
Overweight (BMI 25–30)2.4 ± 1.92 ± 110 ± 245–90°
Obese (BMI >30)2.9 ± 2.512 (median)13 ± 490°
Data are presented as mean ± standard deviation, median, or degrees from horizontal
Source: Hurd WW, et al 7

Gaining intraperitoneal access: Which approach is best?

A number of studies and case series have explored the fundamental difficulty of gaining intraperitoneal access. Pasic et al9 retrospectively analyzed outcomes in separate cohorts of obese and nonobese patients, focusing on 4 entry approaches:

  • transumbilical open,
  • transumbilical Veress needle placement,
  • subcostal Veress needle placement in the midclavicular line of the left upper quadrant, and
  • transuterine Veress needle placement.
The only group that demonstrated a significantly higher failure rate for obese patients was the open approach. Ultimately, the authors recommended using the Veress needle in the left upper quadrant or via the uterus for obese patients.

In contrast, the Pelosi case series of 67 consecutive obese patients6 reported no failures with a transumbilical open approach after realignment of the umbilical access. This entailed assessing the position of the umbilicus in relation to a line drawn between the 2 anterior superior iliac spines. The umbilicus then was repositioned 8 cm above this line in its “anatomical” position prior to initiating open dissection (FIGURE).

After the open trocar was inserted through the fascia and peritoneum and the patient was placed in the Trendelenburg position, the panniculus maintained its orientation. Pelosi and Pelosi concluded that this realignment of the umbilical axis decreases the depth of open dissection and avoids inadvertent placement of a trocar through both sides of the panniculus.

A prospective, randomized study10 comparing transumbilical and transuterine Veress needle placement in obese patients found the latter approach useful, but recorded a single case of postoperative chlamydial pelvic inflammatory disease. Thus, preoperative testing for sexually transmitted disease is recommended for this approach.

Avoid dogmatic reliance on a single approach

These studies demonstrate a fundamental surgical truism: Sound physiologic and anatomic knowledge, combined with versatility and a grasp of multiple approaches to any problem, are ultimately more successful than unyielding reliance on a single approach. Aim for prudent use of open or closed laparoscopy in a variety of locations, taking into account the patient’s surgical history, distribution of fat, and umbilical displacement.

After achieving pneumoperitoneum

Place a salinefilled spinal needle into the peritoneal cavity on suction to establish abdominal wall thickness. In this way, trocars of appropriate length can be selected.

Some authorities advocate insufflation to a high intraperitoneal pressure (25 to 30mm Hg) prior to placing the initial umbilical trocar if a closed technique is being used.11 This further elevates the abdominal wall and decreases the risk of preperitoneal trocar placement. After successful trocar placement, immediately reduce intraabdominal pressure to 15 mm Hg to avoid pulmonary compromise, excessive catecholamine release, and subcutaneous emphysema.

 

 

Techniques to enhance visualization

Excess adipose tissue occupies the pericolic, omental, mesenteric, and retroperitoneal spaces in obese patients, obscuring visualization of intraperitoneal and retroperitoneal structures.

Preoperative mechanical bowel preparation can deflate the bowel and enhance visualization (TABLE 2). At times, an extra ancillary trocar for placement of a bowel retractor also can improve visualization.

In the morbidly obese, insufflation pressure of 15 mm Hg will sometimes produce poor visualization. Obese patients generally tolerate this pressure reasonably well, but increasing it to improve visualization can make adequate oxygenation impossible.

Gasless laparoscopy—in which a mechanical retractor is attached from the table to the patient’s anterior abdominal wall—may help improve pulmonary mechanical parameters. Unfortunately, this technique often produces poorer visualization than insufflation at normal pressure.

A new technique that combines approaches may help avoid the need to convert to laparotomy.12 In this “Foley lap lift,” a 14-French Foley catheter is passed through the anterior abdominal wall, and the balloon is inflated. The catheter then is elevated and clamped to a retractor holder attached to the angled foot of the bed. This upward traction with continuous gas flow at normal pressure improves visualization without pulmonary compromise.

TABLE 2

Techniques to enhance visualization

  • Preoperative mechanical bowel preparation
  • Ancillary trocar for placement of bowel retractor
  • Gasless laparoscopy*
  • Foley lap lift*
*See page 70 for details

Close port sites at the fascial level

The risk of bowel herniation through a trocar site is higher in obese patients than the general population because of the greater intraabdominal pressures. Increases in atelectasis from diminished functional residual capacity also predispose the obese patient to postoperative pulmonary complications and can lead to recurrent Valsalva (cough) and subsequent bowel herniation.

Given these risks, it is imperative that all port sites 10 mm or larger be closed at the fascial level. Unfortunately, the distance from the anterior abdominal wall to the fascia underlying these sites makes direct visualization and closure almost impossible.

Fortunately, several fascial closure devices are available and are reasonably inexpensive and easy to use. When using them, be sure to maintain the other port sites, as closure requires direct visualization and a second instrument.

Postoperative strategies

Successful postoperative care builds on preoperative and intraoperative tactics.

Perform aggressive pulmonary toilet

With intraoperative decreases in functional residual capacity, postoperative atelectasis is likely to be profound, with a potential for ventilation/perfusion mismatch and hypoxemia.

Aggressive pulmonary toilet including regular incentive spirometry and deep breathing and coughing exercises is important to reinflate dependent lung regions. Pulse oximetry with sufficient supplementary oxygen also is important to maintain adequate saturation.

Encourage early ambulation

This requires adequate but not oversedating analgesia, early catheter removal, and a motivated nursing staff.

Early ambulation is associated with fewer episodes of deep venous thrombosis, pulmonary complications, and ileus, and also eases pain management.

Continue thrombosis prophylaxis with sequential compression devices, subcutaneous heparin, or both, until the patient is spending most of her time out of bed.

Dr. Robinson reports no relevant financial relationships.

Dr. Isaacson serves on the speakers bureau for Karl Storz Endoscopy.

References

1. Mokdad AH, Bowman BA, Ford ES, et al. The continuing epidemics of obesity and diabetes in the United States. JAMA. 2001;286:1195-1200.

2. Ford ES, Mokdad AH, et al. Trends in waist circumference among US adults. Obes Res. 2003;11:1223-1231.

3. Bluman LG, Mosca L, Newman N, Simon DG. Preoperative smoking habits and postoperative pulmonary complications. Chest. 1998;113:883-889.

4. Mokdad AH, Ford ES, Bowman BA, et al. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003;289:76-79.

5. Lamvu G, Zolnoun D, Boggess J, Steege JF. Obesity: physiologic changes and challenges during laparoscopy. Am J Obstet Gynecol. 2004;191:669-674.

6. Pelosi MA 3rd, Pelosi MA. Alignment of the umbilical axis: an effective maneuver for laparoscopic entry in the obese patient. Obstet Gynecol. 1998;92:869-872.

7. Hurd WW, et al. The relationship of the umbilicus to the aortic bifurcation: implications for laparoscopic technique. Obstet Gynecol. 1992;80:48-51.

8. Hurd WH, Bude RO, et al. Abdominal wall characterization with magnetic resonance imaging and computed tomography. The effect of obesity on the laparoscopic approach. J Reprod Med. 1991;36:473-476.

9. Pasic R, Levine RL, Wolf WM, Jr. Laparoscopy in morbidly obese patients. J Am Assoc Gynecol Laparosc. 1999;6:307-312.

10. Santala M, Jarvela I, Kauppila A. Transfundal insertion of a Veress needle in laparoscopy of obese subjects: a practical alternative. Hum Reprod. 1999;14:2277-2278.

11. Vilos GA, Vilos AG. Safe laparoscopic entry guided by Veress needle CO2 insufflation pressure. J Am Assoc Gynecol Laparosc. 2003;10:415-420.

12. Stany MP, Winter WE, 3rd, Dainty L, Lockrow E, Carlson JW. Laparoscopic exposure in obese highrisk patients with mechanical displacement of the abdominal wall. Obstet Gynecol. 2004;103:383-386.

13. Sprung J, Whalley DG, Falcone T, et al. The impact of morbid obesity, pneumoperitoneum, and posture on respiratory system mechanics and oxygenation during laparoscopy. Anesth Analg. 2002;94:1345-1350.

14. Demiroluk S, Salihoglu Z, et al. The effects of pneumoperitoneum on respiratory mechanics during bariatric surgery. Obes Surg. 2002;12:376-379.

15. Heinberg EM, Crawford BL, 3rd, Weitzen SH, Bonilla DJ. Total laparoscopic hysterectomy in obese versus nonobese patients. Obstet Gynecol. 2004;103:674-680.

16. O’Hanlan KA, Lopez L, Dibble SL, et al. Total laparoscopic hysterectomy: body mass index and outcomes. Obstet Gynecol. 2003;102:1384-1392.

17. Holub Z, Jabor A, Kliment L, Fischlova D, Wagnerova M. Laparoscopic hysterectomy in obese women: a clinical prospective study. Eur J Obstet Gynecol Reprod Biol. 2001;98:77-82.

18. Ostrzenski A. Laparoscopic total abdominal hysterectomy in morbidly obese women. A pilotphase report. J Reprod Med. 1999;44:853-858.

19. Loffer FD, Pent D. Laparoscopy in the obese patient. Am J Obstet Gynecol. 1976;125:104-107.

20. Eltabbakh GH, Shamonki MI, et al. Hysterectomy for obese women with endometrial cancer: laparoscopy or laparotomy? Gynecol Oncol. 2000;78:329-335.

21. Scribner DR, Jr, Walker JL, Johnson GA, et al. Laparoscopic pelvic and paraaortic lymph node dissection in the obese. Gynecol Oncol. 2002;84:426-430.

22. Bai SW, Lim JH, Kim JY, Chung KA, Kim SK, Park KH. Relationship between obesity and the risk of gynecologic laparoscopy in Korean women. J Am Assoc Gynecol Laparosc. 2002;9:165-169.

23. Eltabbakh GH, Piver MS, Hempling RE, Recio FO. Laparoscopic surgery in obese women. Obstet Gynecol. 1999;94:704-708.

24. Hsu S, Mitwally MF, Aly A, Al-Saleh M, Batt RE, Yeh J. Laparoscopic management of tubal ectopic pregnancy in obese women. Fertil Steril. 2004;81:198-202.

25. Fugita OE, Chan DY, Roberts WW, Kavoussi LR, Jarrett TW. Laparoscopic radical nephrectomy in obese patients: outcomes and technical considerations. Urology. 2004;63:247-252; discussion 252.

26. Senagore AJ, Delaney CP, Madboulay K, et al. Laparoscopic colectomy in obese and nonobese patients. J Gastrointest Surg. 2003;7:558-561.

27. Pikarsky AJ, Saida Y, Yamaguchi T, et al. Is obesity a high-risk factor for laparoscopic colorectal surgery? Surg Endosc. 2002;16:855-858.

28. Tuech JJ, Regenet N, Hennekinne S, et al. [Impact of obesity on postoperative results of elective laparoscopic colectomy in sigmoid diverticulitis: a prospective study]. Ann Chir. 2001;126:996-1000.

29. Fraser J, Watson DI, O’Boyle CJ, Jamieson GG. Obesity and its effect on outcome of laparoscopic Nissen fundoplication. Dis Esophagus. 2001;14:50-53.

30. Birgisson G, Park AE, Mastrangelo MJ, Jr, Witzke DB, Chu UB. Obesity and laparoscopic repair of ventral hernias. Surg Endosc. 2001;15:1419-1422.

31. Enochsson L, Hellberg A, Rudberg C, et al. Laparoscopic vs open appendectomy in overweight patients. Surg Endosc. 2001;15:387-392.

32. Fried M, Peskova M, Kasalicky M. The role of laparoscopy in the treatment of morbid obesity. Obes Surg. 1998;8:520-523.

33. Fazeli-Matin S, Gill IS, Hsu TH, Sung GT, Novick AC. Laparoscopic renal and adrenal surgery in obese patients: comparison to open surgery. J Urol. 1999;162:665-669.

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Gynecologic laparoscopy in the obese? What was once the purview of the very talented or the foolhardy may now be the preferred surgical approach.

Obese women who undergo laparoscopy recover faster, with less pain, fewer wound infections, and shorter hospital stays than with laparotomy. Though it is true that obesity increases operative time and the risk for conversion to laparotomy, little evidence supports the theory that a body mass index (BMI) of 30 kg/m2 or higher should exclude laparoscopy.

Preoperative management

Unique elements of the physical

It is important to identify central obesity, which is more difficult to accommodate than distribution around the hips. Unfortunately, the roughly 40 million obese Americans tend to have central fat distribution.1,2

In central obesity, the subcutaneous tissue is thick, often requiring extra long ports to attain peritoneal access.

The relationship of the umbilicus to the underlying aortic bifurcation also shifts more caudally. This relationship should be noted and planned for before going to the operating room (FIGURE).

Abdominal obesity in particular confers additional risks during all types of surgery: higher rates of atelectasis, thromboembolism, cardiovascular dysfunction, and wound infection.

Closely inspect the skin and panniculus after a routine examination. Obesity predisposes patients to dark, moist, anoxic spaces beneath folds of skin that need to be identified and inspected for evidence of fungal or bacterial infection. To optimize postoperative wound healing, treat any preexisting infections before surgery.

Cigarette smoking further burdens pulmonary mechanics and oxygenation during surgery, so it is important to encourage smokers to kick the habit at least 8 weeks before elective surgery.3

In general, use the history and physical examination to focus on the recognized risk factors of obesity, with specific emphasis on hypertension, coronary artery disease, arrhythmia, pulmonary obstructive disease, peripheral vascular disease, diabetes, gastric reflux, and arthritis.4

Special tests and laboratory studies

EKG and chest x-ray. In morbidly obese patients (BMI >40), preoperative evaluation includes an electrocardiogram (EKG) and chest x-ray to identify any cardiomegaly, arrhythmias, and occult ischemia or conduction blockage.

Arterial blood gas sampling. Given the higher risk of postoperative thrombotic events in obese patients, it can be helpful to assess preoperative oxygenation and ventilation/perfusion status via arterial blood gas sampling. The obese may have elevated baseline Aa gradients, which, if not noted prior to surgery, can confuse later management of suspected pulmonary emboli.

During testing, assess venous access and counsel the patient if central venous line placement may be possible at surgery. Though central line placement is not routinely recommended, it may be warranted in patients with particularly difficult peripheral venous access.

Skip pulmonary function testing because the results rarely change surgical management. We consider its routine use to be wasteful.

Laboratory evaluation should include betahuman chorionic gonadotropin (in premenopausal patients), complete blood count, electrolytes, glucose, renal function, and type and screen.

Spell out risks at informed consent

The preoperative appointment is your chance to answer questions the patient may have and clearly delineate the risks and benefits of surgery. During this discussion, spell out the increased risks of conversion to laparotomy, prolonged anesthesia, postoperative thrombosis, wound infection, and pulmonary complications, and make sure all are listed on the written consent form.

Operative management

Prophylactic measures

Complete bowel preparation is recommended the evening prior to surgery, since intraabdominal visualization can be difficult and conversion to laparotomy may be necessary. Bowel prep decompresses the lumen, improving visualization and the outcome of any bowel injury.

Preoperative histamine receptor blockade is recommended for optimal results, since higher body mass can lead to increases in low pH gastric volume and difficulties with intubation.5 A typical regimen is 50 mg intravenous (IV) ranitidine 20 minutes prior to surgery.

Beta blockade. All patients with hypertension or a history of coronary artery disease should receive preoperative beta blockade, assuming there are no contraindications such as reactive airway disease or cardiac conduction block. Atenolol 10 mg IV 20 minutes prior to surgery is a standard initial dose. All patients already taking beta blockers should simply continue their home regimen through the day of surgery with small sips of water.

 

 

INTEGRATING EVIDENCE AND EXPERIENCE

Zeroing in on pneumoperitoneum

What are the effects of pneumoperitoneum and posture in obese women undergoing gynecologic laparoscopy? A recent study13 compared 8 morbidly obese patients with 9 normal-weight controls and confirmed previous evidence that morbidly obese, supine, anesthetized patients have a 68% increase in inspiratory resistance and a 30% decrease in static pulmonary compliance, compared with controls. Pneumoperitoneum further increases this resistance and diminishes compliance.

Oxygenation is not affected

Somewhat surprisingly, this study did not detect significant changes in respiratory mechanics with head down or up positioning, and despite the exacerbation of pulmonary mechanics with pneumoperitoneum, there was no significant change in oxygenation.

The conclusion: While pneumoperitoneum impairs respiratory mechanics during anesthesia in the obese, body mass is the only variable that significantly affects oxygenation. If an obese patient can tolerate anesthesia and supine positioning—necessary for both laparoscopy and laparotomy—she is likely to tolerate changes in position and pneumoperitoneum as well.

These findings also hold true in patients undergoing bariatric surgery,14 with no significant differences in respiratory mechanics or arterial oxygenation during either laparoscopic or laparotomic surgery.

Virtually all procedures are safe

In gynecology alone, practically all of the procedures commonly performed in women of normal weight have been studied and found to be safe in obese patients. They include adnexal surgery, myomectomy, total laparoscopic hysterectomy,15-18 management of tubal ectopic pregnancy,19 endometrial cancer,20 and pelvic/periaortic lymph node dissection.20,21

Two ways of comparing outcomes

Well-designed studies tend to fall into 2 camps: those that compare laparoscopy in obese patients with laparoscopy in nonobese patients, and those that compare laparoscopy in obese patients with laparotomy in obese patients.

  1. A review of the gynecologic literature in the first camp15-18,22-24 reveals little to no difference between cohorts with respect to estimated blood loss, operative and postoperative complications, and hospital stay. The nongynecologic literature on laparoscopy in obese versus nonobese patients tends to corroborate these findings, with an overall trend toward increased operating times and conversion rates.25-30
  2. In comparing laparoscopy with laparotomy, researchers found that total operative time tends to rise with laparoscopy.20,21,31 Otherwise, laparoscopy confers benefit or no difference with respect to hospital stay, postoperative pain, estimated blood loss, lymph node counts, postoperative complications (fever, ileus, wound infection), convalescence, and total medical cost.32,33
Antibiotics. The high rate of postoperative wound infection in obese patients makes preoperative antibiotic treatment logical. Although we were unable to find any studies demonstrating the benefit of routine antibiotic prophylaxis in obese patients undergoing laparoscopy, data do show a benefit when laparotomy is performed.

If no allergies or contraindications exist, give 1 to 2 g of a first-or second-generation cephalosporin intravenously 20 to 30 minutes prior to anesthesia induction.

Sequential compression devices. Since both obesity and gynecologic surgery are risk factors for deep venous thrombosis, use large sequential compression devices on the lower extremities, beginning before induction of anesthesia.

Position the patient for optimal access

Only 1 recent publication explores this issue in obese laparoscopy patients. Lamvu et al5 advocate the armstucked (“military”), low lithotomy position, with liberal padding on the legs and arms and a gel pad under the lower back. They also recommend stationary shoulder blocks to help maintain positioning in the Trendelenburg (head down) position, and they use clamps, gauze, weights, and tape to maintain the panniculus in its caudad position.

Novel technique realigns umbilical axis. We, too, use padding liberally on all pressure points, but do not weight the panniculus. In fact, we prefer its cephalad migration in the Trendelenburg position. Pelosi and Pelosi6 describe a useful technique to realign the umbilical axis cephalad before placing the first trocar (FIGURE). Once the Trendelenburg position is attained (after initial trocar placement), this cephalad position eases ancillary port placement.

Tucking 1 arm facilitates surgery, anesthesia access. Tucking both arms is ideal but not always feasible. It is especially problematic when adipose tissue surrounding the biceps makes the military position impossible. Further, anesthesiologists may be unwilling to abandon access to the peripheral intravenous site, since placement and emergency replacement can be difficult.

Central venous access is always an option but is not without risk and should be avoided, if possible. A creative alternative: Tuck the nonaccessed arm at the patient’s side and place the other arm over the chest. Maintain this position by tucking a sheet over the chest. This gives the anesthesia team access to 1 arm while facilitating ideal surgeon positioning.

Do not use shoulder blocks when the patient’s arms are extended, as this increases the risk of brachial plexus injury should the patient slide.

Success hinges on port placement, pneumoperitoneum

The success or failure of most laparoscopic surgeries is determined in the initial minutes during placement of the operative ports. This is especially true in obese patients. No single variable is more important to successful laparoscopy in obese patients than the establishment of pneumoperitoneum.

 

 

Entry variables of 3 body types. Obesity increases the distance between skin and fascia, and can increase the distance between fascia and peritoneum. The difficulty of placing the Veress needle or trocar into the peritoneal cavity increases with this distance. Preperitoneal insufflation of gas exacerbates the problem. In addition, dissection to the level of the fascia for an open (Hasson) approach sometimes requires incision extension and increases the risk of postoperative wound infection.

Obesity also changes the relationship of the umbilicus to the aortic bifurcation. Utilizing computed tomography, Hurd et al7 demonstrated that the umbilicus migrates caudally in relation to the aortic bifurcation as the BMI increases. In nonobese patients (BMI 30) patients, the umbilicus had a median location 2.4 and 2.9 cm caudal to the aortic bifurcation, respectively. However, in both groups, the umbilicus was directly over the aortic bifurcation in 30% of patients.

The same group of researchers, again using computed tomography, demonstrated that the distance between the umbilicus and peritoneum at a 45° angle from the umbilicus into the pelvis, in both nonobese and overweight patients, was only 2 cm. In obese patients, this distance increased to a median of 12 cm. Hurd et al8 also noted that the distance between the umbilicus and the underlying vessels was only 6 cm at a 90° angle in nonobese patients, but averaged 13 cm in obese patients.

To optimize intraperitoneal Veress needle and trocar placement while minimizing risk to the underlying vasculature, Hurd and colleagues recommend a 45° angle from the umbilicus toward the pelvis in nonobese patients and a 90° approach in obese patients. In overweight patients, the approach should range between 45° and 90° (TABLE 1).

TABLE 1

Instrument placement in laparoscopy: Anatomic distances and suggested angles

 DISTANCE FROM THE UMBILICUS (CM) 
GROUPTO BIFURCATIONTO PERITONEUMTO VESSELS AT 90°RECOMMENDED PLACEMENT ANGLE
Nonobese (BMI 0.4 ± 1.62 ± 26 ± 345°
Overweight (BMI 25–30)2.4 ± 1.92 ± 110 ± 245–90°
Obese (BMI >30)2.9 ± 2.512 (median)13 ± 490°
Data are presented as mean ± standard deviation, median, or degrees from horizontal
Source: Hurd WW, et al 7

Gaining intraperitoneal access: Which approach is best?

A number of studies and case series have explored the fundamental difficulty of gaining intraperitoneal access. Pasic et al9 retrospectively analyzed outcomes in separate cohorts of obese and nonobese patients, focusing on 4 entry approaches:

  • transumbilical open,
  • transumbilical Veress needle placement,
  • subcostal Veress needle placement in the midclavicular line of the left upper quadrant, and
  • transuterine Veress needle placement.
The only group that demonstrated a significantly higher failure rate for obese patients was the open approach. Ultimately, the authors recommended using the Veress needle in the left upper quadrant or via the uterus for obese patients.

In contrast, the Pelosi case series of 67 consecutive obese patients6 reported no failures with a transumbilical open approach after realignment of the umbilical access. This entailed assessing the position of the umbilicus in relation to a line drawn between the 2 anterior superior iliac spines. The umbilicus then was repositioned 8 cm above this line in its “anatomical” position prior to initiating open dissection (FIGURE).

After the open trocar was inserted through the fascia and peritoneum and the patient was placed in the Trendelenburg position, the panniculus maintained its orientation. Pelosi and Pelosi concluded that this realignment of the umbilical axis decreases the depth of open dissection and avoids inadvertent placement of a trocar through both sides of the panniculus.

A prospective, randomized study10 comparing transumbilical and transuterine Veress needle placement in obese patients found the latter approach useful, but recorded a single case of postoperative chlamydial pelvic inflammatory disease. Thus, preoperative testing for sexually transmitted disease is recommended for this approach.

Avoid dogmatic reliance on a single approach

These studies demonstrate a fundamental surgical truism: Sound physiologic and anatomic knowledge, combined with versatility and a grasp of multiple approaches to any problem, are ultimately more successful than unyielding reliance on a single approach. Aim for prudent use of open or closed laparoscopy in a variety of locations, taking into account the patient’s surgical history, distribution of fat, and umbilical displacement.

After achieving pneumoperitoneum

Place a salinefilled spinal needle into the peritoneal cavity on suction to establish abdominal wall thickness. In this way, trocars of appropriate length can be selected.

Some authorities advocate insufflation to a high intraperitoneal pressure (25 to 30mm Hg) prior to placing the initial umbilical trocar if a closed technique is being used.11 This further elevates the abdominal wall and decreases the risk of preperitoneal trocar placement. After successful trocar placement, immediately reduce intraabdominal pressure to 15 mm Hg to avoid pulmonary compromise, excessive catecholamine release, and subcutaneous emphysema.

 

 

Techniques to enhance visualization

Excess adipose tissue occupies the pericolic, omental, mesenteric, and retroperitoneal spaces in obese patients, obscuring visualization of intraperitoneal and retroperitoneal structures.

Preoperative mechanical bowel preparation can deflate the bowel and enhance visualization (TABLE 2). At times, an extra ancillary trocar for placement of a bowel retractor also can improve visualization.

In the morbidly obese, insufflation pressure of 15 mm Hg will sometimes produce poor visualization. Obese patients generally tolerate this pressure reasonably well, but increasing it to improve visualization can make adequate oxygenation impossible.

Gasless laparoscopy—in which a mechanical retractor is attached from the table to the patient’s anterior abdominal wall—may help improve pulmonary mechanical parameters. Unfortunately, this technique often produces poorer visualization than insufflation at normal pressure.

A new technique that combines approaches may help avoid the need to convert to laparotomy.12 In this “Foley lap lift,” a 14-French Foley catheter is passed through the anterior abdominal wall, and the balloon is inflated. The catheter then is elevated and clamped to a retractor holder attached to the angled foot of the bed. This upward traction with continuous gas flow at normal pressure improves visualization without pulmonary compromise.

TABLE 2

Techniques to enhance visualization

  • Preoperative mechanical bowel preparation
  • Ancillary trocar for placement of bowel retractor
  • Gasless laparoscopy*
  • Foley lap lift*
*See page 70 for details

Close port sites at the fascial level

The risk of bowel herniation through a trocar site is higher in obese patients than the general population because of the greater intraabdominal pressures. Increases in atelectasis from diminished functional residual capacity also predispose the obese patient to postoperative pulmonary complications and can lead to recurrent Valsalva (cough) and subsequent bowel herniation.

Given these risks, it is imperative that all port sites 10 mm or larger be closed at the fascial level. Unfortunately, the distance from the anterior abdominal wall to the fascia underlying these sites makes direct visualization and closure almost impossible.

Fortunately, several fascial closure devices are available and are reasonably inexpensive and easy to use. When using them, be sure to maintain the other port sites, as closure requires direct visualization and a second instrument.

Postoperative strategies

Successful postoperative care builds on preoperative and intraoperative tactics.

Perform aggressive pulmonary toilet

With intraoperative decreases in functional residual capacity, postoperative atelectasis is likely to be profound, with a potential for ventilation/perfusion mismatch and hypoxemia.

Aggressive pulmonary toilet including regular incentive spirometry and deep breathing and coughing exercises is important to reinflate dependent lung regions. Pulse oximetry with sufficient supplementary oxygen also is important to maintain adequate saturation.

Encourage early ambulation

This requires adequate but not oversedating analgesia, early catheter removal, and a motivated nursing staff.

Early ambulation is associated with fewer episodes of deep venous thrombosis, pulmonary complications, and ileus, and also eases pain management.

Continue thrombosis prophylaxis with sequential compression devices, subcutaneous heparin, or both, until the patient is spending most of her time out of bed.

Dr. Robinson reports no relevant financial relationships.

Dr. Isaacson serves on the speakers bureau for Karl Storz Endoscopy.

Gynecologic laparoscopy in the obese? What was once the purview of the very talented or the foolhardy may now be the preferred surgical approach.

Obese women who undergo laparoscopy recover faster, with less pain, fewer wound infections, and shorter hospital stays than with laparotomy. Though it is true that obesity increases operative time and the risk for conversion to laparotomy, little evidence supports the theory that a body mass index (BMI) of 30 kg/m2 or higher should exclude laparoscopy.

Preoperative management

Unique elements of the physical

It is important to identify central obesity, which is more difficult to accommodate than distribution around the hips. Unfortunately, the roughly 40 million obese Americans tend to have central fat distribution.1,2

In central obesity, the subcutaneous tissue is thick, often requiring extra long ports to attain peritoneal access.

The relationship of the umbilicus to the underlying aortic bifurcation also shifts more caudally. This relationship should be noted and planned for before going to the operating room (FIGURE).

Abdominal obesity in particular confers additional risks during all types of surgery: higher rates of atelectasis, thromboembolism, cardiovascular dysfunction, and wound infection.

Closely inspect the skin and panniculus after a routine examination. Obesity predisposes patients to dark, moist, anoxic spaces beneath folds of skin that need to be identified and inspected for evidence of fungal or bacterial infection. To optimize postoperative wound healing, treat any preexisting infections before surgery.

Cigarette smoking further burdens pulmonary mechanics and oxygenation during surgery, so it is important to encourage smokers to kick the habit at least 8 weeks before elective surgery.3

In general, use the history and physical examination to focus on the recognized risk factors of obesity, with specific emphasis on hypertension, coronary artery disease, arrhythmia, pulmonary obstructive disease, peripheral vascular disease, diabetes, gastric reflux, and arthritis.4

Special tests and laboratory studies

EKG and chest x-ray. In morbidly obese patients (BMI >40), preoperative evaluation includes an electrocardiogram (EKG) and chest x-ray to identify any cardiomegaly, arrhythmias, and occult ischemia or conduction blockage.

Arterial blood gas sampling. Given the higher risk of postoperative thrombotic events in obese patients, it can be helpful to assess preoperative oxygenation and ventilation/perfusion status via arterial blood gas sampling. The obese may have elevated baseline Aa gradients, which, if not noted prior to surgery, can confuse later management of suspected pulmonary emboli.

During testing, assess venous access and counsel the patient if central venous line placement may be possible at surgery. Though central line placement is not routinely recommended, it may be warranted in patients with particularly difficult peripheral venous access.

Skip pulmonary function testing because the results rarely change surgical management. We consider its routine use to be wasteful.

Laboratory evaluation should include betahuman chorionic gonadotropin (in premenopausal patients), complete blood count, electrolytes, glucose, renal function, and type and screen.

Spell out risks at informed consent

The preoperative appointment is your chance to answer questions the patient may have and clearly delineate the risks and benefits of surgery. During this discussion, spell out the increased risks of conversion to laparotomy, prolonged anesthesia, postoperative thrombosis, wound infection, and pulmonary complications, and make sure all are listed on the written consent form.

Operative management

Prophylactic measures

Complete bowel preparation is recommended the evening prior to surgery, since intraabdominal visualization can be difficult and conversion to laparotomy may be necessary. Bowel prep decompresses the lumen, improving visualization and the outcome of any bowel injury.

Preoperative histamine receptor blockade is recommended for optimal results, since higher body mass can lead to increases in low pH gastric volume and difficulties with intubation.5 A typical regimen is 50 mg intravenous (IV) ranitidine 20 minutes prior to surgery.

Beta blockade. All patients with hypertension or a history of coronary artery disease should receive preoperative beta blockade, assuming there are no contraindications such as reactive airway disease or cardiac conduction block. Atenolol 10 mg IV 20 minutes prior to surgery is a standard initial dose. All patients already taking beta blockers should simply continue their home regimen through the day of surgery with small sips of water.

 

 

INTEGRATING EVIDENCE AND EXPERIENCE

Zeroing in on pneumoperitoneum

What are the effects of pneumoperitoneum and posture in obese women undergoing gynecologic laparoscopy? A recent study13 compared 8 morbidly obese patients with 9 normal-weight controls and confirmed previous evidence that morbidly obese, supine, anesthetized patients have a 68% increase in inspiratory resistance and a 30% decrease in static pulmonary compliance, compared with controls. Pneumoperitoneum further increases this resistance and diminishes compliance.

Oxygenation is not affected

Somewhat surprisingly, this study did not detect significant changes in respiratory mechanics with head down or up positioning, and despite the exacerbation of pulmonary mechanics with pneumoperitoneum, there was no significant change in oxygenation.

The conclusion: While pneumoperitoneum impairs respiratory mechanics during anesthesia in the obese, body mass is the only variable that significantly affects oxygenation. If an obese patient can tolerate anesthesia and supine positioning—necessary for both laparoscopy and laparotomy—she is likely to tolerate changes in position and pneumoperitoneum as well.

These findings also hold true in patients undergoing bariatric surgery,14 with no significant differences in respiratory mechanics or arterial oxygenation during either laparoscopic or laparotomic surgery.

Virtually all procedures are safe

In gynecology alone, practically all of the procedures commonly performed in women of normal weight have been studied and found to be safe in obese patients. They include adnexal surgery, myomectomy, total laparoscopic hysterectomy,15-18 management of tubal ectopic pregnancy,19 endometrial cancer,20 and pelvic/periaortic lymph node dissection.20,21

Two ways of comparing outcomes

Well-designed studies tend to fall into 2 camps: those that compare laparoscopy in obese patients with laparoscopy in nonobese patients, and those that compare laparoscopy in obese patients with laparotomy in obese patients.

  1. A review of the gynecologic literature in the first camp15-18,22-24 reveals little to no difference between cohorts with respect to estimated blood loss, operative and postoperative complications, and hospital stay. The nongynecologic literature on laparoscopy in obese versus nonobese patients tends to corroborate these findings, with an overall trend toward increased operating times and conversion rates.25-30
  2. In comparing laparoscopy with laparotomy, researchers found that total operative time tends to rise with laparoscopy.20,21,31 Otherwise, laparoscopy confers benefit or no difference with respect to hospital stay, postoperative pain, estimated blood loss, lymph node counts, postoperative complications (fever, ileus, wound infection), convalescence, and total medical cost.32,33
Antibiotics. The high rate of postoperative wound infection in obese patients makes preoperative antibiotic treatment logical. Although we were unable to find any studies demonstrating the benefit of routine antibiotic prophylaxis in obese patients undergoing laparoscopy, data do show a benefit when laparotomy is performed.

If no allergies or contraindications exist, give 1 to 2 g of a first-or second-generation cephalosporin intravenously 20 to 30 minutes prior to anesthesia induction.

Sequential compression devices. Since both obesity and gynecologic surgery are risk factors for deep venous thrombosis, use large sequential compression devices on the lower extremities, beginning before induction of anesthesia.

Position the patient for optimal access

Only 1 recent publication explores this issue in obese laparoscopy patients. Lamvu et al5 advocate the armstucked (“military”), low lithotomy position, with liberal padding on the legs and arms and a gel pad under the lower back. They also recommend stationary shoulder blocks to help maintain positioning in the Trendelenburg (head down) position, and they use clamps, gauze, weights, and tape to maintain the panniculus in its caudad position.

Novel technique realigns umbilical axis. We, too, use padding liberally on all pressure points, but do not weight the panniculus. In fact, we prefer its cephalad migration in the Trendelenburg position. Pelosi and Pelosi6 describe a useful technique to realign the umbilical axis cephalad before placing the first trocar (FIGURE). Once the Trendelenburg position is attained (after initial trocar placement), this cephalad position eases ancillary port placement.

Tucking 1 arm facilitates surgery, anesthesia access. Tucking both arms is ideal but not always feasible. It is especially problematic when adipose tissue surrounding the biceps makes the military position impossible. Further, anesthesiologists may be unwilling to abandon access to the peripheral intravenous site, since placement and emergency replacement can be difficult.

Central venous access is always an option but is not without risk and should be avoided, if possible. A creative alternative: Tuck the nonaccessed arm at the patient’s side and place the other arm over the chest. Maintain this position by tucking a sheet over the chest. This gives the anesthesia team access to 1 arm while facilitating ideal surgeon positioning.

Do not use shoulder blocks when the patient’s arms are extended, as this increases the risk of brachial plexus injury should the patient slide.

Success hinges on port placement, pneumoperitoneum

The success or failure of most laparoscopic surgeries is determined in the initial minutes during placement of the operative ports. This is especially true in obese patients. No single variable is more important to successful laparoscopy in obese patients than the establishment of pneumoperitoneum.

 

 

Entry variables of 3 body types. Obesity increases the distance between skin and fascia, and can increase the distance between fascia and peritoneum. The difficulty of placing the Veress needle or trocar into the peritoneal cavity increases with this distance. Preperitoneal insufflation of gas exacerbates the problem. In addition, dissection to the level of the fascia for an open (Hasson) approach sometimes requires incision extension and increases the risk of postoperative wound infection.

Obesity also changes the relationship of the umbilicus to the aortic bifurcation. Utilizing computed tomography, Hurd et al7 demonstrated that the umbilicus migrates caudally in relation to the aortic bifurcation as the BMI increases. In nonobese patients (BMI 30) patients, the umbilicus had a median location 2.4 and 2.9 cm caudal to the aortic bifurcation, respectively. However, in both groups, the umbilicus was directly over the aortic bifurcation in 30% of patients.

The same group of researchers, again using computed tomography, demonstrated that the distance between the umbilicus and peritoneum at a 45° angle from the umbilicus into the pelvis, in both nonobese and overweight patients, was only 2 cm. In obese patients, this distance increased to a median of 12 cm. Hurd et al8 also noted that the distance between the umbilicus and the underlying vessels was only 6 cm at a 90° angle in nonobese patients, but averaged 13 cm in obese patients.

To optimize intraperitoneal Veress needle and trocar placement while minimizing risk to the underlying vasculature, Hurd and colleagues recommend a 45° angle from the umbilicus toward the pelvis in nonobese patients and a 90° approach in obese patients. In overweight patients, the approach should range between 45° and 90° (TABLE 1).

TABLE 1

Instrument placement in laparoscopy: Anatomic distances and suggested angles

 DISTANCE FROM THE UMBILICUS (CM) 
GROUPTO BIFURCATIONTO PERITONEUMTO VESSELS AT 90°RECOMMENDED PLACEMENT ANGLE
Nonobese (BMI 0.4 ± 1.62 ± 26 ± 345°
Overweight (BMI 25–30)2.4 ± 1.92 ± 110 ± 245–90°
Obese (BMI >30)2.9 ± 2.512 (median)13 ± 490°
Data are presented as mean ± standard deviation, median, or degrees from horizontal
Source: Hurd WW, et al 7

Gaining intraperitoneal access: Which approach is best?

A number of studies and case series have explored the fundamental difficulty of gaining intraperitoneal access. Pasic et al9 retrospectively analyzed outcomes in separate cohorts of obese and nonobese patients, focusing on 4 entry approaches:

  • transumbilical open,
  • transumbilical Veress needle placement,
  • subcostal Veress needle placement in the midclavicular line of the left upper quadrant, and
  • transuterine Veress needle placement.
The only group that demonstrated a significantly higher failure rate for obese patients was the open approach. Ultimately, the authors recommended using the Veress needle in the left upper quadrant or via the uterus for obese patients.

In contrast, the Pelosi case series of 67 consecutive obese patients6 reported no failures with a transumbilical open approach after realignment of the umbilical access. This entailed assessing the position of the umbilicus in relation to a line drawn between the 2 anterior superior iliac spines. The umbilicus then was repositioned 8 cm above this line in its “anatomical” position prior to initiating open dissection (FIGURE).

After the open trocar was inserted through the fascia and peritoneum and the patient was placed in the Trendelenburg position, the panniculus maintained its orientation. Pelosi and Pelosi concluded that this realignment of the umbilical axis decreases the depth of open dissection and avoids inadvertent placement of a trocar through both sides of the panniculus.

A prospective, randomized study10 comparing transumbilical and transuterine Veress needle placement in obese patients found the latter approach useful, but recorded a single case of postoperative chlamydial pelvic inflammatory disease. Thus, preoperative testing for sexually transmitted disease is recommended for this approach.

Avoid dogmatic reliance on a single approach

These studies demonstrate a fundamental surgical truism: Sound physiologic and anatomic knowledge, combined with versatility and a grasp of multiple approaches to any problem, are ultimately more successful than unyielding reliance on a single approach. Aim for prudent use of open or closed laparoscopy in a variety of locations, taking into account the patient’s surgical history, distribution of fat, and umbilical displacement.

After achieving pneumoperitoneum

Place a salinefilled spinal needle into the peritoneal cavity on suction to establish abdominal wall thickness. In this way, trocars of appropriate length can be selected.

Some authorities advocate insufflation to a high intraperitoneal pressure (25 to 30mm Hg) prior to placing the initial umbilical trocar if a closed technique is being used.11 This further elevates the abdominal wall and decreases the risk of preperitoneal trocar placement. After successful trocar placement, immediately reduce intraabdominal pressure to 15 mm Hg to avoid pulmonary compromise, excessive catecholamine release, and subcutaneous emphysema.

 

 

Techniques to enhance visualization

Excess adipose tissue occupies the pericolic, omental, mesenteric, and retroperitoneal spaces in obese patients, obscuring visualization of intraperitoneal and retroperitoneal structures.

Preoperative mechanical bowel preparation can deflate the bowel and enhance visualization (TABLE 2). At times, an extra ancillary trocar for placement of a bowel retractor also can improve visualization.

In the morbidly obese, insufflation pressure of 15 mm Hg will sometimes produce poor visualization. Obese patients generally tolerate this pressure reasonably well, but increasing it to improve visualization can make adequate oxygenation impossible.

Gasless laparoscopy—in which a mechanical retractor is attached from the table to the patient’s anterior abdominal wall—may help improve pulmonary mechanical parameters. Unfortunately, this technique often produces poorer visualization than insufflation at normal pressure.

A new technique that combines approaches may help avoid the need to convert to laparotomy.12 In this “Foley lap lift,” a 14-French Foley catheter is passed through the anterior abdominal wall, and the balloon is inflated. The catheter then is elevated and clamped to a retractor holder attached to the angled foot of the bed. This upward traction with continuous gas flow at normal pressure improves visualization without pulmonary compromise.

TABLE 2

Techniques to enhance visualization

  • Preoperative mechanical bowel preparation
  • Ancillary trocar for placement of bowel retractor
  • Gasless laparoscopy*
  • Foley lap lift*
*See page 70 for details

Close port sites at the fascial level

The risk of bowel herniation through a trocar site is higher in obese patients than the general population because of the greater intraabdominal pressures. Increases in atelectasis from diminished functional residual capacity also predispose the obese patient to postoperative pulmonary complications and can lead to recurrent Valsalva (cough) and subsequent bowel herniation.

Given these risks, it is imperative that all port sites 10 mm or larger be closed at the fascial level. Unfortunately, the distance from the anterior abdominal wall to the fascia underlying these sites makes direct visualization and closure almost impossible.

Fortunately, several fascial closure devices are available and are reasonably inexpensive and easy to use. When using them, be sure to maintain the other port sites, as closure requires direct visualization and a second instrument.

Postoperative strategies

Successful postoperative care builds on preoperative and intraoperative tactics.

Perform aggressive pulmonary toilet

With intraoperative decreases in functional residual capacity, postoperative atelectasis is likely to be profound, with a potential for ventilation/perfusion mismatch and hypoxemia.

Aggressive pulmonary toilet including regular incentive spirometry and deep breathing and coughing exercises is important to reinflate dependent lung regions. Pulse oximetry with sufficient supplementary oxygen also is important to maintain adequate saturation.

Encourage early ambulation

This requires adequate but not oversedating analgesia, early catheter removal, and a motivated nursing staff.

Early ambulation is associated with fewer episodes of deep venous thrombosis, pulmonary complications, and ileus, and also eases pain management.

Continue thrombosis prophylaxis with sequential compression devices, subcutaneous heparin, or both, until the patient is spending most of her time out of bed.

Dr. Robinson reports no relevant financial relationships.

Dr. Isaacson serves on the speakers bureau for Karl Storz Endoscopy.

References

1. Mokdad AH, Bowman BA, Ford ES, et al. The continuing epidemics of obesity and diabetes in the United States. JAMA. 2001;286:1195-1200.

2. Ford ES, Mokdad AH, et al. Trends in waist circumference among US adults. Obes Res. 2003;11:1223-1231.

3. Bluman LG, Mosca L, Newman N, Simon DG. Preoperative smoking habits and postoperative pulmonary complications. Chest. 1998;113:883-889.

4. Mokdad AH, Ford ES, Bowman BA, et al. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003;289:76-79.

5. Lamvu G, Zolnoun D, Boggess J, Steege JF. Obesity: physiologic changes and challenges during laparoscopy. Am J Obstet Gynecol. 2004;191:669-674.

6. Pelosi MA 3rd, Pelosi MA. Alignment of the umbilical axis: an effective maneuver for laparoscopic entry in the obese patient. Obstet Gynecol. 1998;92:869-872.

7. Hurd WW, et al. The relationship of the umbilicus to the aortic bifurcation: implications for laparoscopic technique. Obstet Gynecol. 1992;80:48-51.

8. Hurd WH, Bude RO, et al. Abdominal wall characterization with magnetic resonance imaging and computed tomography. The effect of obesity on the laparoscopic approach. J Reprod Med. 1991;36:473-476.

9. Pasic R, Levine RL, Wolf WM, Jr. Laparoscopy in morbidly obese patients. J Am Assoc Gynecol Laparosc. 1999;6:307-312.

10. Santala M, Jarvela I, Kauppila A. Transfundal insertion of a Veress needle in laparoscopy of obese subjects: a practical alternative. Hum Reprod. 1999;14:2277-2278.

11. Vilos GA, Vilos AG. Safe laparoscopic entry guided by Veress needle CO2 insufflation pressure. J Am Assoc Gynecol Laparosc. 2003;10:415-420.

12. Stany MP, Winter WE, 3rd, Dainty L, Lockrow E, Carlson JW. Laparoscopic exposure in obese highrisk patients with mechanical displacement of the abdominal wall. Obstet Gynecol. 2004;103:383-386.

13. Sprung J, Whalley DG, Falcone T, et al. The impact of morbid obesity, pneumoperitoneum, and posture on respiratory system mechanics and oxygenation during laparoscopy. Anesth Analg. 2002;94:1345-1350.

14. Demiroluk S, Salihoglu Z, et al. The effects of pneumoperitoneum on respiratory mechanics during bariatric surgery. Obes Surg. 2002;12:376-379.

15. Heinberg EM, Crawford BL, 3rd, Weitzen SH, Bonilla DJ. Total laparoscopic hysterectomy in obese versus nonobese patients. Obstet Gynecol. 2004;103:674-680.

16. O’Hanlan KA, Lopez L, Dibble SL, et al. Total laparoscopic hysterectomy: body mass index and outcomes. Obstet Gynecol. 2003;102:1384-1392.

17. Holub Z, Jabor A, Kliment L, Fischlova D, Wagnerova M. Laparoscopic hysterectomy in obese women: a clinical prospective study. Eur J Obstet Gynecol Reprod Biol. 2001;98:77-82.

18. Ostrzenski A. Laparoscopic total abdominal hysterectomy in morbidly obese women. A pilotphase report. J Reprod Med. 1999;44:853-858.

19. Loffer FD, Pent D. Laparoscopy in the obese patient. Am J Obstet Gynecol. 1976;125:104-107.

20. Eltabbakh GH, Shamonki MI, et al. Hysterectomy for obese women with endometrial cancer: laparoscopy or laparotomy? Gynecol Oncol. 2000;78:329-335.

21. Scribner DR, Jr, Walker JL, Johnson GA, et al. Laparoscopic pelvic and paraaortic lymph node dissection in the obese. Gynecol Oncol. 2002;84:426-430.

22. Bai SW, Lim JH, Kim JY, Chung KA, Kim SK, Park KH. Relationship between obesity and the risk of gynecologic laparoscopy in Korean women. J Am Assoc Gynecol Laparosc. 2002;9:165-169.

23. Eltabbakh GH, Piver MS, Hempling RE, Recio FO. Laparoscopic surgery in obese women. Obstet Gynecol. 1999;94:704-708.

24. Hsu S, Mitwally MF, Aly A, Al-Saleh M, Batt RE, Yeh J. Laparoscopic management of tubal ectopic pregnancy in obese women. Fertil Steril. 2004;81:198-202.

25. Fugita OE, Chan DY, Roberts WW, Kavoussi LR, Jarrett TW. Laparoscopic radical nephrectomy in obese patients: outcomes and technical considerations. Urology. 2004;63:247-252; discussion 252.

26. Senagore AJ, Delaney CP, Madboulay K, et al. Laparoscopic colectomy in obese and nonobese patients. J Gastrointest Surg. 2003;7:558-561.

27. Pikarsky AJ, Saida Y, Yamaguchi T, et al. Is obesity a high-risk factor for laparoscopic colorectal surgery? Surg Endosc. 2002;16:855-858.

28. Tuech JJ, Regenet N, Hennekinne S, et al. [Impact of obesity on postoperative results of elective laparoscopic colectomy in sigmoid diverticulitis: a prospective study]. Ann Chir. 2001;126:996-1000.

29. Fraser J, Watson DI, O’Boyle CJ, Jamieson GG. Obesity and its effect on outcome of laparoscopic Nissen fundoplication. Dis Esophagus. 2001;14:50-53.

30. Birgisson G, Park AE, Mastrangelo MJ, Jr, Witzke DB, Chu UB. Obesity and laparoscopic repair of ventral hernias. Surg Endosc. 2001;15:1419-1422.

31. Enochsson L, Hellberg A, Rudberg C, et al. Laparoscopic vs open appendectomy in overweight patients. Surg Endosc. 2001;15:387-392.

32. Fried M, Peskova M, Kasalicky M. The role of laparoscopy in the treatment of morbid obesity. Obes Surg. 1998;8:520-523.

33. Fazeli-Matin S, Gill IS, Hsu TH, Sung GT, Novick AC. Laparoscopic renal and adrenal surgery in obese patients: comparison to open surgery. J Urol. 1999;162:665-669.

References

1. Mokdad AH, Bowman BA, Ford ES, et al. The continuing epidemics of obesity and diabetes in the United States. JAMA. 2001;286:1195-1200.

2. Ford ES, Mokdad AH, et al. Trends in waist circumference among US adults. Obes Res. 2003;11:1223-1231.

3. Bluman LG, Mosca L, Newman N, Simon DG. Preoperative smoking habits and postoperative pulmonary complications. Chest. 1998;113:883-889.

4. Mokdad AH, Ford ES, Bowman BA, et al. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003;289:76-79.

5. Lamvu G, Zolnoun D, Boggess J, Steege JF. Obesity: physiologic changes and challenges during laparoscopy. Am J Obstet Gynecol. 2004;191:669-674.

6. Pelosi MA 3rd, Pelosi MA. Alignment of the umbilical axis: an effective maneuver for laparoscopic entry in the obese patient. Obstet Gynecol. 1998;92:869-872.

7. Hurd WW, et al. The relationship of the umbilicus to the aortic bifurcation: implications for laparoscopic technique. Obstet Gynecol. 1992;80:48-51.

8. Hurd WH, Bude RO, et al. Abdominal wall characterization with magnetic resonance imaging and computed tomography. The effect of obesity on the laparoscopic approach. J Reprod Med. 1991;36:473-476.

9. Pasic R, Levine RL, Wolf WM, Jr. Laparoscopy in morbidly obese patients. J Am Assoc Gynecol Laparosc. 1999;6:307-312.

10. Santala M, Jarvela I, Kauppila A. Transfundal insertion of a Veress needle in laparoscopy of obese subjects: a practical alternative. Hum Reprod. 1999;14:2277-2278.

11. Vilos GA, Vilos AG. Safe laparoscopic entry guided by Veress needle CO2 insufflation pressure. J Am Assoc Gynecol Laparosc. 2003;10:415-420.

12. Stany MP, Winter WE, 3rd, Dainty L, Lockrow E, Carlson JW. Laparoscopic exposure in obese highrisk patients with mechanical displacement of the abdominal wall. Obstet Gynecol. 2004;103:383-386.

13. Sprung J, Whalley DG, Falcone T, et al. The impact of morbid obesity, pneumoperitoneum, and posture on respiratory system mechanics and oxygenation during laparoscopy. Anesth Analg. 2002;94:1345-1350.

14. Demiroluk S, Salihoglu Z, et al. The effects of pneumoperitoneum on respiratory mechanics during bariatric surgery. Obes Surg. 2002;12:376-379.

15. Heinberg EM, Crawford BL, 3rd, Weitzen SH, Bonilla DJ. Total laparoscopic hysterectomy in obese versus nonobese patients. Obstet Gynecol. 2004;103:674-680.

16. O’Hanlan KA, Lopez L, Dibble SL, et al. Total laparoscopic hysterectomy: body mass index and outcomes. Obstet Gynecol. 2003;102:1384-1392.

17. Holub Z, Jabor A, Kliment L, Fischlova D, Wagnerova M. Laparoscopic hysterectomy in obese women: a clinical prospective study. Eur J Obstet Gynecol Reprod Biol. 2001;98:77-82.

18. Ostrzenski A. Laparoscopic total abdominal hysterectomy in morbidly obese women. A pilotphase report. J Reprod Med. 1999;44:853-858.

19. Loffer FD, Pent D. Laparoscopy in the obese patient. Am J Obstet Gynecol. 1976;125:104-107.

20. Eltabbakh GH, Shamonki MI, et al. Hysterectomy for obese women with endometrial cancer: laparoscopy or laparotomy? Gynecol Oncol. 2000;78:329-335.

21. Scribner DR, Jr, Walker JL, Johnson GA, et al. Laparoscopic pelvic and paraaortic lymph node dissection in the obese. Gynecol Oncol. 2002;84:426-430.

22. Bai SW, Lim JH, Kim JY, Chung KA, Kim SK, Park KH. Relationship between obesity and the risk of gynecologic laparoscopy in Korean women. J Am Assoc Gynecol Laparosc. 2002;9:165-169.

23. Eltabbakh GH, Piver MS, Hempling RE, Recio FO. Laparoscopic surgery in obese women. Obstet Gynecol. 1999;94:704-708.

24. Hsu S, Mitwally MF, Aly A, Al-Saleh M, Batt RE, Yeh J. Laparoscopic management of tubal ectopic pregnancy in obese women. Fertil Steril. 2004;81:198-202.

25. Fugita OE, Chan DY, Roberts WW, Kavoussi LR, Jarrett TW. Laparoscopic radical nephrectomy in obese patients: outcomes and technical considerations. Urology. 2004;63:247-252; discussion 252.

26. Senagore AJ, Delaney CP, Madboulay K, et al. Laparoscopic colectomy in obese and nonobese patients. J Gastrointest Surg. 2003;7:558-561.

27. Pikarsky AJ, Saida Y, Yamaguchi T, et al. Is obesity a high-risk factor for laparoscopic colorectal surgery? Surg Endosc. 2002;16:855-858.

28. Tuech JJ, Regenet N, Hennekinne S, et al. [Impact of obesity on postoperative results of elective laparoscopic colectomy in sigmoid diverticulitis: a prospective study]. Ann Chir. 2001;126:996-1000.

29. Fraser J, Watson DI, O’Boyle CJ, Jamieson GG. Obesity and its effect on outcome of laparoscopic Nissen fundoplication. Dis Esophagus. 2001;14:50-53.

30. Birgisson G, Park AE, Mastrangelo MJ, Jr, Witzke DB, Chu UB. Obesity and laparoscopic repair of ventral hernias. Surg Endosc. 2001;15:1419-1422.

31. Enochsson L, Hellberg A, Rudberg C, et al. Laparoscopic vs open appendectomy in overweight patients. Surg Endosc. 2001;15:387-392.

32. Fried M, Peskova M, Kasalicky M. The role of laparoscopy in the treatment of morbid obesity. Obes Surg. 1998;8:520-523.

33. Fazeli-Matin S, Gill IS, Hsu TH, Sung GT, Novick AC. Laparoscopic renal and adrenal surgery in obese patients: comparison to open surgery. J Urol. 1999;162:665-669.

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Hysteroscopy: Managing and minimizing operative complications

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KEY POINTS

  • Perform endometrial sampling for abnormal uterine bleeding before scheduling operative hysteroscopy.
  • Most uterine perforations do not require treatment— even those involving large dilators—although further assessment may be necessary to rule out bowel injury.
  • Most complications of electrosurgery involve activating an electrode at the time of perforation, or diverting current to the outer sheath.
  • Scrupulously monitor fluid intake and output to prevent hyponatremic complications.

WHAT WENT WRONG?

A 44-year-old woman undergoing resection of a submucous myoma from the left cornual region has persistent bleeding at the resection site. The surgeon continues coagulation at the bleeding site, using a rollerball electrode in an attempt to achieve hemostasis, but perforates the uterus. Immediate laparoscopy to identify collateral injury reveals some thermal damage on the posterior leaf of the broad ligament, but no bowel injury. After 24 hours of observation, she is afebrile without leukocytosis. She is discharged with explicit instructions to return if she has symptoms suggesting bowel injury. She returns in 72 hours, with abdominal pain and low-grade fever. CT reveals extravasation of contrast from the left ureter in the pelvis. Immediate laparotomy finds perforation of the left ureter secondary to a thermal injury. She undergoes ureteroneocystotomy and recovers.

This case illustrates one of the most common complications of operative hysteroscopy: uterine perforation with collateral injury. Both could have been avoided if the Ob/Gyn had stopped the procedure when bleeding first occurred, removed the instruments, and allowed the uterus to contract spontaneously.

This is just one of the strategies that can reduce the risks of hysteroscopic surgery. Numerous reports confirm that operative hysteroscopy is safe and effective, but as more gynecologists perform an increasing number of procedures, we must be aware of potential complications and do our best to minimize risk to our patients.

Complications cannot be completely avoided, and may occur when a procedure is done correctly by experienced doctors. They are far more likely if techniques or equipment are used improperly. This article describes ways to minimize risk.

When the American Association of Gynecologic Laparoscopists (AAGL) surveyed its members in 1993, it found a complication rate of 2% for operative hysteroscopy.1 The rate of major complications—perforation, hemorrhage, fluid overload, and bowel or urinary tract injury—was less than 1%. A prospective multicenter trial2 of 13,600 procedures in the Netherlands found a higher complication rate for operative (0.95%) than for diagnostic hysteroscopy (0.13%).

Preoperative precautions

We can reduce the risk of complications if contraindications are not ignored, equipment is thoroughly inspected and understood, and the surgeon goes through a mental checklist and plans each procedure. A “time out”before the operation begins, when every member of the team is briefed, is also valuable in preventing errors.

A hands-on course necessary before undertaking advanced resectoscopic surgery, to become familiar with equipment and techniques, followed by proctoring by a surgeon credentialed for the procedure.

Contraindications

Ignoring contraindications to hysteroscopic surgery increases the risk of complications and is the single greatest factor leading to patient injury and physician liability.

Contraindications include:

  • Unfamiliarity with equipment, instruments, or technique
  • Lack of appropriate equipment or staff familiar with the equipment
  • Acute pelvic inflammatory disease
  • Pregnancy
  • Genital tract malignancies
  • Lack of informed consent
  • Inability to dilate the cervix
  • Inability to distend the uterus to obtain visualization
  • Poor surgical candidates who may not tolerate fluid overload because of renal disease, or radiofrequency current when a cardiac pacemaker is present
  • The patient desires and expects complete amenorrhea3

Mechanical or traumatic complications

These types of complications are among the most common. Other categories include preoperative complications (ie, improper patient selection and lack of informed consent), electrosurgical and gaseous, complications related to distention media, and postoperative complications (ie, infection and late sequelae).

 

 

Inability to insert the hysteroscope

This may be caused by a stenotic, nulliparous cervix; menopause; GnRH agonists; previous cone biopsy, laceration, or cryosurgery; or an acutely retroflexed or anteflexed uterus.

Acute flexion problems can be corrected using a long-bladed, open-sided Graves speculum deep in the anterior or posterior fornix. The speculum pushes the fundus to the midposition and facilitates dilation. Once the hysteroscope is inserted, remove the speculum.

Placing a tenaculum on the posterior lip of the cervix of an acutely retroflexed uterus will straighten the cervical canal when traction is applied.

Inserting a laminaria tent the evening before surgery helps dilate the cervix easily and atraumatically.4 However, the laminaria can sometimes create a false passage, leading to perforation.

Cervical ripening agents such as intravaginal or oral misoprostol (200 μg inserted vaginally or 400 μg orally 8 to 12 hours preoperatively) also can facilitate dilation.

Intracervical injection of vasopressin solution (4 IU in 100 cc sodium chloride, injected at the 4 and 8 o’clock positions) can reduce the force needed to dilate the cervix.5 Half-size dilators may help; they also reduce the risk of cervical laceration.

Laceration of the cervix

Although this is a minor complication, substantial bleeding sometimes occurs when the cervix is lacerated by the tenaculum. In these cases, suture the cervix.

Occasionally, a touch of cautery from the rollerball electrode at low power (20 to 30 W) can control the bleeding.

Silver nitrate sticks or ferric subsulfate (Monsel’s) paste are also effective on superficial lacerations.

Bleeding from lower uterus or cervical canal can obscure view

In some cases, bleeding is delayed, necessitating additional surgery. Intravasation of distention fluid also can occur at these lacerations. Coagulation with the electrode may be necessary when bleeding is heavy.

Check for collateral injury when uterine perforation occurs

Perforation is a well-documented risk of operative hysteroscopy and should be discussed with the patient when obtaining informed consent. In the AAGL survey,1 the incidence of perforation was 14 per 1,000. It was even higher during transection of lateral and fundal adhesions: 2 to 3 per 100.6

Although perforation is more common with thermal energy sources, it may occur mechanically when scissors are used to transect a uterine septum, synechiae, or polyps.

When the cervix is stenotic or the uterus is acutely ante- or retroflexed, sounds and dilators can perforate the uterus.

Most perforations—even those involving large dilators—usually do not require treatment, although further assessment may be necessary to rule out bowel injury. Most perforations occur in the fundal region or posterior lower segment.

A false passage can be created when entering the uterus. Occasionally the surgeon may be fooled into thinking the hysteroscope is in the uterine cavity, since the false passage distends (FIGURE 1). If muscle fibers are visible and the tubal ostea are not, assume the passage is false. Slowly remove the hysteroscope and identify the true cavity for confirmation. Discontinue the procedure—even if no perforation is detected—to prevent distention fluid from being absorbed into the circulation through the injury. Adequate distention is not possible at this time.

Delay repeat hysteroscopy for 2 to 3 months.

To avoid creating a false passage, dilate the cervix with slow, steady pressure and stop as soon as the internal os opens; do not attempt to push the dilator to the uterine fundus.

Often the external os opens, but the internal os cannot be dilated the extra 1 to 2 mm necessary to accommodate the 27-French resectoscope. Rather than exert more force and risk perforation or laceration, simply turn on the resectoscope’s inflow with the outflow shut off, and let the fluid pressure dilate the cervix.

Always insert the hysteroscope or resectoscope under direct vision rather than use an obturator. Keep the “dark circle” in the center of the field and slowly advance the hysteroscope toward it until the cavity is reached.

Avulsion of the myometrium sometimes occurs during removal of incompletely resected myomas (FIGURE 2). Keep the myoma grasper away from the fundus when removing myoma segments, and avoid excessive traction on what may be a thin segment of myometrium. Injuries can occur when the grasper perforates the uterus and bowel is inadvertently grasped. Large injuries require laparoscopic repair.

Perforation is more likely in repeat procedures. In a report of 80 repeat endometrial ablations, Townsend and colleagues7 noted 8 perforations that prevented completion of the procedure. In a series of 75 repeat ablations compared with 800 primary ablations by the same surgeon, the rate of serious perioperative complications was significantly higher in the repeat ablation group (9.3% versus 2.0%).8

 

 

When perforation occurs during the use of thermal energy, laparoscopy is necessary to assess the organs overlying the site.9 During setup for laparoscopy, bring the hysteroscope near the area of perforation to inspect the bowel beyond the uterus. Since the pelvis fills quickly with distention fluid, the hysteroscope can even be placed through the perforation to yield an excellent view of the undersurfaces of the bowel immediately adjacent to the injured area (FIGURE 3). (Disconnect the electrosurgical cord before doing this!)

Thorough laparoscopic inspection of the bowel in the pelvis often reveals thermal injury, which appears as a whitish patch on the bowel serosa. To repair bowel injuries, bring the injured segment out through a minilaparotomy and excise the damage with a 2- to 3-cm border. A general surgeon should be called in to consult.

When perforation is imminent, the “serosal sign” appears

A 42-year-old woman who underwent endometrial ablation 2 years earlier presents with persistent menorrhagia and a 12-week–size fibroid uterus and expresses a desire for repeat ablation. At the second surgery, the uterine cavity appears scarred, with multiple synechiae.

As the procedure progresses, the uterine serosa becomes visible from within the cavity, appearing as a smooth, bluish structure that can be moved with only slight pressure. As the ablation continues, the uterus perforates, necessitating laparoscopic inspection of the organs overlying the site.

Although the patient recovers, her menorrhagia eventually returns, and she opts for laparoscopically assisted vaginal hysterectomy 1 year later.

Uterine perforation is more likely during repeat procedures

This case illustrates one of the most common risks of operative hysteroscopy: uterine perforation, which occurs more frequenly in repeat procedures.

The case also highlights an important indicator of perforation: the serosal sign, which I first described in 1996.24 When the smooth, bluish structure appears, cease ablation in the region immediately.

If no injury is apparent, discharge the patient but follow her closely, including daily white blood cell counts for 4 to 5 days. Instruct her to take her temperature twice daily and return to the hospital immediately if any signs of bowel perforation develop. Delayed perforation from thermal injury can occur as late as 2 weeks following surgery, and the patient should be apprised of this possibility.

FIGURE 1 Signs of a false passage


Myometrial fibers signal that a false passage has been created. Stop the procedure even if no perforation is detected, to prevent distention fluid from being absorbed into the circulation through the injury.

FIGURE 2 Risk of myomectomy: Myometrial avulsion


Small bowel visible within the uterine cavity after avulsion of uterine wall at the time of myomectomy

FIGURE 3 Use the hysteroscope to assess perforation site


Hysteroscopic view of perforation at the fundus. The small bowel is visible beyond the perforation at left.

Intraoperative bleeding is rare

Bleeding is unlikely unless vessels are lacerated or injured in the cervical canal or lower uterine segment during dilation or deep ablation or vaporization. Bleeding is more common when endomyometrial resection is performed with the wire loop electrode or during ablation or vaporization of fibroids. Bleeding sufficient to require intervention occurs at a rate of 0.5% to 1.9% in several reported series.

To achieve hemostasis via balloon tamponade, insert a Foley catheter with a 30-cc balloon into the uterine cavity, inject 15 to 20 mL (or more for a larger cavity) of fluid into the balloon, and observe the patient.10 If there is no bleeding in 1 hour, remove half the fluid. Remove the remainder of the fluid and the catheter over the next hour if no further bleeding occurs.

Alternative method: Pack the uterus. I prefer 1/2-inch–gauge packing that has been soaked in a dilute vasopressin solution (20 U [1 mL] in 60 mL normal saline).11

The benefits of vasopressin. Before balloon tamponade or packing the uterus, I inject very dilute vasopressin (4 U [0.2 mL] in 60 mL normal saline) directly into the cervix 2 cm deep, at the 4 and 8 o’clock positions. Phillips12 demonstrated a marked decrease in blood loss during resectoscopic surgery using this approach. I also do this routinely prior to operative hysteroscopy, since the vasopressin-induced vasoconstriction reduces intravasation of distention media.

A vaporizing electrode may prevent significant blood loss during myoma resection by sealing blood vessels as the tissue is vaporized.13 All major manufacturers of hysteroscopic equipment produce these electrodes.

In my series of 44 endometrial ablations and hysteroscopic myomectomies performed with the vaporizing electrode, blood loss was “minimal” or less than 50 mL in 29 cases. The maximum blood loss was 300 mL in a patient with a 4-cm submucous myoma who was managed emergently for hemorrhage.14 In another case, during resection of a 5-cm submucous myoma, I encountered significant bleeding from large vessels at the base of the myoma, which required intrauterine tamponade with a vasopressin-soaked pack.

 

 

Preoperative measures may decrease vascularity. In their analysis of 16 randomized and nonrandomized controlled trials published in the English literature between 1990 and 1996, Parazzini and colleagues15 found that preoperative danazol or GnRH agonists decreased the thickness and vascularity of the endometrium and shrank myomata, resulting in shorter operating times, less blood loss, and less intravasation of distending fluid.

Electrosurgical and gaseous complications

Most electrosurgical complications involve activation of an electrode at the time of perforation, or current diversion to the outer sheath.

Thermal injuries also can be caused by overheating of the return pad or use of a weighted speculum that has not fully cooled after removal from the autoclave. The latter can be avoided by immersing the entire speculum in cool saline for at least 1 to 2 minutes prior to inserting it into the vagina. The blade cools much faster than the weighted ball, so be sure to check both to prevent a perineal or buttock burn.

Perforation with an active electrode

This usually occurs when current is applied as the electrode is extended or the resectoscope is moved toward the fundus. It can be avoided if the electrode is activated only when moving it toward the operator.

Perforations with intraabdominal burns also have occurred during attempts to coagulate bleeders—especially in the cornual regions.

Diversion of current can be destructive

Genital tract injuries have occurred as a result of current diversion. Vilos and colleagues16 reported 13 electrical burns during endometrial ablation, and mention many more anecdotal reports. The usual cause: electrode insulation failure, which allows current to jump to the outer sheath of the resectoscope.

To avoid this, inspect all electrodes thoroughly before surgery and use them only once.

Capacitative coupling also diverts current

Since the sheath-within-a-sheath design of the resectoscope resembles a capacitor, high-voltage current can jump to the outer sheath without direct contact from the electrode. When Munro17 bench-tested electrosurgical generators and electrodes with and without insulation defects, he found that capacitative coupling with intact electrodes occurred more frequently with high-voltage coagulation current than with lower-voltage cutting current.

One way to avoid these injuries is to activate the electrode intermittently, with short bursts, rather than rolling back and forth over an area with continuous current. Another strategy is placing a damp sponge in the posterior vagina extending out the introitus; this protects the mucosa and perineal skin—especially in obese patients.

How to avoid return-pad injuries

Keep the patient’s thigh completely dry; ensure that the pad is flat against the skin at application, with no bubbles or creases; and use only return electrode monitor (REM) dispersive pads.

Especially when using vaporization electrodes, avoid prolonged activation of the electrode at high power. To minimize risk of vaporization, use a second dispersive pad connected to the first via a “y” connector to further disperse current and heat at the return pad.

Also, limit the use of coagulation current and use a maximum generator setting of 60 to 80 W in the coagulation mode.

Take steps to avert gas embolism, but watch closely for signs

Initial reports of this potentially fatal complication came mostly from laser ablation procedures, but gas embolism can occur during all diagnostic and operative hysteroscopic procedures, especially the latter.

Sources of gas embolism: room air, carbon dioxide, carbon monoxide, and other gaseous products of vaporization or tissue combustion. The anesthesiologist is usually the first to identify the signs.

Signs of gas embolism. The surgeon should ask to be immediately alerted to any sudden fall in oxygen saturation, as well as to hypotension, hypercarbia, arrhythmias, tachypnea, or a “mill wheel” murmur. If any of these signs are detected and a gas embolism is suspected, stop the procedure and ventilate the patient with 100% oxygen.

Carbon dioxide is a soluble gas, so these emboli generally resolve rapidly. In contrast, room air emboli are more likely to be fatal.

Reduce the risk of air embolism by avoiding the Trendelenburg position and leaving the last dilator in the cervix until just before inserting the resectoscope.

Also limit repetitive removal and reinsertion of the resectoscope, as often occurs during myoma resection. By vaporizing rather than resecting myomas, it is possible to eliminate the need to continually remove fibroid chips. Preoperative GnRH agonists narrow venous sinuses and help prevent this complication.

Intracervical injection of dilute vasopressin prior to dilatation of the cervix creates vascular spasm and may help prevent gas from entering the circulation.

Complications from distention media

Excess absorption of distention media is one of the most frequent complications. Most surgeons use low-viscosity, sodium-free fluids for operative hysteroscopy, since fluids that contain electrolytes are incompatible with monopolar electrosurgical instruments. The use of 3% sorbitol, 1.5% glycine, or sorbitol-mannitol solutions can lead to dilutional hyponatremia and hypoosmolality.18 Although the vast majority of women quickly recover from these conditions, some cases of permanent morbidity and even death have been reported.19 The overall incidence of dilutional hyponatremia was 0.2% in 1993, according to the AAGL member survey.1

 

 

Hyponatremia and hypoosmolality more likely in premenopausal women

These conditions may have catastrophic consequences if they are not recognized and corrected promptly. The brain swells as it attempts to become isoosmotic with the vascular system. If swelling exceeds 5%, the risk of severe neurological damage dramatically increases.

This is an important problem in premenopausal women, since estrogen and progesterone inhibit sodium-potassium adenosine triphosphatase (ATPase) activity in the brain. This sodium pump protects the brain against cerebral edema, which can cause herniation of the brain stem and death. Although men and postmenopausal women develop dilutional hyponatremia, they are less likely to suffer brain damage because the sodium pump is intact.

Taskin et al20 conducted a randomized trial showing an increase in the sodium-potassium ATPase pump activity and decreased volume deficit during hysteroscopic surgery in patients pretreated with a GnRH agonist, compared with a control group. This increased pump activity in the brain and endometrium may decrease women’s susceptibility to hyponatremic complications and brain damage.

Vigilant monitoring of fluid intake/output during hysteroscopic surgery is necessary to prevent hyponatremic complications. Avoid the pitfall of erroneously attributing deficits to fluid “in the drapes” by using drapes with a fluid-collection pouch.

The standard of care is use of electronic inflow-outflow measuring systems. Manufacturers of hysteroscopic equipment offer highly accurate electronic fluid monitoring systems that measure the weight of the distending fluid infused and collected rather than relying on manual estimation of deficit. The latter method may be inaccurate since the volume of the supply bag can vary by as much as 10%.

Adjust intrauterine pressure to reduce the likelihood of intravasation. High intrauterine pressure may be desirable for visualization, but it greatly increases the risk of intravasation.

I adjust pressure and flow rates by opening or closing the inflow and outflow valves of the resectoscope until slight amounts of bleeding from resected tissue can be visualized. Since intrauterine pressure is extremely difficult to monitor accurately during operative hysteroscopy, this practice ensures that it remains below the patient’s mean arterial pressure, thus minimizing the risk of intravasation.

Use a dilute vasopressin injection to constrict blood vessels and decrease the chance of intravasation.

Vaporizing electrodes for myoma resection and ablation seal blood vessels and reduce fluid absorption.

Guidelines for distention media

To reduce the likelihood of these complications, I recommend that surgeons:

  • Draw preoperative serum electrolytes for a baseline in all patients.
  • Give all patients with myomas 2 monthly injections of depot leuprolide acetate (3.75 mg intramuscularly). Give patients without fibroids a single injection 4 to 6 weeks prior to the procedure.
  • Place a fluid-collection drape or a larger, plastic Mayo stand cover with the bottom cut off under the patient’s buttocks so that fluid drains into a “kick” bucket. Also adjust the resectoscope’s outflow tubing to drain into the collection bag, which should be kept on constant suction to the flow-stat electronic fluid monitor.
  • Continuously record inflow and outflow using the electronic monitor with the deficit alarm set to 500 mL.
  • Keep distention fluid at room temperature and monitor the patient’s core temperature continuously. Significant fluid intravasation will lower the patient’s temperature, and this may be the first sign of fluid overload.
  • Perform operative hysteroscopy under spinal or epidural anesthesia so the anesthesiologist can continually assess the patient’s sensorium. Confusion and irritability are early signs of dilutional hyponatremia.
  • If the fluid deficit reaches 750 mL, immediately give 20 to 40 mg of intravenous furosemide and draw a serum sodium. Do not wait for the result of the sodium level before treatment, since a 5- to 20-minute delay can be catastrophic.
  • Interrupt the procedure for 5 to 10 minutes to allow the uterus to contract and to seal off small blood vessels.
  • Discontinue the procedure if the fluid deficit reaches 1,500 mL or if the serum sodium level is below 125 mEq/L.

I do not limit the duration of resectoscopic procedures as long as fluid deficits are below 750 mL, as measured by electronic fluid monitor. I also ensure that the operating room staff is well educated in the use of the monitor and able to troubleshoot intraoperatively.

If the machine fails during the procedure, reset it with the alarm limit lowered to reflect the deficit recorded before failure.

Monitor the color of the outflow fluid. Excessive blood loss counted as part of the outflow can occasionally mask a distention fluid deficit.

Choosing a distention medium

There is no ideal distention medium for monopolar operative hysteroscopy. Several authors have suggested that 5% mannitol is advantageous since it is isosmolar and acts as an osmotic diuretic. However, it does not prevent hyponatremia. The main disadvantage of 5% mannitol is its high cost and limited availability in 3-L bags or 4-L bottles.

 

 

The use of bipolar devices in normal saline prevents dilutional hyponatremia, but fluid deficits must still be monitored electronically so they do not exceed 2,000 mL. The false sense of security that may occur when normal saline is used for distention may lead to inaction when a large deficit occurs. This can lead to pulmonary edema and death.

Postoperative and late complications

These include infection, endometrial cancer, iatrogenic adenomyosis, hematometria, post-ablation tubal ligation syndrome, and pregnancy.

Infection rate is 0.3% to 2%

Infection is relatively rare following endometrial ablation, with a rate of 0.3% to 0.5% reported in most series. Endometritis, parametritis, and pyometra are more common following resection of submucous myomas, with rates as high as 2% reported.

Infection is more likely after prolonged procedures, especially when the hysteroscope is repeatedly inserted and removed. It also is more likely if the patient has a history of pelvic inflammatory disease. I generally administer prophylactic antibiotics (1 dose of intravenous ceftizoxime, 1 g, approximately 30 to 60 minutes prior to surgery).

I also insert a laminaria tent the evening prior to surgery. Patients with a history of pelvic inflammatory disease are discharged on doxycycline (100 mg twice daily for 7 days).

Be alert for endometrial cancer

This malignancy has been diagnosed at the time of endometrial ablation and reported in patients who have undergone prior endometrial ablations or fibroid resections. Thus, endometrial sampling should be part of the workup of abnormal uterine bleeding before the patient is scheduled for operative hysteroscopy. In women at high risk for endometrial cancer, perform office diagnostic hysteroscopy, with directed biopsy of any suspicious areas.

When viable endometrial glands are “buried” during ablation, or synechiae develop, preventing the egress of blood, there is a chance that diagnosis of endometrial cancer will be delayed. However, this theoretical fear has not been proven clinically.

Patients whose abnormal bleeding recurs after ablation should undergo sampling and office hysteroscopy, just as if they had not undergone a previous ablation. Theoretically, women who undergo endomyometrial resection or vaporization should have a lower incidence of endometrial cancer, since the tissue most susceptible to malignancy is removed. This has not yet been proven scientifically.

In their comprehensive review of late complications of operative hysteroscopy, Cooper and Brady21 suggest that patients at high risk for endometrial cancer who present with abnormal uterine bleeding not controlled by hormones might be better served by hysterectomy. Unfortunately, these patients tend to be high-risk surgical candidates.

If atypia is present, do not perform endometrial ablation or resection. I do perform ablation and resection in patients with complex hyperplasia without atypia if it has been reversed with progestin and does not recur for at least 6 months without progestin therapy. These patients undergo office hysteroscopy and sampling of the endometrium before operative hysteroscopy is scheduled.

Iatrogenic adenomyosis

Two theories suggest this is a late complication of operative hysteroscopy. According to the first, when the endometrium is incompletely resected, scarring over this tissue causes the viable glands to grow into the myometrium. The other theory suggests that viable endometrial debris is transported into the myometrium by vessels opened at resection.

I have found that using the vaporization electrode followed by application of a rollerball over the surface of the cavity most effectively reaches maximal tissue depth and, theoretically, prevents adenomyosis. Since most adenomyosis occurs on the posterior wall, I take a strip from this area for pathologic analysis to determine whether adenomyosis preceded the ablation or developed subsequent to it.

Hematometria

This can occur following operative hysteroscopy if viable glands are left in the fundal or cornual region and synechiae develop in the lower segment, preventing egress of blood. It also can occur if the upper endocervix is ablated and subsequently scars, causing stenosis. To avoid this, ablate only to the level of the internal os.

Diagnosis and treatment. Hematometria can be diagnosed easily by ultrasound and treated with office hysteroscopy using a narrow-diameter, rigid, continuous-flow hysteroscope with an operating channel to pass small instruments.

Post-ablation tubal ligation syndrome

This is cornual hematometria that develops when viable endometrial cells are left in the cornua when the cavity also contains synechiae, causing cyclic bleeding. Since there is no egress from the cervix or tubes, blood gradually builds up, leading to hematosalpinx and pain. One way to avoid this is to ensure complete ablation of the cornual endometrium.

Prevention. Some experts recommend that the small rollerball electrode be placed in the cornua, with slightly reduced intrauterine pressure, to allow the cornual endometrium to collapse around the rollerball. A short burst of current is then applied to ablate the tissue.

 

 

This complication is less likely after hydrothermablation, since the free-flowing saline ablates the cornua completely. After more than 50 hydrothermablations performed in patients with prior tubal sterilizations, I have not seen any cases of post-ablation tubal ligation syndrome.

Treatment consists of bilateral salpingectomy or tubal fulguration at the cornual region and repeat ablation or resection of viable endometrial tissue. Another option is hysterectomy.

Post-ablation pregnancy can be very complicated

Pregnancy after endometrial ablation occurs at a rate of 0.2% to 1.6%. Counsel patients that this procedure does not prevent pregnancy and that contraception is vital. Uterine rupture after fibroid resection has been reported.

In a review of 37 post-ablation pregnancies, only 11 of 17 women who chose not to terminate carried the gestation beyond 28 weeks. In addition, there was a high incidence of intrauterine growth restriction, prematurity, and placenta accreta.22

Hysteroscopic tubal sterilization with the Essure system (Conceptus, San Carlos, Calif), or laparoscopic tubal fulguration performed at the time of ablation averts these complications.

Complications of global ablation

Global ablation technologies were developed to enable gynecologists with limited operative hysteroscopy skills to perform endometrial ablation and to make ablation safer for the patient. These technologies completely eliminate the risk of distention-media complications, but widespread use has resulted in other complications that have been reported in the literature to only a limited extent.

Most published articles on global endometrial ablation are from the original US Food and Drug Administration (FDA) trials, in which the complication rates were extraordinarily low. Widespread commercial use of these technologies since FDA approval, especially by practitioners with limited skills, has increased complications.

Do not override safety systems

Complications are more frequent when devices are misused or safety systems overridden. And, fear of litigation makes physicians unwilling to report complications.

In the FDA Manufacturer and User Facility Device Experience (MAUDE) database (www.fda.gov.cdrh/maude.html), complications include bowel burns after unrecognized perforation, and bowel burns associated with electrosurgical, microwave energy, or heat transferred through intact myometrium.23 Vaginal burns, uterine necrosis myometritis requiring hysterectomy, and death from unrecognized bowel burn also have been reported.

Most global procedures are performed blindly, and some doctors fail to perform diagnostic hysteroscopy before and after surgery, which I feel is mandatory with any endometrial ablation. Hydrothermablation is the only global technique that has the advantage of direct observation. In more than 150 procedures done in my office under local anesthesia, the only complications were 2 false passages. Both were promptly identified during diagnostic hysteroscopy, and the surgery was rescheduled 2 to 3 months later.

The author has served on the speakers’ bureau for Boston Scientific.

References

1. Hulka JF, Peterson HA, Philips JM, Surrey MW. Operative hysteroscopy: American Association of Gynecologic Laparoscopists’ 1993 Member Survey. J Am Assoc Gynecol Laparos. 1995;2:131-132.

2. Jansen FW, Vredevoogd CB, Van Ulzen K, et al. Complications of hysteroscopy: a prospective multicenter study. Obstet Gynecol. 2000;96:266-270.

3. Vilos GA. Hysteroscopic surgery: indications, contraindications, and complications. In: Pasic and Levine’s A Practical Manual of Hysteroscopy and Endometrial Ablation Techniques. London and New York: Taylor and Francis; 2004;237-258.

4. Ostrzenski A. Resectoscopic cervical trauma minimized by inserting Laminaria digitata preoperatively. Int J Fertil. 1994;39:111-113

5. Phillips DA, Nathanson HG, Millim SJ, et al. The effect of dilute vasopressin solution on the force needed for cervical dilatation: a randomized controlled trial. Obstet Gynecol. 1997;89:507-511

6. Valle RF, Sciarra JJ. Intrauterine adhesions; hysteroscopic diagnosis, classification, treatment, and reproductive outcome. Am J Obstet Gynecol. 1988;158:1459-1470

7. Townsend DE, Quinlan DJ, Johnson GH. Repeat endometrial ablation. Presented at the World Congress of Hysteroscopy, Miami, Florida, 1996.

8. MacLean-Fraser E, Penava D, Vilos GA. Perioperative complication rates of primary and repeat hysteroscopic endometrial ablations. J Am Assoc Gynecol Laparosc. 2002;9:175-177.

9. Loffer FD. Complications of hysteroscopy—their cause, prevention, and correction. J Am Assoc Gynecol Laparosc; 1995;3:11-26

10. Goldrath MH. Uterine tamponade for the control of acute uterine bleeding. Am J Obstet Gynecol. 1983;147:869-872

11. Townsend DE. Vasopressin pack for treatment of bleeding after myoma resection. Am J Obstet Gynecol. 1991;165:1405-1407

12. Phillips DR, Nathanson HG, Milim SJ, et al. The effect of dilute vasopressin solution on intraoperative blood loss during operative hysteroscopy: a randomized controlled trial. Obstet Gynecol. 1996;88:761-766

13. Brooks PG. Resectoscopic myoma vaporizer. J Reprod Med. 1995;40:791-795

14. Glasser MH. Endometrial ablation and hysteroscopic myomectomy by electrosurgical vaporization. J Am Assoc Gynecol Laparosc. 1997;4:369-374

15. Parazzini F, Vercellini P, Di Giorgio O, et al. Efficacy of preoperative medical treatment in facilitating endometrial resection, myomectomy and metroplasty: literature review. Hum Reprod. 1998;13:2592-2597

16. Vilos GA, Brown S, Graham G, et al. Genital tract electrical burns during hysteroscopic endometrial ablation: report of 13 cases in the United States and Canada. J Am Assoc Gynecol Laparosc. 2000;7:141-147

17. Munro MG. Factors affecting capacitative current diversion with a uterine resectoscope: an in vitro study. J Am Assoc Gynecol Laparosc. 2003;10:450-460

18. Istre O, Shajaa K, Schjoensky AP, et al. Changes in serum electrolytes after transcervical resection of endometrium and submucous fibroids with the use of 1.5% glycine for irrigation. Obstet Gynecol. 1992;80:218-222

19. Arieff AI, Azus JC. Hyponatremic encephalopathy after endometrial ablation. JAMA. 1994;271:345.-

20. Taskin O, Buhur A, Birincioglu M, et al. Endometrial Na+, K+–ATPase pump function and vasopressin levels during hysteroscopic surgery in patients pretreated with GnRH agonist. J Am Assoc Gynecol Laparosc. 1998;5:119-124

21. Cooper JM, Brady RM. Late complications of operative hysteroscopy. Obstet Gynecol Clin North Am. 2000;27:367-374

22. Rogerson L, Gannon, O’Donovan P. Outcome of pregnancy following endometrial ablation. J Gynecol Surg. 1997;13:155-160

23. Gurtcheff SE, Sharp MT. Complications associated with global endometrial ablation: the utility of the MAUDE database. Obstet Gynecol. 2003;102:1278-1282

24. Glasser MH. The serosal sign: the hysteroscopic appearance of the uterine cavity just prior to perforation. Presented at the World Congress of Hysteroscopy, Miami, Florida, 1996.

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KEY POINTS

  • Perform endometrial sampling for abnormal uterine bleeding before scheduling operative hysteroscopy.
  • Most uterine perforations do not require treatment— even those involving large dilators—although further assessment may be necessary to rule out bowel injury.
  • Most complications of electrosurgery involve activating an electrode at the time of perforation, or diverting current to the outer sheath.
  • Scrupulously monitor fluid intake and output to prevent hyponatremic complications.

WHAT WENT WRONG?

A 44-year-old woman undergoing resection of a submucous myoma from the left cornual region has persistent bleeding at the resection site. The surgeon continues coagulation at the bleeding site, using a rollerball electrode in an attempt to achieve hemostasis, but perforates the uterus. Immediate laparoscopy to identify collateral injury reveals some thermal damage on the posterior leaf of the broad ligament, but no bowel injury. After 24 hours of observation, she is afebrile without leukocytosis. She is discharged with explicit instructions to return if she has symptoms suggesting bowel injury. She returns in 72 hours, with abdominal pain and low-grade fever. CT reveals extravasation of contrast from the left ureter in the pelvis. Immediate laparotomy finds perforation of the left ureter secondary to a thermal injury. She undergoes ureteroneocystotomy and recovers.

This case illustrates one of the most common complications of operative hysteroscopy: uterine perforation with collateral injury. Both could have been avoided if the Ob/Gyn had stopped the procedure when bleeding first occurred, removed the instruments, and allowed the uterus to contract spontaneously.

This is just one of the strategies that can reduce the risks of hysteroscopic surgery. Numerous reports confirm that operative hysteroscopy is safe and effective, but as more gynecologists perform an increasing number of procedures, we must be aware of potential complications and do our best to minimize risk to our patients.

Complications cannot be completely avoided, and may occur when a procedure is done correctly by experienced doctors. They are far more likely if techniques or equipment are used improperly. This article describes ways to minimize risk.

When the American Association of Gynecologic Laparoscopists (AAGL) surveyed its members in 1993, it found a complication rate of 2% for operative hysteroscopy.1 The rate of major complications—perforation, hemorrhage, fluid overload, and bowel or urinary tract injury—was less than 1%. A prospective multicenter trial2 of 13,600 procedures in the Netherlands found a higher complication rate for operative (0.95%) than for diagnostic hysteroscopy (0.13%).

Preoperative precautions

We can reduce the risk of complications if contraindications are not ignored, equipment is thoroughly inspected and understood, and the surgeon goes through a mental checklist and plans each procedure. A “time out”before the operation begins, when every member of the team is briefed, is also valuable in preventing errors.

A hands-on course necessary before undertaking advanced resectoscopic surgery, to become familiar with equipment and techniques, followed by proctoring by a surgeon credentialed for the procedure.

Contraindications

Ignoring contraindications to hysteroscopic surgery increases the risk of complications and is the single greatest factor leading to patient injury and physician liability.

Contraindications include:

  • Unfamiliarity with equipment, instruments, or technique
  • Lack of appropriate equipment or staff familiar with the equipment
  • Acute pelvic inflammatory disease
  • Pregnancy
  • Genital tract malignancies
  • Lack of informed consent
  • Inability to dilate the cervix
  • Inability to distend the uterus to obtain visualization
  • Poor surgical candidates who may not tolerate fluid overload because of renal disease, or radiofrequency current when a cardiac pacemaker is present
  • The patient desires and expects complete amenorrhea3

Mechanical or traumatic complications

These types of complications are among the most common. Other categories include preoperative complications (ie, improper patient selection and lack of informed consent), electrosurgical and gaseous, complications related to distention media, and postoperative complications (ie, infection and late sequelae).

 

 

Inability to insert the hysteroscope

This may be caused by a stenotic, nulliparous cervix; menopause; GnRH agonists; previous cone biopsy, laceration, or cryosurgery; or an acutely retroflexed or anteflexed uterus.

Acute flexion problems can be corrected using a long-bladed, open-sided Graves speculum deep in the anterior or posterior fornix. The speculum pushes the fundus to the midposition and facilitates dilation. Once the hysteroscope is inserted, remove the speculum.

Placing a tenaculum on the posterior lip of the cervix of an acutely retroflexed uterus will straighten the cervical canal when traction is applied.

Inserting a laminaria tent the evening before surgery helps dilate the cervix easily and atraumatically.4 However, the laminaria can sometimes create a false passage, leading to perforation.

Cervical ripening agents such as intravaginal or oral misoprostol (200 μg inserted vaginally or 400 μg orally 8 to 12 hours preoperatively) also can facilitate dilation.

Intracervical injection of vasopressin solution (4 IU in 100 cc sodium chloride, injected at the 4 and 8 o’clock positions) can reduce the force needed to dilate the cervix.5 Half-size dilators may help; they also reduce the risk of cervical laceration.

Laceration of the cervix

Although this is a minor complication, substantial bleeding sometimes occurs when the cervix is lacerated by the tenaculum. In these cases, suture the cervix.

Occasionally, a touch of cautery from the rollerball electrode at low power (20 to 30 W) can control the bleeding.

Silver nitrate sticks or ferric subsulfate (Monsel’s) paste are also effective on superficial lacerations.

Bleeding from lower uterus or cervical canal can obscure view

In some cases, bleeding is delayed, necessitating additional surgery. Intravasation of distention fluid also can occur at these lacerations. Coagulation with the electrode may be necessary when bleeding is heavy.

Check for collateral injury when uterine perforation occurs

Perforation is a well-documented risk of operative hysteroscopy and should be discussed with the patient when obtaining informed consent. In the AAGL survey,1 the incidence of perforation was 14 per 1,000. It was even higher during transection of lateral and fundal adhesions: 2 to 3 per 100.6

Although perforation is more common with thermal energy sources, it may occur mechanically when scissors are used to transect a uterine septum, synechiae, or polyps.

When the cervix is stenotic or the uterus is acutely ante- or retroflexed, sounds and dilators can perforate the uterus.

Most perforations—even those involving large dilators—usually do not require treatment, although further assessment may be necessary to rule out bowel injury. Most perforations occur in the fundal region or posterior lower segment.

A false passage can be created when entering the uterus. Occasionally the surgeon may be fooled into thinking the hysteroscope is in the uterine cavity, since the false passage distends (FIGURE 1). If muscle fibers are visible and the tubal ostea are not, assume the passage is false. Slowly remove the hysteroscope and identify the true cavity for confirmation. Discontinue the procedure—even if no perforation is detected—to prevent distention fluid from being absorbed into the circulation through the injury. Adequate distention is not possible at this time.

Delay repeat hysteroscopy for 2 to 3 months.

To avoid creating a false passage, dilate the cervix with slow, steady pressure and stop as soon as the internal os opens; do not attempt to push the dilator to the uterine fundus.

Often the external os opens, but the internal os cannot be dilated the extra 1 to 2 mm necessary to accommodate the 27-French resectoscope. Rather than exert more force and risk perforation or laceration, simply turn on the resectoscope’s inflow with the outflow shut off, and let the fluid pressure dilate the cervix.

Always insert the hysteroscope or resectoscope under direct vision rather than use an obturator. Keep the “dark circle” in the center of the field and slowly advance the hysteroscope toward it until the cavity is reached.

Avulsion of the myometrium sometimes occurs during removal of incompletely resected myomas (FIGURE 2). Keep the myoma grasper away from the fundus when removing myoma segments, and avoid excessive traction on what may be a thin segment of myometrium. Injuries can occur when the grasper perforates the uterus and bowel is inadvertently grasped. Large injuries require laparoscopic repair.

Perforation is more likely in repeat procedures. In a report of 80 repeat endometrial ablations, Townsend and colleagues7 noted 8 perforations that prevented completion of the procedure. In a series of 75 repeat ablations compared with 800 primary ablations by the same surgeon, the rate of serious perioperative complications was significantly higher in the repeat ablation group (9.3% versus 2.0%).8

 

 

When perforation occurs during the use of thermal energy, laparoscopy is necessary to assess the organs overlying the site.9 During setup for laparoscopy, bring the hysteroscope near the area of perforation to inspect the bowel beyond the uterus. Since the pelvis fills quickly with distention fluid, the hysteroscope can even be placed through the perforation to yield an excellent view of the undersurfaces of the bowel immediately adjacent to the injured area (FIGURE 3). (Disconnect the electrosurgical cord before doing this!)

Thorough laparoscopic inspection of the bowel in the pelvis often reveals thermal injury, which appears as a whitish patch on the bowel serosa. To repair bowel injuries, bring the injured segment out through a minilaparotomy and excise the damage with a 2- to 3-cm border. A general surgeon should be called in to consult.

When perforation is imminent, the “serosal sign” appears

A 42-year-old woman who underwent endometrial ablation 2 years earlier presents with persistent menorrhagia and a 12-week–size fibroid uterus and expresses a desire for repeat ablation. At the second surgery, the uterine cavity appears scarred, with multiple synechiae.

As the procedure progresses, the uterine serosa becomes visible from within the cavity, appearing as a smooth, bluish structure that can be moved with only slight pressure. As the ablation continues, the uterus perforates, necessitating laparoscopic inspection of the organs overlying the site.

Although the patient recovers, her menorrhagia eventually returns, and she opts for laparoscopically assisted vaginal hysterectomy 1 year later.

Uterine perforation is more likely during repeat procedures

This case illustrates one of the most common risks of operative hysteroscopy: uterine perforation, which occurs more frequenly in repeat procedures.

The case also highlights an important indicator of perforation: the serosal sign, which I first described in 1996.24 When the smooth, bluish structure appears, cease ablation in the region immediately.

If no injury is apparent, discharge the patient but follow her closely, including daily white blood cell counts for 4 to 5 days. Instruct her to take her temperature twice daily and return to the hospital immediately if any signs of bowel perforation develop. Delayed perforation from thermal injury can occur as late as 2 weeks following surgery, and the patient should be apprised of this possibility.

FIGURE 1 Signs of a false passage


Myometrial fibers signal that a false passage has been created. Stop the procedure even if no perforation is detected, to prevent distention fluid from being absorbed into the circulation through the injury.

FIGURE 2 Risk of myomectomy: Myometrial avulsion


Small bowel visible within the uterine cavity after avulsion of uterine wall at the time of myomectomy

FIGURE 3 Use the hysteroscope to assess perforation site


Hysteroscopic view of perforation at the fundus. The small bowel is visible beyond the perforation at left.

Intraoperative bleeding is rare

Bleeding is unlikely unless vessels are lacerated or injured in the cervical canal or lower uterine segment during dilation or deep ablation or vaporization. Bleeding is more common when endomyometrial resection is performed with the wire loop electrode or during ablation or vaporization of fibroids. Bleeding sufficient to require intervention occurs at a rate of 0.5% to 1.9% in several reported series.

To achieve hemostasis via balloon tamponade, insert a Foley catheter with a 30-cc balloon into the uterine cavity, inject 15 to 20 mL (or more for a larger cavity) of fluid into the balloon, and observe the patient.10 If there is no bleeding in 1 hour, remove half the fluid. Remove the remainder of the fluid and the catheter over the next hour if no further bleeding occurs.

Alternative method: Pack the uterus. I prefer 1/2-inch–gauge packing that has been soaked in a dilute vasopressin solution (20 U [1 mL] in 60 mL normal saline).11

The benefits of vasopressin. Before balloon tamponade or packing the uterus, I inject very dilute vasopressin (4 U [0.2 mL] in 60 mL normal saline) directly into the cervix 2 cm deep, at the 4 and 8 o’clock positions. Phillips12 demonstrated a marked decrease in blood loss during resectoscopic surgery using this approach. I also do this routinely prior to operative hysteroscopy, since the vasopressin-induced vasoconstriction reduces intravasation of distention media.

A vaporizing electrode may prevent significant blood loss during myoma resection by sealing blood vessels as the tissue is vaporized.13 All major manufacturers of hysteroscopic equipment produce these electrodes.

In my series of 44 endometrial ablations and hysteroscopic myomectomies performed with the vaporizing electrode, blood loss was “minimal” or less than 50 mL in 29 cases. The maximum blood loss was 300 mL in a patient with a 4-cm submucous myoma who was managed emergently for hemorrhage.14 In another case, during resection of a 5-cm submucous myoma, I encountered significant bleeding from large vessels at the base of the myoma, which required intrauterine tamponade with a vasopressin-soaked pack.

 

 

Preoperative measures may decrease vascularity. In their analysis of 16 randomized and nonrandomized controlled trials published in the English literature between 1990 and 1996, Parazzini and colleagues15 found that preoperative danazol or GnRH agonists decreased the thickness and vascularity of the endometrium and shrank myomata, resulting in shorter operating times, less blood loss, and less intravasation of distending fluid.

Electrosurgical and gaseous complications

Most electrosurgical complications involve activation of an electrode at the time of perforation, or current diversion to the outer sheath.

Thermal injuries also can be caused by overheating of the return pad or use of a weighted speculum that has not fully cooled after removal from the autoclave. The latter can be avoided by immersing the entire speculum in cool saline for at least 1 to 2 minutes prior to inserting it into the vagina. The blade cools much faster than the weighted ball, so be sure to check both to prevent a perineal or buttock burn.

Perforation with an active electrode

This usually occurs when current is applied as the electrode is extended or the resectoscope is moved toward the fundus. It can be avoided if the electrode is activated only when moving it toward the operator.

Perforations with intraabdominal burns also have occurred during attempts to coagulate bleeders—especially in the cornual regions.

Diversion of current can be destructive

Genital tract injuries have occurred as a result of current diversion. Vilos and colleagues16 reported 13 electrical burns during endometrial ablation, and mention many more anecdotal reports. The usual cause: electrode insulation failure, which allows current to jump to the outer sheath of the resectoscope.

To avoid this, inspect all electrodes thoroughly before surgery and use them only once.

Capacitative coupling also diverts current

Since the sheath-within-a-sheath design of the resectoscope resembles a capacitor, high-voltage current can jump to the outer sheath without direct contact from the electrode. When Munro17 bench-tested electrosurgical generators and electrodes with and without insulation defects, he found that capacitative coupling with intact electrodes occurred more frequently with high-voltage coagulation current than with lower-voltage cutting current.

One way to avoid these injuries is to activate the electrode intermittently, with short bursts, rather than rolling back and forth over an area with continuous current. Another strategy is placing a damp sponge in the posterior vagina extending out the introitus; this protects the mucosa and perineal skin—especially in obese patients.

How to avoid return-pad injuries

Keep the patient’s thigh completely dry; ensure that the pad is flat against the skin at application, with no bubbles or creases; and use only return electrode monitor (REM) dispersive pads.

Especially when using vaporization electrodes, avoid prolonged activation of the electrode at high power. To minimize risk of vaporization, use a second dispersive pad connected to the first via a “y” connector to further disperse current and heat at the return pad.

Also, limit the use of coagulation current and use a maximum generator setting of 60 to 80 W in the coagulation mode.

Take steps to avert gas embolism, but watch closely for signs

Initial reports of this potentially fatal complication came mostly from laser ablation procedures, but gas embolism can occur during all diagnostic and operative hysteroscopic procedures, especially the latter.

Sources of gas embolism: room air, carbon dioxide, carbon monoxide, and other gaseous products of vaporization or tissue combustion. The anesthesiologist is usually the first to identify the signs.

Signs of gas embolism. The surgeon should ask to be immediately alerted to any sudden fall in oxygen saturation, as well as to hypotension, hypercarbia, arrhythmias, tachypnea, or a “mill wheel” murmur. If any of these signs are detected and a gas embolism is suspected, stop the procedure and ventilate the patient with 100% oxygen.

Carbon dioxide is a soluble gas, so these emboli generally resolve rapidly. In contrast, room air emboli are more likely to be fatal.

Reduce the risk of air embolism by avoiding the Trendelenburg position and leaving the last dilator in the cervix until just before inserting the resectoscope.

Also limit repetitive removal and reinsertion of the resectoscope, as often occurs during myoma resection. By vaporizing rather than resecting myomas, it is possible to eliminate the need to continually remove fibroid chips. Preoperative GnRH agonists narrow venous sinuses and help prevent this complication.

Intracervical injection of dilute vasopressin prior to dilatation of the cervix creates vascular spasm and may help prevent gas from entering the circulation.

Complications from distention media

Excess absorption of distention media is one of the most frequent complications. Most surgeons use low-viscosity, sodium-free fluids for operative hysteroscopy, since fluids that contain electrolytes are incompatible with monopolar electrosurgical instruments. The use of 3% sorbitol, 1.5% glycine, or sorbitol-mannitol solutions can lead to dilutional hyponatremia and hypoosmolality.18 Although the vast majority of women quickly recover from these conditions, some cases of permanent morbidity and even death have been reported.19 The overall incidence of dilutional hyponatremia was 0.2% in 1993, according to the AAGL member survey.1

 

 

Hyponatremia and hypoosmolality more likely in premenopausal women

These conditions may have catastrophic consequences if they are not recognized and corrected promptly. The brain swells as it attempts to become isoosmotic with the vascular system. If swelling exceeds 5%, the risk of severe neurological damage dramatically increases.

This is an important problem in premenopausal women, since estrogen and progesterone inhibit sodium-potassium adenosine triphosphatase (ATPase) activity in the brain. This sodium pump protects the brain against cerebral edema, which can cause herniation of the brain stem and death. Although men and postmenopausal women develop dilutional hyponatremia, they are less likely to suffer brain damage because the sodium pump is intact.

Taskin et al20 conducted a randomized trial showing an increase in the sodium-potassium ATPase pump activity and decreased volume deficit during hysteroscopic surgery in patients pretreated with a GnRH agonist, compared with a control group. This increased pump activity in the brain and endometrium may decrease women’s susceptibility to hyponatremic complications and brain damage.

Vigilant monitoring of fluid intake/output during hysteroscopic surgery is necessary to prevent hyponatremic complications. Avoid the pitfall of erroneously attributing deficits to fluid “in the drapes” by using drapes with a fluid-collection pouch.

The standard of care is use of electronic inflow-outflow measuring systems. Manufacturers of hysteroscopic equipment offer highly accurate electronic fluid monitoring systems that measure the weight of the distending fluid infused and collected rather than relying on manual estimation of deficit. The latter method may be inaccurate since the volume of the supply bag can vary by as much as 10%.

Adjust intrauterine pressure to reduce the likelihood of intravasation. High intrauterine pressure may be desirable for visualization, but it greatly increases the risk of intravasation.

I adjust pressure and flow rates by opening or closing the inflow and outflow valves of the resectoscope until slight amounts of bleeding from resected tissue can be visualized. Since intrauterine pressure is extremely difficult to monitor accurately during operative hysteroscopy, this practice ensures that it remains below the patient’s mean arterial pressure, thus minimizing the risk of intravasation.

Use a dilute vasopressin injection to constrict blood vessels and decrease the chance of intravasation.

Vaporizing electrodes for myoma resection and ablation seal blood vessels and reduce fluid absorption.

Guidelines for distention media

To reduce the likelihood of these complications, I recommend that surgeons:

  • Draw preoperative serum electrolytes for a baseline in all patients.
  • Give all patients with myomas 2 monthly injections of depot leuprolide acetate (3.75 mg intramuscularly). Give patients without fibroids a single injection 4 to 6 weeks prior to the procedure.
  • Place a fluid-collection drape or a larger, plastic Mayo stand cover with the bottom cut off under the patient’s buttocks so that fluid drains into a “kick” bucket. Also adjust the resectoscope’s outflow tubing to drain into the collection bag, which should be kept on constant suction to the flow-stat electronic fluid monitor.
  • Continuously record inflow and outflow using the electronic monitor with the deficit alarm set to 500 mL.
  • Keep distention fluid at room temperature and monitor the patient’s core temperature continuously. Significant fluid intravasation will lower the patient’s temperature, and this may be the first sign of fluid overload.
  • Perform operative hysteroscopy under spinal or epidural anesthesia so the anesthesiologist can continually assess the patient’s sensorium. Confusion and irritability are early signs of dilutional hyponatremia.
  • If the fluid deficit reaches 750 mL, immediately give 20 to 40 mg of intravenous furosemide and draw a serum sodium. Do not wait for the result of the sodium level before treatment, since a 5- to 20-minute delay can be catastrophic.
  • Interrupt the procedure for 5 to 10 minutes to allow the uterus to contract and to seal off small blood vessels.
  • Discontinue the procedure if the fluid deficit reaches 1,500 mL or if the serum sodium level is below 125 mEq/L.

I do not limit the duration of resectoscopic procedures as long as fluid deficits are below 750 mL, as measured by electronic fluid monitor. I also ensure that the operating room staff is well educated in the use of the monitor and able to troubleshoot intraoperatively.

If the machine fails during the procedure, reset it with the alarm limit lowered to reflect the deficit recorded before failure.

Monitor the color of the outflow fluid. Excessive blood loss counted as part of the outflow can occasionally mask a distention fluid deficit.

Choosing a distention medium

There is no ideal distention medium for monopolar operative hysteroscopy. Several authors have suggested that 5% mannitol is advantageous since it is isosmolar and acts as an osmotic diuretic. However, it does not prevent hyponatremia. The main disadvantage of 5% mannitol is its high cost and limited availability in 3-L bags or 4-L bottles.

 

 

The use of bipolar devices in normal saline prevents dilutional hyponatremia, but fluid deficits must still be monitored electronically so they do not exceed 2,000 mL. The false sense of security that may occur when normal saline is used for distention may lead to inaction when a large deficit occurs. This can lead to pulmonary edema and death.

Postoperative and late complications

These include infection, endometrial cancer, iatrogenic adenomyosis, hematometria, post-ablation tubal ligation syndrome, and pregnancy.

Infection rate is 0.3% to 2%

Infection is relatively rare following endometrial ablation, with a rate of 0.3% to 0.5% reported in most series. Endometritis, parametritis, and pyometra are more common following resection of submucous myomas, with rates as high as 2% reported.

Infection is more likely after prolonged procedures, especially when the hysteroscope is repeatedly inserted and removed. It also is more likely if the patient has a history of pelvic inflammatory disease. I generally administer prophylactic antibiotics (1 dose of intravenous ceftizoxime, 1 g, approximately 30 to 60 minutes prior to surgery).

I also insert a laminaria tent the evening prior to surgery. Patients with a history of pelvic inflammatory disease are discharged on doxycycline (100 mg twice daily for 7 days).

Be alert for endometrial cancer

This malignancy has been diagnosed at the time of endometrial ablation and reported in patients who have undergone prior endometrial ablations or fibroid resections. Thus, endometrial sampling should be part of the workup of abnormal uterine bleeding before the patient is scheduled for operative hysteroscopy. In women at high risk for endometrial cancer, perform office diagnostic hysteroscopy, with directed biopsy of any suspicious areas.

When viable endometrial glands are “buried” during ablation, or synechiae develop, preventing the egress of blood, there is a chance that diagnosis of endometrial cancer will be delayed. However, this theoretical fear has not been proven clinically.

Patients whose abnormal bleeding recurs after ablation should undergo sampling and office hysteroscopy, just as if they had not undergone a previous ablation. Theoretically, women who undergo endomyometrial resection or vaporization should have a lower incidence of endometrial cancer, since the tissue most susceptible to malignancy is removed. This has not yet been proven scientifically.

In their comprehensive review of late complications of operative hysteroscopy, Cooper and Brady21 suggest that patients at high risk for endometrial cancer who present with abnormal uterine bleeding not controlled by hormones might be better served by hysterectomy. Unfortunately, these patients tend to be high-risk surgical candidates.

If atypia is present, do not perform endometrial ablation or resection. I do perform ablation and resection in patients with complex hyperplasia without atypia if it has been reversed with progestin and does not recur for at least 6 months without progestin therapy. These patients undergo office hysteroscopy and sampling of the endometrium before operative hysteroscopy is scheduled.

Iatrogenic adenomyosis

Two theories suggest this is a late complication of operative hysteroscopy. According to the first, when the endometrium is incompletely resected, scarring over this tissue causes the viable glands to grow into the myometrium. The other theory suggests that viable endometrial debris is transported into the myometrium by vessels opened at resection.

I have found that using the vaporization electrode followed by application of a rollerball over the surface of the cavity most effectively reaches maximal tissue depth and, theoretically, prevents adenomyosis. Since most adenomyosis occurs on the posterior wall, I take a strip from this area for pathologic analysis to determine whether adenomyosis preceded the ablation or developed subsequent to it.

Hematometria

This can occur following operative hysteroscopy if viable glands are left in the fundal or cornual region and synechiae develop in the lower segment, preventing egress of blood. It also can occur if the upper endocervix is ablated and subsequently scars, causing stenosis. To avoid this, ablate only to the level of the internal os.

Diagnosis and treatment. Hematometria can be diagnosed easily by ultrasound and treated with office hysteroscopy using a narrow-diameter, rigid, continuous-flow hysteroscope with an operating channel to pass small instruments.

Post-ablation tubal ligation syndrome

This is cornual hematometria that develops when viable endometrial cells are left in the cornua when the cavity also contains synechiae, causing cyclic bleeding. Since there is no egress from the cervix or tubes, blood gradually builds up, leading to hematosalpinx and pain. One way to avoid this is to ensure complete ablation of the cornual endometrium.

Prevention. Some experts recommend that the small rollerball electrode be placed in the cornua, with slightly reduced intrauterine pressure, to allow the cornual endometrium to collapse around the rollerball. A short burst of current is then applied to ablate the tissue.

 

 

This complication is less likely after hydrothermablation, since the free-flowing saline ablates the cornua completely. After more than 50 hydrothermablations performed in patients with prior tubal sterilizations, I have not seen any cases of post-ablation tubal ligation syndrome.

Treatment consists of bilateral salpingectomy or tubal fulguration at the cornual region and repeat ablation or resection of viable endometrial tissue. Another option is hysterectomy.

Post-ablation pregnancy can be very complicated

Pregnancy after endometrial ablation occurs at a rate of 0.2% to 1.6%. Counsel patients that this procedure does not prevent pregnancy and that contraception is vital. Uterine rupture after fibroid resection has been reported.

In a review of 37 post-ablation pregnancies, only 11 of 17 women who chose not to terminate carried the gestation beyond 28 weeks. In addition, there was a high incidence of intrauterine growth restriction, prematurity, and placenta accreta.22

Hysteroscopic tubal sterilization with the Essure system (Conceptus, San Carlos, Calif), or laparoscopic tubal fulguration performed at the time of ablation averts these complications.

Complications of global ablation

Global ablation technologies were developed to enable gynecologists with limited operative hysteroscopy skills to perform endometrial ablation and to make ablation safer for the patient. These technologies completely eliminate the risk of distention-media complications, but widespread use has resulted in other complications that have been reported in the literature to only a limited extent.

Most published articles on global endometrial ablation are from the original US Food and Drug Administration (FDA) trials, in which the complication rates were extraordinarily low. Widespread commercial use of these technologies since FDA approval, especially by practitioners with limited skills, has increased complications.

Do not override safety systems

Complications are more frequent when devices are misused or safety systems overridden. And, fear of litigation makes physicians unwilling to report complications.

In the FDA Manufacturer and User Facility Device Experience (MAUDE) database (www.fda.gov.cdrh/maude.html), complications include bowel burns after unrecognized perforation, and bowel burns associated with electrosurgical, microwave energy, or heat transferred through intact myometrium.23 Vaginal burns, uterine necrosis myometritis requiring hysterectomy, and death from unrecognized bowel burn also have been reported.

Most global procedures are performed blindly, and some doctors fail to perform diagnostic hysteroscopy before and after surgery, which I feel is mandatory with any endometrial ablation. Hydrothermablation is the only global technique that has the advantage of direct observation. In more than 150 procedures done in my office under local anesthesia, the only complications were 2 false passages. Both were promptly identified during diagnostic hysteroscopy, and the surgery was rescheduled 2 to 3 months later.

The author has served on the speakers’ bureau for Boston Scientific.

KEY POINTS

  • Perform endometrial sampling for abnormal uterine bleeding before scheduling operative hysteroscopy.
  • Most uterine perforations do not require treatment— even those involving large dilators—although further assessment may be necessary to rule out bowel injury.
  • Most complications of electrosurgery involve activating an electrode at the time of perforation, or diverting current to the outer sheath.
  • Scrupulously monitor fluid intake and output to prevent hyponatremic complications.

WHAT WENT WRONG?

A 44-year-old woman undergoing resection of a submucous myoma from the left cornual region has persistent bleeding at the resection site. The surgeon continues coagulation at the bleeding site, using a rollerball electrode in an attempt to achieve hemostasis, but perforates the uterus. Immediate laparoscopy to identify collateral injury reveals some thermal damage on the posterior leaf of the broad ligament, but no bowel injury. After 24 hours of observation, she is afebrile without leukocytosis. She is discharged with explicit instructions to return if she has symptoms suggesting bowel injury. She returns in 72 hours, with abdominal pain and low-grade fever. CT reveals extravasation of contrast from the left ureter in the pelvis. Immediate laparotomy finds perforation of the left ureter secondary to a thermal injury. She undergoes ureteroneocystotomy and recovers.

This case illustrates one of the most common complications of operative hysteroscopy: uterine perforation with collateral injury. Both could have been avoided if the Ob/Gyn had stopped the procedure when bleeding first occurred, removed the instruments, and allowed the uterus to contract spontaneously.

This is just one of the strategies that can reduce the risks of hysteroscopic surgery. Numerous reports confirm that operative hysteroscopy is safe and effective, but as more gynecologists perform an increasing number of procedures, we must be aware of potential complications and do our best to minimize risk to our patients.

Complications cannot be completely avoided, and may occur when a procedure is done correctly by experienced doctors. They are far more likely if techniques or equipment are used improperly. This article describes ways to minimize risk.

When the American Association of Gynecologic Laparoscopists (AAGL) surveyed its members in 1993, it found a complication rate of 2% for operative hysteroscopy.1 The rate of major complications—perforation, hemorrhage, fluid overload, and bowel or urinary tract injury—was less than 1%. A prospective multicenter trial2 of 13,600 procedures in the Netherlands found a higher complication rate for operative (0.95%) than for diagnostic hysteroscopy (0.13%).

Preoperative precautions

We can reduce the risk of complications if contraindications are not ignored, equipment is thoroughly inspected and understood, and the surgeon goes through a mental checklist and plans each procedure. A “time out”before the operation begins, when every member of the team is briefed, is also valuable in preventing errors.

A hands-on course necessary before undertaking advanced resectoscopic surgery, to become familiar with equipment and techniques, followed by proctoring by a surgeon credentialed for the procedure.

Contraindications

Ignoring contraindications to hysteroscopic surgery increases the risk of complications and is the single greatest factor leading to patient injury and physician liability.

Contraindications include:

  • Unfamiliarity with equipment, instruments, or technique
  • Lack of appropriate equipment or staff familiar with the equipment
  • Acute pelvic inflammatory disease
  • Pregnancy
  • Genital tract malignancies
  • Lack of informed consent
  • Inability to dilate the cervix
  • Inability to distend the uterus to obtain visualization
  • Poor surgical candidates who may not tolerate fluid overload because of renal disease, or radiofrequency current when a cardiac pacemaker is present
  • The patient desires and expects complete amenorrhea3

Mechanical or traumatic complications

These types of complications are among the most common. Other categories include preoperative complications (ie, improper patient selection and lack of informed consent), electrosurgical and gaseous, complications related to distention media, and postoperative complications (ie, infection and late sequelae).

 

 

Inability to insert the hysteroscope

This may be caused by a stenotic, nulliparous cervix; menopause; GnRH agonists; previous cone biopsy, laceration, or cryosurgery; or an acutely retroflexed or anteflexed uterus.

Acute flexion problems can be corrected using a long-bladed, open-sided Graves speculum deep in the anterior or posterior fornix. The speculum pushes the fundus to the midposition and facilitates dilation. Once the hysteroscope is inserted, remove the speculum.

Placing a tenaculum on the posterior lip of the cervix of an acutely retroflexed uterus will straighten the cervical canal when traction is applied.

Inserting a laminaria tent the evening before surgery helps dilate the cervix easily and atraumatically.4 However, the laminaria can sometimes create a false passage, leading to perforation.

Cervical ripening agents such as intravaginal or oral misoprostol (200 μg inserted vaginally or 400 μg orally 8 to 12 hours preoperatively) also can facilitate dilation.

Intracervical injection of vasopressin solution (4 IU in 100 cc sodium chloride, injected at the 4 and 8 o’clock positions) can reduce the force needed to dilate the cervix.5 Half-size dilators may help; they also reduce the risk of cervical laceration.

Laceration of the cervix

Although this is a minor complication, substantial bleeding sometimes occurs when the cervix is lacerated by the tenaculum. In these cases, suture the cervix.

Occasionally, a touch of cautery from the rollerball electrode at low power (20 to 30 W) can control the bleeding.

Silver nitrate sticks or ferric subsulfate (Monsel’s) paste are also effective on superficial lacerations.

Bleeding from lower uterus or cervical canal can obscure view

In some cases, bleeding is delayed, necessitating additional surgery. Intravasation of distention fluid also can occur at these lacerations. Coagulation with the electrode may be necessary when bleeding is heavy.

Check for collateral injury when uterine perforation occurs

Perforation is a well-documented risk of operative hysteroscopy and should be discussed with the patient when obtaining informed consent. In the AAGL survey,1 the incidence of perforation was 14 per 1,000. It was even higher during transection of lateral and fundal adhesions: 2 to 3 per 100.6

Although perforation is more common with thermal energy sources, it may occur mechanically when scissors are used to transect a uterine septum, synechiae, or polyps.

When the cervix is stenotic or the uterus is acutely ante- or retroflexed, sounds and dilators can perforate the uterus.

Most perforations—even those involving large dilators—usually do not require treatment, although further assessment may be necessary to rule out bowel injury. Most perforations occur in the fundal region or posterior lower segment.

A false passage can be created when entering the uterus. Occasionally the surgeon may be fooled into thinking the hysteroscope is in the uterine cavity, since the false passage distends (FIGURE 1). If muscle fibers are visible and the tubal ostea are not, assume the passage is false. Slowly remove the hysteroscope and identify the true cavity for confirmation. Discontinue the procedure—even if no perforation is detected—to prevent distention fluid from being absorbed into the circulation through the injury. Adequate distention is not possible at this time.

Delay repeat hysteroscopy for 2 to 3 months.

To avoid creating a false passage, dilate the cervix with slow, steady pressure and stop as soon as the internal os opens; do not attempt to push the dilator to the uterine fundus.

Often the external os opens, but the internal os cannot be dilated the extra 1 to 2 mm necessary to accommodate the 27-French resectoscope. Rather than exert more force and risk perforation or laceration, simply turn on the resectoscope’s inflow with the outflow shut off, and let the fluid pressure dilate the cervix.

Always insert the hysteroscope or resectoscope under direct vision rather than use an obturator. Keep the “dark circle” in the center of the field and slowly advance the hysteroscope toward it until the cavity is reached.

Avulsion of the myometrium sometimes occurs during removal of incompletely resected myomas (FIGURE 2). Keep the myoma grasper away from the fundus when removing myoma segments, and avoid excessive traction on what may be a thin segment of myometrium. Injuries can occur when the grasper perforates the uterus and bowel is inadvertently grasped. Large injuries require laparoscopic repair.

Perforation is more likely in repeat procedures. In a report of 80 repeat endometrial ablations, Townsend and colleagues7 noted 8 perforations that prevented completion of the procedure. In a series of 75 repeat ablations compared with 800 primary ablations by the same surgeon, the rate of serious perioperative complications was significantly higher in the repeat ablation group (9.3% versus 2.0%).8

 

 

When perforation occurs during the use of thermal energy, laparoscopy is necessary to assess the organs overlying the site.9 During setup for laparoscopy, bring the hysteroscope near the area of perforation to inspect the bowel beyond the uterus. Since the pelvis fills quickly with distention fluid, the hysteroscope can even be placed through the perforation to yield an excellent view of the undersurfaces of the bowel immediately adjacent to the injured area (FIGURE 3). (Disconnect the electrosurgical cord before doing this!)

Thorough laparoscopic inspection of the bowel in the pelvis often reveals thermal injury, which appears as a whitish patch on the bowel serosa. To repair bowel injuries, bring the injured segment out through a minilaparotomy and excise the damage with a 2- to 3-cm border. A general surgeon should be called in to consult.

When perforation is imminent, the “serosal sign” appears

A 42-year-old woman who underwent endometrial ablation 2 years earlier presents with persistent menorrhagia and a 12-week–size fibroid uterus and expresses a desire for repeat ablation. At the second surgery, the uterine cavity appears scarred, with multiple synechiae.

As the procedure progresses, the uterine serosa becomes visible from within the cavity, appearing as a smooth, bluish structure that can be moved with only slight pressure. As the ablation continues, the uterus perforates, necessitating laparoscopic inspection of the organs overlying the site.

Although the patient recovers, her menorrhagia eventually returns, and she opts for laparoscopically assisted vaginal hysterectomy 1 year later.

Uterine perforation is more likely during repeat procedures

This case illustrates one of the most common risks of operative hysteroscopy: uterine perforation, which occurs more frequenly in repeat procedures.

The case also highlights an important indicator of perforation: the serosal sign, which I first described in 1996.24 When the smooth, bluish structure appears, cease ablation in the region immediately.

If no injury is apparent, discharge the patient but follow her closely, including daily white blood cell counts for 4 to 5 days. Instruct her to take her temperature twice daily and return to the hospital immediately if any signs of bowel perforation develop. Delayed perforation from thermal injury can occur as late as 2 weeks following surgery, and the patient should be apprised of this possibility.

FIGURE 1 Signs of a false passage


Myometrial fibers signal that a false passage has been created. Stop the procedure even if no perforation is detected, to prevent distention fluid from being absorbed into the circulation through the injury.

FIGURE 2 Risk of myomectomy: Myometrial avulsion


Small bowel visible within the uterine cavity after avulsion of uterine wall at the time of myomectomy

FIGURE 3 Use the hysteroscope to assess perforation site


Hysteroscopic view of perforation at the fundus. The small bowel is visible beyond the perforation at left.

Intraoperative bleeding is rare

Bleeding is unlikely unless vessels are lacerated or injured in the cervical canal or lower uterine segment during dilation or deep ablation or vaporization. Bleeding is more common when endomyometrial resection is performed with the wire loop electrode or during ablation or vaporization of fibroids. Bleeding sufficient to require intervention occurs at a rate of 0.5% to 1.9% in several reported series.

To achieve hemostasis via balloon tamponade, insert a Foley catheter with a 30-cc balloon into the uterine cavity, inject 15 to 20 mL (or more for a larger cavity) of fluid into the balloon, and observe the patient.10 If there is no bleeding in 1 hour, remove half the fluid. Remove the remainder of the fluid and the catheter over the next hour if no further bleeding occurs.

Alternative method: Pack the uterus. I prefer 1/2-inch–gauge packing that has been soaked in a dilute vasopressin solution (20 U [1 mL] in 60 mL normal saline).11

The benefits of vasopressin. Before balloon tamponade or packing the uterus, I inject very dilute vasopressin (4 U [0.2 mL] in 60 mL normal saline) directly into the cervix 2 cm deep, at the 4 and 8 o’clock positions. Phillips12 demonstrated a marked decrease in blood loss during resectoscopic surgery using this approach. I also do this routinely prior to operative hysteroscopy, since the vasopressin-induced vasoconstriction reduces intravasation of distention media.

A vaporizing electrode may prevent significant blood loss during myoma resection by sealing blood vessels as the tissue is vaporized.13 All major manufacturers of hysteroscopic equipment produce these electrodes.

In my series of 44 endometrial ablations and hysteroscopic myomectomies performed with the vaporizing electrode, blood loss was “minimal” or less than 50 mL in 29 cases. The maximum blood loss was 300 mL in a patient with a 4-cm submucous myoma who was managed emergently for hemorrhage.14 In another case, during resection of a 5-cm submucous myoma, I encountered significant bleeding from large vessels at the base of the myoma, which required intrauterine tamponade with a vasopressin-soaked pack.

 

 

Preoperative measures may decrease vascularity. In their analysis of 16 randomized and nonrandomized controlled trials published in the English literature between 1990 and 1996, Parazzini and colleagues15 found that preoperative danazol or GnRH agonists decreased the thickness and vascularity of the endometrium and shrank myomata, resulting in shorter operating times, less blood loss, and less intravasation of distending fluid.

Electrosurgical and gaseous complications

Most electrosurgical complications involve activation of an electrode at the time of perforation, or current diversion to the outer sheath.

Thermal injuries also can be caused by overheating of the return pad or use of a weighted speculum that has not fully cooled after removal from the autoclave. The latter can be avoided by immersing the entire speculum in cool saline for at least 1 to 2 minutes prior to inserting it into the vagina. The blade cools much faster than the weighted ball, so be sure to check both to prevent a perineal or buttock burn.

Perforation with an active electrode

This usually occurs when current is applied as the electrode is extended or the resectoscope is moved toward the fundus. It can be avoided if the electrode is activated only when moving it toward the operator.

Perforations with intraabdominal burns also have occurred during attempts to coagulate bleeders—especially in the cornual regions.

Diversion of current can be destructive

Genital tract injuries have occurred as a result of current diversion. Vilos and colleagues16 reported 13 electrical burns during endometrial ablation, and mention many more anecdotal reports. The usual cause: electrode insulation failure, which allows current to jump to the outer sheath of the resectoscope.

To avoid this, inspect all electrodes thoroughly before surgery and use them only once.

Capacitative coupling also diverts current

Since the sheath-within-a-sheath design of the resectoscope resembles a capacitor, high-voltage current can jump to the outer sheath without direct contact from the electrode. When Munro17 bench-tested electrosurgical generators and electrodes with and without insulation defects, he found that capacitative coupling with intact electrodes occurred more frequently with high-voltage coagulation current than with lower-voltage cutting current.

One way to avoid these injuries is to activate the electrode intermittently, with short bursts, rather than rolling back and forth over an area with continuous current. Another strategy is placing a damp sponge in the posterior vagina extending out the introitus; this protects the mucosa and perineal skin—especially in obese patients.

How to avoid return-pad injuries

Keep the patient’s thigh completely dry; ensure that the pad is flat against the skin at application, with no bubbles or creases; and use only return electrode monitor (REM) dispersive pads.

Especially when using vaporization electrodes, avoid prolonged activation of the electrode at high power. To minimize risk of vaporization, use a second dispersive pad connected to the first via a “y” connector to further disperse current and heat at the return pad.

Also, limit the use of coagulation current and use a maximum generator setting of 60 to 80 W in the coagulation mode.

Take steps to avert gas embolism, but watch closely for signs

Initial reports of this potentially fatal complication came mostly from laser ablation procedures, but gas embolism can occur during all diagnostic and operative hysteroscopic procedures, especially the latter.

Sources of gas embolism: room air, carbon dioxide, carbon monoxide, and other gaseous products of vaporization or tissue combustion. The anesthesiologist is usually the first to identify the signs.

Signs of gas embolism. The surgeon should ask to be immediately alerted to any sudden fall in oxygen saturation, as well as to hypotension, hypercarbia, arrhythmias, tachypnea, or a “mill wheel” murmur. If any of these signs are detected and a gas embolism is suspected, stop the procedure and ventilate the patient with 100% oxygen.

Carbon dioxide is a soluble gas, so these emboli generally resolve rapidly. In contrast, room air emboli are more likely to be fatal.

Reduce the risk of air embolism by avoiding the Trendelenburg position and leaving the last dilator in the cervix until just before inserting the resectoscope.

Also limit repetitive removal and reinsertion of the resectoscope, as often occurs during myoma resection. By vaporizing rather than resecting myomas, it is possible to eliminate the need to continually remove fibroid chips. Preoperative GnRH agonists narrow venous sinuses and help prevent this complication.

Intracervical injection of dilute vasopressin prior to dilatation of the cervix creates vascular spasm and may help prevent gas from entering the circulation.

Complications from distention media

Excess absorption of distention media is one of the most frequent complications. Most surgeons use low-viscosity, sodium-free fluids for operative hysteroscopy, since fluids that contain electrolytes are incompatible with monopolar electrosurgical instruments. The use of 3% sorbitol, 1.5% glycine, or sorbitol-mannitol solutions can lead to dilutional hyponatremia and hypoosmolality.18 Although the vast majority of women quickly recover from these conditions, some cases of permanent morbidity and even death have been reported.19 The overall incidence of dilutional hyponatremia was 0.2% in 1993, according to the AAGL member survey.1

 

 

Hyponatremia and hypoosmolality more likely in premenopausal women

These conditions may have catastrophic consequences if they are not recognized and corrected promptly. The brain swells as it attempts to become isoosmotic with the vascular system. If swelling exceeds 5%, the risk of severe neurological damage dramatically increases.

This is an important problem in premenopausal women, since estrogen and progesterone inhibit sodium-potassium adenosine triphosphatase (ATPase) activity in the brain. This sodium pump protects the brain against cerebral edema, which can cause herniation of the brain stem and death. Although men and postmenopausal women develop dilutional hyponatremia, they are less likely to suffer brain damage because the sodium pump is intact.

Taskin et al20 conducted a randomized trial showing an increase in the sodium-potassium ATPase pump activity and decreased volume deficit during hysteroscopic surgery in patients pretreated with a GnRH agonist, compared with a control group. This increased pump activity in the brain and endometrium may decrease women’s susceptibility to hyponatremic complications and brain damage.

Vigilant monitoring of fluid intake/output during hysteroscopic surgery is necessary to prevent hyponatremic complications. Avoid the pitfall of erroneously attributing deficits to fluid “in the drapes” by using drapes with a fluid-collection pouch.

The standard of care is use of electronic inflow-outflow measuring systems. Manufacturers of hysteroscopic equipment offer highly accurate electronic fluid monitoring systems that measure the weight of the distending fluid infused and collected rather than relying on manual estimation of deficit. The latter method may be inaccurate since the volume of the supply bag can vary by as much as 10%.

Adjust intrauterine pressure to reduce the likelihood of intravasation. High intrauterine pressure may be desirable for visualization, but it greatly increases the risk of intravasation.

I adjust pressure and flow rates by opening or closing the inflow and outflow valves of the resectoscope until slight amounts of bleeding from resected tissue can be visualized. Since intrauterine pressure is extremely difficult to monitor accurately during operative hysteroscopy, this practice ensures that it remains below the patient’s mean arterial pressure, thus minimizing the risk of intravasation.

Use a dilute vasopressin injection to constrict blood vessels and decrease the chance of intravasation.

Vaporizing electrodes for myoma resection and ablation seal blood vessels and reduce fluid absorption.

Guidelines for distention media

To reduce the likelihood of these complications, I recommend that surgeons:

  • Draw preoperative serum electrolytes for a baseline in all patients.
  • Give all patients with myomas 2 monthly injections of depot leuprolide acetate (3.75 mg intramuscularly). Give patients without fibroids a single injection 4 to 6 weeks prior to the procedure.
  • Place a fluid-collection drape or a larger, plastic Mayo stand cover with the bottom cut off under the patient’s buttocks so that fluid drains into a “kick” bucket. Also adjust the resectoscope’s outflow tubing to drain into the collection bag, which should be kept on constant suction to the flow-stat electronic fluid monitor.
  • Continuously record inflow and outflow using the electronic monitor with the deficit alarm set to 500 mL.
  • Keep distention fluid at room temperature and monitor the patient’s core temperature continuously. Significant fluid intravasation will lower the patient’s temperature, and this may be the first sign of fluid overload.
  • Perform operative hysteroscopy under spinal or epidural anesthesia so the anesthesiologist can continually assess the patient’s sensorium. Confusion and irritability are early signs of dilutional hyponatremia.
  • If the fluid deficit reaches 750 mL, immediately give 20 to 40 mg of intravenous furosemide and draw a serum sodium. Do not wait for the result of the sodium level before treatment, since a 5- to 20-minute delay can be catastrophic.
  • Interrupt the procedure for 5 to 10 minutes to allow the uterus to contract and to seal off small blood vessels.
  • Discontinue the procedure if the fluid deficit reaches 1,500 mL or if the serum sodium level is below 125 mEq/L.

I do not limit the duration of resectoscopic procedures as long as fluid deficits are below 750 mL, as measured by electronic fluid monitor. I also ensure that the operating room staff is well educated in the use of the monitor and able to troubleshoot intraoperatively.

If the machine fails during the procedure, reset it with the alarm limit lowered to reflect the deficit recorded before failure.

Monitor the color of the outflow fluid. Excessive blood loss counted as part of the outflow can occasionally mask a distention fluid deficit.

Choosing a distention medium

There is no ideal distention medium for monopolar operative hysteroscopy. Several authors have suggested that 5% mannitol is advantageous since it is isosmolar and acts as an osmotic diuretic. However, it does not prevent hyponatremia. The main disadvantage of 5% mannitol is its high cost and limited availability in 3-L bags or 4-L bottles.

 

 

The use of bipolar devices in normal saline prevents dilutional hyponatremia, but fluid deficits must still be monitored electronically so they do not exceed 2,000 mL. The false sense of security that may occur when normal saline is used for distention may lead to inaction when a large deficit occurs. This can lead to pulmonary edema and death.

Postoperative and late complications

These include infection, endometrial cancer, iatrogenic adenomyosis, hematometria, post-ablation tubal ligation syndrome, and pregnancy.

Infection rate is 0.3% to 2%

Infection is relatively rare following endometrial ablation, with a rate of 0.3% to 0.5% reported in most series. Endometritis, parametritis, and pyometra are more common following resection of submucous myomas, with rates as high as 2% reported.

Infection is more likely after prolonged procedures, especially when the hysteroscope is repeatedly inserted and removed. It also is more likely if the patient has a history of pelvic inflammatory disease. I generally administer prophylactic antibiotics (1 dose of intravenous ceftizoxime, 1 g, approximately 30 to 60 minutes prior to surgery).

I also insert a laminaria tent the evening prior to surgery. Patients with a history of pelvic inflammatory disease are discharged on doxycycline (100 mg twice daily for 7 days).

Be alert for endometrial cancer

This malignancy has been diagnosed at the time of endometrial ablation and reported in patients who have undergone prior endometrial ablations or fibroid resections. Thus, endometrial sampling should be part of the workup of abnormal uterine bleeding before the patient is scheduled for operative hysteroscopy. In women at high risk for endometrial cancer, perform office diagnostic hysteroscopy, with directed biopsy of any suspicious areas.

When viable endometrial glands are “buried” during ablation, or synechiae develop, preventing the egress of blood, there is a chance that diagnosis of endometrial cancer will be delayed. However, this theoretical fear has not been proven clinically.

Patients whose abnormal bleeding recurs after ablation should undergo sampling and office hysteroscopy, just as if they had not undergone a previous ablation. Theoretically, women who undergo endomyometrial resection or vaporization should have a lower incidence of endometrial cancer, since the tissue most susceptible to malignancy is removed. This has not yet been proven scientifically.

In their comprehensive review of late complications of operative hysteroscopy, Cooper and Brady21 suggest that patients at high risk for endometrial cancer who present with abnormal uterine bleeding not controlled by hormones might be better served by hysterectomy. Unfortunately, these patients tend to be high-risk surgical candidates.

If atypia is present, do not perform endometrial ablation or resection. I do perform ablation and resection in patients with complex hyperplasia without atypia if it has been reversed with progestin and does not recur for at least 6 months without progestin therapy. These patients undergo office hysteroscopy and sampling of the endometrium before operative hysteroscopy is scheduled.

Iatrogenic adenomyosis

Two theories suggest this is a late complication of operative hysteroscopy. According to the first, when the endometrium is incompletely resected, scarring over this tissue causes the viable glands to grow into the myometrium. The other theory suggests that viable endometrial debris is transported into the myometrium by vessels opened at resection.

I have found that using the vaporization electrode followed by application of a rollerball over the surface of the cavity most effectively reaches maximal tissue depth and, theoretically, prevents adenomyosis. Since most adenomyosis occurs on the posterior wall, I take a strip from this area for pathologic analysis to determine whether adenomyosis preceded the ablation or developed subsequent to it.

Hematometria

This can occur following operative hysteroscopy if viable glands are left in the fundal or cornual region and synechiae develop in the lower segment, preventing egress of blood. It also can occur if the upper endocervix is ablated and subsequently scars, causing stenosis. To avoid this, ablate only to the level of the internal os.

Diagnosis and treatment. Hematometria can be diagnosed easily by ultrasound and treated with office hysteroscopy using a narrow-diameter, rigid, continuous-flow hysteroscope with an operating channel to pass small instruments.

Post-ablation tubal ligation syndrome

This is cornual hematometria that develops when viable endometrial cells are left in the cornua when the cavity also contains synechiae, causing cyclic bleeding. Since there is no egress from the cervix or tubes, blood gradually builds up, leading to hematosalpinx and pain. One way to avoid this is to ensure complete ablation of the cornual endometrium.

Prevention. Some experts recommend that the small rollerball electrode be placed in the cornua, with slightly reduced intrauterine pressure, to allow the cornual endometrium to collapse around the rollerball. A short burst of current is then applied to ablate the tissue.

 

 

This complication is less likely after hydrothermablation, since the free-flowing saline ablates the cornua completely. After more than 50 hydrothermablations performed in patients with prior tubal sterilizations, I have not seen any cases of post-ablation tubal ligation syndrome.

Treatment consists of bilateral salpingectomy or tubal fulguration at the cornual region and repeat ablation or resection of viable endometrial tissue. Another option is hysterectomy.

Post-ablation pregnancy can be very complicated

Pregnancy after endometrial ablation occurs at a rate of 0.2% to 1.6%. Counsel patients that this procedure does not prevent pregnancy and that contraception is vital. Uterine rupture after fibroid resection has been reported.

In a review of 37 post-ablation pregnancies, only 11 of 17 women who chose not to terminate carried the gestation beyond 28 weeks. In addition, there was a high incidence of intrauterine growth restriction, prematurity, and placenta accreta.22

Hysteroscopic tubal sterilization with the Essure system (Conceptus, San Carlos, Calif), or laparoscopic tubal fulguration performed at the time of ablation averts these complications.

Complications of global ablation

Global ablation technologies were developed to enable gynecologists with limited operative hysteroscopy skills to perform endometrial ablation and to make ablation safer for the patient. These technologies completely eliminate the risk of distention-media complications, but widespread use has resulted in other complications that have been reported in the literature to only a limited extent.

Most published articles on global endometrial ablation are from the original US Food and Drug Administration (FDA) trials, in which the complication rates were extraordinarily low. Widespread commercial use of these technologies since FDA approval, especially by practitioners with limited skills, has increased complications.

Do not override safety systems

Complications are more frequent when devices are misused or safety systems overridden. And, fear of litigation makes physicians unwilling to report complications.

In the FDA Manufacturer and User Facility Device Experience (MAUDE) database (www.fda.gov.cdrh/maude.html), complications include bowel burns after unrecognized perforation, and bowel burns associated with electrosurgical, microwave energy, or heat transferred through intact myometrium.23 Vaginal burns, uterine necrosis myometritis requiring hysterectomy, and death from unrecognized bowel burn also have been reported.

Most global procedures are performed blindly, and some doctors fail to perform diagnostic hysteroscopy before and after surgery, which I feel is mandatory with any endometrial ablation. Hydrothermablation is the only global technique that has the advantage of direct observation. In more than 150 procedures done in my office under local anesthesia, the only complications were 2 false passages. Both were promptly identified during diagnostic hysteroscopy, and the surgery was rescheduled 2 to 3 months later.

The author has served on the speakers’ bureau for Boston Scientific.

References

1. Hulka JF, Peterson HA, Philips JM, Surrey MW. Operative hysteroscopy: American Association of Gynecologic Laparoscopists’ 1993 Member Survey. J Am Assoc Gynecol Laparos. 1995;2:131-132.

2. Jansen FW, Vredevoogd CB, Van Ulzen K, et al. Complications of hysteroscopy: a prospective multicenter study. Obstet Gynecol. 2000;96:266-270.

3. Vilos GA. Hysteroscopic surgery: indications, contraindications, and complications. In: Pasic and Levine’s A Practical Manual of Hysteroscopy and Endometrial Ablation Techniques. London and New York: Taylor and Francis; 2004;237-258.

4. Ostrzenski A. Resectoscopic cervical trauma minimized by inserting Laminaria digitata preoperatively. Int J Fertil. 1994;39:111-113

5. Phillips DA, Nathanson HG, Millim SJ, et al. The effect of dilute vasopressin solution on the force needed for cervical dilatation: a randomized controlled trial. Obstet Gynecol. 1997;89:507-511

6. Valle RF, Sciarra JJ. Intrauterine adhesions; hysteroscopic diagnosis, classification, treatment, and reproductive outcome. Am J Obstet Gynecol. 1988;158:1459-1470

7. Townsend DE, Quinlan DJ, Johnson GH. Repeat endometrial ablation. Presented at the World Congress of Hysteroscopy, Miami, Florida, 1996.

8. MacLean-Fraser E, Penava D, Vilos GA. Perioperative complication rates of primary and repeat hysteroscopic endometrial ablations. J Am Assoc Gynecol Laparosc. 2002;9:175-177.

9. Loffer FD. Complications of hysteroscopy—their cause, prevention, and correction. J Am Assoc Gynecol Laparosc; 1995;3:11-26

10. Goldrath MH. Uterine tamponade for the control of acute uterine bleeding. Am J Obstet Gynecol. 1983;147:869-872

11. Townsend DE. Vasopressin pack for treatment of bleeding after myoma resection. Am J Obstet Gynecol. 1991;165:1405-1407

12. Phillips DR, Nathanson HG, Milim SJ, et al. The effect of dilute vasopressin solution on intraoperative blood loss during operative hysteroscopy: a randomized controlled trial. Obstet Gynecol. 1996;88:761-766

13. Brooks PG. Resectoscopic myoma vaporizer. J Reprod Med. 1995;40:791-795

14. Glasser MH. Endometrial ablation and hysteroscopic myomectomy by electrosurgical vaporization. J Am Assoc Gynecol Laparosc. 1997;4:369-374

15. Parazzini F, Vercellini P, Di Giorgio O, et al. Efficacy of preoperative medical treatment in facilitating endometrial resection, myomectomy and metroplasty: literature review. Hum Reprod. 1998;13:2592-2597

16. Vilos GA, Brown S, Graham G, et al. Genital tract electrical burns during hysteroscopic endometrial ablation: report of 13 cases in the United States and Canada. J Am Assoc Gynecol Laparosc. 2000;7:141-147

17. Munro MG. Factors affecting capacitative current diversion with a uterine resectoscope: an in vitro study. J Am Assoc Gynecol Laparosc. 2003;10:450-460

18. Istre O, Shajaa K, Schjoensky AP, et al. Changes in serum electrolytes after transcervical resection of endometrium and submucous fibroids with the use of 1.5% glycine for irrigation. Obstet Gynecol. 1992;80:218-222

19. Arieff AI, Azus JC. Hyponatremic encephalopathy after endometrial ablation. JAMA. 1994;271:345.-

20. Taskin O, Buhur A, Birincioglu M, et al. Endometrial Na+, K+–ATPase pump function and vasopressin levels during hysteroscopic surgery in patients pretreated with GnRH agonist. J Am Assoc Gynecol Laparosc. 1998;5:119-124

21. Cooper JM, Brady RM. Late complications of operative hysteroscopy. Obstet Gynecol Clin North Am. 2000;27:367-374

22. Rogerson L, Gannon, O’Donovan P. Outcome of pregnancy following endometrial ablation. J Gynecol Surg. 1997;13:155-160

23. Gurtcheff SE, Sharp MT. Complications associated with global endometrial ablation: the utility of the MAUDE database. Obstet Gynecol. 2003;102:1278-1282

24. Glasser MH. The serosal sign: the hysteroscopic appearance of the uterine cavity just prior to perforation. Presented at the World Congress of Hysteroscopy, Miami, Florida, 1996.

References

1. Hulka JF, Peterson HA, Philips JM, Surrey MW. Operative hysteroscopy: American Association of Gynecologic Laparoscopists’ 1993 Member Survey. J Am Assoc Gynecol Laparos. 1995;2:131-132.

2. Jansen FW, Vredevoogd CB, Van Ulzen K, et al. Complications of hysteroscopy: a prospective multicenter study. Obstet Gynecol. 2000;96:266-270.

3. Vilos GA. Hysteroscopic surgery: indications, contraindications, and complications. In: Pasic and Levine’s A Practical Manual of Hysteroscopy and Endometrial Ablation Techniques. London and New York: Taylor and Francis; 2004;237-258.

4. Ostrzenski A. Resectoscopic cervical trauma minimized by inserting Laminaria digitata preoperatively. Int J Fertil. 1994;39:111-113

5. Phillips DA, Nathanson HG, Millim SJ, et al. The effect of dilute vasopressin solution on the force needed for cervical dilatation: a randomized controlled trial. Obstet Gynecol. 1997;89:507-511

6. Valle RF, Sciarra JJ. Intrauterine adhesions; hysteroscopic diagnosis, classification, treatment, and reproductive outcome. Am J Obstet Gynecol. 1988;158:1459-1470

7. Townsend DE, Quinlan DJ, Johnson GH. Repeat endometrial ablation. Presented at the World Congress of Hysteroscopy, Miami, Florida, 1996.

8. MacLean-Fraser E, Penava D, Vilos GA. Perioperative complication rates of primary and repeat hysteroscopic endometrial ablations. J Am Assoc Gynecol Laparosc. 2002;9:175-177.

9. Loffer FD. Complications of hysteroscopy—their cause, prevention, and correction. J Am Assoc Gynecol Laparosc; 1995;3:11-26

10. Goldrath MH. Uterine tamponade for the control of acute uterine bleeding. Am J Obstet Gynecol. 1983;147:869-872

11. Townsend DE. Vasopressin pack for treatment of bleeding after myoma resection. Am J Obstet Gynecol. 1991;165:1405-1407

12. Phillips DR, Nathanson HG, Milim SJ, et al. The effect of dilute vasopressin solution on intraoperative blood loss during operative hysteroscopy: a randomized controlled trial. Obstet Gynecol. 1996;88:761-766

13. Brooks PG. Resectoscopic myoma vaporizer. J Reprod Med. 1995;40:791-795

14. Glasser MH. Endometrial ablation and hysteroscopic myomectomy by electrosurgical vaporization. J Am Assoc Gynecol Laparosc. 1997;4:369-374

15. Parazzini F, Vercellini P, Di Giorgio O, et al. Efficacy of preoperative medical treatment in facilitating endometrial resection, myomectomy and metroplasty: literature review. Hum Reprod. 1998;13:2592-2597

16. Vilos GA, Brown S, Graham G, et al. Genital tract electrical burns during hysteroscopic endometrial ablation: report of 13 cases in the United States and Canada. J Am Assoc Gynecol Laparosc. 2000;7:141-147

17. Munro MG. Factors affecting capacitative current diversion with a uterine resectoscope: an in vitro study. J Am Assoc Gynecol Laparosc. 2003;10:450-460

18. Istre O, Shajaa K, Schjoensky AP, et al. Changes in serum electrolytes after transcervical resection of endometrium and submucous fibroids with the use of 1.5% glycine for irrigation. Obstet Gynecol. 1992;80:218-222

19. Arieff AI, Azus JC. Hyponatremic encephalopathy after endometrial ablation. JAMA. 1994;271:345.-

20. Taskin O, Buhur A, Birincioglu M, et al. Endometrial Na+, K+–ATPase pump function and vasopressin levels during hysteroscopic surgery in patients pretreated with GnRH agonist. J Am Assoc Gynecol Laparosc. 1998;5:119-124

21. Cooper JM, Brady RM. Late complications of operative hysteroscopy. Obstet Gynecol Clin North Am. 2000;27:367-374

22. Rogerson L, Gannon, O’Donovan P. Outcome of pregnancy following endometrial ablation. J Gynecol Surg. 1997;13:155-160

23. Gurtcheff SE, Sharp MT. Complications associated with global endometrial ablation: the utility of the MAUDE database. Obstet Gynecol. 2003;102:1278-1282

24. Glasser MH. The serosal sign: the hysteroscopic appearance of the uterine cavity just prior to perforation. Presented at the World Congress of Hysteroscopy, Miami, Florida, 1996.

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Choosing the best technique for vaginal vault prolapse

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Choosing the best technique for vaginal vault prolapse

KEY POINTS

  • Look for vault prolapse in any woman who has an advanced degree of vaginal prolapse.
  • Goals of surgery: to normalize support of all anatomic compartments; alleviate clinical symptoms; and optimize sexual, bowel, and bladder function.
  • If sexual function is critical to the patient, a sacrocolpopexy should be the primary surgical option.
  • Preoperative low-dose estrogen cream is crucial in most postmenopausal women.

Identifying vault prolapse can be difficult in a woman with extensive vaginal prolapse, and operative failure is likely if support to the apex is not restored.

Because this condition is so challenging to identify, many women undergoing anterior and/or posterior colporrhaphy likely have undiagnosed vault prolapse. This may contribute to the 29.2% rate of reoperation in women who undergo pelvic floor reconstructive procedures.1

This article reviews the anatomy of apical support, tells how to identify vaginal vault prolapse during the physical exam, and outlines effective surgical options—both vaginal and abdominal—for its correction. We focus on accurate pelvic assessment as the basis for planning the surgery.

Vaginal stability is fragile

The stability of vaginal anatomy is precarious, since it depends on a series of interrelationships between both dynamic and static structures. When the relationships between the ligaments and fascia at the vaginal apex or vault are impaired, vault prolapse ensues.

Thanks to cadaveric and radiographic studies, our understanding of the complexities of vaginal anatomy has improved considerably; still, the area of vaginal support we least understand is the coalescence of ligaments and fascia at the vaginal apex or vault.

Grade II prolapse, at least, in 64.8%

An analysis of Women’s Health Initiative enrollees with an intact uterus found that 64.8% had at least grade II prolapse (ie, leading edge of prolapse at –1 to +1 cm from the hymen) according to the Pelvic Organ Prolapse Quantification System (POP-Q).2 Approximately 8% of enrollees had a point D (vaginal apex) of greater than –6 cm, suggesting some degree of vault prolapse.

Hysterectomy appears to contribute. The incidence is about 1% at 3 years; 5% at 17 years.3

In the United States, approximately 30,000 vaginal vault repairs were performed in 1999.

Normal support structure

Several support structures coalesce at the vaginal apex. If the cervix is present, it serves as an obvious strong attachment site (FIGURE 1). In hysterectomized women, the structures may lack a strong attachment site, resulting in weakness and prolapse.

FIGURE 1 Vaginal support system


The coalescence of both sets of ligaments forms the uterosacral-cardinal ligament complex at the vaginal apex, which is likely crucial to vault support. Reprinted with permission of The Cleveland Clinic Foundation.

2 sets of ligaments determine support

Uterosacral ligaments—peritoneal and fibromuscular tissue bands extending from the vaginal apex to the sacrum—are the principal support for the vaginal apex, despite their apparent lack of strength.

The role of the cardinal ligaments—which extend laterally from the apex to the pelvic sidewall, adjacent to the ischial spine—is less clear. Since they lie proximal to the ureters, restoring vault support by shortening or reattaching them to the apex is a less attractive option.

The coalescence of these 2 sets of ligaments forms the complex that likely maintains vault support.

In hysterectomized women, locating the attachment of this complex to the vaginal cuff (seen on the exam as apical “dimples”) is key to identifying vault prolapse.

New view of cystoceles, rectoceles

The fibromuscular tissue layer underlying the vaginal epithelium envelops the entire vaginal canal, extending from apex to perineum and from arcus tendineus to arcus tendineus.

As the aponeurosis does for the abdominal wall, the endopelvic fascia maintains integrity of the anterior and posterior vaginal walls. If the fascial layer detaches from the vaginal apex, a true hernia can develop in the form of an enterocele—anterior or posterior—further weakening vault integrity (FIGURE 2).

Reconstructive surgeons are beginning to view cystoceles and rectoceles as a detachment of the endopelvic fascia from the vaginal apex. Thus, it is critical to restore anterior and posterior vaginal wall fascial integrity from apex to perineum by reattaching the endogenous fascia to the vaginal apex, or by placing a biologic or synthetic graft.

FIGURE 2 Apical defects contribute to vault prolapse


 

 

Vault prolapse is often associated with defects of the apical fascia, represented here by dark lines, which must be addressed during vault reconstruction. Reprinted with permission of The Cleveland Clinic Foundation.

Specific technique, tools to help identify prolapse

Any patient with an advanced degree of vaginal prolapse should be assessed for vault prolapse using a careful, structured pelvic exam. In many cases, this can be difficult, even if the uterus is present.

Necessary tools include a bivalved speculum and a right-angle retractor, or the posterior blade of another gynecologic speculum.

When the uterus is present

An exteriorized cervix does not necessarily mean vault prolapse; this may occur with substantial cervical hypertrophy, while the apex remains well supported (FIGURE 3).

Exam technique. Place the right-angle speculum blade in the posterior fornix, inserting it to its full extent, and ask the patient to perform a Valsalva maneuver. If vault prolapse is present, the uterus will descend further as the speculum is slowly removed; reinsertion of the speculum will resuspend the uterus. If the vault is well supported, the cervix will remain in place despite Valsalva efforts.

Assess the degree of vault prolapse during this examination, to determine whether a McCall culdoplasty will restore vault support.

If uterine suspension is performed in a woman with substantial cervical hypertrophy, cervical prolapse may persist, necessitating partial amputation (Manchester procedure).

FIGURE 3 Exteriorized cervix does not necessarily mean vault prolapse


Cervical prolapse may be associated with vault prolapse (left) or simply represent cervical hypertrophy without vault prolapse (right). Reprinted with permission of The Cleveland Clinic Foundation.

In the hysterectomized patient

The goal of physical exam is to identify the apical scar tissue (cuff) resultant from the hysterectomy. In most women, the cuff is visible as a transverse band of tissue firmer than the adjacent vaginal walls. If the woman has extensive prolapse, the tissue is stretched and thus not as obvious.

Exam technique. Use a bivalved speculum to visualize the apex. In women with extensive prolapse, redundant vaginal tissue may impede visualization. Fortunately, the sites of previous attachment of the uterosacral-cardinal ligament complex can usually be identified as “dimples” on either side of the midline at the cuff (FIGURE 4).

Use both right-angle speculum blades, or 1 blade along the anterior vaginal wall and the index and middle fingers of your other hand along the posterior vaginal wall, to identify the dimples. Then place the tip of the speculum between the dimples, elevate the vault while the patient performs a Valsalva effort, and determine the degree of vault prolapse. This can be confirmed by digital exam by identifying the dimples by tact and elevating them to their ipsilateral ischial spines.

FIGURE 4 Identifying the vault in the hysterectomized patient


Posthysterectomy vault prolapse can be identified by looking for “dimples” at the apex, which represent sites of previous uterosacral-cardinal ligament complex attachment. Reprinted with permission of The Cleveland Clinic Foundation.

Which exam findings point to which technique?

The importance of accurate pelvic assessment is impossible to overemphasize. Besides determining the degree and type of prolapse present, the exam enhances surgical planning. Fascial tears or defects are usually identifiable during careful vaginal exam as areas of sudden change in the thickness of the vaginal wall.

By the end of the pelvic exam, we usually have developed a surgical plan for the prolapse repair, pending urodynamic assessment to determine the best anti-incontinence procedure, if necessary.

What are the surgical goals?

Objectives are to normalize support of all anatomic compartments; alleviate clinical symptoms; and optimize sexual, bowel, and bladder function—without precipitating new support or functional problems.

Abdominal versus vaginal approach

Most surgeons prefer a vaginal approach to pelvic reconstruction. However, this decision should be based on the patient’s individual variables.

If sexual function is critical to the patient, a sacrocolpopexy should be the primary option. Note that age does not always predict the importance of sexual function.

Vaginal length. If the vaginal apex (dimples) reaches the ischial spines with ease, a vaginal procedure should suffice. If it does not reach the spines, or extends far above, an abdominal sacrocolpopexy or obliterative procedure may more be appropriate.

Previous reconstructive procedures. Keep in mind that the area around the sacral promontory, or sacrospinous ligaments, may be difficult or risky to reach due to scarring and fibrosis. This is doubly important in this age of commonplace graft use.

Large paravaginal defects. Vaginal repairs can be technically difficult, and long-term outcomes have not been reported. An abdominal approach is probably better if substantial paravaginal defects are present.

 

 

Medical comorbidities. Use a vaginal or obliterative procedure under regional anesthesia if the patient is medically delicate or elderly.

Tissue quality usually improves with preoperative local estrogen, but large fascial defects adjacent to the cuff or perineum may require graft reinforcement.

Colorectal dysfunction frequently coexists in women with vault prolapse. Thus, a woman with extensive rectal prolapse should probably undergo concomitant Ripstein rectopexy and sacrocolpopexy, or a perineal proctosigmoidectomy and vaginal-approach vault suspension.

Careful and consistent preparation

Surgical success depends in great part on developing a clear understanding of anatomic defects and urodynamic dysfunction during the preoperative evaluation, to determine the most appropriate procedures.

Tissue preparation with low-dose estrogen

cream (1 g, two nights per week) is crucial for most postmenopausal women.

Obtain medical clearance, and optimize

perioperative safety by using spinal anesthesia, antiembolism stockings, and prophylactic intravenous antibiotics.

Retain vaginal packing at least 24 hours to prevent stress on sutures due to coughing or vomiting.

Advise patients in advance that, for 6 weeks after surgery, they must avoid overexertion and lifting more than 5 lb.

After 6 weeks, we restart estrogen cream and prescribe routine, daily Kegel exercise.

Vaginal procedures

McCall/Mayo culdoplasty

This involves plicating the uterosacral ligaments in the midline while reefing the peritoneum in the cul-de-sac, resulting in posterior culdoplasty. It usually is performed at the time of vaginal hysterectomy using nonabsorbable sutures to incorporate both uterosacral ligaments, intervening cul-desac peritoneum, and full-thickness apical vaginal mucosa. Multiple sutures may be required if prolapse is extensive.

Generally, we try to place our uppermost suture on the uterosacral ligaments at a distance from the cuff equal to the amount of vault prolapse (POP-Q: TVL minus point D [point C if uterus is absent]).

Be careful not to injure or kink the ureters when placing the suture through the uterosacral ligaments, as the ureters lie 1 to 2 cm lateral at the level of the cervix. We recommend cystoscopy with visualization of ureteral patency.

Success rates are high, but objective long-term data is scant.4,5

Uterosacral ligament suspension

Excellent anatomic outcomes have been described when the uterosacral ligaments are reattached to the vaginal apex (similar to the McCall technique).6,7 The physiologic nature of this technique makes it very attractive. It involves opening the vaginal wall from anterior to posterior over the apical defect, and identifying the pubocervical fascia, rectovaginal fascia, and uterosacral ligaments.

Technique. Place 1 permanent 1-0 suture and 1 delayed absorbable 1-0 suture in the posteromedial aspect of each uterosacral ligament 1 to 2 cm proximal and medial to each ischial spine. Then place 1 arm of each permanent suture through the pubocervical and rectovaginal fascia, and 1 arm of each delayed absorbable suture through the same tissue, also incorporating the vaginal epithelium. After repairing all additional defects, tie the sutures to suspend the vault.

When prolapse is extensive, redundant peritoneum can hinder identification of the uterosacral ligaments.

Success rates are 87% to 90%, but ureteral injury is a limiting factor, with rates as high as 11%. Therefore, cystoscopy is essential. Long-term data are lacking.

Iliococcygeus suspension

This safe and simple procedure involves elevating the vaginal apex to the iliococcygeus muscles along the lateral pelvic sidewall. This can be done without a vaginal incision by placing a monofilament permanent suture (polypropylene) full thickness through the vaginal wall into the muscle uni-or bilaterally.

Candidates should not be sexually active, as there will be a suture knot in the vagina. The procedure may be useful in elderly patients for whom complete restoration of vaginal anatomy is not a goal. It also can be performed as a salvage operation in women with suboptimal vault support and good distal vaginal anatomy. In addition, it can be performed following posterior vaginal wall dissection with entry into the pararectal space.

Technique. Place the sutures into the fascia overlying the iliococcygeus muscle, anterior to the ischial spine and inferior to the arcus tendineus fascia pelvis, and incorporate the pubocervical fascia anteriorly and the rectovaginal fascia posteriorly.

Success rates. Shull reported a 95% cure rate of the apical compartment among 42 women, at 6 weeks to 5 years.8 However, the prolapse at other sites was 14%. A randomized trial comparing this procedure to sacrospinous fixation demonstrated similar satisfactory outcomes.9

Sacrospinous ligament fixation

Probably the most commonly performed apical suspension procedure from the vaginal approach is fixation of the apex to the sacrospinous ligaments. Although many describe unilateral fixation, we advocate bilateral fixation to avoid lateral deviation of the vaginal axis (FIGURE 5).

Technique. After entering the pararectal space through a posterior vaginal wall dissection, identify the sacrospinous ligaments and place 2 nonabsorbable sutures through each ligament, rather than around it, as the pudendal vessels pass behind it.

 

 

Place the first suture 2 cm medial to the ischial spine, and the second suture 1 cm medial to the first. Then pass each suture through the underside of the vaginal apex—in the midline if the procedure is done unilaterally and under each apex if it is bilateral. When tied, the sutures suspend the vaginal apex by approximating it to the ligament, ideally without a suture bridge.

We use CV-2 GoreTex (WL Gore and Associates, Flagstaff, Ariz) sutures passed through the ligaments with a Miya hook, and we reinforce the underside of the vaginal apex with a rectangular piece of Prolene mesh (Ethicon, Somerville, NJ) if the mucosa is thinned.

Success rates are 70% to 97%.10,11 A significant concern is the nonanatomic posterior axial deflection of the vagina. Many investigators have reported an anterior compartment prolapse rate of up to 20% after fixation, likely secondary to increased force on the anterior compartment with increases in abdominal pressure. This is especially likely if a concomitant anti-incontinence procedure is performed.

Other complications include hemorrhage, vaginal shortening, sexual dysfunction, and buttock pain.

FIGURE 5 Bilateral sacrospinous fixation avoids lateral vaginal deviation


With bilateral fixation of the vault to the sacrospinous ligaments, the vaginal axis is more horizontal. It may be reinforced to enhance longevity. Reprinted with permission of The Cleveland Clinic Foundation.

Posterior IVS vault suspension

This novel, minimally invasive technique uses the posterior intravaginal slingplasty (Posterior IVS; Tyco/US Surgical, Norwalk, Conn). First described as infracoccygeal sacropexy, it was introduced as an outpatient procedure in Australia. Concerns about postoperative vaginal length and risk of rectal injury led to poor acceptance. The procedure was modified by a few US surgeons to enhance safety and vaginal length.

Technique. Enter the pararectal space in a fashion similar to that of sacrospinous fixation. A specially designed tunneler device delivers a multifilament polypropylene tape through bilateral perianal incisions. Secure the tape to the vaginal apex, and adjust it to provide vault support.

We modified this procedure to create neoligaments analogous to cardinal ligaments, by directing the tunneler through the iliococcygeus muscles in close proximity to the ischial spines and arcus tendineus. The resultant vaginal axis is physiologic, and vaginal length is normalized.

By combining this technique with perineoplasty and attaching the rectovaginal and pubocervical fascia to the tape, all levels of pelvic support are repaired once the vault is positioned by pulling on the perianal tape ends.

The new Apogee technique (American Medical Systems, Minnetonka, Minn) uses a similar perianal approach with monofilament polypropylene mesh.

Success rates. Preliminary success rates are 88% to 100%, and complication rates are minimal.12 Vaginal length averages 7 to 8 cm. Most initially reported complications involved graft erosion or rejection; shifting from nylon to polypropylene graft material reduced this problem.

Abdominal procedures

Sacral colpopexy

Considered the gold standard, the sacral colpopexy vaginal vault suspension technique has a consistent cure rate above 90%.13 It may be the ideal procedure for pelvic floor muscle weakness and/or attenuated fascia with multiple defects, for women for whom optimal sexual function is critical, and for those with other indications for abdominal surgery.

A graft is placed between the vagina and the sacral promontory to restore vaginal support (FIGURE 6). Materials have included autologous and synthetic materials. We use polypropylene mesh because of its high tensile strength, biocompatibility, low infection rate, and low incidence of erosion. Biologic grafts such as cadaveric fascia lata have increased failure rates due to graft breakdown.

The resultant vaginal axis is the most physiologic of all vault reconstructive procedures. This procedure appears to have the best longevity of all vault suspension procedures. It can be performed laparo-scopically at selected centers.

Technique. First, access the presacral space overlying the sacral promontory, taking care not to disturb the presacral and middle sacral vessels. We perform this step first to avoid potential periosteal tissue contamination. We routinely use 2 bone anchors to secure the mesh—making sterility imperative. Bone anchors reduce periosteal tissue trauma and decrease risk of potentially life-threatening hemorrhage.

Mobilize the bladder from the anterior vaginal apex. Repair any apical fascial defects, restoring continuity of the pubocervical and rectovaginal fascia, which often detach from the apex. Using 2-0 Prolene sutures, suture the y-shaped graft to both the anterior and posterior vaginal walls, incorporating all fascial edges.

Culdoplasty follows; this obliterates the cul-de-sac to prevent subsequent enterocele formation.

Next, place the graft in a tension-free manner, creating a suspensory bridge from the apex to the sacral promontory. Irrigate copiously. Close the peritoneum over the graft along its entire length.

 

 

Follow with any anti-incontinence and paravaginal support procedures as well as posterior colporrhaphy as needed.14,15

Major complications include hemorrhage, usually involving periosteal perforators along the sacrum. Graft erosion may affect up to 5% to 7% of sacral colpopexies.

FIGURE 6 Mesh bridge aids vault suspension


Abdominal sacrocolpopexy with a mesh bridge from the vaginal apex to the sacral promontory. Reprinted with permission of The Cleveland Clinic Foundation.

Uterosacral ligament suspension

In this procedure, which can be performed open or laparoscopically, the remnants of the uterosacral ligaments suspend the vaginal apex. The laparoscopic procedure is simple, especially if the uterus is in place.

Technique. Identify the course of the ureters in relation to the ligaments, and use nonabsorbable sutures to incorporate both of the uterosacral ligaments, peritoneum, and the vaginal apex—including the pubocervical and rectovaginal fascia (FIGURE 7).

Place multiple sutures (include the posterior vaginal wall) to obliterate the cul-de-sac and prevent enterocele development.

Success rates. Long-term data are minimal, but outcomes should be similar to the vaginal-approach culdoplasty.

FIGURE 7 Suspension from uterosacral ligaments


Laparoscopic uterosacral ligament suspension incorporating both uterosacral ligaments and cervix or vaginal cuff.

Reprinted with permission of The Cleveland Clinic Foundation.

Obliterative procedures

LeForte colpocleisis or colpectomy/vaginectomy are the simplest treatments for advanced prolapse in elderly women who are not—and will not be—sexually active.16

We prefer the LeForte colpocleisis, in which rectangular segments of the anterior and posterior vaginal walls are denuded of their epithelium, followed by approximation of the rectangles to one another.

Success rates exceed 95%, and safety is maintained if spinal anesthesia is used in conjunction with a high perineoplasty.

Dr. Biller reports no relevant financial relationships. Dr. Davila reports research support from AMS and Tyco/US Surgical. He also serves as a consultant to AMS, and as a speaker for AMS and Tyco/US Surgical.

References

1. Olsen AL, Smith VJ, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89:501-506.

2. Nygaard I, Bradley C, Brandt D, et al. Pelvic organ prolapse in older women: Prevalence and risk factors. Obstet Gynecol. 2004;104:489-497.

3. Thakar R, Stanton S. Management of genital prolapse. BMJ. 2002;324:1258-1262.

4. McCall ML. Posterior culdoplasty: surgical correction of enterocele during vaginal hysterectomy. A preliminary report. Obstet Gynecol. 1957;10:595-602.

5. Webb MJ, Aronson MP, et al. Posthysterectomy vaginal vault prolapse: primary repair in 693 patients. Obstet Gynecol. 1998;92:281-285.

6. Shull BL, Bachofen C, et al. A transvaginal approach to repair of apical and other associated sites of pelvic organ prolapse with uterosacral ligaments. Am J Obstet Gynecol. 2000;183:1365-1374.

7. Barber MD, Visco AG, et al. Bilateral uterosacral ligament vaginal vault suspension with site specific endopelvic fascia defect repair for treatment of pelvic organ prolapse. Am J Obstet Gynecol. 2000;183:1402-1411.

8. Shull BL, Capen CV, et al. Bilateral attachment of the vaginal cuff to iliococcygeus fascia: an effective method of cuff suspension. Am J Obstet Gynecol. 1993;168:1669-1677.

9. Maher CF, Murray CJ, et al. Iliococcygeus or sacrospinous fixation for vaginal vault prolapse. Obstet Gynecol. 2001;98:40-44.

10. Morley G, DeLancey JO. Sacrospinous ligament fixation for eversion of the vagina. Am J Obstet Gynecol. 1988;158:872.-

11. Shull BL, Capen CV, et al. Preoperative and postoperative analysis of site-specific pelvic support defects in 81 women treated with sacrospinous ligament suspension and pelvic reconstruction. Am J Obstet Gynecol. 1992;166:1764-1771.

12. Davila GW, Miller D. Vaginal vault suspension using the Posterior IVS technique. J Pelvic Med Surg. 2004;10:S39.-

13. Addison WA, Bump RC, et al. Sacral colpopexy is the preferred treatment for vaginal vault prolapse in selected patients. J Gynecol Tech. 1996;2:69-74.

14. Kohli N, Walsh PM, et al. Mesh erosion after abdominal sacrocolpopexy. Obstet Gynecol. 1998;92:999-1004.

15. Visco AG, Weidner AC, et al. Vaginal mesh erosion after abdominal sacral colpopexy. Am J Obstet Gynecol. 2001;184:297-302.

16. Neimark M, Davila GW, Kopka SL. LeForte colpocleisis: a feasible treatment option for pelvic organ prolapse in the elderly woman. J Pelvic Med Surg. 2003;9:1-7.

Author and Disclosure Information

Daniel Biller, MD
Clinical Fellow, Department of Gynecology, Section of Urogynecology and Reconstructive Pelvic Surgery, Cleveland Clinic Florida, Weston

Willy G. Davila, MD
Chairman, Department of Gynecology Head, Section of Urogynecology and Reconstructive Pelvic Surgery, Cleveland Clinic Florida, Weston

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Daniel Biller, MD
Clinical Fellow, Department of Gynecology, Section of Urogynecology and Reconstructive Pelvic Surgery, Cleveland Clinic Florida, Weston

Willy G. Davila, MD
Chairman, Department of Gynecology Head, Section of Urogynecology and Reconstructive Pelvic Surgery, Cleveland Clinic Florida, Weston

Author and Disclosure Information

Daniel Biller, MD
Clinical Fellow, Department of Gynecology, Section of Urogynecology and Reconstructive Pelvic Surgery, Cleveland Clinic Florida, Weston

Willy G. Davila, MD
Chairman, Department of Gynecology Head, Section of Urogynecology and Reconstructive Pelvic Surgery, Cleveland Clinic Florida, Weston

KEY POINTS

  • Look for vault prolapse in any woman who has an advanced degree of vaginal prolapse.
  • Goals of surgery: to normalize support of all anatomic compartments; alleviate clinical symptoms; and optimize sexual, bowel, and bladder function.
  • If sexual function is critical to the patient, a sacrocolpopexy should be the primary surgical option.
  • Preoperative low-dose estrogen cream is crucial in most postmenopausal women.

Identifying vault prolapse can be difficult in a woman with extensive vaginal prolapse, and operative failure is likely if support to the apex is not restored.

Because this condition is so challenging to identify, many women undergoing anterior and/or posterior colporrhaphy likely have undiagnosed vault prolapse. This may contribute to the 29.2% rate of reoperation in women who undergo pelvic floor reconstructive procedures.1

This article reviews the anatomy of apical support, tells how to identify vaginal vault prolapse during the physical exam, and outlines effective surgical options—both vaginal and abdominal—for its correction. We focus on accurate pelvic assessment as the basis for planning the surgery.

Vaginal stability is fragile

The stability of vaginal anatomy is precarious, since it depends on a series of interrelationships between both dynamic and static structures. When the relationships between the ligaments and fascia at the vaginal apex or vault are impaired, vault prolapse ensues.

Thanks to cadaveric and radiographic studies, our understanding of the complexities of vaginal anatomy has improved considerably; still, the area of vaginal support we least understand is the coalescence of ligaments and fascia at the vaginal apex or vault.

Grade II prolapse, at least, in 64.8%

An analysis of Women’s Health Initiative enrollees with an intact uterus found that 64.8% had at least grade II prolapse (ie, leading edge of prolapse at –1 to +1 cm from the hymen) according to the Pelvic Organ Prolapse Quantification System (POP-Q).2 Approximately 8% of enrollees had a point D (vaginal apex) of greater than –6 cm, suggesting some degree of vault prolapse.

Hysterectomy appears to contribute. The incidence is about 1% at 3 years; 5% at 17 years.3

In the United States, approximately 30,000 vaginal vault repairs were performed in 1999.

Normal support structure

Several support structures coalesce at the vaginal apex. If the cervix is present, it serves as an obvious strong attachment site (FIGURE 1). In hysterectomized women, the structures may lack a strong attachment site, resulting in weakness and prolapse.

FIGURE 1 Vaginal support system


The coalescence of both sets of ligaments forms the uterosacral-cardinal ligament complex at the vaginal apex, which is likely crucial to vault support. Reprinted with permission of The Cleveland Clinic Foundation.

2 sets of ligaments determine support

Uterosacral ligaments—peritoneal and fibromuscular tissue bands extending from the vaginal apex to the sacrum—are the principal support for the vaginal apex, despite their apparent lack of strength.

The role of the cardinal ligaments—which extend laterally from the apex to the pelvic sidewall, adjacent to the ischial spine—is less clear. Since they lie proximal to the ureters, restoring vault support by shortening or reattaching them to the apex is a less attractive option.

The coalescence of these 2 sets of ligaments forms the complex that likely maintains vault support.

In hysterectomized women, locating the attachment of this complex to the vaginal cuff (seen on the exam as apical “dimples”) is key to identifying vault prolapse.

New view of cystoceles, rectoceles

The fibromuscular tissue layer underlying the vaginal epithelium envelops the entire vaginal canal, extending from apex to perineum and from arcus tendineus to arcus tendineus.

As the aponeurosis does for the abdominal wall, the endopelvic fascia maintains integrity of the anterior and posterior vaginal walls. If the fascial layer detaches from the vaginal apex, a true hernia can develop in the form of an enterocele—anterior or posterior—further weakening vault integrity (FIGURE 2).

Reconstructive surgeons are beginning to view cystoceles and rectoceles as a detachment of the endopelvic fascia from the vaginal apex. Thus, it is critical to restore anterior and posterior vaginal wall fascial integrity from apex to perineum by reattaching the endogenous fascia to the vaginal apex, or by placing a biologic or synthetic graft.

FIGURE 2 Apical defects contribute to vault prolapse


 

 

Vault prolapse is often associated with defects of the apical fascia, represented here by dark lines, which must be addressed during vault reconstruction. Reprinted with permission of The Cleveland Clinic Foundation.

Specific technique, tools to help identify prolapse

Any patient with an advanced degree of vaginal prolapse should be assessed for vault prolapse using a careful, structured pelvic exam. In many cases, this can be difficult, even if the uterus is present.

Necessary tools include a bivalved speculum and a right-angle retractor, or the posterior blade of another gynecologic speculum.

When the uterus is present

An exteriorized cervix does not necessarily mean vault prolapse; this may occur with substantial cervical hypertrophy, while the apex remains well supported (FIGURE 3).

Exam technique. Place the right-angle speculum blade in the posterior fornix, inserting it to its full extent, and ask the patient to perform a Valsalva maneuver. If vault prolapse is present, the uterus will descend further as the speculum is slowly removed; reinsertion of the speculum will resuspend the uterus. If the vault is well supported, the cervix will remain in place despite Valsalva efforts.

Assess the degree of vault prolapse during this examination, to determine whether a McCall culdoplasty will restore vault support.

If uterine suspension is performed in a woman with substantial cervical hypertrophy, cervical prolapse may persist, necessitating partial amputation (Manchester procedure).

FIGURE 3 Exteriorized cervix does not necessarily mean vault prolapse


Cervical prolapse may be associated with vault prolapse (left) or simply represent cervical hypertrophy without vault prolapse (right). Reprinted with permission of The Cleveland Clinic Foundation.

In the hysterectomized patient

The goal of physical exam is to identify the apical scar tissue (cuff) resultant from the hysterectomy. In most women, the cuff is visible as a transverse band of tissue firmer than the adjacent vaginal walls. If the woman has extensive prolapse, the tissue is stretched and thus not as obvious.

Exam technique. Use a bivalved speculum to visualize the apex. In women with extensive prolapse, redundant vaginal tissue may impede visualization. Fortunately, the sites of previous attachment of the uterosacral-cardinal ligament complex can usually be identified as “dimples” on either side of the midline at the cuff (FIGURE 4).

Use both right-angle speculum blades, or 1 blade along the anterior vaginal wall and the index and middle fingers of your other hand along the posterior vaginal wall, to identify the dimples. Then place the tip of the speculum between the dimples, elevate the vault while the patient performs a Valsalva effort, and determine the degree of vault prolapse. This can be confirmed by digital exam by identifying the dimples by tact and elevating them to their ipsilateral ischial spines.

FIGURE 4 Identifying the vault in the hysterectomized patient


Posthysterectomy vault prolapse can be identified by looking for “dimples” at the apex, which represent sites of previous uterosacral-cardinal ligament complex attachment. Reprinted with permission of The Cleveland Clinic Foundation.

Which exam findings point to which technique?

The importance of accurate pelvic assessment is impossible to overemphasize. Besides determining the degree and type of prolapse present, the exam enhances surgical planning. Fascial tears or defects are usually identifiable during careful vaginal exam as areas of sudden change in the thickness of the vaginal wall.

By the end of the pelvic exam, we usually have developed a surgical plan for the prolapse repair, pending urodynamic assessment to determine the best anti-incontinence procedure, if necessary.

What are the surgical goals?

Objectives are to normalize support of all anatomic compartments; alleviate clinical symptoms; and optimize sexual, bowel, and bladder function—without precipitating new support or functional problems.

Abdominal versus vaginal approach

Most surgeons prefer a vaginal approach to pelvic reconstruction. However, this decision should be based on the patient’s individual variables.

If sexual function is critical to the patient, a sacrocolpopexy should be the primary option. Note that age does not always predict the importance of sexual function.

Vaginal length. If the vaginal apex (dimples) reaches the ischial spines with ease, a vaginal procedure should suffice. If it does not reach the spines, or extends far above, an abdominal sacrocolpopexy or obliterative procedure may more be appropriate.

Previous reconstructive procedures. Keep in mind that the area around the sacral promontory, or sacrospinous ligaments, may be difficult or risky to reach due to scarring and fibrosis. This is doubly important in this age of commonplace graft use.

Large paravaginal defects. Vaginal repairs can be technically difficult, and long-term outcomes have not been reported. An abdominal approach is probably better if substantial paravaginal defects are present.

 

 

Medical comorbidities. Use a vaginal or obliterative procedure under regional anesthesia if the patient is medically delicate or elderly.

Tissue quality usually improves with preoperative local estrogen, but large fascial defects adjacent to the cuff or perineum may require graft reinforcement.

Colorectal dysfunction frequently coexists in women with vault prolapse. Thus, a woman with extensive rectal prolapse should probably undergo concomitant Ripstein rectopexy and sacrocolpopexy, or a perineal proctosigmoidectomy and vaginal-approach vault suspension.

Careful and consistent preparation

Surgical success depends in great part on developing a clear understanding of anatomic defects and urodynamic dysfunction during the preoperative evaluation, to determine the most appropriate procedures.

Tissue preparation with low-dose estrogen

cream (1 g, two nights per week) is crucial for most postmenopausal women.

Obtain medical clearance, and optimize

perioperative safety by using spinal anesthesia, antiembolism stockings, and prophylactic intravenous antibiotics.

Retain vaginal packing at least 24 hours to prevent stress on sutures due to coughing or vomiting.

Advise patients in advance that, for 6 weeks after surgery, they must avoid overexertion and lifting more than 5 lb.

After 6 weeks, we restart estrogen cream and prescribe routine, daily Kegel exercise.

Vaginal procedures

McCall/Mayo culdoplasty

This involves plicating the uterosacral ligaments in the midline while reefing the peritoneum in the cul-de-sac, resulting in posterior culdoplasty. It usually is performed at the time of vaginal hysterectomy using nonabsorbable sutures to incorporate both uterosacral ligaments, intervening cul-desac peritoneum, and full-thickness apical vaginal mucosa. Multiple sutures may be required if prolapse is extensive.

Generally, we try to place our uppermost suture on the uterosacral ligaments at a distance from the cuff equal to the amount of vault prolapse (POP-Q: TVL minus point D [point C if uterus is absent]).

Be careful not to injure or kink the ureters when placing the suture through the uterosacral ligaments, as the ureters lie 1 to 2 cm lateral at the level of the cervix. We recommend cystoscopy with visualization of ureteral patency.

Success rates are high, but objective long-term data is scant.4,5

Uterosacral ligament suspension

Excellent anatomic outcomes have been described when the uterosacral ligaments are reattached to the vaginal apex (similar to the McCall technique).6,7 The physiologic nature of this technique makes it very attractive. It involves opening the vaginal wall from anterior to posterior over the apical defect, and identifying the pubocervical fascia, rectovaginal fascia, and uterosacral ligaments.

Technique. Place 1 permanent 1-0 suture and 1 delayed absorbable 1-0 suture in the posteromedial aspect of each uterosacral ligament 1 to 2 cm proximal and medial to each ischial spine. Then place 1 arm of each permanent suture through the pubocervical and rectovaginal fascia, and 1 arm of each delayed absorbable suture through the same tissue, also incorporating the vaginal epithelium. After repairing all additional defects, tie the sutures to suspend the vault.

When prolapse is extensive, redundant peritoneum can hinder identification of the uterosacral ligaments.

Success rates are 87% to 90%, but ureteral injury is a limiting factor, with rates as high as 11%. Therefore, cystoscopy is essential. Long-term data are lacking.

Iliococcygeus suspension

This safe and simple procedure involves elevating the vaginal apex to the iliococcygeus muscles along the lateral pelvic sidewall. This can be done without a vaginal incision by placing a monofilament permanent suture (polypropylene) full thickness through the vaginal wall into the muscle uni-or bilaterally.

Candidates should not be sexually active, as there will be a suture knot in the vagina. The procedure may be useful in elderly patients for whom complete restoration of vaginal anatomy is not a goal. It also can be performed as a salvage operation in women with suboptimal vault support and good distal vaginal anatomy. In addition, it can be performed following posterior vaginal wall dissection with entry into the pararectal space.

Technique. Place the sutures into the fascia overlying the iliococcygeus muscle, anterior to the ischial spine and inferior to the arcus tendineus fascia pelvis, and incorporate the pubocervical fascia anteriorly and the rectovaginal fascia posteriorly.

Success rates. Shull reported a 95% cure rate of the apical compartment among 42 women, at 6 weeks to 5 years.8 However, the prolapse at other sites was 14%. A randomized trial comparing this procedure to sacrospinous fixation demonstrated similar satisfactory outcomes.9

Sacrospinous ligament fixation

Probably the most commonly performed apical suspension procedure from the vaginal approach is fixation of the apex to the sacrospinous ligaments. Although many describe unilateral fixation, we advocate bilateral fixation to avoid lateral deviation of the vaginal axis (FIGURE 5).

Technique. After entering the pararectal space through a posterior vaginal wall dissection, identify the sacrospinous ligaments and place 2 nonabsorbable sutures through each ligament, rather than around it, as the pudendal vessels pass behind it.

 

 

Place the first suture 2 cm medial to the ischial spine, and the second suture 1 cm medial to the first. Then pass each suture through the underside of the vaginal apex—in the midline if the procedure is done unilaterally and under each apex if it is bilateral. When tied, the sutures suspend the vaginal apex by approximating it to the ligament, ideally without a suture bridge.

We use CV-2 GoreTex (WL Gore and Associates, Flagstaff, Ariz) sutures passed through the ligaments with a Miya hook, and we reinforce the underside of the vaginal apex with a rectangular piece of Prolene mesh (Ethicon, Somerville, NJ) if the mucosa is thinned.

Success rates are 70% to 97%.10,11 A significant concern is the nonanatomic posterior axial deflection of the vagina. Many investigators have reported an anterior compartment prolapse rate of up to 20% after fixation, likely secondary to increased force on the anterior compartment with increases in abdominal pressure. This is especially likely if a concomitant anti-incontinence procedure is performed.

Other complications include hemorrhage, vaginal shortening, sexual dysfunction, and buttock pain.

FIGURE 5 Bilateral sacrospinous fixation avoids lateral vaginal deviation


With bilateral fixation of the vault to the sacrospinous ligaments, the vaginal axis is more horizontal. It may be reinforced to enhance longevity. Reprinted with permission of The Cleveland Clinic Foundation.

Posterior IVS vault suspension

This novel, minimally invasive technique uses the posterior intravaginal slingplasty (Posterior IVS; Tyco/US Surgical, Norwalk, Conn). First described as infracoccygeal sacropexy, it was introduced as an outpatient procedure in Australia. Concerns about postoperative vaginal length and risk of rectal injury led to poor acceptance. The procedure was modified by a few US surgeons to enhance safety and vaginal length.

Technique. Enter the pararectal space in a fashion similar to that of sacrospinous fixation. A specially designed tunneler device delivers a multifilament polypropylene tape through bilateral perianal incisions. Secure the tape to the vaginal apex, and adjust it to provide vault support.

We modified this procedure to create neoligaments analogous to cardinal ligaments, by directing the tunneler through the iliococcygeus muscles in close proximity to the ischial spines and arcus tendineus. The resultant vaginal axis is physiologic, and vaginal length is normalized.

By combining this technique with perineoplasty and attaching the rectovaginal and pubocervical fascia to the tape, all levels of pelvic support are repaired once the vault is positioned by pulling on the perianal tape ends.

The new Apogee technique (American Medical Systems, Minnetonka, Minn) uses a similar perianal approach with monofilament polypropylene mesh.

Success rates. Preliminary success rates are 88% to 100%, and complication rates are minimal.12 Vaginal length averages 7 to 8 cm. Most initially reported complications involved graft erosion or rejection; shifting from nylon to polypropylene graft material reduced this problem.

Abdominal procedures

Sacral colpopexy

Considered the gold standard, the sacral colpopexy vaginal vault suspension technique has a consistent cure rate above 90%.13 It may be the ideal procedure for pelvic floor muscle weakness and/or attenuated fascia with multiple defects, for women for whom optimal sexual function is critical, and for those with other indications for abdominal surgery.

A graft is placed between the vagina and the sacral promontory to restore vaginal support (FIGURE 6). Materials have included autologous and synthetic materials. We use polypropylene mesh because of its high tensile strength, biocompatibility, low infection rate, and low incidence of erosion. Biologic grafts such as cadaveric fascia lata have increased failure rates due to graft breakdown.

The resultant vaginal axis is the most physiologic of all vault reconstructive procedures. This procedure appears to have the best longevity of all vault suspension procedures. It can be performed laparo-scopically at selected centers.

Technique. First, access the presacral space overlying the sacral promontory, taking care not to disturb the presacral and middle sacral vessels. We perform this step first to avoid potential periosteal tissue contamination. We routinely use 2 bone anchors to secure the mesh—making sterility imperative. Bone anchors reduce periosteal tissue trauma and decrease risk of potentially life-threatening hemorrhage.

Mobilize the bladder from the anterior vaginal apex. Repair any apical fascial defects, restoring continuity of the pubocervical and rectovaginal fascia, which often detach from the apex. Using 2-0 Prolene sutures, suture the y-shaped graft to both the anterior and posterior vaginal walls, incorporating all fascial edges.

Culdoplasty follows; this obliterates the cul-de-sac to prevent subsequent enterocele formation.

Next, place the graft in a tension-free manner, creating a suspensory bridge from the apex to the sacral promontory. Irrigate copiously. Close the peritoneum over the graft along its entire length.

 

 

Follow with any anti-incontinence and paravaginal support procedures as well as posterior colporrhaphy as needed.14,15

Major complications include hemorrhage, usually involving periosteal perforators along the sacrum. Graft erosion may affect up to 5% to 7% of sacral colpopexies.

FIGURE 6 Mesh bridge aids vault suspension


Abdominal sacrocolpopexy with a mesh bridge from the vaginal apex to the sacral promontory. Reprinted with permission of The Cleveland Clinic Foundation.

Uterosacral ligament suspension

In this procedure, which can be performed open or laparoscopically, the remnants of the uterosacral ligaments suspend the vaginal apex. The laparoscopic procedure is simple, especially if the uterus is in place.

Technique. Identify the course of the ureters in relation to the ligaments, and use nonabsorbable sutures to incorporate both of the uterosacral ligaments, peritoneum, and the vaginal apex—including the pubocervical and rectovaginal fascia (FIGURE 7).

Place multiple sutures (include the posterior vaginal wall) to obliterate the cul-de-sac and prevent enterocele development.

Success rates. Long-term data are minimal, but outcomes should be similar to the vaginal-approach culdoplasty.

FIGURE 7 Suspension from uterosacral ligaments


Laparoscopic uterosacral ligament suspension incorporating both uterosacral ligaments and cervix or vaginal cuff.

Reprinted with permission of The Cleveland Clinic Foundation.

Obliterative procedures

LeForte colpocleisis or colpectomy/vaginectomy are the simplest treatments for advanced prolapse in elderly women who are not—and will not be—sexually active.16

We prefer the LeForte colpocleisis, in which rectangular segments of the anterior and posterior vaginal walls are denuded of their epithelium, followed by approximation of the rectangles to one another.

Success rates exceed 95%, and safety is maintained if spinal anesthesia is used in conjunction with a high perineoplasty.

Dr. Biller reports no relevant financial relationships. Dr. Davila reports research support from AMS and Tyco/US Surgical. He also serves as a consultant to AMS, and as a speaker for AMS and Tyco/US Surgical.

KEY POINTS

  • Look for vault prolapse in any woman who has an advanced degree of vaginal prolapse.
  • Goals of surgery: to normalize support of all anatomic compartments; alleviate clinical symptoms; and optimize sexual, bowel, and bladder function.
  • If sexual function is critical to the patient, a sacrocolpopexy should be the primary surgical option.
  • Preoperative low-dose estrogen cream is crucial in most postmenopausal women.

Identifying vault prolapse can be difficult in a woman with extensive vaginal prolapse, and operative failure is likely if support to the apex is not restored.

Because this condition is so challenging to identify, many women undergoing anterior and/or posterior colporrhaphy likely have undiagnosed vault prolapse. This may contribute to the 29.2% rate of reoperation in women who undergo pelvic floor reconstructive procedures.1

This article reviews the anatomy of apical support, tells how to identify vaginal vault prolapse during the physical exam, and outlines effective surgical options—both vaginal and abdominal—for its correction. We focus on accurate pelvic assessment as the basis for planning the surgery.

Vaginal stability is fragile

The stability of vaginal anatomy is precarious, since it depends on a series of interrelationships between both dynamic and static structures. When the relationships between the ligaments and fascia at the vaginal apex or vault are impaired, vault prolapse ensues.

Thanks to cadaveric and radiographic studies, our understanding of the complexities of vaginal anatomy has improved considerably; still, the area of vaginal support we least understand is the coalescence of ligaments and fascia at the vaginal apex or vault.

Grade II prolapse, at least, in 64.8%

An analysis of Women’s Health Initiative enrollees with an intact uterus found that 64.8% had at least grade II prolapse (ie, leading edge of prolapse at –1 to +1 cm from the hymen) according to the Pelvic Organ Prolapse Quantification System (POP-Q).2 Approximately 8% of enrollees had a point D (vaginal apex) of greater than –6 cm, suggesting some degree of vault prolapse.

Hysterectomy appears to contribute. The incidence is about 1% at 3 years; 5% at 17 years.3

In the United States, approximately 30,000 vaginal vault repairs were performed in 1999.

Normal support structure

Several support structures coalesce at the vaginal apex. If the cervix is present, it serves as an obvious strong attachment site (FIGURE 1). In hysterectomized women, the structures may lack a strong attachment site, resulting in weakness and prolapse.

FIGURE 1 Vaginal support system


The coalescence of both sets of ligaments forms the uterosacral-cardinal ligament complex at the vaginal apex, which is likely crucial to vault support. Reprinted with permission of The Cleveland Clinic Foundation.

2 sets of ligaments determine support

Uterosacral ligaments—peritoneal and fibromuscular tissue bands extending from the vaginal apex to the sacrum—are the principal support for the vaginal apex, despite their apparent lack of strength.

The role of the cardinal ligaments—which extend laterally from the apex to the pelvic sidewall, adjacent to the ischial spine—is less clear. Since they lie proximal to the ureters, restoring vault support by shortening or reattaching them to the apex is a less attractive option.

The coalescence of these 2 sets of ligaments forms the complex that likely maintains vault support.

In hysterectomized women, locating the attachment of this complex to the vaginal cuff (seen on the exam as apical “dimples”) is key to identifying vault prolapse.

New view of cystoceles, rectoceles

The fibromuscular tissue layer underlying the vaginal epithelium envelops the entire vaginal canal, extending from apex to perineum and from arcus tendineus to arcus tendineus.

As the aponeurosis does for the abdominal wall, the endopelvic fascia maintains integrity of the anterior and posterior vaginal walls. If the fascial layer detaches from the vaginal apex, a true hernia can develop in the form of an enterocele—anterior or posterior—further weakening vault integrity (FIGURE 2).

Reconstructive surgeons are beginning to view cystoceles and rectoceles as a detachment of the endopelvic fascia from the vaginal apex. Thus, it is critical to restore anterior and posterior vaginal wall fascial integrity from apex to perineum by reattaching the endogenous fascia to the vaginal apex, or by placing a biologic or synthetic graft.

FIGURE 2 Apical defects contribute to vault prolapse


 

 

Vault prolapse is often associated with defects of the apical fascia, represented here by dark lines, which must be addressed during vault reconstruction. Reprinted with permission of The Cleveland Clinic Foundation.

Specific technique, tools to help identify prolapse

Any patient with an advanced degree of vaginal prolapse should be assessed for vault prolapse using a careful, structured pelvic exam. In many cases, this can be difficult, even if the uterus is present.

Necessary tools include a bivalved speculum and a right-angle retractor, or the posterior blade of another gynecologic speculum.

When the uterus is present

An exteriorized cervix does not necessarily mean vault prolapse; this may occur with substantial cervical hypertrophy, while the apex remains well supported (FIGURE 3).

Exam technique. Place the right-angle speculum blade in the posterior fornix, inserting it to its full extent, and ask the patient to perform a Valsalva maneuver. If vault prolapse is present, the uterus will descend further as the speculum is slowly removed; reinsertion of the speculum will resuspend the uterus. If the vault is well supported, the cervix will remain in place despite Valsalva efforts.

Assess the degree of vault prolapse during this examination, to determine whether a McCall culdoplasty will restore vault support.

If uterine suspension is performed in a woman with substantial cervical hypertrophy, cervical prolapse may persist, necessitating partial amputation (Manchester procedure).

FIGURE 3 Exteriorized cervix does not necessarily mean vault prolapse


Cervical prolapse may be associated with vault prolapse (left) or simply represent cervical hypertrophy without vault prolapse (right). Reprinted with permission of The Cleveland Clinic Foundation.

In the hysterectomized patient

The goal of physical exam is to identify the apical scar tissue (cuff) resultant from the hysterectomy. In most women, the cuff is visible as a transverse band of tissue firmer than the adjacent vaginal walls. If the woman has extensive prolapse, the tissue is stretched and thus not as obvious.

Exam technique. Use a bivalved speculum to visualize the apex. In women with extensive prolapse, redundant vaginal tissue may impede visualization. Fortunately, the sites of previous attachment of the uterosacral-cardinal ligament complex can usually be identified as “dimples” on either side of the midline at the cuff (FIGURE 4).

Use both right-angle speculum blades, or 1 blade along the anterior vaginal wall and the index and middle fingers of your other hand along the posterior vaginal wall, to identify the dimples. Then place the tip of the speculum between the dimples, elevate the vault while the patient performs a Valsalva effort, and determine the degree of vault prolapse. This can be confirmed by digital exam by identifying the dimples by tact and elevating them to their ipsilateral ischial spines.

FIGURE 4 Identifying the vault in the hysterectomized patient


Posthysterectomy vault prolapse can be identified by looking for “dimples” at the apex, which represent sites of previous uterosacral-cardinal ligament complex attachment. Reprinted with permission of The Cleveland Clinic Foundation.

Which exam findings point to which technique?

The importance of accurate pelvic assessment is impossible to overemphasize. Besides determining the degree and type of prolapse present, the exam enhances surgical planning. Fascial tears or defects are usually identifiable during careful vaginal exam as areas of sudden change in the thickness of the vaginal wall.

By the end of the pelvic exam, we usually have developed a surgical plan for the prolapse repair, pending urodynamic assessment to determine the best anti-incontinence procedure, if necessary.

What are the surgical goals?

Objectives are to normalize support of all anatomic compartments; alleviate clinical symptoms; and optimize sexual, bowel, and bladder function—without precipitating new support or functional problems.

Abdominal versus vaginal approach

Most surgeons prefer a vaginal approach to pelvic reconstruction. However, this decision should be based on the patient’s individual variables.

If sexual function is critical to the patient, a sacrocolpopexy should be the primary option. Note that age does not always predict the importance of sexual function.

Vaginal length. If the vaginal apex (dimples) reaches the ischial spines with ease, a vaginal procedure should suffice. If it does not reach the spines, or extends far above, an abdominal sacrocolpopexy or obliterative procedure may more be appropriate.

Previous reconstructive procedures. Keep in mind that the area around the sacral promontory, or sacrospinous ligaments, may be difficult or risky to reach due to scarring and fibrosis. This is doubly important in this age of commonplace graft use.

Large paravaginal defects. Vaginal repairs can be technically difficult, and long-term outcomes have not been reported. An abdominal approach is probably better if substantial paravaginal defects are present.

 

 

Medical comorbidities. Use a vaginal or obliterative procedure under regional anesthesia if the patient is medically delicate or elderly.

Tissue quality usually improves with preoperative local estrogen, but large fascial defects adjacent to the cuff or perineum may require graft reinforcement.

Colorectal dysfunction frequently coexists in women with vault prolapse. Thus, a woman with extensive rectal prolapse should probably undergo concomitant Ripstein rectopexy and sacrocolpopexy, or a perineal proctosigmoidectomy and vaginal-approach vault suspension.

Careful and consistent preparation

Surgical success depends in great part on developing a clear understanding of anatomic defects and urodynamic dysfunction during the preoperative evaluation, to determine the most appropriate procedures.

Tissue preparation with low-dose estrogen

cream (1 g, two nights per week) is crucial for most postmenopausal women.

Obtain medical clearance, and optimize

perioperative safety by using spinal anesthesia, antiembolism stockings, and prophylactic intravenous antibiotics.

Retain vaginal packing at least 24 hours to prevent stress on sutures due to coughing or vomiting.

Advise patients in advance that, for 6 weeks after surgery, they must avoid overexertion and lifting more than 5 lb.

After 6 weeks, we restart estrogen cream and prescribe routine, daily Kegel exercise.

Vaginal procedures

McCall/Mayo culdoplasty

This involves plicating the uterosacral ligaments in the midline while reefing the peritoneum in the cul-de-sac, resulting in posterior culdoplasty. It usually is performed at the time of vaginal hysterectomy using nonabsorbable sutures to incorporate both uterosacral ligaments, intervening cul-desac peritoneum, and full-thickness apical vaginal mucosa. Multiple sutures may be required if prolapse is extensive.

Generally, we try to place our uppermost suture on the uterosacral ligaments at a distance from the cuff equal to the amount of vault prolapse (POP-Q: TVL minus point D [point C if uterus is absent]).

Be careful not to injure or kink the ureters when placing the suture through the uterosacral ligaments, as the ureters lie 1 to 2 cm lateral at the level of the cervix. We recommend cystoscopy with visualization of ureteral patency.

Success rates are high, but objective long-term data is scant.4,5

Uterosacral ligament suspension

Excellent anatomic outcomes have been described when the uterosacral ligaments are reattached to the vaginal apex (similar to the McCall technique).6,7 The physiologic nature of this technique makes it very attractive. It involves opening the vaginal wall from anterior to posterior over the apical defect, and identifying the pubocervical fascia, rectovaginal fascia, and uterosacral ligaments.

Technique. Place 1 permanent 1-0 suture and 1 delayed absorbable 1-0 suture in the posteromedial aspect of each uterosacral ligament 1 to 2 cm proximal and medial to each ischial spine. Then place 1 arm of each permanent suture through the pubocervical and rectovaginal fascia, and 1 arm of each delayed absorbable suture through the same tissue, also incorporating the vaginal epithelium. After repairing all additional defects, tie the sutures to suspend the vault.

When prolapse is extensive, redundant peritoneum can hinder identification of the uterosacral ligaments.

Success rates are 87% to 90%, but ureteral injury is a limiting factor, with rates as high as 11%. Therefore, cystoscopy is essential. Long-term data are lacking.

Iliococcygeus suspension

This safe and simple procedure involves elevating the vaginal apex to the iliococcygeus muscles along the lateral pelvic sidewall. This can be done without a vaginal incision by placing a monofilament permanent suture (polypropylene) full thickness through the vaginal wall into the muscle uni-or bilaterally.

Candidates should not be sexually active, as there will be a suture knot in the vagina. The procedure may be useful in elderly patients for whom complete restoration of vaginal anatomy is not a goal. It also can be performed as a salvage operation in women with suboptimal vault support and good distal vaginal anatomy. In addition, it can be performed following posterior vaginal wall dissection with entry into the pararectal space.

Technique. Place the sutures into the fascia overlying the iliococcygeus muscle, anterior to the ischial spine and inferior to the arcus tendineus fascia pelvis, and incorporate the pubocervical fascia anteriorly and the rectovaginal fascia posteriorly.

Success rates. Shull reported a 95% cure rate of the apical compartment among 42 women, at 6 weeks to 5 years.8 However, the prolapse at other sites was 14%. A randomized trial comparing this procedure to sacrospinous fixation demonstrated similar satisfactory outcomes.9

Sacrospinous ligament fixation

Probably the most commonly performed apical suspension procedure from the vaginal approach is fixation of the apex to the sacrospinous ligaments. Although many describe unilateral fixation, we advocate bilateral fixation to avoid lateral deviation of the vaginal axis (FIGURE 5).

Technique. After entering the pararectal space through a posterior vaginal wall dissection, identify the sacrospinous ligaments and place 2 nonabsorbable sutures through each ligament, rather than around it, as the pudendal vessels pass behind it.

 

 

Place the first suture 2 cm medial to the ischial spine, and the second suture 1 cm medial to the first. Then pass each suture through the underside of the vaginal apex—in the midline if the procedure is done unilaterally and under each apex if it is bilateral. When tied, the sutures suspend the vaginal apex by approximating it to the ligament, ideally without a suture bridge.

We use CV-2 GoreTex (WL Gore and Associates, Flagstaff, Ariz) sutures passed through the ligaments with a Miya hook, and we reinforce the underside of the vaginal apex with a rectangular piece of Prolene mesh (Ethicon, Somerville, NJ) if the mucosa is thinned.

Success rates are 70% to 97%.10,11 A significant concern is the nonanatomic posterior axial deflection of the vagina. Many investigators have reported an anterior compartment prolapse rate of up to 20% after fixation, likely secondary to increased force on the anterior compartment with increases in abdominal pressure. This is especially likely if a concomitant anti-incontinence procedure is performed.

Other complications include hemorrhage, vaginal shortening, sexual dysfunction, and buttock pain.

FIGURE 5 Bilateral sacrospinous fixation avoids lateral vaginal deviation


With bilateral fixation of the vault to the sacrospinous ligaments, the vaginal axis is more horizontal. It may be reinforced to enhance longevity. Reprinted with permission of The Cleveland Clinic Foundation.

Posterior IVS vault suspension

This novel, minimally invasive technique uses the posterior intravaginal slingplasty (Posterior IVS; Tyco/US Surgical, Norwalk, Conn). First described as infracoccygeal sacropexy, it was introduced as an outpatient procedure in Australia. Concerns about postoperative vaginal length and risk of rectal injury led to poor acceptance. The procedure was modified by a few US surgeons to enhance safety and vaginal length.

Technique. Enter the pararectal space in a fashion similar to that of sacrospinous fixation. A specially designed tunneler device delivers a multifilament polypropylene tape through bilateral perianal incisions. Secure the tape to the vaginal apex, and adjust it to provide vault support.

We modified this procedure to create neoligaments analogous to cardinal ligaments, by directing the tunneler through the iliococcygeus muscles in close proximity to the ischial spines and arcus tendineus. The resultant vaginal axis is physiologic, and vaginal length is normalized.

By combining this technique with perineoplasty and attaching the rectovaginal and pubocervical fascia to the tape, all levels of pelvic support are repaired once the vault is positioned by pulling on the perianal tape ends.

The new Apogee technique (American Medical Systems, Minnetonka, Minn) uses a similar perianal approach with monofilament polypropylene mesh.

Success rates. Preliminary success rates are 88% to 100%, and complication rates are minimal.12 Vaginal length averages 7 to 8 cm. Most initially reported complications involved graft erosion or rejection; shifting from nylon to polypropylene graft material reduced this problem.

Abdominal procedures

Sacral colpopexy

Considered the gold standard, the sacral colpopexy vaginal vault suspension technique has a consistent cure rate above 90%.13 It may be the ideal procedure for pelvic floor muscle weakness and/or attenuated fascia with multiple defects, for women for whom optimal sexual function is critical, and for those with other indications for abdominal surgery.

A graft is placed between the vagina and the sacral promontory to restore vaginal support (FIGURE 6). Materials have included autologous and synthetic materials. We use polypropylene mesh because of its high tensile strength, biocompatibility, low infection rate, and low incidence of erosion. Biologic grafts such as cadaveric fascia lata have increased failure rates due to graft breakdown.

The resultant vaginal axis is the most physiologic of all vault reconstructive procedures. This procedure appears to have the best longevity of all vault suspension procedures. It can be performed laparo-scopically at selected centers.

Technique. First, access the presacral space overlying the sacral promontory, taking care not to disturb the presacral and middle sacral vessels. We perform this step first to avoid potential periosteal tissue contamination. We routinely use 2 bone anchors to secure the mesh—making sterility imperative. Bone anchors reduce periosteal tissue trauma and decrease risk of potentially life-threatening hemorrhage.

Mobilize the bladder from the anterior vaginal apex. Repair any apical fascial defects, restoring continuity of the pubocervical and rectovaginal fascia, which often detach from the apex. Using 2-0 Prolene sutures, suture the y-shaped graft to both the anterior and posterior vaginal walls, incorporating all fascial edges.

Culdoplasty follows; this obliterates the cul-de-sac to prevent subsequent enterocele formation.

Next, place the graft in a tension-free manner, creating a suspensory bridge from the apex to the sacral promontory. Irrigate copiously. Close the peritoneum over the graft along its entire length.

 

 

Follow with any anti-incontinence and paravaginal support procedures as well as posterior colporrhaphy as needed.14,15

Major complications include hemorrhage, usually involving periosteal perforators along the sacrum. Graft erosion may affect up to 5% to 7% of sacral colpopexies.

FIGURE 6 Mesh bridge aids vault suspension


Abdominal sacrocolpopexy with a mesh bridge from the vaginal apex to the sacral promontory. Reprinted with permission of The Cleveland Clinic Foundation.

Uterosacral ligament suspension

In this procedure, which can be performed open or laparoscopically, the remnants of the uterosacral ligaments suspend the vaginal apex. The laparoscopic procedure is simple, especially if the uterus is in place.

Technique. Identify the course of the ureters in relation to the ligaments, and use nonabsorbable sutures to incorporate both of the uterosacral ligaments, peritoneum, and the vaginal apex—including the pubocervical and rectovaginal fascia (FIGURE 7).

Place multiple sutures (include the posterior vaginal wall) to obliterate the cul-de-sac and prevent enterocele development.

Success rates. Long-term data are minimal, but outcomes should be similar to the vaginal-approach culdoplasty.

FIGURE 7 Suspension from uterosacral ligaments


Laparoscopic uterosacral ligament suspension incorporating both uterosacral ligaments and cervix or vaginal cuff.

Reprinted with permission of The Cleveland Clinic Foundation.

Obliterative procedures

LeForte colpocleisis or colpectomy/vaginectomy are the simplest treatments for advanced prolapse in elderly women who are not—and will not be—sexually active.16

We prefer the LeForte colpocleisis, in which rectangular segments of the anterior and posterior vaginal walls are denuded of their epithelium, followed by approximation of the rectangles to one another.

Success rates exceed 95%, and safety is maintained if spinal anesthesia is used in conjunction with a high perineoplasty.

Dr. Biller reports no relevant financial relationships. Dr. Davila reports research support from AMS and Tyco/US Surgical. He also serves as a consultant to AMS, and as a speaker for AMS and Tyco/US Surgical.

References

1. Olsen AL, Smith VJ, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89:501-506.

2. Nygaard I, Bradley C, Brandt D, et al. Pelvic organ prolapse in older women: Prevalence and risk factors. Obstet Gynecol. 2004;104:489-497.

3. Thakar R, Stanton S. Management of genital prolapse. BMJ. 2002;324:1258-1262.

4. McCall ML. Posterior culdoplasty: surgical correction of enterocele during vaginal hysterectomy. A preliminary report. Obstet Gynecol. 1957;10:595-602.

5. Webb MJ, Aronson MP, et al. Posthysterectomy vaginal vault prolapse: primary repair in 693 patients. Obstet Gynecol. 1998;92:281-285.

6. Shull BL, Bachofen C, et al. A transvaginal approach to repair of apical and other associated sites of pelvic organ prolapse with uterosacral ligaments. Am J Obstet Gynecol. 2000;183:1365-1374.

7. Barber MD, Visco AG, et al. Bilateral uterosacral ligament vaginal vault suspension with site specific endopelvic fascia defect repair for treatment of pelvic organ prolapse. Am J Obstet Gynecol. 2000;183:1402-1411.

8. Shull BL, Capen CV, et al. Bilateral attachment of the vaginal cuff to iliococcygeus fascia: an effective method of cuff suspension. Am J Obstet Gynecol. 1993;168:1669-1677.

9. Maher CF, Murray CJ, et al. Iliococcygeus or sacrospinous fixation for vaginal vault prolapse. Obstet Gynecol. 2001;98:40-44.

10. Morley G, DeLancey JO. Sacrospinous ligament fixation for eversion of the vagina. Am J Obstet Gynecol. 1988;158:872.-

11. Shull BL, Capen CV, et al. Preoperative and postoperative analysis of site-specific pelvic support defects in 81 women treated with sacrospinous ligament suspension and pelvic reconstruction. Am J Obstet Gynecol. 1992;166:1764-1771.

12. Davila GW, Miller D. Vaginal vault suspension using the Posterior IVS technique. J Pelvic Med Surg. 2004;10:S39.-

13. Addison WA, Bump RC, et al. Sacral colpopexy is the preferred treatment for vaginal vault prolapse in selected patients. J Gynecol Tech. 1996;2:69-74.

14. Kohli N, Walsh PM, et al. Mesh erosion after abdominal sacrocolpopexy. Obstet Gynecol. 1998;92:999-1004.

15. Visco AG, Weidner AC, et al. Vaginal mesh erosion after abdominal sacral colpopexy. Am J Obstet Gynecol. 2001;184:297-302.

16. Neimark M, Davila GW, Kopka SL. LeForte colpocleisis: a feasible treatment option for pelvic organ prolapse in the elderly woman. J Pelvic Med Surg. 2003;9:1-7.

References

1. Olsen AL, Smith VJ, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89:501-506.

2. Nygaard I, Bradley C, Brandt D, et al. Pelvic organ prolapse in older women: Prevalence and risk factors. Obstet Gynecol. 2004;104:489-497.

3. Thakar R, Stanton S. Management of genital prolapse. BMJ. 2002;324:1258-1262.

4. McCall ML. Posterior culdoplasty: surgical correction of enterocele during vaginal hysterectomy. A preliminary report. Obstet Gynecol. 1957;10:595-602.

5. Webb MJ, Aronson MP, et al. Posthysterectomy vaginal vault prolapse: primary repair in 693 patients. Obstet Gynecol. 1998;92:281-285.

6. Shull BL, Bachofen C, et al. A transvaginal approach to repair of apical and other associated sites of pelvic organ prolapse with uterosacral ligaments. Am J Obstet Gynecol. 2000;183:1365-1374.

7. Barber MD, Visco AG, et al. Bilateral uterosacral ligament vaginal vault suspension with site specific endopelvic fascia defect repair for treatment of pelvic organ prolapse. Am J Obstet Gynecol. 2000;183:1402-1411.

8. Shull BL, Capen CV, et al. Bilateral attachment of the vaginal cuff to iliococcygeus fascia: an effective method of cuff suspension. Am J Obstet Gynecol. 1993;168:1669-1677.

9. Maher CF, Murray CJ, et al. Iliococcygeus or sacrospinous fixation for vaginal vault prolapse. Obstet Gynecol. 2001;98:40-44.

10. Morley G, DeLancey JO. Sacrospinous ligament fixation for eversion of the vagina. Am J Obstet Gynecol. 1988;158:872.-

11. Shull BL, Capen CV, et al. Preoperative and postoperative analysis of site-specific pelvic support defects in 81 women treated with sacrospinous ligament suspension and pelvic reconstruction. Am J Obstet Gynecol. 1992;166:1764-1771.

12. Davila GW, Miller D. Vaginal vault suspension using the Posterior IVS technique. J Pelvic Med Surg. 2004;10:S39.-

13. Addison WA, Bump RC, et al. Sacral colpopexy is the preferred treatment for vaginal vault prolapse in selected patients. J Gynecol Tech. 1996;2:69-74.

14. Kohli N, Walsh PM, et al. Mesh erosion after abdominal sacrocolpopexy. Obstet Gynecol. 1998;92:999-1004.

15. Visco AG, Weidner AC, et al. Vaginal mesh erosion after abdominal sacral colpopexy. Am J Obstet Gynecol. 2001;184:297-302.

16. Neimark M, Davila GW, Kopka SL. LeForte colpocleisis: a feasible treatment option for pelvic organ prolapse in the elderly woman. J Pelvic Med Surg. 2003;9:1-7.

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Ovarian cancer: What can we expect of second-look laparotomy?

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Ovarian cancer: What can we expect of second-look laparotomy?

KEY POINTS

  • Second-look laparotomy (SLL) is the only way to confirm complete pathologic response to ovarian cancer therapy.
  • Offer SLL only to patients for whom results will affect decision-making—and only after discussion with the patient and a gynecologic oncologist.
  • Although negative SLL findings confer improved prognosis, disease recurs in up to 60% of patients.
  • Candidates should be in clinical remission as determined by physical examination, abdominopelvic imaging, and serum CA-125 determination.
The disturbing fact that epithelial ovarian cancer often recurs after clinical remission poses this challenge: How do we identify the women with subclinical disease who may benefit from additional consolidation therapy?

Given the inability of noninvasive studies such as computed tomography, magnetic resonance imaging, and positron emission tomography to reliably detect small-volume and microscopic disease, second-look laparotomy (SLL) is the only technique capable of confirming a complete pathologic response to therapy.

Ob/Gyns involved in care of women with advanced ovarian cancer face the challenge of weighing the benefits of SLL against the potential morbidities of invasive surgery. This article describes those benefits, surgical technique, the prognostic significance of findings, and the status of salvage and consolidation therapies.

What SLL conveys

“Second look laparotomy” has rather loosely described many secondary surgeries for ovarian cancer, but we adopt the more rigorous definition: “a systematic surgical reexploration in asymptomatic patients who have no clinical evidence of tumor following initial surgery and completion of a planned program of chemotherapy.”1

Procedures to debulk recurrent or residual disease, relieve symptomatic tumor, or accomplish interval cytoreduction cannot be deemed second-look laparotomy.

Prognostic, therapeutic limitations complicate the decision

Although negative findings at SLL confer an improved prognosis, disease ultimately recurs in up to 60% of patients.2,3 Moreover, despite intensive research, consistently effective consolidation and salvage regimens remain elusive.

SLL may provide some information about prognosis, but that information is far from certain. Because of the cost and morbidity inherent in SLL, routine use has largely been limited to patients in clinical trials, where findings may serve as a surrogate endpoint for investigational therapies.

For these reasons, we strongly recommend careful discussion of this complex decision with patients prior to surgery, in consultation with a gynecologic oncologist.

Which patients are and are not candidates?

Candidates should be in clinical remission as determined by physical examination, abdominopelvic imaging, and serum CA-125 determination. Although SLL will detect residual disease in up to 50% of patients undergoing the procedure after primary chemotherapy, SLL is an imperfect method of determining the true response to therapy. Thus, it should be offered only to patients for whom results will influence clinical decision-making.

Patients with stage I disease treated with appropriate chemotherapy should not undergo SLL because of the low incidence of positive findings.4

Residual disease: 30% to 50%

Second-look laparotomy requires thorough inspection of the peritoneal cavity and retroperitoneum, but when properly performed on appropriate candidates, SLL detects residual disease in 30% to 50% of patients.2,5

Generally, stage and volume of residual disease at initial surgery are most closely correlated with findings. In a review of 31 series, patients with stage III and IV disease undergoing surgery had fewer negative SLLs (39% and 33%, respectively) than patients with stage I and II disease (81% and 69%, respectively).6 Similarly, in pooled data on 1,797 patients, 72% of those with no gross residual disease at the conclusion of primary surgery had negative findings at SLL, compared with 50% of those with optimal residual, and only 23% of those with suboptimal residual.6

Surgical technique

Surgery begins with a large vertical incision and involves the components listed in the TABLE.

If gross disease is apparent:

Consider surgical cytoreduction, which is typically performed at the surgeon’s discretion.

In the absence of gross tumor:

Use a 5-point strategy to search thoroughly for occult disease.

  • Take washings for cytology from the abdomen and pelvis;
  • lyse any adhesions to allow adequate examination of all peritoneal surfaces;
  • obtain random biopsies from the pelvis, bladder serosa, vaginal cuff, culde-sac, paracolic gutters, and hemidiaphragms, as well as adhesions, sites of prior documented tumor, infundibulopelvic ligament pedicles, and areas suspicious for tumor recurrence;
  • consider removing the uterus, adnexae, omentum, and appendix, if not done at the primary surgery; and
  • sample any remaining pelvic and paraaortic lymph nodes.

Meticulous sampling is crucial

 

 

Although the number of biopsies performed at SLL varies widely by surgeon, meticulous sampling of peritoneal surfaces may be necessary to detect occult tumor. In cases of microscopic disease, fewer than 5% of biopsies may be positive for tumor.7 Not surprisingly, some studies have noted a significantly worse survival rate among patients deemed to be in complete pathologic remission who underwent fewer biopsies at the time of SLL.8

TABLE

Components of second-look laparotomy

Vertical incision
Thorough inspection of abdomen and pelvis
Abdominopelvic washings for cytologic analysis
Complete adhesiolysis
Systematic biopsy of:
  • Undersurfaces of bilateral hemidiaphragms
  • Paracolic gutters
  • Pelvic peritoneum
  • Pedicles of ovarian vessels
  • Any suspicious lesions
  • Areas of known prior tumor
  • Adhesions
If necessary: Complete hysterectomy, salpingo-oophorectomy, omentectomy, and appendectomy
Pelvic and paraaortic lymph node sampling

What do SLL findings predict?

Survival rates

Women who achieve a complete pathologic response after primary chemotherapy have the greatest survival. Rubin et al3 noted a 10-year survival rate of 51% for 91 patients after negative SLL. Median survivals for patients with negative findings have been reported in excess of 70 months.7,9 Tuxen et al9 examined 242 patients after SLL and reported a median survival of 149 months for those with negative findings, versus 39 and 24 months for those with microscopic and gross disease, respectively (P<.0005>

Survival rates among women with negative findings were substantially higher than among patients with positive findings, even though the latter group received salvage chemotherapy.

Recurrence rates

In a review of 38 studies encompassing 1,511 patients, Barter and Barnes6 noted a 23% rate of recurrence among women with negative findings at SLL. Other studies from single institutions document recurrence rates approximating 50%.3,10 Patients experiencing recurrence after negative SLL have median survivals of 11 to 45 months.3,8,10-12

Gross versus microscopic disease

Studies comparing outcomes based on volume of disease detected at SLL have found statistically improved survival for patients without evidence of gross tumor.9,13-15 Podratz et al14 reported 4-year survival of 55% for women with microscopic findings versus 19% for those with gross disease (P<.01>

The presence of gross tumor at SLL indicates a grave prognosis; median survival ranges between 13 and 24 months.9,16,17 Nevertheless, several studies have shown that patients able to undergo debulking of all visible disease derive a survival benefit.4,15,18,19

Given the potential complications of extensive debulking surgery and lack of a proven survival benefit for patients unable to achieve complete cytoreduction, debulking should only be attempted if persistent disease is judged to be completely resectable.

When SLL is positive: Salvage therapy regimens

Many different salvage regimens for epithelial ovarian cancer have been investigated for use after positive second-look laparotomy, including intraperitoneal radioactive phosphorus (32P), systemic chemotherapy, whole abdominal radiation (WAR), hormonal therapy, and biologic response modifiers. Unfortunately, studies of salvage therapy tend to be retrospective, nonrandomized, and uncontrolled, and no proven regimen has yet been found.

Whole abdominal radiation

This modality appears to confer no definitive survival benefit and does produce toxicity. MacGibbon et al20 treated 51 patients with WAR for both salvage and consolidation. Of these, 27% could not complete treatment because of progressive disease, bowel perforation, myelosuppression, and bowel toxicity. An additional 24% required treatment delays because of hematologic and gastrointestinal toxicity. Among those completing the prescribed course of radiation, 6 developed late bowel symptoms, and 2 of these required surgical intervention to relieve bowel obstruction.

Other salvage therapies

Recently, Dowdy et al18 reported long-term follow-up for 145 patients with positive findings at SLL. Neither intraperitoneal 32P nor WAR provided a survival benefit. Multivariate analysis indicated that only grade and volume of residual disease following cytoreduction were associated with improved survival.

Other trials involving intraperitoneal interferon-alpha and carboplatin,21 and high-dose chemotherapy with autologous stem cell rescue22 have also failed to demonstrate any significant advantages in survival or rate of progression. An early phase II study of intraperitoneal paclitaxel showed promise: Markman et al23 noted a complete pathologic response in 61% of patients with microscopic disease at SLL, but only 4% of those with gross disease achieved a complete response.

Need for effective consolidation therapy

A critical component of cancer care is targeting patients at highest risk of recurrence for effective consolidation therapy. The factors most strongly correlated with disease progression are stage at diagnosis, tumor grade, and volume of residual disease after initial cytoreduction.

Many consolidation therapies have been described, including systemic and intraperitoneal chemotherapy, WAR, intraperitoneal 32P, and biologic response modifiers.

Significant risk of distant recurrences

Although most tumors recur in the abdomen and pelvis, approximately 30% recur at distant locations. For this reason, consider systemic treatment when planning the consolidation regimen. Bertucci et al22 studied systemic melphalan-based, high-dose chemotherapy with autologous stem cell rescue and noted a 5-year progression-free survival of 43% and overall survival of 75%.

 

 

Most therapies are localized. Most other studies have focused on therapies localized to the peritoneal cavity. Results for intraperitoneal 32P and WAR are mixed. Several different regimens of intraperitoneal chemotherapy have produced median disease-free survival rates of 18 to 41 months.24-27 In 1998, Barakat et al27 examined the use of intraperitoneal cisplatin and etoposide, reporting a statistically improved median disease-free survival for patients receiving intraperitoneal consolidation (median disease-free survival not yet reached), compared with patients treated by observation (28.5 months).

Bottom line

Second-look laparotomy reveals that approximately 50% of patients with a complete clinical response still harbor residual disease after primary chemotherapy. Even women who achieve a complete pathologic response have recurrence rates as high as 60%. While SLL can be a useful tool, the information it yields must be weighed against the potential morbidities of invasive surgery. Given its limited prognostic value, SLL should be offered only when results will influence clinical decision-making, or as part of a clinical trial.

Is laparoscopy equal to laparotomy for second-look procedures?

Advocates of laparoscopy as a substitute for SLL report lower blood loss, shorter hospitalization, and decreased costs for laparoscopy.28

Clough et al29 performed the first study of second-look laparoscopy in 20 patients, using immediate laparotomy as a control. In 12 patients, adequate exploration was hindered by adhesions, and only 2 were able to undergo sufficient laparoscopic adhesiolysis. Overall, only 41% of patients could be completely explored at laparoscopy, versus 95% for laparotomy. However, obvious carcinomatosis was apparent in 3 patients at laparoscopy, rendering laparotomy unnecessary.

In general, laparoscopic second look has been reported to be a safe, feasible alternative to laparotomy. Although intraabdominal adhesions occur in as many as 70% of patients,30,31 complete laparoscopic evaluation may still be possible in up to 92%.32,33

How accurate?

Concerns remain about the accuracy of laparoscopic second look. Prior to 1985, several studies reported false-negative rates of 19% to 77%,33,34 although a 1999 study documented a false-negative rate of only 14%.29 The clinical impact of these false negatives is controversial. Some authors have reported no differences in clinical endpoints such as disease recurrence28 and overall survival35 for patients undergoing laparoscopy versus laparotomy. In contrast, a multivariate analysis by Gadducci et al10 showed a significantly prolonged disease-free interval for patients treated by laparotomy.

Switch to laparotomy for maximal cytoreduction

Laparoscopy may spare patients with obvious unresectable carcinomatosis a full laparotomy, though many patients will still require conversion to an open procedure to achieve maximal cytoreduction. Given these considerations, laparoscopy has only a limited role in second-look evaluation.

The authors report no financial relationships relevant to this article.
References

1. Rubin SC, Lewis JL, Jr. Second-look surgery in ovarian carcinoma. Crit Rev Oncol Hematol. 1988;8:75-91.

2. van der Burg ME. More than 20 years second-look surgery in advanced epithelial ovarian cancer: what did we learn? Ann Oncol. 1997;8:627-629.

3. Rubin SC, Randall TC, Armstrong KA, Chi DS, Hoskins WJ. Ten-year follow-up of ovarian cancer patients after second-look laparotomy with negative findings. Obstet Gynecol. 1999;93:21-24.

4. Hempling RE, Wesolowski JA, Piver MS. Second-look laparotomy in advanced ovarian cancer: a critical assessment of morbidity and impact on survival. Ann Surg Oncol. 1997;4:349-54.

5. Katsoulis M, Vorgias G, Panagiotides J, Dertimas B, Zis J. The prognostic significance of second-look laparotomy in advanced ovarian cancer. Eur J Gynaecol Oncol. 1997;18:200-202.

6. Barter JF, Barnes WA. Second-look laparotomy. In: Rubin SC, Sutton GP, eds. Ovarian Cancer. New York, NY: McGraw-Hill; 1993;269-300.

7. Friedman RL, Eisenkop SM, Wang HJ. Second-look laparotomy for ovarian cancer provides reliable prognostic information and improves survival. Gynecol Oncol. 1997;67:88-94.

8. Gershenson DM, Copeland LJ, Wharton JT, et al. Prognosis of surgically determined complete responders in advanced ovarian cancer. Cancer. 1985;55:1129-1135.

9. Tuxen MK, Strauss G, Lund B, Hansen M. The role of second-look laparotomy in the long-term survival in ovarian cancer. Ann Oncol. 1997;8:643-648.

10. Gadducci A, Sartori E, Maggino T, et al. Analysis of failures after negative second-look in patients with advanced ovarian cancer: an Italian multicenter study. Gynecol Oncol. 1998;68:150-155.

11. Rubin SC, Hoskins WJ, Hakes TB, Markman M, Cain JM, Lewis JL, Jr. Recurrence after negative second-look laparotomy for ovarian cancer: analysis of risk factors. Am J Obstet Gynecol. 1988;159:1094-1098.

12. Ghatage P, Krepart GV, Lotocki R. Factor analysis of false-negative second-look laparotomy. Gynecol Oncol. 1990;36:172-175.

13. Dauplat J, Ferriere JP, Gorbinet M, et al. Second-look laparotomy in managing epithelial ovarian carcinoma. Cancer. 1986;57:1627-1631.

14. Podratz KC, Schray MF, Wieand HS, et al. Evaluation of treatment and survival after positive second-look laparotomy. Gynecol Oncol. 1988;31:9-24.

15. Lippman SM, Alberts DS, Slymen DJ, et al. Second-look laparotomy in epithelial ovarian carcinoma. Prognostic factors associated with survival duration. Cancer. 1988;61:2571-2577.

16. Raju KS, McKinna JA, Barker GH, Wiltshaw E, Jones JM. Second-look operations in the planned management of advanced ovarian carcinoma. Am J Obstet Gynecol. 1982;144:650-654.

17. Williams L, Brunetto VL, Yordan E, DiSaia PJ, Creasman WT. Secondary cytoreductive surgery at second-look laparotomy in advanced ovarian cancer: a Gynecologic Oncology Group Study. Gynecol Oncol. 1997;66:171-178.

18. Dowdy SC, Constantinou CL, Hartmann LC, et al. Long-term follow-up of women with ovarian cancer after positive second-look laparotomy. Gynecol Oncol. 2003;91:563-568.

19. Schwartz PE, Smith JP. Second-look operations in ovarian cancer. Am J Obstet Gynecol. 1980;138:1124-1130.

20. MacGibbon A, Bucci J, MacLeod C, et al. Whole abdominal radiotherapy following second-look laparotomy for ovarian carcinoma. Gynecol Oncol. 1999;75:62-67.

21. Bruzzone M, Rubagotti A, Gadducci A, et al. Intraperitoneal carboplatin with or without interferonalpha in advanced ovarian cancer patients with minimal residual disease at second look: a prospective randomized trial of 111 patients. G.O.N.O. Gruppo Oncologic Nord Ovest. Gynecol Oncol. 1997;65:499-505.

22. Bertucci F, Viens P, Delpero JR, et al. High-dose melphalan-based chemotherapy and autologous stem cell transplantation after second look laparotomy in patients with chemosensitive advanced ovarian carcinoma: long-term results. Bone Marrow Transplant. 2000;26:61-67.

23. Markman M, Brady MF, Spirtos NM, Hanjani P, Rubin SC. Phase II trial of intraperitoneal paclitaxel in carcinoma of the ovary, tube, and peritoneum: a Gynecologic Oncology Group Study. J Clin Oncol. 1998;16:2620-2624.

24. Menczer J, Ben-Baruch G, Rizel S, Brenner H. Intraperitoneal cisplatin chemotherapy in ovarian carcinoma patients who are clinically in complete remission. Gynecol Oncol. 1992;46:222-225.

25. Tarraza HM,, Jr, Boyce CR, Smith WG, Jones MA. Consolidation intraperitoneal chemotherapy in epithelial ovarian cancer patients following negative second-look laparotomy. Gynecol Oncol. 1993;50:287-290.

26. Dufour P, Bergerat JP, Barats JC, et al. Intraperitoneal mitoxantrone as consolidation treatment for patients with ovarian carcinoma in pathologic complete remission. Cancer. 1994;73:1865-1869.

27. Barakat RR, Almadrones L, Venkatraman ES, et al. A phase II trial of intraperitoneal cisplatin and etoposide as consolidation therapy in patients with Stage II-IV epithelial ovarian cancer following negative surgical assessment. Gynecol Oncol. 1998;69:17-22.

28. Abu-Rustum NR, Barakat RR, Siegel PL, Venkatraman E, Curtin JP, Hoskins WJ. Second-look operation for epithelial ovarian cancer: laparoscopy or laparotomy? Obstet Gynecol. 1996;88:549-553.

29. Clough KB, Ladonne JM, Nos C, Renolleau C, Validire P, Durand JC. Second look for ovarian cancer: laparoscopy or laparotomy? A prospective comparative study. Gynecol Oncol. 1999;72:411-417.

30. Spinelli P, Luini A, Pizzetti P, de Palo GM. Laparoscopy in staging and restaging of 95 patients with ovarian carcinoma. Tumori. 1976;62:493-501.

31. Smith WG, Day TG, Jr, Smith JP. The use of laparoscopy to determine the results of chemotherapy for ovarian cancer. J Reprod Med. 1977;18:257-260.

32. Canis M, Chapron C, Mage G, et al. [Technique and preliminary results in second-look laparoscopy in epithelial malignant ovarian tumors]. J Gynecol Obstet Biol Reprod (Paris). 1992;21:655-663.

33. Quinn MA, Bishop GJ, Campbell JJ, Rodgerson J, Pepperell RJ. Laparoscopic follow-up of patients with ovarian carcinoma. Br J Obstet Gynaecol. 1980;87:1132-1139.

34. Xygakis AM, Politis GS, Michalas SP, Kaskarelis DB. Second-look laparoscopy in ovarian cancer. J Reprod Med. 1984;29:583-585.

35. Nicoletto MO, Tumolo S, Talamini R, et al. Surgical second look in ovarian cancer: a randomized study in patients with laparoscopic complete remission—a Northeastern Oncology Cooperative Group-Ovarian Cancer Cooperative Group Study. J Clin Oncol. 1997;15:994-999.

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Christina S. Chu, MD
Assistant Professor, Division of Gynecologic Oncology,
Department of Ob/Gyn, University of Pennsylvania Medical Center, Philadelphia

Stephen C. Rubin, MD
Professor and Chief, Division of Gynecologic Oncology,
Department of Ob/Gyn, University of Pennsylvania Medical Center, Philadelphia

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Assistant Professor, Division of Gynecologic Oncology,
Department of Ob/Gyn, University of Pennsylvania Medical Center, Philadelphia

Stephen C. Rubin, MD
Professor and Chief, Division of Gynecologic Oncology,
Department of Ob/Gyn, University of Pennsylvania Medical Center, Philadelphia

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Christina S. Chu, MD
Assistant Professor, Division of Gynecologic Oncology,
Department of Ob/Gyn, University of Pennsylvania Medical Center, Philadelphia

Stephen C. Rubin, MD
Professor and Chief, Division of Gynecologic Oncology,
Department of Ob/Gyn, University of Pennsylvania Medical Center, Philadelphia

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KEY POINTS

  • Second-look laparotomy (SLL) is the only way to confirm complete pathologic response to ovarian cancer therapy.
  • Offer SLL only to patients for whom results will affect decision-making—and only after discussion with the patient and a gynecologic oncologist.
  • Although negative SLL findings confer improved prognosis, disease recurs in up to 60% of patients.
  • Candidates should be in clinical remission as determined by physical examination, abdominopelvic imaging, and serum CA-125 determination.
The disturbing fact that epithelial ovarian cancer often recurs after clinical remission poses this challenge: How do we identify the women with subclinical disease who may benefit from additional consolidation therapy?

Given the inability of noninvasive studies such as computed tomography, magnetic resonance imaging, and positron emission tomography to reliably detect small-volume and microscopic disease, second-look laparotomy (SLL) is the only technique capable of confirming a complete pathologic response to therapy.

Ob/Gyns involved in care of women with advanced ovarian cancer face the challenge of weighing the benefits of SLL against the potential morbidities of invasive surgery. This article describes those benefits, surgical technique, the prognostic significance of findings, and the status of salvage and consolidation therapies.

What SLL conveys

“Second look laparotomy” has rather loosely described many secondary surgeries for ovarian cancer, but we adopt the more rigorous definition: “a systematic surgical reexploration in asymptomatic patients who have no clinical evidence of tumor following initial surgery and completion of a planned program of chemotherapy.”1

Procedures to debulk recurrent or residual disease, relieve symptomatic tumor, or accomplish interval cytoreduction cannot be deemed second-look laparotomy.

Prognostic, therapeutic limitations complicate the decision

Although negative findings at SLL confer an improved prognosis, disease ultimately recurs in up to 60% of patients.2,3 Moreover, despite intensive research, consistently effective consolidation and salvage regimens remain elusive.

SLL may provide some information about prognosis, but that information is far from certain. Because of the cost and morbidity inherent in SLL, routine use has largely been limited to patients in clinical trials, where findings may serve as a surrogate endpoint for investigational therapies.

For these reasons, we strongly recommend careful discussion of this complex decision with patients prior to surgery, in consultation with a gynecologic oncologist.

Which patients are and are not candidates?

Candidates should be in clinical remission as determined by physical examination, abdominopelvic imaging, and serum CA-125 determination. Although SLL will detect residual disease in up to 50% of patients undergoing the procedure after primary chemotherapy, SLL is an imperfect method of determining the true response to therapy. Thus, it should be offered only to patients for whom results will influence clinical decision-making.

Patients with stage I disease treated with appropriate chemotherapy should not undergo SLL because of the low incidence of positive findings.4

Residual disease: 30% to 50%

Second-look laparotomy requires thorough inspection of the peritoneal cavity and retroperitoneum, but when properly performed on appropriate candidates, SLL detects residual disease in 30% to 50% of patients.2,5

Generally, stage and volume of residual disease at initial surgery are most closely correlated with findings. In a review of 31 series, patients with stage III and IV disease undergoing surgery had fewer negative SLLs (39% and 33%, respectively) than patients with stage I and II disease (81% and 69%, respectively).6 Similarly, in pooled data on 1,797 patients, 72% of those with no gross residual disease at the conclusion of primary surgery had negative findings at SLL, compared with 50% of those with optimal residual, and only 23% of those with suboptimal residual.6

Surgical technique

Surgery begins with a large vertical incision and involves the components listed in the TABLE.

If gross disease is apparent:

Consider surgical cytoreduction, which is typically performed at the surgeon’s discretion.

In the absence of gross tumor:

Use a 5-point strategy to search thoroughly for occult disease.

  • Take washings for cytology from the abdomen and pelvis;
  • lyse any adhesions to allow adequate examination of all peritoneal surfaces;
  • obtain random biopsies from the pelvis, bladder serosa, vaginal cuff, culde-sac, paracolic gutters, and hemidiaphragms, as well as adhesions, sites of prior documented tumor, infundibulopelvic ligament pedicles, and areas suspicious for tumor recurrence;
  • consider removing the uterus, adnexae, omentum, and appendix, if not done at the primary surgery; and
  • sample any remaining pelvic and paraaortic lymph nodes.

Meticulous sampling is crucial

 

 

Although the number of biopsies performed at SLL varies widely by surgeon, meticulous sampling of peritoneal surfaces may be necessary to detect occult tumor. In cases of microscopic disease, fewer than 5% of biopsies may be positive for tumor.7 Not surprisingly, some studies have noted a significantly worse survival rate among patients deemed to be in complete pathologic remission who underwent fewer biopsies at the time of SLL.8

TABLE

Components of second-look laparotomy

Vertical incision
Thorough inspection of abdomen and pelvis
Abdominopelvic washings for cytologic analysis
Complete adhesiolysis
Systematic biopsy of:
  • Undersurfaces of bilateral hemidiaphragms
  • Paracolic gutters
  • Pelvic peritoneum
  • Pedicles of ovarian vessels
  • Any suspicious lesions
  • Areas of known prior tumor
  • Adhesions
If necessary: Complete hysterectomy, salpingo-oophorectomy, omentectomy, and appendectomy
Pelvic and paraaortic lymph node sampling

What do SLL findings predict?

Survival rates

Women who achieve a complete pathologic response after primary chemotherapy have the greatest survival. Rubin et al3 noted a 10-year survival rate of 51% for 91 patients after negative SLL. Median survivals for patients with negative findings have been reported in excess of 70 months.7,9 Tuxen et al9 examined 242 patients after SLL and reported a median survival of 149 months for those with negative findings, versus 39 and 24 months for those with microscopic and gross disease, respectively (P<.0005>

Survival rates among women with negative findings were substantially higher than among patients with positive findings, even though the latter group received salvage chemotherapy.

Recurrence rates

In a review of 38 studies encompassing 1,511 patients, Barter and Barnes6 noted a 23% rate of recurrence among women with negative findings at SLL. Other studies from single institutions document recurrence rates approximating 50%.3,10 Patients experiencing recurrence after negative SLL have median survivals of 11 to 45 months.3,8,10-12

Gross versus microscopic disease

Studies comparing outcomes based on volume of disease detected at SLL have found statistically improved survival for patients without evidence of gross tumor.9,13-15 Podratz et al14 reported 4-year survival of 55% for women with microscopic findings versus 19% for those with gross disease (P<.01>

The presence of gross tumor at SLL indicates a grave prognosis; median survival ranges between 13 and 24 months.9,16,17 Nevertheless, several studies have shown that patients able to undergo debulking of all visible disease derive a survival benefit.4,15,18,19

Given the potential complications of extensive debulking surgery and lack of a proven survival benefit for patients unable to achieve complete cytoreduction, debulking should only be attempted if persistent disease is judged to be completely resectable.

When SLL is positive: Salvage therapy regimens

Many different salvage regimens for epithelial ovarian cancer have been investigated for use after positive second-look laparotomy, including intraperitoneal radioactive phosphorus (32P), systemic chemotherapy, whole abdominal radiation (WAR), hormonal therapy, and biologic response modifiers. Unfortunately, studies of salvage therapy tend to be retrospective, nonrandomized, and uncontrolled, and no proven regimen has yet been found.

Whole abdominal radiation

This modality appears to confer no definitive survival benefit and does produce toxicity. MacGibbon et al20 treated 51 patients with WAR for both salvage and consolidation. Of these, 27% could not complete treatment because of progressive disease, bowel perforation, myelosuppression, and bowel toxicity. An additional 24% required treatment delays because of hematologic and gastrointestinal toxicity. Among those completing the prescribed course of radiation, 6 developed late bowel symptoms, and 2 of these required surgical intervention to relieve bowel obstruction.

Other salvage therapies

Recently, Dowdy et al18 reported long-term follow-up for 145 patients with positive findings at SLL. Neither intraperitoneal 32P nor WAR provided a survival benefit. Multivariate analysis indicated that only grade and volume of residual disease following cytoreduction were associated with improved survival.

Other trials involving intraperitoneal interferon-alpha and carboplatin,21 and high-dose chemotherapy with autologous stem cell rescue22 have also failed to demonstrate any significant advantages in survival or rate of progression. An early phase II study of intraperitoneal paclitaxel showed promise: Markman et al23 noted a complete pathologic response in 61% of patients with microscopic disease at SLL, but only 4% of those with gross disease achieved a complete response.

Need for effective consolidation therapy

A critical component of cancer care is targeting patients at highest risk of recurrence for effective consolidation therapy. The factors most strongly correlated with disease progression are stage at diagnosis, tumor grade, and volume of residual disease after initial cytoreduction.

Many consolidation therapies have been described, including systemic and intraperitoneal chemotherapy, WAR, intraperitoneal 32P, and biologic response modifiers.

Significant risk of distant recurrences

Although most tumors recur in the abdomen and pelvis, approximately 30% recur at distant locations. For this reason, consider systemic treatment when planning the consolidation regimen. Bertucci et al22 studied systemic melphalan-based, high-dose chemotherapy with autologous stem cell rescue and noted a 5-year progression-free survival of 43% and overall survival of 75%.

 

 

Most therapies are localized. Most other studies have focused on therapies localized to the peritoneal cavity. Results for intraperitoneal 32P and WAR are mixed. Several different regimens of intraperitoneal chemotherapy have produced median disease-free survival rates of 18 to 41 months.24-27 In 1998, Barakat et al27 examined the use of intraperitoneal cisplatin and etoposide, reporting a statistically improved median disease-free survival for patients receiving intraperitoneal consolidation (median disease-free survival not yet reached), compared with patients treated by observation (28.5 months).

Bottom line

Second-look laparotomy reveals that approximately 50% of patients with a complete clinical response still harbor residual disease after primary chemotherapy. Even women who achieve a complete pathologic response have recurrence rates as high as 60%. While SLL can be a useful tool, the information it yields must be weighed against the potential morbidities of invasive surgery. Given its limited prognostic value, SLL should be offered only when results will influence clinical decision-making, or as part of a clinical trial.

Is laparoscopy equal to laparotomy for second-look procedures?

Advocates of laparoscopy as a substitute for SLL report lower blood loss, shorter hospitalization, and decreased costs for laparoscopy.28

Clough et al29 performed the first study of second-look laparoscopy in 20 patients, using immediate laparotomy as a control. In 12 patients, adequate exploration was hindered by adhesions, and only 2 were able to undergo sufficient laparoscopic adhesiolysis. Overall, only 41% of patients could be completely explored at laparoscopy, versus 95% for laparotomy. However, obvious carcinomatosis was apparent in 3 patients at laparoscopy, rendering laparotomy unnecessary.

In general, laparoscopic second look has been reported to be a safe, feasible alternative to laparotomy. Although intraabdominal adhesions occur in as many as 70% of patients,30,31 complete laparoscopic evaluation may still be possible in up to 92%.32,33

How accurate?

Concerns remain about the accuracy of laparoscopic second look. Prior to 1985, several studies reported false-negative rates of 19% to 77%,33,34 although a 1999 study documented a false-negative rate of only 14%.29 The clinical impact of these false negatives is controversial. Some authors have reported no differences in clinical endpoints such as disease recurrence28 and overall survival35 for patients undergoing laparoscopy versus laparotomy. In contrast, a multivariate analysis by Gadducci et al10 showed a significantly prolonged disease-free interval for patients treated by laparotomy.

Switch to laparotomy for maximal cytoreduction

Laparoscopy may spare patients with obvious unresectable carcinomatosis a full laparotomy, though many patients will still require conversion to an open procedure to achieve maximal cytoreduction. Given these considerations, laparoscopy has only a limited role in second-look evaluation.

The authors report no financial relationships relevant to this article.

KEY POINTS

  • Second-look laparotomy (SLL) is the only way to confirm complete pathologic response to ovarian cancer therapy.
  • Offer SLL only to patients for whom results will affect decision-making—and only after discussion with the patient and a gynecologic oncologist.
  • Although negative SLL findings confer improved prognosis, disease recurs in up to 60% of patients.
  • Candidates should be in clinical remission as determined by physical examination, abdominopelvic imaging, and serum CA-125 determination.
The disturbing fact that epithelial ovarian cancer often recurs after clinical remission poses this challenge: How do we identify the women with subclinical disease who may benefit from additional consolidation therapy?

Given the inability of noninvasive studies such as computed tomography, magnetic resonance imaging, and positron emission tomography to reliably detect small-volume and microscopic disease, second-look laparotomy (SLL) is the only technique capable of confirming a complete pathologic response to therapy.

Ob/Gyns involved in care of women with advanced ovarian cancer face the challenge of weighing the benefits of SLL against the potential morbidities of invasive surgery. This article describes those benefits, surgical technique, the prognostic significance of findings, and the status of salvage and consolidation therapies.

What SLL conveys

“Second look laparotomy” has rather loosely described many secondary surgeries for ovarian cancer, but we adopt the more rigorous definition: “a systematic surgical reexploration in asymptomatic patients who have no clinical evidence of tumor following initial surgery and completion of a planned program of chemotherapy.”1

Procedures to debulk recurrent or residual disease, relieve symptomatic tumor, or accomplish interval cytoreduction cannot be deemed second-look laparotomy.

Prognostic, therapeutic limitations complicate the decision

Although negative findings at SLL confer an improved prognosis, disease ultimately recurs in up to 60% of patients.2,3 Moreover, despite intensive research, consistently effective consolidation and salvage regimens remain elusive.

SLL may provide some information about prognosis, but that information is far from certain. Because of the cost and morbidity inherent in SLL, routine use has largely been limited to patients in clinical trials, where findings may serve as a surrogate endpoint for investigational therapies.

For these reasons, we strongly recommend careful discussion of this complex decision with patients prior to surgery, in consultation with a gynecologic oncologist.

Which patients are and are not candidates?

Candidates should be in clinical remission as determined by physical examination, abdominopelvic imaging, and serum CA-125 determination. Although SLL will detect residual disease in up to 50% of patients undergoing the procedure after primary chemotherapy, SLL is an imperfect method of determining the true response to therapy. Thus, it should be offered only to patients for whom results will influence clinical decision-making.

Patients with stage I disease treated with appropriate chemotherapy should not undergo SLL because of the low incidence of positive findings.4

Residual disease: 30% to 50%

Second-look laparotomy requires thorough inspection of the peritoneal cavity and retroperitoneum, but when properly performed on appropriate candidates, SLL detects residual disease in 30% to 50% of patients.2,5

Generally, stage and volume of residual disease at initial surgery are most closely correlated with findings. In a review of 31 series, patients with stage III and IV disease undergoing surgery had fewer negative SLLs (39% and 33%, respectively) than patients with stage I and II disease (81% and 69%, respectively).6 Similarly, in pooled data on 1,797 patients, 72% of those with no gross residual disease at the conclusion of primary surgery had negative findings at SLL, compared with 50% of those with optimal residual, and only 23% of those with suboptimal residual.6

Surgical technique

Surgery begins with a large vertical incision and involves the components listed in the TABLE.

If gross disease is apparent:

Consider surgical cytoreduction, which is typically performed at the surgeon’s discretion.

In the absence of gross tumor:

Use a 5-point strategy to search thoroughly for occult disease.

  • Take washings for cytology from the abdomen and pelvis;
  • lyse any adhesions to allow adequate examination of all peritoneal surfaces;
  • obtain random biopsies from the pelvis, bladder serosa, vaginal cuff, culde-sac, paracolic gutters, and hemidiaphragms, as well as adhesions, sites of prior documented tumor, infundibulopelvic ligament pedicles, and areas suspicious for tumor recurrence;
  • consider removing the uterus, adnexae, omentum, and appendix, if not done at the primary surgery; and
  • sample any remaining pelvic and paraaortic lymph nodes.

Meticulous sampling is crucial

 

 

Although the number of biopsies performed at SLL varies widely by surgeon, meticulous sampling of peritoneal surfaces may be necessary to detect occult tumor. In cases of microscopic disease, fewer than 5% of biopsies may be positive for tumor.7 Not surprisingly, some studies have noted a significantly worse survival rate among patients deemed to be in complete pathologic remission who underwent fewer biopsies at the time of SLL.8

TABLE

Components of second-look laparotomy

Vertical incision
Thorough inspection of abdomen and pelvis
Abdominopelvic washings for cytologic analysis
Complete adhesiolysis
Systematic biopsy of:
  • Undersurfaces of bilateral hemidiaphragms
  • Paracolic gutters
  • Pelvic peritoneum
  • Pedicles of ovarian vessels
  • Any suspicious lesions
  • Areas of known prior tumor
  • Adhesions
If necessary: Complete hysterectomy, salpingo-oophorectomy, omentectomy, and appendectomy
Pelvic and paraaortic lymph node sampling

What do SLL findings predict?

Survival rates

Women who achieve a complete pathologic response after primary chemotherapy have the greatest survival. Rubin et al3 noted a 10-year survival rate of 51% for 91 patients after negative SLL. Median survivals for patients with negative findings have been reported in excess of 70 months.7,9 Tuxen et al9 examined 242 patients after SLL and reported a median survival of 149 months for those with negative findings, versus 39 and 24 months for those with microscopic and gross disease, respectively (P<.0005>

Survival rates among women with negative findings were substantially higher than among patients with positive findings, even though the latter group received salvage chemotherapy.

Recurrence rates

In a review of 38 studies encompassing 1,511 patients, Barter and Barnes6 noted a 23% rate of recurrence among women with negative findings at SLL. Other studies from single institutions document recurrence rates approximating 50%.3,10 Patients experiencing recurrence after negative SLL have median survivals of 11 to 45 months.3,8,10-12

Gross versus microscopic disease

Studies comparing outcomes based on volume of disease detected at SLL have found statistically improved survival for patients without evidence of gross tumor.9,13-15 Podratz et al14 reported 4-year survival of 55% for women with microscopic findings versus 19% for those with gross disease (P<.01>

The presence of gross tumor at SLL indicates a grave prognosis; median survival ranges between 13 and 24 months.9,16,17 Nevertheless, several studies have shown that patients able to undergo debulking of all visible disease derive a survival benefit.4,15,18,19

Given the potential complications of extensive debulking surgery and lack of a proven survival benefit for patients unable to achieve complete cytoreduction, debulking should only be attempted if persistent disease is judged to be completely resectable.

When SLL is positive: Salvage therapy regimens

Many different salvage regimens for epithelial ovarian cancer have been investigated for use after positive second-look laparotomy, including intraperitoneal radioactive phosphorus (32P), systemic chemotherapy, whole abdominal radiation (WAR), hormonal therapy, and biologic response modifiers. Unfortunately, studies of salvage therapy tend to be retrospective, nonrandomized, and uncontrolled, and no proven regimen has yet been found.

Whole abdominal radiation

This modality appears to confer no definitive survival benefit and does produce toxicity. MacGibbon et al20 treated 51 patients with WAR for both salvage and consolidation. Of these, 27% could not complete treatment because of progressive disease, bowel perforation, myelosuppression, and bowel toxicity. An additional 24% required treatment delays because of hematologic and gastrointestinal toxicity. Among those completing the prescribed course of radiation, 6 developed late bowel symptoms, and 2 of these required surgical intervention to relieve bowel obstruction.

Other salvage therapies

Recently, Dowdy et al18 reported long-term follow-up for 145 patients with positive findings at SLL. Neither intraperitoneal 32P nor WAR provided a survival benefit. Multivariate analysis indicated that only grade and volume of residual disease following cytoreduction were associated with improved survival.

Other trials involving intraperitoneal interferon-alpha and carboplatin,21 and high-dose chemotherapy with autologous stem cell rescue22 have also failed to demonstrate any significant advantages in survival or rate of progression. An early phase II study of intraperitoneal paclitaxel showed promise: Markman et al23 noted a complete pathologic response in 61% of patients with microscopic disease at SLL, but only 4% of those with gross disease achieved a complete response.

Need for effective consolidation therapy

A critical component of cancer care is targeting patients at highest risk of recurrence for effective consolidation therapy. The factors most strongly correlated with disease progression are stage at diagnosis, tumor grade, and volume of residual disease after initial cytoreduction.

Many consolidation therapies have been described, including systemic and intraperitoneal chemotherapy, WAR, intraperitoneal 32P, and biologic response modifiers.

Significant risk of distant recurrences

Although most tumors recur in the abdomen and pelvis, approximately 30% recur at distant locations. For this reason, consider systemic treatment when planning the consolidation regimen. Bertucci et al22 studied systemic melphalan-based, high-dose chemotherapy with autologous stem cell rescue and noted a 5-year progression-free survival of 43% and overall survival of 75%.

 

 

Most therapies are localized. Most other studies have focused on therapies localized to the peritoneal cavity. Results for intraperitoneal 32P and WAR are mixed. Several different regimens of intraperitoneal chemotherapy have produced median disease-free survival rates of 18 to 41 months.24-27 In 1998, Barakat et al27 examined the use of intraperitoneal cisplatin and etoposide, reporting a statistically improved median disease-free survival for patients receiving intraperitoneal consolidation (median disease-free survival not yet reached), compared with patients treated by observation (28.5 months).

Bottom line

Second-look laparotomy reveals that approximately 50% of patients with a complete clinical response still harbor residual disease after primary chemotherapy. Even women who achieve a complete pathologic response have recurrence rates as high as 60%. While SLL can be a useful tool, the information it yields must be weighed against the potential morbidities of invasive surgery. Given its limited prognostic value, SLL should be offered only when results will influence clinical decision-making, or as part of a clinical trial.

Is laparoscopy equal to laparotomy for second-look procedures?

Advocates of laparoscopy as a substitute for SLL report lower blood loss, shorter hospitalization, and decreased costs for laparoscopy.28

Clough et al29 performed the first study of second-look laparoscopy in 20 patients, using immediate laparotomy as a control. In 12 patients, adequate exploration was hindered by adhesions, and only 2 were able to undergo sufficient laparoscopic adhesiolysis. Overall, only 41% of patients could be completely explored at laparoscopy, versus 95% for laparotomy. However, obvious carcinomatosis was apparent in 3 patients at laparoscopy, rendering laparotomy unnecessary.

In general, laparoscopic second look has been reported to be a safe, feasible alternative to laparotomy. Although intraabdominal adhesions occur in as many as 70% of patients,30,31 complete laparoscopic evaluation may still be possible in up to 92%.32,33

How accurate?

Concerns remain about the accuracy of laparoscopic second look. Prior to 1985, several studies reported false-negative rates of 19% to 77%,33,34 although a 1999 study documented a false-negative rate of only 14%.29 The clinical impact of these false negatives is controversial. Some authors have reported no differences in clinical endpoints such as disease recurrence28 and overall survival35 for patients undergoing laparoscopy versus laparotomy. In contrast, a multivariate analysis by Gadducci et al10 showed a significantly prolonged disease-free interval for patients treated by laparotomy.

Switch to laparotomy for maximal cytoreduction

Laparoscopy may spare patients with obvious unresectable carcinomatosis a full laparotomy, though many patients will still require conversion to an open procedure to achieve maximal cytoreduction. Given these considerations, laparoscopy has only a limited role in second-look evaluation.

The authors report no financial relationships relevant to this article.
References

1. Rubin SC, Lewis JL, Jr. Second-look surgery in ovarian carcinoma. Crit Rev Oncol Hematol. 1988;8:75-91.

2. van der Burg ME. More than 20 years second-look surgery in advanced epithelial ovarian cancer: what did we learn? Ann Oncol. 1997;8:627-629.

3. Rubin SC, Randall TC, Armstrong KA, Chi DS, Hoskins WJ. Ten-year follow-up of ovarian cancer patients after second-look laparotomy with negative findings. Obstet Gynecol. 1999;93:21-24.

4. Hempling RE, Wesolowski JA, Piver MS. Second-look laparotomy in advanced ovarian cancer: a critical assessment of morbidity and impact on survival. Ann Surg Oncol. 1997;4:349-54.

5. Katsoulis M, Vorgias G, Panagiotides J, Dertimas B, Zis J. The prognostic significance of second-look laparotomy in advanced ovarian cancer. Eur J Gynaecol Oncol. 1997;18:200-202.

6. Barter JF, Barnes WA. Second-look laparotomy. In: Rubin SC, Sutton GP, eds. Ovarian Cancer. New York, NY: McGraw-Hill; 1993;269-300.

7. Friedman RL, Eisenkop SM, Wang HJ. Second-look laparotomy for ovarian cancer provides reliable prognostic information and improves survival. Gynecol Oncol. 1997;67:88-94.

8. Gershenson DM, Copeland LJ, Wharton JT, et al. Prognosis of surgically determined complete responders in advanced ovarian cancer. Cancer. 1985;55:1129-1135.

9. Tuxen MK, Strauss G, Lund B, Hansen M. The role of second-look laparotomy in the long-term survival in ovarian cancer. Ann Oncol. 1997;8:643-648.

10. Gadducci A, Sartori E, Maggino T, et al. Analysis of failures after negative second-look in patients with advanced ovarian cancer: an Italian multicenter study. Gynecol Oncol. 1998;68:150-155.

11. Rubin SC, Hoskins WJ, Hakes TB, Markman M, Cain JM, Lewis JL, Jr. Recurrence after negative second-look laparotomy for ovarian cancer: analysis of risk factors. Am J Obstet Gynecol. 1988;159:1094-1098.

12. Ghatage P, Krepart GV, Lotocki R. Factor analysis of false-negative second-look laparotomy. Gynecol Oncol. 1990;36:172-175.

13. Dauplat J, Ferriere JP, Gorbinet M, et al. Second-look laparotomy in managing epithelial ovarian carcinoma. Cancer. 1986;57:1627-1631.

14. Podratz KC, Schray MF, Wieand HS, et al. Evaluation of treatment and survival after positive second-look laparotomy. Gynecol Oncol. 1988;31:9-24.

15. Lippman SM, Alberts DS, Slymen DJ, et al. Second-look laparotomy in epithelial ovarian carcinoma. Prognostic factors associated with survival duration. Cancer. 1988;61:2571-2577.

16. Raju KS, McKinna JA, Barker GH, Wiltshaw E, Jones JM. Second-look operations in the planned management of advanced ovarian carcinoma. Am J Obstet Gynecol. 1982;144:650-654.

17. Williams L, Brunetto VL, Yordan E, DiSaia PJ, Creasman WT. Secondary cytoreductive surgery at second-look laparotomy in advanced ovarian cancer: a Gynecologic Oncology Group Study. Gynecol Oncol. 1997;66:171-178.

18. Dowdy SC, Constantinou CL, Hartmann LC, et al. Long-term follow-up of women with ovarian cancer after positive second-look laparotomy. Gynecol Oncol. 2003;91:563-568.

19. Schwartz PE, Smith JP. Second-look operations in ovarian cancer. Am J Obstet Gynecol. 1980;138:1124-1130.

20. MacGibbon A, Bucci J, MacLeod C, et al. Whole abdominal radiotherapy following second-look laparotomy for ovarian carcinoma. Gynecol Oncol. 1999;75:62-67.

21. Bruzzone M, Rubagotti A, Gadducci A, et al. Intraperitoneal carboplatin with or without interferonalpha in advanced ovarian cancer patients with minimal residual disease at second look: a prospective randomized trial of 111 patients. G.O.N.O. Gruppo Oncologic Nord Ovest. Gynecol Oncol. 1997;65:499-505.

22. Bertucci F, Viens P, Delpero JR, et al. High-dose melphalan-based chemotherapy and autologous stem cell transplantation after second look laparotomy in patients with chemosensitive advanced ovarian carcinoma: long-term results. Bone Marrow Transplant. 2000;26:61-67.

23. Markman M, Brady MF, Spirtos NM, Hanjani P, Rubin SC. Phase II trial of intraperitoneal paclitaxel in carcinoma of the ovary, tube, and peritoneum: a Gynecologic Oncology Group Study. J Clin Oncol. 1998;16:2620-2624.

24. Menczer J, Ben-Baruch G, Rizel S, Brenner H. Intraperitoneal cisplatin chemotherapy in ovarian carcinoma patients who are clinically in complete remission. Gynecol Oncol. 1992;46:222-225.

25. Tarraza HM,, Jr, Boyce CR, Smith WG, Jones MA. Consolidation intraperitoneal chemotherapy in epithelial ovarian cancer patients following negative second-look laparotomy. Gynecol Oncol. 1993;50:287-290.

26. Dufour P, Bergerat JP, Barats JC, et al. Intraperitoneal mitoxantrone as consolidation treatment for patients with ovarian carcinoma in pathologic complete remission. Cancer. 1994;73:1865-1869.

27. Barakat RR, Almadrones L, Venkatraman ES, et al. A phase II trial of intraperitoneal cisplatin and etoposide as consolidation therapy in patients with Stage II-IV epithelial ovarian cancer following negative surgical assessment. Gynecol Oncol. 1998;69:17-22.

28. Abu-Rustum NR, Barakat RR, Siegel PL, Venkatraman E, Curtin JP, Hoskins WJ. Second-look operation for epithelial ovarian cancer: laparoscopy or laparotomy? Obstet Gynecol. 1996;88:549-553.

29. Clough KB, Ladonne JM, Nos C, Renolleau C, Validire P, Durand JC. Second look for ovarian cancer: laparoscopy or laparotomy? A prospective comparative study. Gynecol Oncol. 1999;72:411-417.

30. Spinelli P, Luini A, Pizzetti P, de Palo GM. Laparoscopy in staging and restaging of 95 patients with ovarian carcinoma. Tumori. 1976;62:493-501.

31. Smith WG, Day TG, Jr, Smith JP. The use of laparoscopy to determine the results of chemotherapy for ovarian cancer. J Reprod Med. 1977;18:257-260.

32. Canis M, Chapron C, Mage G, et al. [Technique and preliminary results in second-look laparoscopy in epithelial malignant ovarian tumors]. J Gynecol Obstet Biol Reprod (Paris). 1992;21:655-663.

33. Quinn MA, Bishop GJ, Campbell JJ, Rodgerson J, Pepperell RJ. Laparoscopic follow-up of patients with ovarian carcinoma. Br J Obstet Gynaecol. 1980;87:1132-1139.

34. Xygakis AM, Politis GS, Michalas SP, Kaskarelis DB. Second-look laparoscopy in ovarian cancer. J Reprod Med. 1984;29:583-585.

35. Nicoletto MO, Tumolo S, Talamini R, et al. Surgical second look in ovarian cancer: a randomized study in patients with laparoscopic complete remission—a Northeastern Oncology Cooperative Group-Ovarian Cancer Cooperative Group Study. J Clin Oncol. 1997;15:994-999.

References

1. Rubin SC, Lewis JL, Jr. Second-look surgery in ovarian carcinoma. Crit Rev Oncol Hematol. 1988;8:75-91.

2. van der Burg ME. More than 20 years second-look surgery in advanced epithelial ovarian cancer: what did we learn? Ann Oncol. 1997;8:627-629.

3. Rubin SC, Randall TC, Armstrong KA, Chi DS, Hoskins WJ. Ten-year follow-up of ovarian cancer patients after second-look laparotomy with negative findings. Obstet Gynecol. 1999;93:21-24.

4. Hempling RE, Wesolowski JA, Piver MS. Second-look laparotomy in advanced ovarian cancer: a critical assessment of morbidity and impact on survival. Ann Surg Oncol. 1997;4:349-54.

5. Katsoulis M, Vorgias G, Panagiotides J, Dertimas B, Zis J. The prognostic significance of second-look laparotomy in advanced ovarian cancer. Eur J Gynaecol Oncol. 1997;18:200-202.

6. Barter JF, Barnes WA. Second-look laparotomy. In: Rubin SC, Sutton GP, eds. Ovarian Cancer. New York, NY: McGraw-Hill; 1993;269-300.

7. Friedman RL, Eisenkop SM, Wang HJ. Second-look laparotomy for ovarian cancer provides reliable prognostic information and improves survival. Gynecol Oncol. 1997;67:88-94.

8. Gershenson DM, Copeland LJ, Wharton JT, et al. Prognosis of surgically determined complete responders in advanced ovarian cancer. Cancer. 1985;55:1129-1135.

9. Tuxen MK, Strauss G, Lund B, Hansen M. The role of second-look laparotomy in the long-term survival in ovarian cancer. Ann Oncol. 1997;8:643-648.

10. Gadducci A, Sartori E, Maggino T, et al. Analysis of failures after negative second-look in patients with advanced ovarian cancer: an Italian multicenter study. Gynecol Oncol. 1998;68:150-155.

11. Rubin SC, Hoskins WJ, Hakes TB, Markman M, Cain JM, Lewis JL, Jr. Recurrence after negative second-look laparotomy for ovarian cancer: analysis of risk factors. Am J Obstet Gynecol. 1988;159:1094-1098.

12. Ghatage P, Krepart GV, Lotocki R. Factor analysis of false-negative second-look laparotomy. Gynecol Oncol. 1990;36:172-175.

13. Dauplat J, Ferriere JP, Gorbinet M, et al. Second-look laparotomy in managing epithelial ovarian carcinoma. Cancer. 1986;57:1627-1631.

14. Podratz KC, Schray MF, Wieand HS, et al. Evaluation of treatment and survival after positive second-look laparotomy. Gynecol Oncol. 1988;31:9-24.

15. Lippman SM, Alberts DS, Slymen DJ, et al. Second-look laparotomy in epithelial ovarian carcinoma. Prognostic factors associated with survival duration. Cancer. 1988;61:2571-2577.

16. Raju KS, McKinna JA, Barker GH, Wiltshaw E, Jones JM. Second-look operations in the planned management of advanced ovarian carcinoma. Am J Obstet Gynecol. 1982;144:650-654.

17. Williams L, Brunetto VL, Yordan E, DiSaia PJ, Creasman WT. Secondary cytoreductive surgery at second-look laparotomy in advanced ovarian cancer: a Gynecologic Oncology Group Study. Gynecol Oncol. 1997;66:171-178.

18. Dowdy SC, Constantinou CL, Hartmann LC, et al. Long-term follow-up of women with ovarian cancer after positive second-look laparotomy. Gynecol Oncol. 2003;91:563-568.

19. Schwartz PE, Smith JP. Second-look operations in ovarian cancer. Am J Obstet Gynecol. 1980;138:1124-1130.

20. MacGibbon A, Bucci J, MacLeod C, et al. Whole abdominal radiotherapy following second-look laparotomy for ovarian carcinoma. Gynecol Oncol. 1999;75:62-67.

21. Bruzzone M, Rubagotti A, Gadducci A, et al. Intraperitoneal carboplatin with or without interferonalpha in advanced ovarian cancer patients with minimal residual disease at second look: a prospective randomized trial of 111 patients. G.O.N.O. Gruppo Oncologic Nord Ovest. Gynecol Oncol. 1997;65:499-505.

22. Bertucci F, Viens P, Delpero JR, et al. High-dose melphalan-based chemotherapy and autologous stem cell transplantation after second look laparotomy in patients with chemosensitive advanced ovarian carcinoma: long-term results. Bone Marrow Transplant. 2000;26:61-67.

23. Markman M, Brady MF, Spirtos NM, Hanjani P, Rubin SC. Phase II trial of intraperitoneal paclitaxel in carcinoma of the ovary, tube, and peritoneum: a Gynecologic Oncology Group Study. J Clin Oncol. 1998;16:2620-2624.

24. Menczer J, Ben-Baruch G, Rizel S, Brenner H. Intraperitoneal cisplatin chemotherapy in ovarian carcinoma patients who are clinically in complete remission. Gynecol Oncol. 1992;46:222-225.

25. Tarraza HM,, Jr, Boyce CR, Smith WG, Jones MA. Consolidation intraperitoneal chemotherapy in epithelial ovarian cancer patients following negative second-look laparotomy. Gynecol Oncol. 1993;50:287-290.

26. Dufour P, Bergerat JP, Barats JC, et al. Intraperitoneal mitoxantrone as consolidation treatment for patients with ovarian carcinoma in pathologic complete remission. Cancer. 1994;73:1865-1869.

27. Barakat RR, Almadrones L, Venkatraman ES, et al. A phase II trial of intraperitoneal cisplatin and etoposide as consolidation therapy in patients with Stage II-IV epithelial ovarian cancer following negative surgical assessment. Gynecol Oncol. 1998;69:17-22.

28. Abu-Rustum NR, Barakat RR, Siegel PL, Venkatraman E, Curtin JP, Hoskins WJ. Second-look operation for epithelial ovarian cancer: laparoscopy or laparotomy? Obstet Gynecol. 1996;88:549-553.

29. Clough KB, Ladonne JM, Nos C, Renolleau C, Validire P, Durand JC. Second look for ovarian cancer: laparoscopy or laparotomy? A prospective comparative study. Gynecol Oncol. 1999;72:411-417.

30. Spinelli P, Luini A, Pizzetti P, de Palo GM. Laparoscopy in staging and restaging of 95 patients with ovarian carcinoma. Tumori. 1976;62:493-501.

31. Smith WG, Day TG, Jr, Smith JP. The use of laparoscopy to determine the results of chemotherapy for ovarian cancer. J Reprod Med. 1977;18:257-260.

32. Canis M, Chapron C, Mage G, et al. [Technique and preliminary results in second-look laparoscopy in epithelial malignant ovarian tumors]. J Gynecol Obstet Biol Reprod (Paris). 1992;21:655-663.

33. Quinn MA, Bishop GJ, Campbell JJ, Rodgerson J, Pepperell RJ. Laparoscopic follow-up of patients with ovarian carcinoma. Br J Obstet Gynaecol. 1980;87:1132-1139.

34. Xygakis AM, Politis GS, Michalas SP, Kaskarelis DB. Second-look laparoscopy in ovarian cancer. J Reprod Med. 1984;29:583-585.

35. Nicoletto MO, Tumolo S, Talamini R, et al. Surgical second look in ovarian cancer: a randomized study in patients with laparoscopic complete remission—a Northeastern Oncology Cooperative Group-Ovarian Cancer Cooperative Group Study. J Clin Oncol. 1997;15:994-999.

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• New sling procedures • Correcting site-specific defects • Mesh augmentation

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• New sling procedures • Correcting site-specific defects • Mesh augmentation

After several decades of slow progress, the field of urogynecology is experiencing dynamic change, including:

  • new minimally invasive, tension-free, midurethral sling procedures, especially the transobturator approach,
  • correction of size-specific defects to repair prolapse, and
  • use of mesh/graft augmentation in pro lapse repair.

These developments are some of the most important since Kelly and Dunn first described suburethral fascial plication for stress incontinence and cystocele in 1914.1 They have come about through increased understanding of the pathophysiology of incontinence and prolapse, innovative technology and techniques, and improved communication and coordination among physicians worldwide.

New sling procedures, promising outcomes

The minimally invasive midurethral sling procedure spawned notable new approaches and is a mainstay of surgical treatment for stress urinary incontinence.

First described in Sweden by Ulmsten in 1995,2 the tension-free vaginal tape procedure is a revolutionary change in the suburethral sling procedure and is now the most widely performed surgery for stress incontinence worldwide.

In it, a tension-free vaginal tape (TVT) (Gynecare, Somerville, NJ) of synthetic polypropylene mesh is attached to 2 needles and passed through a vaginal incision and the retropubic space, exiting to small incisions in the suprapubic region to create a suburethral sling or hammock and provide urethral support during increased abdominal pressure. The sling remains fixed by friction and subsequent adhesions.

Although the traditional suburethral sling was less invasive than other abdominal incontinence procedures, it was associated with a steep learning curve and a high incidence of postoperative irritative bladder symptoms and voiding dysfunction.3

Tension-free vaginal tape: Excellent long-term cure

It can be performed routinely in under 30 minutes using local anesthesia, with minimal postoperative complications. Five-year cure rates approach 95%,4 and data presented at the 2003 International Urogynecology Association clinical meeting describe an objective 7-year cure rate of 82%.5

The incidence and severity of postoperative voiding dysfunction following the TVT procedure is significantly lower than that reported after traditional suburethral sling (2%–40%) or transvaginal needle suspension (2%–50%) procedures.6-9 Although bladder perforation has occurred in up to 10% of patients, reports of complications, including major hemorrhage, tape erosion, and bowel and nerve injury, are rare.10,11

Modifications

These products have a modified approach, materials, or refinements in technique to address various needs. For example, American Medical Systems (Minnetonka, Minn) introduced the SPARC procedure, which allows abdominal placement of the midurethral sling, similar to a needle suspension technique.

CR Bard (Murray Hill, NJ) introduced a midurethral sling of porcine dermis (Pelvicol) to address concerns physicians may have about using synthetic materials.

Minimally invasive midurethral slings include the Advantage (Boston Scientific, Natick, Mass), Centrasorb (Caldera Medical, Thousand Oaks, Calif), Stratasis TF (Cook, West Lafayette, Ind), and Uretex (CR Bard).

Newest approach: Transobturator sling

In this technique, the sling is placed in the midurethral position, but the insertion points are in the genital area lateral to the vagina, and the needle passes through the obturator membrane and paraurethral space. Because it avoids passage of the needles through the retropubic space, the transobturator approach theoretically should reduce the risk of bowel, bladder, and major blood vessel injury.

The procedure was initially described in Europe and introduced in the United States in 2003. Current product offerings include the outside-in approach of ObTape (Mentor, Santa Barbara, Calif), Monarc (American Medical Systems), and Uretex (CR Bard). Gynecare offers a variation of its TVT—the TVT-Obturator—which involves an inside-out approach to further minimize risk of vascular injury.

Shortage of long-term data, but good early results

In a 1-year follow-up of patients undergoing a sling procedure with the UraTape transobturator sling (Mentor), Delorme and colleagues12 reported that 29 of 32 patients (90.6%) were cured and 3 (9.4%) improved. De Leval13 described his inside-out approach with equally good results: no bladder or urethral injuries and no vascular (hematoma or bleeding) or neurological complications. A transobturator technique using porcine dermis has also been described.

Tension-free vaginal tape versus transobturator sling

In 2004, a small randomized, prospective trial of TVT (n = 29) versus transobturator tape (n = 27) with 1-year follow-up found the transobturator approach to be safer and easier to place with equivalent short-term results.14 Mean operative time was significantly shorter in the transobturator group (15±4 minutes versus 27±8 minutes, P <.001).

No bladder injury occurred in the transobturator group versus 9.7% (n = 3) in the TVT group (P >.05). The rate of postoperative urinary retention was 25.8% (n = 8) in the TVT group versus 13.3% (n = 4) in the transobturator group (P >.05). Cure rates were similar for the TVT and transobturator groups: 83.9% versus 90%, respectively), improvement (9.7% versus 3.3%), and failure (6.5% versus 6.7%). No vaginal erosion occurred in either group.

 

 

Additional investigations of the transobturator tape procedure are underway.

Correcting site-specific defects in prolapse repair

This repair rationale should become the standard, although it has yet to be widely adopted and procedural refinement and research are continuing.

As early as 1908, site-specific defects in the endopelvic fascia were identified as the likely cause of anterior vaginal segment prolapse. Like hernia repair, which requires closure of the fascial defect, the “cystocele hernia” repair advocated by George White involved reattaching the endopelvic fascia to the arcus tendineus fascia pelvis using a series of interrupted sutures through an abdominal retropubic approach.

Although this view was later abandoned, it resurfaced in the 1980s, when Cullen Richardson described midline, lateral, and transverse defects (FIGURE 1) in the endopelvic fascia as the cause of cystocele and rectocele.15 Richardson advocated diagnosis that identified these fascial defects, along with treatment with site-specific repair.

(In the intervening decades, prolapse was thought to result from generalized weakening or attenuation of the endopelvic fascia that supports the bladder, rectum, or vagina, leading to cystocele, rectocele, or uterine prolapse, respectively. Traditional repairs, still widely performed by most gynecologists, consist of the anterior and posterior colporrhaphy, which involve midline plication of the endopelvic fascia to reduce the prolapse and recreate support by strengthening the weakened fascial layer.)

FIGURE 1 Identify the site of defect


Whether the defect that causes a rectocele or cystocele is transverse, central, or lateral determines the type of repair to be performed. Reprinted with permission from Richardson AC. The rectovaginal septum revisited: its relationship to rectocele and its importance in rectocele repair. Clin Obstet Gynecol.1993;36(4):976–983.

Excellent cure rates with fewer complications

Site-specific repair (FIGURE 2) has been adopted by many pelvic surgeons, who report excellent cure rates with fewer complications such as dyspareunia, vaginal narrowing, and increased blood loss—all of which are more common with traditional anterior and posterior colporrhaphy.

Traditional colporrhaphy does correct the underlying fascial defect when the “hernia” is in the midline. However, for lateral and transverse defects, traditional colporrhaphy leaves the defect uncorrected and may even create additional tension, resulting in recurrence.

Site-specific repair also is useful in the treatment of enterocele, which has been described as a herniation of the peritoneum through a defect of the anterior and posterior fascial planes at the vaginal apex.16

Widening but not broad acceptance

Although cure rates for site-specific prolapse repair range from 75% to 85%,17,18 the concept has yet to be widely adopted and continues to undergo procedural refinement and research, as well as physician education. With increasing experience and clinical data, it may become the standard for pelvic prolapse repair.

FIGURE 2 Repair the defect to correct the rectocele


Surgical technique for a transverse tear in the rectovaginal fascia: After identifying the defect, place a series of interrupted sutures to reapproximate the fascial edges (copyright Miklos/Kohli).

Mesh augmentation: Useful in selected patients

Although augmentation with mesh or biomaterials is easy to perform, it remains unclear which technique and materials are optimal.

The use of mesh and biomaterials to augment repair of a cystocele, rectocele, or enterocele is slowly increasing, although general surgeons have been utilizing these materials for many years in hernia repair.

Augmentation has been advocated for “pelvic hernias” because of poor long-term cure rates for traditional prolapse surgeries (which range from 40% to 80%—well behind rates of 90% or more for incontinence procedures).

A recent informal survey of the members of the American Urogynecologic Society and International Urogynecologic Association revealed that most pelvic surgeons are using some type of graft or mesh to augment repairs in selected patients.

Synthetic mesh versus autologous and heterologous grafts

Synthetic materials have the advantage of being readily available, cost-effective, and consistent in quality, but they may cause significant complications, including infection, stricture, and erosion. This is especially important in the vagina, which needs to stretch during intercourse and which alters in thickness and other properties during a woman’s lifetime.

In contrast, autologous and heterologous donor grafts provide naturally occurring biomaterials capable of remodeling. Unfortunately, the in vivo tissue response is not yet fully understood. Other disadvantages: Biomaterials may lack consistent tissue properties and can be expensive.

For these reasons, graft materials remain in an early period of evaluation, although their use is expected to rise steadily with increasing experience and new product development.

Limited data on safety and efficacy

Although many pelvic surgeons use graft/mesh materials in prolapse repair, data on their safety and efficacy are limited, partly due to the variety of surgical techniques and materials available. Another factor is the difficulty of obtaining good long-term data with large patient numbers. Most of the literature is comprised of case reports, with few prospective, randomized trials.

 

 

That said, initial data suggest a significant improvement in cure rates, compared with traditional techniques, with minimal short-term complications. Long-term results and complication rates are not yet available.

What existing studies show

A variety of synthetic materials have been used in surgical correction of cystocele. In the largest series to date, Flood and colleagues19 reported their 12-year experience with 142 women undergoing a modified anterior colporrhaphy reinforced with Marlex (Davol, Cranston, RI) mesh: 100% success in correcting cystocele and a 74% success rate for urinary stress incontinence, with a mean follow-up of 3.2 years and no significant intraoperative complications.

In a prospective randomized trial of 125 patients utilizing absorbable polyglactin 910 mesh (Vicryl) (Ethicon, Somerville, NJ) to augment standard anterior colporrhaphy, Koduri et al20 reported a failure rate of 13% in the colporrhaphy-alone group compared to 1% in the colporrhaphy-mesh group at the 1-year follow-up. Subjectively, both groups improved equally.

Clemons et al21 used a human dermis graft to treat advanced recurrent cystocele in 33 women, with a follow-up of 18 months. They noted 13 (41%) objective failures and 1 (3%) subjective failure. Complications included 1 case of febrile morbidity, 1 cystotomy, and 1 anterior wall breakdown secondary to hematoma formation caused by heparin therapy. No other erosions or rejections were seen.

Most effective applications

Graft/mesh augmentation may be most effective in posterior vaginal segment reconstruction and rectocele repair, as it obviates the need for levatorplasty in patients with poor rectovaginal fascia. A variety of synthetic materials have been used for posterior wall reconstruction in small series.

Mersilene mesh

Mersilene mesh (Ethicon) was used by Fox and Stanton22 to augment traditional rectocele repair in 29 women followed for 14 months. Most of the women had undergone previous rectocele repair with recurrence of their prolapse. All women with stage II and stage III vault prolapse were corrected, with an increase in stage I prolapse from 20% to 27%. All women with stage II and stage III rectocele were corrected, with a decrease in stage I prolapse from 36% to 7%. The only significant intraoperative complication was a cystotomy. One mesh became infected postoperatively, requiring removal.

Cadaveric dermal graft

Recently, Kohli and Miklos23 reported their experience with 57 patients undergoing augmented rectocele repair using a cadaveric dermal graft (FIGURE 3) over a 2-year period. Average follow-up was 11 months. Average patient age in the follow-up group was 63.6±10.9 years (range: 33–79 years) and average parity was 2.8±1.5 (range: 0–7). No major intraoperative complications (hollow viscous injury, blood loss greater than 500 cc, or transfusion) or post-operative complications (infection, abscess, or hematoma) were noted. No graft-related complications such as rejection, erosion, infection, and fistula formation were noted during the follow-up period.

Using previously accepted Pelvic Organ Prolapse Quantification (POP-Q) parameters for success, Kohli and Miklos found 54 of 57 women (95%) to have surgical cure at follow-up. These authors have also described the use of a dermal graft in the repair of a complicated rectovaginal fistula.24

FIGURE 3 Placement of mesh augmentation


Augment enterocele/rectocele repair by attaching the mesh apically, laterally, and distally (copyright Miklos/Kohli).

Future outlook

Further data on the efficacy and safety of graft/mesh augmentation—including identification of the optimal technique and ideal material—are necessary before this approach can be widely adopted. However, in selected patients, it represents a significant advance in the surgical treatment of pelvic prolapse.

The author is a preceptor for American Medical Systems, Gynecare, CR Bard, and Mentor and a consultant for Boston Scientific.

References

1. Kelly HA, Dunn WM. Urinary incontinence in women without manifest injury to the bladder. Surg Gynecol Obstet. 1914;18:444.-

2. Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol. 1995;29:75-82.

3. Weinberger MW, Ostergard DR. Postoperative catheterization, urinary retention, and permanent voiding dysfunction after polytetrafluroethylene suburethral sling placement. Obstet Gynecol. 1996;87:50-54.

4. Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(Suppl 2):S5-8.

5. Nilsson CG, Rezapour M, Falconer C. Seven years follow-up of the tension-free vaginal tape (TVT) procedure. Presented at the 2003 International Urogynecology Association Annual Meeting.

6. Horbach N. Suburethral sling procedures. In: Ostergard DR, Bent AE, eds. Urogynecology and Urodynamics: Theory and Practice. 3rd ed. Baltimore: Williams & Wilkins; 1991;449-458.

7. Stanton SL, Reynolds SF, Creighton SM. The modified Pereyra (Raz) procedure for genuine stress incontinence—a useful option in the elderly or frail patient? Int Urogynecol J. 1995;6:22-25.

8. Nygaard IE, Kreder KJ. Complications of incontinence surgery. Int Urogynecol J. 1994;5:353-360.

9. Lockhart vJL, Tirado A, Morillo G, Politano VA. Vesicourethral dysfunction following cystourethropexy. J Urol. 1982;128:943-945.

10. Leboeuf L, Tellez CA, Ead D, Gousse AE. Complication of bowel perforation during insertion of tension-free vaginal tape. J Urol. 2003;170(4 Pt 1):1310.-

11. Abouassaly R, Steinberg JR, Lemieux M, et al. Complications of tension-free vaginal tape surgery: a multi-institutional review. BJU Int. 2004;94:110-113.

12. Delorme E, Droupy S, de Tayrac R, Delmas V. [Transobturator tape (UraTape). A new minimally invasive method in the treatment of urinary incontinence in women.] Prog Urol. 2003;13:656-659.

13. de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol. 2003;44:724-730.

14. De Tayrac R, Deffieux X, Droupy S, ChauveaudLambling A, Calvanese-Benamour L, Fernandez H. A prospective randomized trial comparing tensionfree vaginal tape and transobturator suburethral tape for surgical treatment of stress urinary incontinence. Am J Obstet Gynecol. 2004;190:602-608.

15. Richardson AC. The rectovaginal septum revisited: its relationship to rectocele and its importance in rectocele repair. Clin Obstet Gynecol. 1993;36:976-983.

16. Miklos JR, Kohli N, Lucente V, Saye WB. Site-specific fascial defects in the diagnosis and surgical management of enterocele. Am J Obstet Gynecol. 1998;179 (6 Pt 1):1418-1422; discussion 1422-823.

17. Porter WE, Steele A, Walsh P, Kohli N, Karram MM. The anatomic and functional outcomes of defectspecific rectocele repairs. Am J Obstet Gynecol. 1999;181:1353-1358; discussion 1358-1359.

18. Kenton K, Shott S, Brubaker L. Outcome after rectovaginal fascia reattachment for rectocele repair. Am J Obstet Gynecol. 1999;181:1360-1363; discussion 1363-1364.

19. Flood CG, Drutz HP, Waja L. Anterior colporrhaphy reinforced with Marlex mesh for the treatment of cystoceles. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9:200-204.

20. Koduri S, Lobel RW, Winkler HA, Tomezsko J, Culligan PJ, Sand PK. Prospective randomized trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles. Proceedings of the 25th Annual Meeting of the International Urogynecological Association, 2000. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11:S80.-

21. Clemons JL, Myers DL, Aguilar VC, Arya LA. Vaginal paravaginal repair with an AlloDerm graft. Am J Obstet Gynecol. 2003;189:1612-1618; discussion 1618-1619.

22. Fox SD, Stanton SL. Vault prolapse and rectocele: assessment of repair using sacrocolpopexy with mesh interposition. BJOG. 2000;107:1371-1375.

23. Kohli N, Miklos JR. Site specific rectocele repair augmented with a cadaveric dermal graft. Proceedings of the 21st Annual Scientific Meeting of the American Urogynecologic Society, 2000. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12:S9.-

24. Miklos JR, Kohli N. Rectovaginal fistula repair utilizing a cadaveric dermal allograft. Int Urogynecol J Pelvic Floor Dysfunct. 1999;10:405-406.

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Author and Disclosure Information

Neeraj Kohli, MD, MBA
Director, Division of Urogynecology, Brigham and Women’s Hospital,
Assistant Professor, Harvard Medical School, Boston, Mass,
and Board of Editors member, OBG Management.

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Neeraj Kohli, MD, MBA
Director, Division of Urogynecology, Brigham and Women’s Hospital,
Assistant Professor, Harvard Medical School, Boston, Mass,
and Board of Editors member, OBG Management.

Author and Disclosure Information

Neeraj Kohli, MD, MBA
Director, Division of Urogynecology, Brigham and Women’s Hospital,
Assistant Professor, Harvard Medical School, Boston, Mass,
and Board of Editors member, OBG Management.

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After several decades of slow progress, the field of urogynecology is experiencing dynamic change, including:

  • new minimally invasive, tension-free, midurethral sling procedures, especially the transobturator approach,
  • correction of size-specific defects to repair prolapse, and
  • use of mesh/graft augmentation in pro lapse repair.

These developments are some of the most important since Kelly and Dunn first described suburethral fascial plication for stress incontinence and cystocele in 1914.1 They have come about through increased understanding of the pathophysiology of incontinence and prolapse, innovative technology and techniques, and improved communication and coordination among physicians worldwide.

New sling procedures, promising outcomes

The minimally invasive midurethral sling procedure spawned notable new approaches and is a mainstay of surgical treatment for stress urinary incontinence.

First described in Sweden by Ulmsten in 1995,2 the tension-free vaginal tape procedure is a revolutionary change in the suburethral sling procedure and is now the most widely performed surgery for stress incontinence worldwide.

In it, a tension-free vaginal tape (TVT) (Gynecare, Somerville, NJ) of synthetic polypropylene mesh is attached to 2 needles and passed through a vaginal incision and the retropubic space, exiting to small incisions in the suprapubic region to create a suburethral sling or hammock and provide urethral support during increased abdominal pressure. The sling remains fixed by friction and subsequent adhesions.

Although the traditional suburethral sling was less invasive than other abdominal incontinence procedures, it was associated with a steep learning curve and a high incidence of postoperative irritative bladder symptoms and voiding dysfunction.3

Tension-free vaginal tape: Excellent long-term cure

It can be performed routinely in under 30 minutes using local anesthesia, with minimal postoperative complications. Five-year cure rates approach 95%,4 and data presented at the 2003 International Urogynecology Association clinical meeting describe an objective 7-year cure rate of 82%.5

The incidence and severity of postoperative voiding dysfunction following the TVT procedure is significantly lower than that reported after traditional suburethral sling (2%–40%) or transvaginal needle suspension (2%–50%) procedures.6-9 Although bladder perforation has occurred in up to 10% of patients, reports of complications, including major hemorrhage, tape erosion, and bowel and nerve injury, are rare.10,11

Modifications

These products have a modified approach, materials, or refinements in technique to address various needs. For example, American Medical Systems (Minnetonka, Minn) introduced the SPARC procedure, which allows abdominal placement of the midurethral sling, similar to a needle suspension technique.

CR Bard (Murray Hill, NJ) introduced a midurethral sling of porcine dermis (Pelvicol) to address concerns physicians may have about using synthetic materials.

Minimally invasive midurethral slings include the Advantage (Boston Scientific, Natick, Mass), Centrasorb (Caldera Medical, Thousand Oaks, Calif), Stratasis TF (Cook, West Lafayette, Ind), and Uretex (CR Bard).

Newest approach: Transobturator sling

In this technique, the sling is placed in the midurethral position, but the insertion points are in the genital area lateral to the vagina, and the needle passes through the obturator membrane and paraurethral space. Because it avoids passage of the needles through the retropubic space, the transobturator approach theoretically should reduce the risk of bowel, bladder, and major blood vessel injury.

The procedure was initially described in Europe and introduced in the United States in 2003. Current product offerings include the outside-in approach of ObTape (Mentor, Santa Barbara, Calif), Monarc (American Medical Systems), and Uretex (CR Bard). Gynecare offers a variation of its TVT—the TVT-Obturator—which involves an inside-out approach to further minimize risk of vascular injury.

Shortage of long-term data, but good early results

In a 1-year follow-up of patients undergoing a sling procedure with the UraTape transobturator sling (Mentor), Delorme and colleagues12 reported that 29 of 32 patients (90.6%) were cured and 3 (9.4%) improved. De Leval13 described his inside-out approach with equally good results: no bladder or urethral injuries and no vascular (hematoma or bleeding) or neurological complications. A transobturator technique using porcine dermis has also been described.

Tension-free vaginal tape versus transobturator sling

In 2004, a small randomized, prospective trial of TVT (n = 29) versus transobturator tape (n = 27) with 1-year follow-up found the transobturator approach to be safer and easier to place with equivalent short-term results.14 Mean operative time was significantly shorter in the transobturator group (15±4 minutes versus 27±8 minutes, P <.001).

No bladder injury occurred in the transobturator group versus 9.7% (n = 3) in the TVT group (P >.05). The rate of postoperative urinary retention was 25.8% (n = 8) in the TVT group versus 13.3% (n = 4) in the transobturator group (P >.05). Cure rates were similar for the TVT and transobturator groups: 83.9% versus 90%, respectively), improvement (9.7% versus 3.3%), and failure (6.5% versus 6.7%). No vaginal erosion occurred in either group.

 

 

Additional investigations of the transobturator tape procedure are underway.

Correcting site-specific defects in prolapse repair

This repair rationale should become the standard, although it has yet to be widely adopted and procedural refinement and research are continuing.

As early as 1908, site-specific defects in the endopelvic fascia were identified as the likely cause of anterior vaginal segment prolapse. Like hernia repair, which requires closure of the fascial defect, the “cystocele hernia” repair advocated by George White involved reattaching the endopelvic fascia to the arcus tendineus fascia pelvis using a series of interrupted sutures through an abdominal retropubic approach.

Although this view was later abandoned, it resurfaced in the 1980s, when Cullen Richardson described midline, lateral, and transverse defects (FIGURE 1) in the endopelvic fascia as the cause of cystocele and rectocele.15 Richardson advocated diagnosis that identified these fascial defects, along with treatment with site-specific repair.

(In the intervening decades, prolapse was thought to result from generalized weakening or attenuation of the endopelvic fascia that supports the bladder, rectum, or vagina, leading to cystocele, rectocele, or uterine prolapse, respectively. Traditional repairs, still widely performed by most gynecologists, consist of the anterior and posterior colporrhaphy, which involve midline plication of the endopelvic fascia to reduce the prolapse and recreate support by strengthening the weakened fascial layer.)

FIGURE 1 Identify the site of defect


Whether the defect that causes a rectocele or cystocele is transverse, central, or lateral determines the type of repair to be performed. Reprinted with permission from Richardson AC. The rectovaginal septum revisited: its relationship to rectocele and its importance in rectocele repair. Clin Obstet Gynecol.1993;36(4):976–983.

Excellent cure rates with fewer complications

Site-specific repair (FIGURE 2) has been adopted by many pelvic surgeons, who report excellent cure rates with fewer complications such as dyspareunia, vaginal narrowing, and increased blood loss—all of which are more common with traditional anterior and posterior colporrhaphy.

Traditional colporrhaphy does correct the underlying fascial defect when the “hernia” is in the midline. However, for lateral and transverse defects, traditional colporrhaphy leaves the defect uncorrected and may even create additional tension, resulting in recurrence.

Site-specific repair also is useful in the treatment of enterocele, which has been described as a herniation of the peritoneum through a defect of the anterior and posterior fascial planes at the vaginal apex.16

Widening but not broad acceptance

Although cure rates for site-specific prolapse repair range from 75% to 85%,17,18 the concept has yet to be widely adopted and continues to undergo procedural refinement and research, as well as physician education. With increasing experience and clinical data, it may become the standard for pelvic prolapse repair.

FIGURE 2 Repair the defect to correct the rectocele


Surgical technique for a transverse tear in the rectovaginal fascia: After identifying the defect, place a series of interrupted sutures to reapproximate the fascial edges (copyright Miklos/Kohli).

Mesh augmentation: Useful in selected patients

Although augmentation with mesh or biomaterials is easy to perform, it remains unclear which technique and materials are optimal.

The use of mesh and biomaterials to augment repair of a cystocele, rectocele, or enterocele is slowly increasing, although general surgeons have been utilizing these materials for many years in hernia repair.

Augmentation has been advocated for “pelvic hernias” because of poor long-term cure rates for traditional prolapse surgeries (which range from 40% to 80%—well behind rates of 90% or more for incontinence procedures).

A recent informal survey of the members of the American Urogynecologic Society and International Urogynecologic Association revealed that most pelvic surgeons are using some type of graft or mesh to augment repairs in selected patients.

Synthetic mesh versus autologous and heterologous grafts

Synthetic materials have the advantage of being readily available, cost-effective, and consistent in quality, but they may cause significant complications, including infection, stricture, and erosion. This is especially important in the vagina, which needs to stretch during intercourse and which alters in thickness and other properties during a woman’s lifetime.

In contrast, autologous and heterologous donor grafts provide naturally occurring biomaterials capable of remodeling. Unfortunately, the in vivo tissue response is not yet fully understood. Other disadvantages: Biomaterials may lack consistent tissue properties and can be expensive.

For these reasons, graft materials remain in an early period of evaluation, although their use is expected to rise steadily with increasing experience and new product development.

Limited data on safety and efficacy

Although many pelvic surgeons use graft/mesh materials in prolapse repair, data on their safety and efficacy are limited, partly due to the variety of surgical techniques and materials available. Another factor is the difficulty of obtaining good long-term data with large patient numbers. Most of the literature is comprised of case reports, with few prospective, randomized trials.

 

 

That said, initial data suggest a significant improvement in cure rates, compared with traditional techniques, with minimal short-term complications. Long-term results and complication rates are not yet available.

What existing studies show

A variety of synthetic materials have been used in surgical correction of cystocele. In the largest series to date, Flood and colleagues19 reported their 12-year experience with 142 women undergoing a modified anterior colporrhaphy reinforced with Marlex (Davol, Cranston, RI) mesh: 100% success in correcting cystocele and a 74% success rate for urinary stress incontinence, with a mean follow-up of 3.2 years and no significant intraoperative complications.

In a prospective randomized trial of 125 patients utilizing absorbable polyglactin 910 mesh (Vicryl) (Ethicon, Somerville, NJ) to augment standard anterior colporrhaphy, Koduri et al20 reported a failure rate of 13% in the colporrhaphy-alone group compared to 1% in the colporrhaphy-mesh group at the 1-year follow-up. Subjectively, both groups improved equally.

Clemons et al21 used a human dermis graft to treat advanced recurrent cystocele in 33 women, with a follow-up of 18 months. They noted 13 (41%) objective failures and 1 (3%) subjective failure. Complications included 1 case of febrile morbidity, 1 cystotomy, and 1 anterior wall breakdown secondary to hematoma formation caused by heparin therapy. No other erosions or rejections were seen.

Most effective applications

Graft/mesh augmentation may be most effective in posterior vaginal segment reconstruction and rectocele repair, as it obviates the need for levatorplasty in patients with poor rectovaginal fascia. A variety of synthetic materials have been used for posterior wall reconstruction in small series.

Mersilene mesh

Mersilene mesh (Ethicon) was used by Fox and Stanton22 to augment traditional rectocele repair in 29 women followed for 14 months. Most of the women had undergone previous rectocele repair with recurrence of their prolapse. All women with stage II and stage III vault prolapse were corrected, with an increase in stage I prolapse from 20% to 27%. All women with stage II and stage III rectocele were corrected, with a decrease in stage I prolapse from 36% to 7%. The only significant intraoperative complication was a cystotomy. One mesh became infected postoperatively, requiring removal.

Cadaveric dermal graft

Recently, Kohli and Miklos23 reported their experience with 57 patients undergoing augmented rectocele repair using a cadaveric dermal graft (FIGURE 3) over a 2-year period. Average follow-up was 11 months. Average patient age in the follow-up group was 63.6±10.9 years (range: 33–79 years) and average parity was 2.8±1.5 (range: 0–7). No major intraoperative complications (hollow viscous injury, blood loss greater than 500 cc, or transfusion) or post-operative complications (infection, abscess, or hematoma) were noted. No graft-related complications such as rejection, erosion, infection, and fistula formation were noted during the follow-up period.

Using previously accepted Pelvic Organ Prolapse Quantification (POP-Q) parameters for success, Kohli and Miklos found 54 of 57 women (95%) to have surgical cure at follow-up. These authors have also described the use of a dermal graft in the repair of a complicated rectovaginal fistula.24

FIGURE 3 Placement of mesh augmentation


Augment enterocele/rectocele repair by attaching the mesh apically, laterally, and distally (copyright Miklos/Kohli).

Future outlook

Further data on the efficacy and safety of graft/mesh augmentation—including identification of the optimal technique and ideal material—are necessary before this approach can be widely adopted. However, in selected patients, it represents a significant advance in the surgical treatment of pelvic prolapse.

The author is a preceptor for American Medical Systems, Gynecare, CR Bard, and Mentor and a consultant for Boston Scientific.

After several decades of slow progress, the field of urogynecology is experiencing dynamic change, including:

  • new minimally invasive, tension-free, midurethral sling procedures, especially the transobturator approach,
  • correction of size-specific defects to repair prolapse, and
  • use of mesh/graft augmentation in pro lapse repair.

These developments are some of the most important since Kelly and Dunn first described suburethral fascial plication for stress incontinence and cystocele in 1914.1 They have come about through increased understanding of the pathophysiology of incontinence and prolapse, innovative technology and techniques, and improved communication and coordination among physicians worldwide.

New sling procedures, promising outcomes

The minimally invasive midurethral sling procedure spawned notable new approaches and is a mainstay of surgical treatment for stress urinary incontinence.

First described in Sweden by Ulmsten in 1995,2 the tension-free vaginal tape procedure is a revolutionary change in the suburethral sling procedure and is now the most widely performed surgery for stress incontinence worldwide.

In it, a tension-free vaginal tape (TVT) (Gynecare, Somerville, NJ) of synthetic polypropylene mesh is attached to 2 needles and passed through a vaginal incision and the retropubic space, exiting to small incisions in the suprapubic region to create a suburethral sling or hammock and provide urethral support during increased abdominal pressure. The sling remains fixed by friction and subsequent adhesions.

Although the traditional suburethral sling was less invasive than other abdominal incontinence procedures, it was associated with a steep learning curve and a high incidence of postoperative irritative bladder symptoms and voiding dysfunction.3

Tension-free vaginal tape: Excellent long-term cure

It can be performed routinely in under 30 minutes using local anesthesia, with minimal postoperative complications. Five-year cure rates approach 95%,4 and data presented at the 2003 International Urogynecology Association clinical meeting describe an objective 7-year cure rate of 82%.5

The incidence and severity of postoperative voiding dysfunction following the TVT procedure is significantly lower than that reported after traditional suburethral sling (2%–40%) or transvaginal needle suspension (2%–50%) procedures.6-9 Although bladder perforation has occurred in up to 10% of patients, reports of complications, including major hemorrhage, tape erosion, and bowel and nerve injury, are rare.10,11

Modifications

These products have a modified approach, materials, or refinements in technique to address various needs. For example, American Medical Systems (Minnetonka, Minn) introduced the SPARC procedure, which allows abdominal placement of the midurethral sling, similar to a needle suspension technique.

CR Bard (Murray Hill, NJ) introduced a midurethral sling of porcine dermis (Pelvicol) to address concerns physicians may have about using synthetic materials.

Minimally invasive midurethral slings include the Advantage (Boston Scientific, Natick, Mass), Centrasorb (Caldera Medical, Thousand Oaks, Calif), Stratasis TF (Cook, West Lafayette, Ind), and Uretex (CR Bard).

Newest approach: Transobturator sling

In this technique, the sling is placed in the midurethral position, but the insertion points are in the genital area lateral to the vagina, and the needle passes through the obturator membrane and paraurethral space. Because it avoids passage of the needles through the retropubic space, the transobturator approach theoretically should reduce the risk of bowel, bladder, and major blood vessel injury.

The procedure was initially described in Europe and introduced in the United States in 2003. Current product offerings include the outside-in approach of ObTape (Mentor, Santa Barbara, Calif), Monarc (American Medical Systems), and Uretex (CR Bard). Gynecare offers a variation of its TVT—the TVT-Obturator—which involves an inside-out approach to further minimize risk of vascular injury.

Shortage of long-term data, but good early results

In a 1-year follow-up of patients undergoing a sling procedure with the UraTape transobturator sling (Mentor), Delorme and colleagues12 reported that 29 of 32 patients (90.6%) were cured and 3 (9.4%) improved. De Leval13 described his inside-out approach with equally good results: no bladder or urethral injuries and no vascular (hematoma or bleeding) or neurological complications. A transobturator technique using porcine dermis has also been described.

Tension-free vaginal tape versus transobturator sling

In 2004, a small randomized, prospective trial of TVT (n = 29) versus transobturator tape (n = 27) with 1-year follow-up found the transobturator approach to be safer and easier to place with equivalent short-term results.14 Mean operative time was significantly shorter in the transobturator group (15±4 minutes versus 27±8 minutes, P <.001).

No bladder injury occurred in the transobturator group versus 9.7% (n = 3) in the TVT group (P >.05). The rate of postoperative urinary retention was 25.8% (n = 8) in the TVT group versus 13.3% (n = 4) in the transobturator group (P >.05). Cure rates were similar for the TVT and transobturator groups: 83.9% versus 90%, respectively), improvement (9.7% versus 3.3%), and failure (6.5% versus 6.7%). No vaginal erosion occurred in either group.

 

 

Additional investigations of the transobturator tape procedure are underway.

Correcting site-specific defects in prolapse repair

This repair rationale should become the standard, although it has yet to be widely adopted and procedural refinement and research are continuing.

As early as 1908, site-specific defects in the endopelvic fascia were identified as the likely cause of anterior vaginal segment prolapse. Like hernia repair, which requires closure of the fascial defect, the “cystocele hernia” repair advocated by George White involved reattaching the endopelvic fascia to the arcus tendineus fascia pelvis using a series of interrupted sutures through an abdominal retropubic approach.

Although this view was later abandoned, it resurfaced in the 1980s, when Cullen Richardson described midline, lateral, and transverse defects (FIGURE 1) in the endopelvic fascia as the cause of cystocele and rectocele.15 Richardson advocated diagnosis that identified these fascial defects, along with treatment with site-specific repair.

(In the intervening decades, prolapse was thought to result from generalized weakening or attenuation of the endopelvic fascia that supports the bladder, rectum, or vagina, leading to cystocele, rectocele, or uterine prolapse, respectively. Traditional repairs, still widely performed by most gynecologists, consist of the anterior and posterior colporrhaphy, which involve midline plication of the endopelvic fascia to reduce the prolapse and recreate support by strengthening the weakened fascial layer.)

FIGURE 1 Identify the site of defect


Whether the defect that causes a rectocele or cystocele is transverse, central, or lateral determines the type of repair to be performed. Reprinted with permission from Richardson AC. The rectovaginal septum revisited: its relationship to rectocele and its importance in rectocele repair. Clin Obstet Gynecol.1993;36(4):976–983.

Excellent cure rates with fewer complications

Site-specific repair (FIGURE 2) has been adopted by many pelvic surgeons, who report excellent cure rates with fewer complications such as dyspareunia, vaginal narrowing, and increased blood loss—all of which are more common with traditional anterior and posterior colporrhaphy.

Traditional colporrhaphy does correct the underlying fascial defect when the “hernia” is in the midline. However, for lateral and transverse defects, traditional colporrhaphy leaves the defect uncorrected and may even create additional tension, resulting in recurrence.

Site-specific repair also is useful in the treatment of enterocele, which has been described as a herniation of the peritoneum through a defect of the anterior and posterior fascial planes at the vaginal apex.16

Widening but not broad acceptance

Although cure rates for site-specific prolapse repair range from 75% to 85%,17,18 the concept has yet to be widely adopted and continues to undergo procedural refinement and research, as well as physician education. With increasing experience and clinical data, it may become the standard for pelvic prolapse repair.

FIGURE 2 Repair the defect to correct the rectocele


Surgical technique for a transverse tear in the rectovaginal fascia: After identifying the defect, place a series of interrupted sutures to reapproximate the fascial edges (copyright Miklos/Kohli).

Mesh augmentation: Useful in selected patients

Although augmentation with mesh or biomaterials is easy to perform, it remains unclear which technique and materials are optimal.

The use of mesh and biomaterials to augment repair of a cystocele, rectocele, or enterocele is slowly increasing, although general surgeons have been utilizing these materials for many years in hernia repair.

Augmentation has been advocated for “pelvic hernias” because of poor long-term cure rates for traditional prolapse surgeries (which range from 40% to 80%—well behind rates of 90% or more for incontinence procedures).

A recent informal survey of the members of the American Urogynecologic Society and International Urogynecologic Association revealed that most pelvic surgeons are using some type of graft or mesh to augment repairs in selected patients.

Synthetic mesh versus autologous and heterologous grafts

Synthetic materials have the advantage of being readily available, cost-effective, and consistent in quality, but they may cause significant complications, including infection, stricture, and erosion. This is especially important in the vagina, which needs to stretch during intercourse and which alters in thickness and other properties during a woman’s lifetime.

In contrast, autologous and heterologous donor grafts provide naturally occurring biomaterials capable of remodeling. Unfortunately, the in vivo tissue response is not yet fully understood. Other disadvantages: Biomaterials may lack consistent tissue properties and can be expensive.

For these reasons, graft materials remain in an early period of evaluation, although their use is expected to rise steadily with increasing experience and new product development.

Limited data on safety and efficacy

Although many pelvic surgeons use graft/mesh materials in prolapse repair, data on their safety and efficacy are limited, partly due to the variety of surgical techniques and materials available. Another factor is the difficulty of obtaining good long-term data with large patient numbers. Most of the literature is comprised of case reports, with few prospective, randomized trials.

 

 

That said, initial data suggest a significant improvement in cure rates, compared with traditional techniques, with minimal short-term complications. Long-term results and complication rates are not yet available.

What existing studies show

A variety of synthetic materials have been used in surgical correction of cystocele. In the largest series to date, Flood and colleagues19 reported their 12-year experience with 142 women undergoing a modified anterior colporrhaphy reinforced with Marlex (Davol, Cranston, RI) mesh: 100% success in correcting cystocele and a 74% success rate for urinary stress incontinence, with a mean follow-up of 3.2 years and no significant intraoperative complications.

In a prospective randomized trial of 125 patients utilizing absorbable polyglactin 910 mesh (Vicryl) (Ethicon, Somerville, NJ) to augment standard anterior colporrhaphy, Koduri et al20 reported a failure rate of 13% in the colporrhaphy-alone group compared to 1% in the colporrhaphy-mesh group at the 1-year follow-up. Subjectively, both groups improved equally.

Clemons et al21 used a human dermis graft to treat advanced recurrent cystocele in 33 women, with a follow-up of 18 months. They noted 13 (41%) objective failures and 1 (3%) subjective failure. Complications included 1 case of febrile morbidity, 1 cystotomy, and 1 anterior wall breakdown secondary to hematoma formation caused by heparin therapy. No other erosions or rejections were seen.

Most effective applications

Graft/mesh augmentation may be most effective in posterior vaginal segment reconstruction and rectocele repair, as it obviates the need for levatorplasty in patients with poor rectovaginal fascia. A variety of synthetic materials have been used for posterior wall reconstruction in small series.

Mersilene mesh

Mersilene mesh (Ethicon) was used by Fox and Stanton22 to augment traditional rectocele repair in 29 women followed for 14 months. Most of the women had undergone previous rectocele repair with recurrence of their prolapse. All women with stage II and stage III vault prolapse were corrected, with an increase in stage I prolapse from 20% to 27%. All women with stage II and stage III rectocele were corrected, with a decrease in stage I prolapse from 36% to 7%. The only significant intraoperative complication was a cystotomy. One mesh became infected postoperatively, requiring removal.

Cadaveric dermal graft

Recently, Kohli and Miklos23 reported their experience with 57 patients undergoing augmented rectocele repair using a cadaveric dermal graft (FIGURE 3) over a 2-year period. Average follow-up was 11 months. Average patient age in the follow-up group was 63.6±10.9 years (range: 33–79 years) and average parity was 2.8±1.5 (range: 0–7). No major intraoperative complications (hollow viscous injury, blood loss greater than 500 cc, or transfusion) or post-operative complications (infection, abscess, or hematoma) were noted. No graft-related complications such as rejection, erosion, infection, and fistula formation were noted during the follow-up period.

Using previously accepted Pelvic Organ Prolapse Quantification (POP-Q) parameters for success, Kohli and Miklos found 54 of 57 women (95%) to have surgical cure at follow-up. These authors have also described the use of a dermal graft in the repair of a complicated rectovaginal fistula.24

FIGURE 3 Placement of mesh augmentation


Augment enterocele/rectocele repair by attaching the mesh apically, laterally, and distally (copyright Miklos/Kohli).

Future outlook

Further data on the efficacy and safety of graft/mesh augmentation—including identification of the optimal technique and ideal material—are necessary before this approach can be widely adopted. However, in selected patients, it represents a significant advance in the surgical treatment of pelvic prolapse.

The author is a preceptor for American Medical Systems, Gynecare, CR Bard, and Mentor and a consultant for Boston Scientific.

References

1. Kelly HA, Dunn WM. Urinary incontinence in women without manifest injury to the bladder. Surg Gynecol Obstet. 1914;18:444.-

2. Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol. 1995;29:75-82.

3. Weinberger MW, Ostergard DR. Postoperative catheterization, urinary retention, and permanent voiding dysfunction after polytetrafluroethylene suburethral sling placement. Obstet Gynecol. 1996;87:50-54.

4. Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(Suppl 2):S5-8.

5. Nilsson CG, Rezapour M, Falconer C. Seven years follow-up of the tension-free vaginal tape (TVT) procedure. Presented at the 2003 International Urogynecology Association Annual Meeting.

6. Horbach N. Suburethral sling procedures. In: Ostergard DR, Bent AE, eds. Urogynecology and Urodynamics: Theory and Practice. 3rd ed. Baltimore: Williams & Wilkins; 1991;449-458.

7. Stanton SL, Reynolds SF, Creighton SM. The modified Pereyra (Raz) procedure for genuine stress incontinence—a useful option in the elderly or frail patient? Int Urogynecol J. 1995;6:22-25.

8. Nygaard IE, Kreder KJ. Complications of incontinence surgery. Int Urogynecol J. 1994;5:353-360.

9. Lockhart vJL, Tirado A, Morillo G, Politano VA. Vesicourethral dysfunction following cystourethropexy. J Urol. 1982;128:943-945.

10. Leboeuf L, Tellez CA, Ead D, Gousse AE. Complication of bowel perforation during insertion of tension-free vaginal tape. J Urol. 2003;170(4 Pt 1):1310.-

11. Abouassaly R, Steinberg JR, Lemieux M, et al. Complications of tension-free vaginal tape surgery: a multi-institutional review. BJU Int. 2004;94:110-113.

12. Delorme E, Droupy S, de Tayrac R, Delmas V. [Transobturator tape (UraTape). A new minimally invasive method in the treatment of urinary incontinence in women.] Prog Urol. 2003;13:656-659.

13. de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol. 2003;44:724-730.

14. De Tayrac R, Deffieux X, Droupy S, ChauveaudLambling A, Calvanese-Benamour L, Fernandez H. A prospective randomized trial comparing tensionfree vaginal tape and transobturator suburethral tape for surgical treatment of stress urinary incontinence. Am J Obstet Gynecol. 2004;190:602-608.

15. Richardson AC. The rectovaginal septum revisited: its relationship to rectocele and its importance in rectocele repair. Clin Obstet Gynecol. 1993;36:976-983.

16. Miklos JR, Kohli N, Lucente V, Saye WB. Site-specific fascial defects in the diagnosis and surgical management of enterocele. Am J Obstet Gynecol. 1998;179 (6 Pt 1):1418-1422; discussion 1422-823.

17. Porter WE, Steele A, Walsh P, Kohli N, Karram MM. The anatomic and functional outcomes of defectspecific rectocele repairs. Am J Obstet Gynecol. 1999;181:1353-1358; discussion 1358-1359.

18. Kenton K, Shott S, Brubaker L. Outcome after rectovaginal fascia reattachment for rectocele repair. Am J Obstet Gynecol. 1999;181:1360-1363; discussion 1363-1364.

19. Flood CG, Drutz HP, Waja L. Anterior colporrhaphy reinforced with Marlex mesh for the treatment of cystoceles. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9:200-204.

20. Koduri S, Lobel RW, Winkler HA, Tomezsko J, Culligan PJ, Sand PK. Prospective randomized trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles. Proceedings of the 25th Annual Meeting of the International Urogynecological Association, 2000. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11:S80.-

21. Clemons JL, Myers DL, Aguilar VC, Arya LA. Vaginal paravaginal repair with an AlloDerm graft. Am J Obstet Gynecol. 2003;189:1612-1618; discussion 1618-1619.

22. Fox SD, Stanton SL. Vault prolapse and rectocele: assessment of repair using sacrocolpopexy with mesh interposition. BJOG. 2000;107:1371-1375.

23. Kohli N, Miklos JR. Site specific rectocele repair augmented with a cadaveric dermal graft. Proceedings of the 21st Annual Scientific Meeting of the American Urogynecologic Society, 2000. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12:S9.-

24. Miklos JR, Kohli N. Rectovaginal fistula repair utilizing a cadaveric dermal allograft. Int Urogynecol J Pelvic Floor Dysfunct. 1999;10:405-406.

References

1. Kelly HA, Dunn WM. Urinary incontinence in women without manifest injury to the bladder. Surg Gynecol Obstet. 1914;18:444.-

2. Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol. 1995;29:75-82.

3. Weinberger MW, Ostergard DR. Postoperative catheterization, urinary retention, and permanent voiding dysfunction after polytetrafluroethylene suburethral sling placement. Obstet Gynecol. 1996;87:50-54.

4. Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(Suppl 2):S5-8.

5. Nilsson CG, Rezapour M, Falconer C. Seven years follow-up of the tension-free vaginal tape (TVT) procedure. Presented at the 2003 International Urogynecology Association Annual Meeting.

6. Horbach N. Suburethral sling procedures. In: Ostergard DR, Bent AE, eds. Urogynecology and Urodynamics: Theory and Practice. 3rd ed. Baltimore: Williams & Wilkins; 1991;449-458.

7. Stanton SL, Reynolds SF, Creighton SM. The modified Pereyra (Raz) procedure for genuine stress incontinence—a useful option in the elderly or frail patient? Int Urogynecol J. 1995;6:22-25.

8. Nygaard IE, Kreder KJ. Complications of incontinence surgery. Int Urogynecol J. 1994;5:353-360.

9. Lockhart vJL, Tirado A, Morillo G, Politano VA. Vesicourethral dysfunction following cystourethropexy. J Urol. 1982;128:943-945.

10. Leboeuf L, Tellez CA, Ead D, Gousse AE. Complication of bowel perforation during insertion of tension-free vaginal tape. J Urol. 2003;170(4 Pt 1):1310.-

11. Abouassaly R, Steinberg JR, Lemieux M, et al. Complications of tension-free vaginal tape surgery: a multi-institutional review. BJU Int. 2004;94:110-113.

12. Delorme E, Droupy S, de Tayrac R, Delmas V. [Transobturator tape (UraTape). A new minimally invasive method in the treatment of urinary incontinence in women.] Prog Urol. 2003;13:656-659.

13. de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol. 2003;44:724-730.

14. De Tayrac R, Deffieux X, Droupy S, ChauveaudLambling A, Calvanese-Benamour L, Fernandez H. A prospective randomized trial comparing tensionfree vaginal tape and transobturator suburethral tape for surgical treatment of stress urinary incontinence. Am J Obstet Gynecol. 2004;190:602-608.

15. Richardson AC. The rectovaginal septum revisited: its relationship to rectocele and its importance in rectocele repair. Clin Obstet Gynecol. 1993;36:976-983.

16. Miklos JR, Kohli N, Lucente V, Saye WB. Site-specific fascial defects in the diagnosis and surgical management of enterocele. Am J Obstet Gynecol. 1998;179 (6 Pt 1):1418-1422; discussion 1422-823.

17. Porter WE, Steele A, Walsh P, Kohli N, Karram MM. The anatomic and functional outcomes of defectspecific rectocele repairs. Am J Obstet Gynecol. 1999;181:1353-1358; discussion 1358-1359.

18. Kenton K, Shott S, Brubaker L. Outcome after rectovaginal fascia reattachment for rectocele repair. Am J Obstet Gynecol. 1999;181:1360-1363; discussion 1363-1364.

19. Flood CG, Drutz HP, Waja L. Anterior colporrhaphy reinforced with Marlex mesh for the treatment of cystoceles. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9:200-204.

20. Koduri S, Lobel RW, Winkler HA, Tomezsko J, Culligan PJ, Sand PK. Prospective randomized trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles. Proceedings of the 25th Annual Meeting of the International Urogynecological Association, 2000. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11:S80.-

21. Clemons JL, Myers DL, Aguilar VC, Arya LA. Vaginal paravaginal repair with an AlloDerm graft. Am J Obstet Gynecol. 2003;189:1612-1618; discussion 1618-1619.

22. Fox SD, Stanton SL. Vault prolapse and rectocele: assessment of repair using sacrocolpopexy with mesh interposition. BJOG. 2000;107:1371-1375.

23. Kohli N, Miklos JR. Site specific rectocele repair augmented with a cadaveric dermal graft. Proceedings of the 21st Annual Scientific Meeting of the American Urogynecologic Society, 2000. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12:S9.-

24. Miklos JR, Kohli N. Rectovaginal fistula repair utilizing a cadaveric dermal allograft. Int Urogynecol J Pelvic Floor Dysfunct. 1999;10:405-406.

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Avoiding vascular injury at laparoscopy

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Avoiding vascular injury at laparoscopy

KEY POINTS

  • Distances between the entry trocar and the aorta bifurcation increase directly with body mass index, mainly because of the commensurate increase in abdominal wall thickness.
  • The mean thrusting force for insertion of a disposable trocar is 10.2 lb versus 17.53 lb for a reusable device, and the time to penetrate is shorter for the disposable trocar: mean of 3.54 seconds versus 11.64 seconds. Thus, greater caution is warranted when inserting a disposable trocar.
  • Thrust the primary trocar into the midline of the abdomen at a 45° to 60° angle relative to the plane of the abdominal wall, with the trocar pointing toward the uterus, to avoid injuring the iliac vessels.
  • When injury occurs, call for a vascular surgeon immediately, perform a laparotomy using a vertical incision, and get accurate inputs, outputs, and blood-loss estimates.

Major vessel injury is a two-sided coin: It can occur with alarming speed, but it is preventable.

Fortunately, the laparoscopic surgeon can avoid the problem by following simple precautions and steering clear of scenarios that increase the risk of injury. This article tells how to accomplish both objectives.

In the process, it reviews the evidence, details management for any injuries that occur, and includes a comprehensive table listing typical distances between the entry trocar and vascular structures, to help the surgeon adjust entry strategy.

Adequate prevention depends on:

  • familiarity with the vascular anatomy, particularly in relation to the umbilicus, presacral space, infundibulopelvic ligament, and ovarian fossa.
  • creating a proper pneumoperitoneum, especially when using disposable trocars.
  • careful attention to primary trocar thrusting techniques to ensure midline insertion at the proper angle. Also exercise caution when placing secondary trocars. Specifically, during far lateral insertion, avoid cleaving the inferior epigastric artery from the external iliac or directly hitting the external artery or vein.
  • avoiding long trocars, which are unnecessary to penetrate the peritoneal cavity.
  • reliance on laparotomy if trocar insertion proves too difficult, vision is obscured, or appropriate anatomic dissection planes cannot be developed.
  • when injury occurs, performing laparotomy using a vertical incision.

Insufflating the wrong space: A recipe for disaster

A 36-year-old woman with a body mass index of 38.2, indicating severe obesity, is scheduled to undergo hysteroscopy and dilatation and curettage for irregular bleeding, as well as laparoscopic bilateral partial salpingectomy for elective sterilization. The setting is an outpatient surgery center without a blood bank.

After general anesthesia, the surgeon makes a 1.5-cm incision just below the umbilicus, inserts a Verres needle, and insufflates carbon dioxide gas to a volume of approximately 3.4 L. He then inserts a disposable trocar and places a laparoscope, but views fat. Unbeknownst to him, he has insufflated the properitoneal fat space rather than the peritoneum.

The surgeon finally enters the peritoneum with a “long” trocar after several more attempts. Since the uterus and adnexa appear to be normal, he inserts a second trocar and places a probe. As he is moving the intestines, however, he observes blood, and the field suddenly becomes unclear. He removes the probe and, when the gas-pressure valve of the secondary trocar is opened, blood spews from the site.

The surgeon removes all trocars and performs an emergency laparotomy using a Pfannenstiel incision. He and 2 general surgeons, who arrive within 20 to 30 minutes, work for 2 hours to repair what they believe is a hole in the inferior vena cava. The woman is brought out of anesthesia and transferred to the local community hospital, where she goes into cardiac arrest and dies. A postmortem reveals injury to the right common iliac artery and vein. No sutures were observed in either vessel. Cause of death: exsanguination.

What went wrong?

Three serious errors contributed to the patient’s death:

  • He made multiple attempts to insert the trocar without considering the possibility that the wrong space had been insufflated.
  • He inserted the trocar off the midline and at the wrong angle relative to the abdominal wall.
  • In his frustration, he switched to a “long” trocar, which made it more likely that vascular structures would be injured.

Operating on an obese patient in a center without a blood bank also was unwise, as obese women of short stature are at greatest risk for vascular injury.

How big is the problem?

A French study1 of 103,852 laparoscopic procedures—of which 15.7%, or 16,000 operations, were gynecologic—reported 47 cases of major vascular injury for an incidence of 0.5 per 1,000 cases and a mortality rate of 17%. Several additional articles2-8 reported a range of vascular complications of between 0.1 and 6.4 per 1,000 laparoscopies.

 

 

In a study9 conducted in 7 gynecologic laparoscopy surgery centers in France over 9 years and involving 29,966 diagnostic and operative cases, the overall complication rate was 4.64 per 1,000 laparoscopies (n = 139). Of the 21 major vascular injuries associated with gynecologic surgery, the majority occurred during set-up, and 84.6% during insertion of the primary trocar. Two patients died from their injuries.

Bhoyrul and colleagues10 analyzed data reported to the US Food and Drug Administration and found that 408 of 629 trocar-related injuries involved major blood vessels, as did 26 of 32 deaths (81%). Most of the deaths (87%) were linked to the use of disposable trocars equipped with safety shields; 9% with direct-view trocars. Although surgeons asserted that the trocar malfunctioned in 41 cases, that claim was confirmed in only 1 case (2%).

Another study found that 37 of 79 (46.8%) serious complications involving optical-access trocars between 1994 and 2002 involved major vessels, injuring the aorta, iliac vessels, or vena cava.11

A study12 carried out in the Netherlands in 1994 evaluated the relative number of complications that occurred within a total of 25,764 laparoscopic procedures. The study divided complications into those occurring as the result of the laparoscopic approach (eg, trocar insertion) versus those happening during the performance of the operation. Fifty-seven percent of the 145 complications were caused by the laparoscopic approach; the 2 reported deaths also were secondary to that approach.

Snapshot of vascular injury: A series of 31 patients

In 2003, I published data13 on 31 cases of major vessel injury associated with gynecologic laparoscopy (see). These cases were collected from a variety of sources: medicolegal case files, hospital morbidity-mortality presentations, and quality-assurance departments. Eight cases involved diagnostic procedures, while 23 involved operative laparoscopy.

The medical records of these cases provided details on the nature of the injury. The cases were categorized by body mass index (BMI) and cause, ie, whether they occurred as the result of the laparoscopic approach (ie, entry-related) or arose during surgery.

Of the 31 cases, 22 (71%) involved women with BMIs from 25 to more than 30 (overweight or obese). A large majority—28 cases (90%)—were related to entry. Only 3 injuries occurred during surgery.

In several women, more than 1 vessel was damaged. Of the 49 total injuries, 38 (78%) involved the iliac vessels. Seven (23%) women died as a result of their injuries, all of which involved venous trauma.

Damage to structures in the vicinity of the injured vessels was substantial in 16 cases. Major morbidity included ureteral, nerve, and intestinal injury; arterial and venous thrombosis; compartment syndrome; and suturing of the wrong vessel.

Some patients also experienced edema or pain in an extremity (vascular insufficiency); infection; diffuse intravascular coagulation and/or adult respiratory distress; cardiac arrest; central nervous system injury (stroke); or hospitalization of more than 1 week. Cases also were categorized as early or late diagnosis, depending on whether shock had supervened. Diagnosis was early in 8 cases (26%) and late in 21 (68%). Two patients were diagnosed postoperatively; ie, they had gone to the recovery room prior to developing shock.

The volume of blood loss ranged from 1,000 mL to 7,000 mL, with a mean loss of 3,400 mL. All patients received packed red blood cells and/or a mixture of other blood products. The time required for cross-matching and receiving blood ranged from 10 to 120 minutes.

In all cases, a vascular or general surgeon was called to consult on the case.

Mapping vascular structures to ensure safe trocar entry

Knowing the distances between blood vessels and laparoscopic entry trocars is critical if injury is to be avoided. In pursuit of this goal, Hurd and colleagues14 performed a retrospective study involving women who had undergone magnetic resonance imaging or computed tomography scans of the abdomen. Investigators measured the distance between the lower abdominal wall and the aortic bifurcation in these women, who were all unanesthetized and in the supine position.

Distances increased with BMI

This occurred in the study by Hurd et al,14 as well as in a prospective study by Narendran and Baggish,15 who calculated body mass index in 101 consecutive women who were undergoing diagnostic or operative laparoscopy. These women were anesthetized, with pneumoperitoneum established and a laparoscope inserted; all were in the lithotomy position.

In this study, Narendran and Baggish measured the following distances from the entry trocar:

  • perpendicular distance to aortic bifurcation,
  • oblique distance to the right and left common iliac vessels,
  • oblique distance to the superior margin of the bladder,
  • perpendicular distance from the peritoneum to skin at the umbilicus (abdominal wall thickness), and
  • oblique distance from the subumbilical peritoneal opening to the right and left common iliac vessels.
 

 

Wide range of BMIs

In the study by Narendran and Baggish, successful measurement panels were created for 99 of the 101 cases. Of these, 49 women had a BMI of less than 25 (normal), 29 had a BMI greater than 25 but less than 30 (overweight), and 21 had a BMI greater than 30 (obese).

A significant difference was observed in the perpendicular distance from the entry trocar to aortic bifurcation (TABLE 1). Specifically, as the BMI increased, so did the distance. The only other significant BMI-related increase was the abdominal wall thickness, which also varied directly with the BMI.

Other distances increase with height

The distance between the primary trocar and the iliac vessels and urinary bladder consistently increased with the patient’s height.

However, no significant change in distance between the great vessels and the primary trocar site occurred when the patient’s position changed from level to Trendelenburg.

Trocar insertion: Disposable devices require less force

Laparoscopic trocar thrusting is a dynamic process, and we observed that process in our study.15 When force is applied via trocar to the anterior abdominal wall, that structure is displaced toward the abdominal cavity in the direction of the posterior abdominal wall—even when countertraction is taken into consideration. The movement is more apparent in obese women because of greater elasticity created by the larger mass of properitoneal and subcutaneous fat. We measured the distortion and determined that the depression can be 5 cm or more.

In contrast, thin women have rigid, relatively unyielding anterior abdominal walls and therefore experience minimal displacement. In thin women, the greater risk is the shorter passive distance between the anterior abdominal wall and the great vessels.

Comparing force curves

We16 calculated the force required to thrust a disposable or reusable trocar through the anterior abdominal wall during actual laparoscopic surgery. We used a 25-lb compression load cell connected to the trocar by an Ultem handle, which could be sterilized between cases. A linear variable displacement transducer detected displacement, and the measuring apparata fed data into a computer. Ten women were randomized to a disposable trocar and 10 to a reusable device.

The mean thrusting force for disposable trocars was 10.2 lb versus 17.53 lb for the reusable device. The time to penetrate was likewise significantly shortened for disposable trocars: mean time of 3.54 seconds versus 11.64 seconds. Overall work tilted in favor of disposable trocars: 14.34 pound-seconds versus 103.88 pound-seconds.

The disposable trocar has the advantage for 2 reasons: its razor-sharp cutting edge and streamlined design.

FIGURE 1 shows typical force curves of disposable and reusable trocars.

FIGURE 1 Reusable trocar requires more force than disposable trocar


A considerable difference in force is required for insertion, depending on type of device, as this graph of typical force curves shows. The reusable trocar requires 18 to 20 lb of force over 12 seconds; the disposable, only 5 lb over 2 seconds.

Safe trocar insertion begins with pneumoperitoneum

McDougall et al17 demonstrated that adequate pneumoperitoneum lessens the force required to drive a trocar through the anterior abdominal wall. Although the differences were small, the forces required with an intraperitoneal gas pressure of 30 mm Hg were smaller than those required with a pressure of 15 mm Hg.17

Manufacturers of disposable trocars also recommend creating an adequate pneumoperitoneum prior to aiming and inserting the razor-sharp device. The goal is creating a carbon dioxide gas pocket large enough to permit rapid deployment of the “safety shield” after the trocar tip clears the properitoneal fat and peritoneal membrane.

Slow-motion video sequences of disposable trocar entry show the sharp trocar tip penetrating the parietal peritoneum of the anterior abdominal wall for 1 cm before the spring-loaded shield advances and locks over the blade. During this insertion, the anterior abdominal wall has an elastic reaction to the applied force; this reaction pushes it toward the posterior abdominal wall.

Direct insertions (ie, without adequate pneumoperitoneum) involve less space for the trocar’s safety shield to deploy. Thus, there is a greater risk of the armed trocar tip coming into direct contact with underlying viscera and blood vessels.

8 common mistakes

Delayed diagnosis

The earlier a major vessel incident can be diagnosed, the better for patient, physician, and hospital. Diagnosis after the onset of hypotension, tachycardia, or tachypnia constitutes “late” diagnosis. Dark venous blood pooling in the abdomen, bright red pulsatile blood emitting from a trocar sleeve, or a retroperitoneal hematoma lateral to the iliacs or at the level of the presacral space suggests major vessel injury. Signs of hypovolemic shock or sudden appearance of profound shock places the possibility of major vessel injury at the top of the differential diagnosis.

Relying on observation when a retroperitoneal hematoma develops

Unfortunately, with observation, the surgeon cannot determine the identity or nature of the damaged vessel, know whether the hematoma is expanding beyond the view of the laparoscope, or predict when the patient will go into shock.

Leaving an armed trocar in place in a vessel

Assuming that the trocar is plugging a hole and preventing hemorrhage is a recipe for disaster. The movement of the sharp device against a vessel wall is most likely to create greater trauma to the vessel. In the case of partial penetration, the device may cut the rest of the way through the vessel.

Laparoscopic exploration

Attempts to locate the injury via laparoscopy usually are unsuccessful, and laparoscopic attempts to sew up the injury limit accuracy and efficacy.

Use of the Pfannenstiel incision during emergency laparotomy

Unfortunately, in 1 study,13 27 of 31 women with vascular injuries received this incision. A vertical incision is preferred because it affords greater access and visibility.

Underestimating blood loss

In the case of a major vessel injury, underestimation of blood volume requirements can be fatal. In 1 study,13 19 of 31 women were under-transfused and/or inadequately cross-matched.

Clamping injured vessels

This can lead to arterial or venous thrombosis. Nonvascular clamps can tear large vessels, adding to the damage and complicating the vascular surgeon’s attempt at repair. Rather, apply direct pressure with a sponge stick.

Delay in calling for help

This translates into greater blood loss and a less stable patient. In 1 study,13 the mean time for a vascular surgeon to intercede was 23 minutes.

 

 

Use a shorter insufflation needle

Our data on women with a BMI greater than 30 (obese range) indicate that the mean thickness of the anterior abdominal wall is 5.05 cm and the distance to the aorta is 15.14 cm.15 A standard Verres needle measures 12.5 cm from the tip of the shaft to the point where the shaft joins the hub of the needle. This is clearly excessive length, since women with a BMI above 30 have an abdominal wall thickness of approximately 5.05 cm and women with BMIs between 25 and 30 have a thickness of only 3.85 cm.

I prefer a Touhy epidural needle for subumbilical insertion and creation of the pneumoperitoneum, since it is a relatively short 8.5 cm. Thus, it is less hazardous than the Verres needle. It also is less likely to clog with tissue fragments because of its curved tip, and more likely to create a successful pneumoperitoneum on the first try.

Fortunately, large-vessel injuries caused by the insufflation needle are rare.

Proper insertion technique

I have residents draw a straight line with a marking pen from the lower margin of the umbilicus to the superior margin of the pubic symphysis. This serves as a guide to keep the trocar pointing toward the middle of the abdomen, away from the iliac vessels. I also teach residents to thrust the trocar in the midline at a 45° to 60° angle in relation to the plane of the abdominal wall, with the trocar pointing toward the uterus (FIGURES 2 AND 3).

Many residents twist disposable trocars during insertion. This “door knob” movement works against the design of the trocar and traumatizes tissue. The correct approach is thrusting the device into the abdominal cavity, or holding the trocar (only for disposable trocar devices) like a dart and thrusting it into the abdomen as though throwing a dart. The only trocar designed for twisting is the conical reusable device; the sharp pyramidal reusable trocar should be thrust rather than twisted.

Avoid “long” trocars

These are a full 5 cm longer than the 20-cm standard device (hub of handle to tip of shaft). Abdominal wall measurements indicate that these devices are never required to simply penetrate the anterior abdominal wall; these trocars also carry the risk of hitting the iliac vessels.

Open laparoscopy is not foolproof

Although open laparoscopy would seem to guarantee safe entry of the primary trocar, reports of aortic injuries have recently been published. Similar data have been reported for optical access trocars.11,18

FIGURE 2 Insert the trocar at 45° to 60° angle


At insertion, the trocar should be at a 45°to 60°angle relative to the abdominal wall, with the tip of the device tilted in the direction of the uterus and bladder. A 90°angle of insertion is dangerous.

FIGURE 3 Midline insertion is safest


Insert the primary trocar in the midline pointing toward the uterus; deviation to the right or left is dangerous. Also avoid injuring the inferior epigastric and external iliac vessels with far lateral trocar insertion.

Body habitus and vascular injury

The obese patient of short stature is at the greatest risk for vascular injury. Although the relative distances between the anterior abdominal wall and the aorta are greater at the highest BMI levels, short stature means that the iliac vessels are closer. Significantly, large vessel injuries in the series cited herein were associated with the use of disposable trocars 90% of the time.

I believe high-risk conditions are created when carbon dioxide gas is inadvertently infused into the properitoneal fat space (FIGURE 4). As the volume of gas grows, the anterior wall parietal peritoneum dissects free from the remainder of the anterior abdominal fat, creating a pseudo-pneumoperitoneum. The operator fails to realize that the true peritoneal cavity has not been entered and, in fact, has paradoxically constricted in size because of the enlarging pseudoperitoneal space. Careful attention to the pressure gauges would have aroused suspicion that gas was being infused into the wrong space, since pressures tend to be higher and flow erratic in such situations.

Nevertheless, the surgeon places a trocar into the space, looks through the laparoscope, sees red or yellow, and realizes that the peritoneal cavity has not been entered. More gas is insufflated and the trocar is tried again.

Typically, the duller, reusable trocar pushes the leading edge of the peritoneum rather than penetrating it, further enlarging the properitoneal space and bringing the anterior and posterior peritoneal walls very close together.

In another scenario, the same set of circumstances exists except, rather than employing a reusable trocar, the surgeon selects a disposable device or even, after 2 failures to enter the peritoneal cavity with the reusable device, an extra-long (11-inch) disposable trocar (FIGURE 4).

 

 

In this scenario, an armed trocar enters the pseudospace—without the safety shield deployed—because no resistance was encountered during penetration of the incision, owing to the fact that two 10–12-mm trocars have previously traversed the same skin incision.

As the tip of the trocar comes into contact with the leading edge of the peritoneum, it encounters resistance, and the razor-sharp blade cuts through the anterior peritoneum, traverses the narrow peritoneal space, and cuts through the posterior peritoneum and the underlying great vessel.

Often, the trocar’s knife edge injures an artery by glancing off the curved surface of the vessels and embedding itself in the neighboring or underlying vein.

The best technique to manage a pseudo-pneumoperitoneal pocket is to abandon the subumbilical site, insert a Touhy needle in the left upper quadrant, and enter and overinflate the peritoneal cavity, thereby obliterating the properitoneal gas space.

When injury occurs: 7 recommended management steps

In the event of a vascular injury, early diagnosis and treatment are vital. Do not observe retroperitoneal hematomas. The following steps are recommended:

  1. Call for a vascular surgeon immediately and indicate that the situation is an emergency. Do not waste time trying to locate the injury before calling for help.
  2. Get emergency type and cross-match for at least 6 U of whole blood.
  3. Obtain baseline lab measurements, including hemoglobin, hematocrit, platelets, fibrinogen, and fibrin split products.
  4. Open the abdomen using a vertical incision for maximum access and visibility.
  5. Get accurate outputs and blood-loss estimates and have anesthesia keep careful records of fluids given.
  6. Advise anesthesia staff to obtain additional help. This will facilitate starting additional IV sites, rapidly infusing blood products, obtaining key samples for laboratory data, and maintaining accurate and detailed records of blood gases, blood loss, replacement fluids, and blood products.
  7. Use a circulator to manage urgent medications or laboratory tests.

The author reports no financial relationships relevant to this article.

References

1. Champault G, Cazacu F, Taffinader N. Serious trocar accidents in laparoscopic surgery: a French survey of 103,852 operations. Surg Laparosc Endosc. 1996;6:367.

2. Baadsgaard SE, Bille S, Egelblad K. Major vascular injury during gynecologic laparoscopy: report of a case and review of published cases. Acta Obstet Gynecol Scand. 1989;68:283.

3. Chamberlain G, Brown JD. Gynecologic laparoscopy: report of the working party of the confidential enquiry into gynecologic laparoscopy. Br J Obstet Gynaecol. 1978;85:401.

4. Mintz M. Risk and prophylaxis in laparoscopy: a survey of 100,000 cases. J Reprod Med. 1977;18:269.

5. Phillips JM, Hulka JF, Peterson HB. American Association of Gynecologic Laparoscopists’ 1982 Membership Survey. J Reprod Med. 1984;29:592.

6. Saidi MH, Vancaillie TG, White AJ, et al. Complications of major operative laparoscopy: a review of 452 cases. J Reprod Med. 1996;41:471.

7. Loffer F, Pent D. Indications, contraindications, and complications of laparoscopy. Obstet Gynecol Surv. 1975;30:407.

8. Härkki-Sirén P, Kurki T. A nationwide analysis of laparoscopic complications. Obstet Gynecol. 1997;89:108.

9. Chapron C, Querleu D, Bruhat MA, et al. Surgical complications of diagnostic and operative gynecologic laparoscopy: a series of 29,966 cases. Hum Reprod. 1998;13:867-872.

10. Bhoyrul S, Vierra MA, Nezhat CR, Krummel TM, Way LW. Trocar injuries in laparoscopic surgery. J Am Coll Surg. 2001;192:677-683.

11. Sharp HT, Dodson MK, Draper ML, Watts DA, Doucette RC, Hurd WW. Complications associated with optical-access laparoscopic trocars. Obstet Gynecol. 2002;99:553-555.

12. Jansen FW, Kapiteyn K, Trimbos-Kemper T, Herman J, Trimbos JB. Complications of laparoscopy: a prospective multi-center observational study. Br J Obstet Gynaecol. 1997;104:595-600.

13. Baggish MS. Analysis of 31 cases of major vessel injury associated with gynecologic laparoscopy operations. J Gynecol Surg. 2003;19:63-73.

14. Hurd WW, Bude RO, DeLancey JOL, Gauvin JM, Aisen AM. Abdominal wall characterization by MRI and CT imaging: the effect of obesity on laparoscopic approach. J Reprod Med. 1991;36:473.

15. Narendran M, Baggish MS. Mean distance between primary trocar insertion site and major retroperitoneal vessels during routine laparoscopy. J Gynecol Surg. 2002;18:121-127.

16. Baggish MS, Gandhi S, Kasper G. Force required by laparoscopic trocar devices to penetrate the human female’s anterior abdominal wall. J Gynecol Surg. 2003;19:1-11.

17. McDougall EM, Figenshau RS, Clayman RV, Monk TG, Smith DS. Laparoscopic pneumoperitoneum: impact of body habitus. J Laparosc Endosc Surg. 1994;4:385-391.

18. Hanney RM, Carmalt HL, Merrett N, Tait N. Use of Hassan cannula producing major vascular injury at laparoscopy. Surg Endosc. 1999;13:1238-1240.

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KEY POINTS

  • Distances between the entry trocar and the aorta bifurcation increase directly with body mass index, mainly because of the commensurate increase in abdominal wall thickness.
  • The mean thrusting force for insertion of a disposable trocar is 10.2 lb versus 17.53 lb for a reusable device, and the time to penetrate is shorter for the disposable trocar: mean of 3.54 seconds versus 11.64 seconds. Thus, greater caution is warranted when inserting a disposable trocar.
  • Thrust the primary trocar into the midline of the abdomen at a 45° to 60° angle relative to the plane of the abdominal wall, with the trocar pointing toward the uterus, to avoid injuring the iliac vessels.
  • When injury occurs, call for a vascular surgeon immediately, perform a laparotomy using a vertical incision, and get accurate inputs, outputs, and blood-loss estimates.

Major vessel injury is a two-sided coin: It can occur with alarming speed, but it is preventable.

Fortunately, the laparoscopic surgeon can avoid the problem by following simple precautions and steering clear of scenarios that increase the risk of injury. This article tells how to accomplish both objectives.

In the process, it reviews the evidence, details management for any injuries that occur, and includes a comprehensive table listing typical distances between the entry trocar and vascular structures, to help the surgeon adjust entry strategy.

Adequate prevention depends on:

  • familiarity with the vascular anatomy, particularly in relation to the umbilicus, presacral space, infundibulopelvic ligament, and ovarian fossa.
  • creating a proper pneumoperitoneum, especially when using disposable trocars.
  • careful attention to primary trocar thrusting techniques to ensure midline insertion at the proper angle. Also exercise caution when placing secondary trocars. Specifically, during far lateral insertion, avoid cleaving the inferior epigastric artery from the external iliac or directly hitting the external artery or vein.
  • avoiding long trocars, which are unnecessary to penetrate the peritoneal cavity.
  • reliance on laparotomy if trocar insertion proves too difficult, vision is obscured, or appropriate anatomic dissection planes cannot be developed.
  • when injury occurs, performing laparotomy using a vertical incision.

Insufflating the wrong space: A recipe for disaster

A 36-year-old woman with a body mass index of 38.2, indicating severe obesity, is scheduled to undergo hysteroscopy and dilatation and curettage for irregular bleeding, as well as laparoscopic bilateral partial salpingectomy for elective sterilization. The setting is an outpatient surgery center without a blood bank.

After general anesthesia, the surgeon makes a 1.5-cm incision just below the umbilicus, inserts a Verres needle, and insufflates carbon dioxide gas to a volume of approximately 3.4 L. He then inserts a disposable trocar and places a laparoscope, but views fat. Unbeknownst to him, he has insufflated the properitoneal fat space rather than the peritoneum.

The surgeon finally enters the peritoneum with a “long” trocar after several more attempts. Since the uterus and adnexa appear to be normal, he inserts a second trocar and places a probe. As he is moving the intestines, however, he observes blood, and the field suddenly becomes unclear. He removes the probe and, when the gas-pressure valve of the secondary trocar is opened, blood spews from the site.

The surgeon removes all trocars and performs an emergency laparotomy using a Pfannenstiel incision. He and 2 general surgeons, who arrive within 20 to 30 minutes, work for 2 hours to repair what they believe is a hole in the inferior vena cava. The woman is brought out of anesthesia and transferred to the local community hospital, where she goes into cardiac arrest and dies. A postmortem reveals injury to the right common iliac artery and vein. No sutures were observed in either vessel. Cause of death: exsanguination.

What went wrong?

Three serious errors contributed to the patient’s death:

  • He made multiple attempts to insert the trocar without considering the possibility that the wrong space had been insufflated.
  • He inserted the trocar off the midline and at the wrong angle relative to the abdominal wall.
  • In his frustration, he switched to a “long” trocar, which made it more likely that vascular structures would be injured.

Operating on an obese patient in a center without a blood bank also was unwise, as obese women of short stature are at greatest risk for vascular injury.

How big is the problem?

A French study1 of 103,852 laparoscopic procedures—of which 15.7%, or 16,000 operations, were gynecologic—reported 47 cases of major vascular injury for an incidence of 0.5 per 1,000 cases and a mortality rate of 17%. Several additional articles2-8 reported a range of vascular complications of between 0.1 and 6.4 per 1,000 laparoscopies.

 

 

In a study9 conducted in 7 gynecologic laparoscopy surgery centers in France over 9 years and involving 29,966 diagnostic and operative cases, the overall complication rate was 4.64 per 1,000 laparoscopies (n = 139). Of the 21 major vascular injuries associated with gynecologic surgery, the majority occurred during set-up, and 84.6% during insertion of the primary trocar. Two patients died from their injuries.

Bhoyrul and colleagues10 analyzed data reported to the US Food and Drug Administration and found that 408 of 629 trocar-related injuries involved major blood vessels, as did 26 of 32 deaths (81%). Most of the deaths (87%) were linked to the use of disposable trocars equipped with safety shields; 9% with direct-view trocars. Although surgeons asserted that the trocar malfunctioned in 41 cases, that claim was confirmed in only 1 case (2%).

Another study found that 37 of 79 (46.8%) serious complications involving optical-access trocars between 1994 and 2002 involved major vessels, injuring the aorta, iliac vessels, or vena cava.11

A study12 carried out in the Netherlands in 1994 evaluated the relative number of complications that occurred within a total of 25,764 laparoscopic procedures. The study divided complications into those occurring as the result of the laparoscopic approach (eg, trocar insertion) versus those happening during the performance of the operation. Fifty-seven percent of the 145 complications were caused by the laparoscopic approach; the 2 reported deaths also were secondary to that approach.

Snapshot of vascular injury: A series of 31 patients

In 2003, I published data13 on 31 cases of major vessel injury associated with gynecologic laparoscopy (see). These cases were collected from a variety of sources: medicolegal case files, hospital morbidity-mortality presentations, and quality-assurance departments. Eight cases involved diagnostic procedures, while 23 involved operative laparoscopy.

The medical records of these cases provided details on the nature of the injury. The cases were categorized by body mass index (BMI) and cause, ie, whether they occurred as the result of the laparoscopic approach (ie, entry-related) or arose during surgery.

Of the 31 cases, 22 (71%) involved women with BMIs from 25 to more than 30 (overweight or obese). A large majority—28 cases (90%)—were related to entry. Only 3 injuries occurred during surgery.

In several women, more than 1 vessel was damaged. Of the 49 total injuries, 38 (78%) involved the iliac vessels. Seven (23%) women died as a result of their injuries, all of which involved venous trauma.

Damage to structures in the vicinity of the injured vessels was substantial in 16 cases. Major morbidity included ureteral, nerve, and intestinal injury; arterial and venous thrombosis; compartment syndrome; and suturing of the wrong vessel.

Some patients also experienced edema or pain in an extremity (vascular insufficiency); infection; diffuse intravascular coagulation and/or adult respiratory distress; cardiac arrest; central nervous system injury (stroke); or hospitalization of more than 1 week. Cases also were categorized as early or late diagnosis, depending on whether shock had supervened. Diagnosis was early in 8 cases (26%) and late in 21 (68%). Two patients were diagnosed postoperatively; ie, they had gone to the recovery room prior to developing shock.

The volume of blood loss ranged from 1,000 mL to 7,000 mL, with a mean loss of 3,400 mL. All patients received packed red blood cells and/or a mixture of other blood products. The time required for cross-matching and receiving blood ranged from 10 to 120 minutes.

In all cases, a vascular or general surgeon was called to consult on the case.

Mapping vascular structures to ensure safe trocar entry

Knowing the distances between blood vessels and laparoscopic entry trocars is critical if injury is to be avoided. In pursuit of this goal, Hurd and colleagues14 performed a retrospective study involving women who had undergone magnetic resonance imaging or computed tomography scans of the abdomen. Investigators measured the distance between the lower abdominal wall and the aortic bifurcation in these women, who were all unanesthetized and in the supine position.

Distances increased with BMI

This occurred in the study by Hurd et al,14 as well as in a prospective study by Narendran and Baggish,15 who calculated body mass index in 101 consecutive women who were undergoing diagnostic or operative laparoscopy. These women were anesthetized, with pneumoperitoneum established and a laparoscope inserted; all were in the lithotomy position.

In this study, Narendran and Baggish measured the following distances from the entry trocar:

  • perpendicular distance to aortic bifurcation,
  • oblique distance to the right and left common iliac vessels,
  • oblique distance to the superior margin of the bladder,
  • perpendicular distance from the peritoneum to skin at the umbilicus (abdominal wall thickness), and
  • oblique distance from the subumbilical peritoneal opening to the right and left common iliac vessels.
 

 

Wide range of BMIs

In the study by Narendran and Baggish, successful measurement panels were created for 99 of the 101 cases. Of these, 49 women had a BMI of less than 25 (normal), 29 had a BMI greater than 25 but less than 30 (overweight), and 21 had a BMI greater than 30 (obese).

A significant difference was observed in the perpendicular distance from the entry trocar to aortic bifurcation (TABLE 1). Specifically, as the BMI increased, so did the distance. The only other significant BMI-related increase was the abdominal wall thickness, which also varied directly with the BMI.

Other distances increase with height

The distance between the primary trocar and the iliac vessels and urinary bladder consistently increased with the patient’s height.

However, no significant change in distance between the great vessels and the primary trocar site occurred when the patient’s position changed from level to Trendelenburg.

Trocar insertion: Disposable devices require less force

Laparoscopic trocar thrusting is a dynamic process, and we observed that process in our study.15 When force is applied via trocar to the anterior abdominal wall, that structure is displaced toward the abdominal cavity in the direction of the posterior abdominal wall—even when countertraction is taken into consideration. The movement is more apparent in obese women because of greater elasticity created by the larger mass of properitoneal and subcutaneous fat. We measured the distortion and determined that the depression can be 5 cm or more.

In contrast, thin women have rigid, relatively unyielding anterior abdominal walls and therefore experience minimal displacement. In thin women, the greater risk is the shorter passive distance between the anterior abdominal wall and the great vessels.

Comparing force curves

We16 calculated the force required to thrust a disposable or reusable trocar through the anterior abdominal wall during actual laparoscopic surgery. We used a 25-lb compression load cell connected to the trocar by an Ultem handle, which could be sterilized between cases. A linear variable displacement transducer detected displacement, and the measuring apparata fed data into a computer. Ten women were randomized to a disposable trocar and 10 to a reusable device.

The mean thrusting force for disposable trocars was 10.2 lb versus 17.53 lb for the reusable device. The time to penetrate was likewise significantly shortened for disposable trocars: mean time of 3.54 seconds versus 11.64 seconds. Overall work tilted in favor of disposable trocars: 14.34 pound-seconds versus 103.88 pound-seconds.

The disposable trocar has the advantage for 2 reasons: its razor-sharp cutting edge and streamlined design.

FIGURE 1 shows typical force curves of disposable and reusable trocars.

FIGURE 1 Reusable trocar requires more force than disposable trocar


A considerable difference in force is required for insertion, depending on type of device, as this graph of typical force curves shows. The reusable trocar requires 18 to 20 lb of force over 12 seconds; the disposable, only 5 lb over 2 seconds.

Safe trocar insertion begins with pneumoperitoneum

McDougall et al17 demonstrated that adequate pneumoperitoneum lessens the force required to drive a trocar through the anterior abdominal wall. Although the differences were small, the forces required with an intraperitoneal gas pressure of 30 mm Hg were smaller than those required with a pressure of 15 mm Hg.17

Manufacturers of disposable trocars also recommend creating an adequate pneumoperitoneum prior to aiming and inserting the razor-sharp device. The goal is creating a carbon dioxide gas pocket large enough to permit rapid deployment of the “safety shield” after the trocar tip clears the properitoneal fat and peritoneal membrane.

Slow-motion video sequences of disposable trocar entry show the sharp trocar tip penetrating the parietal peritoneum of the anterior abdominal wall for 1 cm before the spring-loaded shield advances and locks over the blade. During this insertion, the anterior abdominal wall has an elastic reaction to the applied force; this reaction pushes it toward the posterior abdominal wall.

Direct insertions (ie, without adequate pneumoperitoneum) involve less space for the trocar’s safety shield to deploy. Thus, there is a greater risk of the armed trocar tip coming into direct contact with underlying viscera and blood vessels.

8 common mistakes

Delayed diagnosis

The earlier a major vessel incident can be diagnosed, the better for patient, physician, and hospital. Diagnosis after the onset of hypotension, tachycardia, or tachypnia constitutes “late” diagnosis. Dark venous blood pooling in the abdomen, bright red pulsatile blood emitting from a trocar sleeve, or a retroperitoneal hematoma lateral to the iliacs or at the level of the presacral space suggests major vessel injury. Signs of hypovolemic shock or sudden appearance of profound shock places the possibility of major vessel injury at the top of the differential diagnosis.

Relying on observation when a retroperitoneal hematoma develops

Unfortunately, with observation, the surgeon cannot determine the identity or nature of the damaged vessel, know whether the hematoma is expanding beyond the view of the laparoscope, or predict when the patient will go into shock.

Leaving an armed trocar in place in a vessel

Assuming that the trocar is plugging a hole and preventing hemorrhage is a recipe for disaster. The movement of the sharp device against a vessel wall is most likely to create greater trauma to the vessel. In the case of partial penetration, the device may cut the rest of the way through the vessel.

Laparoscopic exploration

Attempts to locate the injury via laparoscopy usually are unsuccessful, and laparoscopic attempts to sew up the injury limit accuracy and efficacy.

Use of the Pfannenstiel incision during emergency laparotomy

Unfortunately, in 1 study,13 27 of 31 women with vascular injuries received this incision. A vertical incision is preferred because it affords greater access and visibility.

Underestimating blood loss

In the case of a major vessel injury, underestimation of blood volume requirements can be fatal. In 1 study,13 19 of 31 women were under-transfused and/or inadequately cross-matched.

Clamping injured vessels

This can lead to arterial or venous thrombosis. Nonvascular clamps can tear large vessels, adding to the damage and complicating the vascular surgeon’s attempt at repair. Rather, apply direct pressure with a sponge stick.

Delay in calling for help

This translates into greater blood loss and a less stable patient. In 1 study,13 the mean time for a vascular surgeon to intercede was 23 minutes.

 

 

Use a shorter insufflation needle

Our data on women with a BMI greater than 30 (obese range) indicate that the mean thickness of the anterior abdominal wall is 5.05 cm and the distance to the aorta is 15.14 cm.15 A standard Verres needle measures 12.5 cm from the tip of the shaft to the point where the shaft joins the hub of the needle. This is clearly excessive length, since women with a BMI above 30 have an abdominal wall thickness of approximately 5.05 cm and women with BMIs between 25 and 30 have a thickness of only 3.85 cm.

I prefer a Touhy epidural needle for subumbilical insertion and creation of the pneumoperitoneum, since it is a relatively short 8.5 cm. Thus, it is less hazardous than the Verres needle. It also is less likely to clog with tissue fragments because of its curved tip, and more likely to create a successful pneumoperitoneum on the first try.

Fortunately, large-vessel injuries caused by the insufflation needle are rare.

Proper insertion technique

I have residents draw a straight line with a marking pen from the lower margin of the umbilicus to the superior margin of the pubic symphysis. This serves as a guide to keep the trocar pointing toward the middle of the abdomen, away from the iliac vessels. I also teach residents to thrust the trocar in the midline at a 45° to 60° angle in relation to the plane of the abdominal wall, with the trocar pointing toward the uterus (FIGURES 2 AND 3).

Many residents twist disposable trocars during insertion. This “door knob” movement works against the design of the trocar and traumatizes tissue. The correct approach is thrusting the device into the abdominal cavity, or holding the trocar (only for disposable trocar devices) like a dart and thrusting it into the abdomen as though throwing a dart. The only trocar designed for twisting is the conical reusable device; the sharp pyramidal reusable trocar should be thrust rather than twisted.

Avoid “long” trocars

These are a full 5 cm longer than the 20-cm standard device (hub of handle to tip of shaft). Abdominal wall measurements indicate that these devices are never required to simply penetrate the anterior abdominal wall; these trocars also carry the risk of hitting the iliac vessels.

Open laparoscopy is not foolproof

Although open laparoscopy would seem to guarantee safe entry of the primary trocar, reports of aortic injuries have recently been published. Similar data have been reported for optical access trocars.11,18

FIGURE 2 Insert the trocar at 45° to 60° angle


At insertion, the trocar should be at a 45°to 60°angle relative to the abdominal wall, with the tip of the device tilted in the direction of the uterus and bladder. A 90°angle of insertion is dangerous.

FIGURE 3 Midline insertion is safest


Insert the primary trocar in the midline pointing toward the uterus; deviation to the right or left is dangerous. Also avoid injuring the inferior epigastric and external iliac vessels with far lateral trocar insertion.

Body habitus and vascular injury

The obese patient of short stature is at the greatest risk for vascular injury. Although the relative distances between the anterior abdominal wall and the aorta are greater at the highest BMI levels, short stature means that the iliac vessels are closer. Significantly, large vessel injuries in the series cited herein were associated with the use of disposable trocars 90% of the time.

I believe high-risk conditions are created when carbon dioxide gas is inadvertently infused into the properitoneal fat space (FIGURE 4). As the volume of gas grows, the anterior wall parietal peritoneum dissects free from the remainder of the anterior abdominal fat, creating a pseudo-pneumoperitoneum. The operator fails to realize that the true peritoneal cavity has not been entered and, in fact, has paradoxically constricted in size because of the enlarging pseudoperitoneal space. Careful attention to the pressure gauges would have aroused suspicion that gas was being infused into the wrong space, since pressures tend to be higher and flow erratic in such situations.

Nevertheless, the surgeon places a trocar into the space, looks through the laparoscope, sees red or yellow, and realizes that the peritoneal cavity has not been entered. More gas is insufflated and the trocar is tried again.

Typically, the duller, reusable trocar pushes the leading edge of the peritoneum rather than penetrating it, further enlarging the properitoneal space and bringing the anterior and posterior peritoneal walls very close together.

In another scenario, the same set of circumstances exists except, rather than employing a reusable trocar, the surgeon selects a disposable device or even, after 2 failures to enter the peritoneal cavity with the reusable device, an extra-long (11-inch) disposable trocar (FIGURE 4).

 

 

In this scenario, an armed trocar enters the pseudospace—without the safety shield deployed—because no resistance was encountered during penetration of the incision, owing to the fact that two 10–12-mm trocars have previously traversed the same skin incision.

As the tip of the trocar comes into contact with the leading edge of the peritoneum, it encounters resistance, and the razor-sharp blade cuts through the anterior peritoneum, traverses the narrow peritoneal space, and cuts through the posterior peritoneum and the underlying great vessel.

Often, the trocar’s knife edge injures an artery by glancing off the curved surface of the vessels and embedding itself in the neighboring or underlying vein.

The best technique to manage a pseudo-pneumoperitoneal pocket is to abandon the subumbilical site, insert a Touhy needle in the left upper quadrant, and enter and overinflate the peritoneal cavity, thereby obliterating the properitoneal gas space.

When injury occurs: 7 recommended management steps

In the event of a vascular injury, early diagnosis and treatment are vital. Do not observe retroperitoneal hematomas. The following steps are recommended:

  1. Call for a vascular surgeon immediately and indicate that the situation is an emergency. Do not waste time trying to locate the injury before calling for help.
  2. Get emergency type and cross-match for at least 6 U of whole blood.
  3. Obtain baseline lab measurements, including hemoglobin, hematocrit, platelets, fibrinogen, and fibrin split products.
  4. Open the abdomen using a vertical incision for maximum access and visibility.
  5. Get accurate outputs and blood-loss estimates and have anesthesia keep careful records of fluids given.
  6. Advise anesthesia staff to obtain additional help. This will facilitate starting additional IV sites, rapidly infusing blood products, obtaining key samples for laboratory data, and maintaining accurate and detailed records of blood gases, blood loss, replacement fluids, and blood products.
  7. Use a circulator to manage urgent medications or laboratory tests.

The author reports no financial relationships relevant to this article.

KEY POINTS

  • Distances between the entry trocar and the aorta bifurcation increase directly with body mass index, mainly because of the commensurate increase in abdominal wall thickness.
  • The mean thrusting force for insertion of a disposable trocar is 10.2 lb versus 17.53 lb for a reusable device, and the time to penetrate is shorter for the disposable trocar: mean of 3.54 seconds versus 11.64 seconds. Thus, greater caution is warranted when inserting a disposable trocar.
  • Thrust the primary trocar into the midline of the abdomen at a 45° to 60° angle relative to the plane of the abdominal wall, with the trocar pointing toward the uterus, to avoid injuring the iliac vessels.
  • When injury occurs, call for a vascular surgeon immediately, perform a laparotomy using a vertical incision, and get accurate inputs, outputs, and blood-loss estimates.

Major vessel injury is a two-sided coin: It can occur with alarming speed, but it is preventable.

Fortunately, the laparoscopic surgeon can avoid the problem by following simple precautions and steering clear of scenarios that increase the risk of injury. This article tells how to accomplish both objectives.

In the process, it reviews the evidence, details management for any injuries that occur, and includes a comprehensive table listing typical distances between the entry trocar and vascular structures, to help the surgeon adjust entry strategy.

Adequate prevention depends on:

  • familiarity with the vascular anatomy, particularly in relation to the umbilicus, presacral space, infundibulopelvic ligament, and ovarian fossa.
  • creating a proper pneumoperitoneum, especially when using disposable trocars.
  • careful attention to primary trocar thrusting techniques to ensure midline insertion at the proper angle. Also exercise caution when placing secondary trocars. Specifically, during far lateral insertion, avoid cleaving the inferior epigastric artery from the external iliac or directly hitting the external artery or vein.
  • avoiding long trocars, which are unnecessary to penetrate the peritoneal cavity.
  • reliance on laparotomy if trocar insertion proves too difficult, vision is obscured, or appropriate anatomic dissection planes cannot be developed.
  • when injury occurs, performing laparotomy using a vertical incision.

Insufflating the wrong space: A recipe for disaster

A 36-year-old woman with a body mass index of 38.2, indicating severe obesity, is scheduled to undergo hysteroscopy and dilatation and curettage for irregular bleeding, as well as laparoscopic bilateral partial salpingectomy for elective sterilization. The setting is an outpatient surgery center without a blood bank.

After general anesthesia, the surgeon makes a 1.5-cm incision just below the umbilicus, inserts a Verres needle, and insufflates carbon dioxide gas to a volume of approximately 3.4 L. He then inserts a disposable trocar and places a laparoscope, but views fat. Unbeknownst to him, he has insufflated the properitoneal fat space rather than the peritoneum.

The surgeon finally enters the peritoneum with a “long” trocar after several more attempts. Since the uterus and adnexa appear to be normal, he inserts a second trocar and places a probe. As he is moving the intestines, however, he observes blood, and the field suddenly becomes unclear. He removes the probe and, when the gas-pressure valve of the secondary trocar is opened, blood spews from the site.

The surgeon removes all trocars and performs an emergency laparotomy using a Pfannenstiel incision. He and 2 general surgeons, who arrive within 20 to 30 minutes, work for 2 hours to repair what they believe is a hole in the inferior vena cava. The woman is brought out of anesthesia and transferred to the local community hospital, where she goes into cardiac arrest and dies. A postmortem reveals injury to the right common iliac artery and vein. No sutures were observed in either vessel. Cause of death: exsanguination.

What went wrong?

Three serious errors contributed to the patient’s death:

  • He made multiple attempts to insert the trocar without considering the possibility that the wrong space had been insufflated.
  • He inserted the trocar off the midline and at the wrong angle relative to the abdominal wall.
  • In his frustration, he switched to a “long” trocar, which made it more likely that vascular structures would be injured.

Operating on an obese patient in a center without a blood bank also was unwise, as obese women of short stature are at greatest risk for vascular injury.

How big is the problem?

A French study1 of 103,852 laparoscopic procedures—of which 15.7%, or 16,000 operations, were gynecologic—reported 47 cases of major vascular injury for an incidence of 0.5 per 1,000 cases and a mortality rate of 17%. Several additional articles2-8 reported a range of vascular complications of between 0.1 and 6.4 per 1,000 laparoscopies.

 

 

In a study9 conducted in 7 gynecologic laparoscopy surgery centers in France over 9 years and involving 29,966 diagnostic and operative cases, the overall complication rate was 4.64 per 1,000 laparoscopies (n = 139). Of the 21 major vascular injuries associated with gynecologic surgery, the majority occurred during set-up, and 84.6% during insertion of the primary trocar. Two patients died from their injuries.

Bhoyrul and colleagues10 analyzed data reported to the US Food and Drug Administration and found that 408 of 629 trocar-related injuries involved major blood vessels, as did 26 of 32 deaths (81%). Most of the deaths (87%) were linked to the use of disposable trocars equipped with safety shields; 9% with direct-view trocars. Although surgeons asserted that the trocar malfunctioned in 41 cases, that claim was confirmed in only 1 case (2%).

Another study found that 37 of 79 (46.8%) serious complications involving optical-access trocars between 1994 and 2002 involved major vessels, injuring the aorta, iliac vessels, or vena cava.11

A study12 carried out in the Netherlands in 1994 evaluated the relative number of complications that occurred within a total of 25,764 laparoscopic procedures. The study divided complications into those occurring as the result of the laparoscopic approach (eg, trocar insertion) versus those happening during the performance of the operation. Fifty-seven percent of the 145 complications were caused by the laparoscopic approach; the 2 reported deaths also were secondary to that approach.

Snapshot of vascular injury: A series of 31 patients

In 2003, I published data13 on 31 cases of major vessel injury associated with gynecologic laparoscopy (see). These cases were collected from a variety of sources: medicolegal case files, hospital morbidity-mortality presentations, and quality-assurance departments. Eight cases involved diagnostic procedures, while 23 involved operative laparoscopy.

The medical records of these cases provided details on the nature of the injury. The cases were categorized by body mass index (BMI) and cause, ie, whether they occurred as the result of the laparoscopic approach (ie, entry-related) or arose during surgery.

Of the 31 cases, 22 (71%) involved women with BMIs from 25 to more than 30 (overweight or obese). A large majority—28 cases (90%)—were related to entry. Only 3 injuries occurred during surgery.

In several women, more than 1 vessel was damaged. Of the 49 total injuries, 38 (78%) involved the iliac vessels. Seven (23%) women died as a result of their injuries, all of which involved venous trauma.

Damage to structures in the vicinity of the injured vessels was substantial in 16 cases. Major morbidity included ureteral, nerve, and intestinal injury; arterial and venous thrombosis; compartment syndrome; and suturing of the wrong vessel.

Some patients also experienced edema or pain in an extremity (vascular insufficiency); infection; diffuse intravascular coagulation and/or adult respiratory distress; cardiac arrest; central nervous system injury (stroke); or hospitalization of more than 1 week. Cases also were categorized as early or late diagnosis, depending on whether shock had supervened. Diagnosis was early in 8 cases (26%) and late in 21 (68%). Two patients were diagnosed postoperatively; ie, they had gone to the recovery room prior to developing shock.

The volume of blood loss ranged from 1,000 mL to 7,000 mL, with a mean loss of 3,400 mL. All patients received packed red blood cells and/or a mixture of other blood products. The time required for cross-matching and receiving blood ranged from 10 to 120 minutes.

In all cases, a vascular or general surgeon was called to consult on the case.

Mapping vascular structures to ensure safe trocar entry

Knowing the distances between blood vessels and laparoscopic entry trocars is critical if injury is to be avoided. In pursuit of this goal, Hurd and colleagues14 performed a retrospective study involving women who had undergone magnetic resonance imaging or computed tomography scans of the abdomen. Investigators measured the distance between the lower abdominal wall and the aortic bifurcation in these women, who were all unanesthetized and in the supine position.

Distances increased with BMI

This occurred in the study by Hurd et al,14 as well as in a prospective study by Narendran and Baggish,15 who calculated body mass index in 101 consecutive women who were undergoing diagnostic or operative laparoscopy. These women were anesthetized, with pneumoperitoneum established and a laparoscope inserted; all were in the lithotomy position.

In this study, Narendran and Baggish measured the following distances from the entry trocar:

  • perpendicular distance to aortic bifurcation,
  • oblique distance to the right and left common iliac vessels,
  • oblique distance to the superior margin of the bladder,
  • perpendicular distance from the peritoneum to skin at the umbilicus (abdominal wall thickness), and
  • oblique distance from the subumbilical peritoneal opening to the right and left common iliac vessels.
 

 

Wide range of BMIs

In the study by Narendran and Baggish, successful measurement panels were created for 99 of the 101 cases. Of these, 49 women had a BMI of less than 25 (normal), 29 had a BMI greater than 25 but less than 30 (overweight), and 21 had a BMI greater than 30 (obese).

A significant difference was observed in the perpendicular distance from the entry trocar to aortic bifurcation (TABLE 1). Specifically, as the BMI increased, so did the distance. The only other significant BMI-related increase was the abdominal wall thickness, which also varied directly with the BMI.

Other distances increase with height

The distance between the primary trocar and the iliac vessels and urinary bladder consistently increased with the patient’s height.

However, no significant change in distance between the great vessels and the primary trocar site occurred when the patient’s position changed from level to Trendelenburg.

Trocar insertion: Disposable devices require less force

Laparoscopic trocar thrusting is a dynamic process, and we observed that process in our study.15 When force is applied via trocar to the anterior abdominal wall, that structure is displaced toward the abdominal cavity in the direction of the posterior abdominal wall—even when countertraction is taken into consideration. The movement is more apparent in obese women because of greater elasticity created by the larger mass of properitoneal and subcutaneous fat. We measured the distortion and determined that the depression can be 5 cm or more.

In contrast, thin women have rigid, relatively unyielding anterior abdominal walls and therefore experience minimal displacement. In thin women, the greater risk is the shorter passive distance between the anterior abdominal wall and the great vessels.

Comparing force curves

We16 calculated the force required to thrust a disposable or reusable trocar through the anterior abdominal wall during actual laparoscopic surgery. We used a 25-lb compression load cell connected to the trocar by an Ultem handle, which could be sterilized between cases. A linear variable displacement transducer detected displacement, and the measuring apparata fed data into a computer. Ten women were randomized to a disposable trocar and 10 to a reusable device.

The mean thrusting force for disposable trocars was 10.2 lb versus 17.53 lb for the reusable device. The time to penetrate was likewise significantly shortened for disposable trocars: mean time of 3.54 seconds versus 11.64 seconds. Overall work tilted in favor of disposable trocars: 14.34 pound-seconds versus 103.88 pound-seconds.

The disposable trocar has the advantage for 2 reasons: its razor-sharp cutting edge and streamlined design.

FIGURE 1 shows typical force curves of disposable and reusable trocars.

FIGURE 1 Reusable trocar requires more force than disposable trocar


A considerable difference in force is required for insertion, depending on type of device, as this graph of typical force curves shows. The reusable trocar requires 18 to 20 lb of force over 12 seconds; the disposable, only 5 lb over 2 seconds.

Safe trocar insertion begins with pneumoperitoneum

McDougall et al17 demonstrated that adequate pneumoperitoneum lessens the force required to drive a trocar through the anterior abdominal wall. Although the differences were small, the forces required with an intraperitoneal gas pressure of 30 mm Hg were smaller than those required with a pressure of 15 mm Hg.17

Manufacturers of disposable trocars also recommend creating an adequate pneumoperitoneum prior to aiming and inserting the razor-sharp device. The goal is creating a carbon dioxide gas pocket large enough to permit rapid deployment of the “safety shield” after the trocar tip clears the properitoneal fat and peritoneal membrane.

Slow-motion video sequences of disposable trocar entry show the sharp trocar tip penetrating the parietal peritoneum of the anterior abdominal wall for 1 cm before the spring-loaded shield advances and locks over the blade. During this insertion, the anterior abdominal wall has an elastic reaction to the applied force; this reaction pushes it toward the posterior abdominal wall.

Direct insertions (ie, without adequate pneumoperitoneum) involve less space for the trocar’s safety shield to deploy. Thus, there is a greater risk of the armed trocar tip coming into direct contact with underlying viscera and blood vessels.

8 common mistakes

Delayed diagnosis

The earlier a major vessel incident can be diagnosed, the better for patient, physician, and hospital. Diagnosis after the onset of hypotension, tachycardia, or tachypnia constitutes “late” diagnosis. Dark venous blood pooling in the abdomen, bright red pulsatile blood emitting from a trocar sleeve, or a retroperitoneal hematoma lateral to the iliacs or at the level of the presacral space suggests major vessel injury. Signs of hypovolemic shock or sudden appearance of profound shock places the possibility of major vessel injury at the top of the differential diagnosis.

Relying on observation when a retroperitoneal hematoma develops

Unfortunately, with observation, the surgeon cannot determine the identity or nature of the damaged vessel, know whether the hematoma is expanding beyond the view of the laparoscope, or predict when the patient will go into shock.

Leaving an armed trocar in place in a vessel

Assuming that the trocar is plugging a hole and preventing hemorrhage is a recipe for disaster. The movement of the sharp device against a vessel wall is most likely to create greater trauma to the vessel. In the case of partial penetration, the device may cut the rest of the way through the vessel.

Laparoscopic exploration

Attempts to locate the injury via laparoscopy usually are unsuccessful, and laparoscopic attempts to sew up the injury limit accuracy and efficacy.

Use of the Pfannenstiel incision during emergency laparotomy

Unfortunately, in 1 study,13 27 of 31 women with vascular injuries received this incision. A vertical incision is preferred because it affords greater access and visibility.

Underestimating blood loss

In the case of a major vessel injury, underestimation of blood volume requirements can be fatal. In 1 study,13 19 of 31 women were under-transfused and/or inadequately cross-matched.

Clamping injured vessels

This can lead to arterial or venous thrombosis. Nonvascular clamps can tear large vessels, adding to the damage and complicating the vascular surgeon’s attempt at repair. Rather, apply direct pressure with a sponge stick.

Delay in calling for help

This translates into greater blood loss and a less stable patient. In 1 study,13 the mean time for a vascular surgeon to intercede was 23 minutes.

 

 

Use a shorter insufflation needle

Our data on women with a BMI greater than 30 (obese range) indicate that the mean thickness of the anterior abdominal wall is 5.05 cm and the distance to the aorta is 15.14 cm.15 A standard Verres needle measures 12.5 cm from the tip of the shaft to the point where the shaft joins the hub of the needle. This is clearly excessive length, since women with a BMI above 30 have an abdominal wall thickness of approximately 5.05 cm and women with BMIs between 25 and 30 have a thickness of only 3.85 cm.

I prefer a Touhy epidural needle for subumbilical insertion and creation of the pneumoperitoneum, since it is a relatively short 8.5 cm. Thus, it is less hazardous than the Verres needle. It also is less likely to clog with tissue fragments because of its curved tip, and more likely to create a successful pneumoperitoneum on the first try.

Fortunately, large-vessel injuries caused by the insufflation needle are rare.

Proper insertion technique

I have residents draw a straight line with a marking pen from the lower margin of the umbilicus to the superior margin of the pubic symphysis. This serves as a guide to keep the trocar pointing toward the middle of the abdomen, away from the iliac vessels. I also teach residents to thrust the trocar in the midline at a 45° to 60° angle in relation to the plane of the abdominal wall, with the trocar pointing toward the uterus (FIGURES 2 AND 3).

Many residents twist disposable trocars during insertion. This “door knob” movement works against the design of the trocar and traumatizes tissue. The correct approach is thrusting the device into the abdominal cavity, or holding the trocar (only for disposable trocar devices) like a dart and thrusting it into the abdomen as though throwing a dart. The only trocar designed for twisting is the conical reusable device; the sharp pyramidal reusable trocar should be thrust rather than twisted.

Avoid “long” trocars

These are a full 5 cm longer than the 20-cm standard device (hub of handle to tip of shaft). Abdominal wall measurements indicate that these devices are never required to simply penetrate the anterior abdominal wall; these trocars also carry the risk of hitting the iliac vessels.

Open laparoscopy is not foolproof

Although open laparoscopy would seem to guarantee safe entry of the primary trocar, reports of aortic injuries have recently been published. Similar data have been reported for optical access trocars.11,18

FIGURE 2 Insert the trocar at 45° to 60° angle


At insertion, the trocar should be at a 45°to 60°angle relative to the abdominal wall, with the tip of the device tilted in the direction of the uterus and bladder. A 90°angle of insertion is dangerous.

FIGURE 3 Midline insertion is safest


Insert the primary trocar in the midline pointing toward the uterus; deviation to the right or left is dangerous. Also avoid injuring the inferior epigastric and external iliac vessels with far lateral trocar insertion.

Body habitus and vascular injury

The obese patient of short stature is at the greatest risk for vascular injury. Although the relative distances between the anterior abdominal wall and the aorta are greater at the highest BMI levels, short stature means that the iliac vessels are closer. Significantly, large vessel injuries in the series cited herein were associated with the use of disposable trocars 90% of the time.

I believe high-risk conditions are created when carbon dioxide gas is inadvertently infused into the properitoneal fat space (FIGURE 4). As the volume of gas grows, the anterior wall parietal peritoneum dissects free from the remainder of the anterior abdominal fat, creating a pseudo-pneumoperitoneum. The operator fails to realize that the true peritoneal cavity has not been entered and, in fact, has paradoxically constricted in size because of the enlarging pseudoperitoneal space. Careful attention to the pressure gauges would have aroused suspicion that gas was being infused into the wrong space, since pressures tend to be higher and flow erratic in such situations.

Nevertheless, the surgeon places a trocar into the space, looks through the laparoscope, sees red or yellow, and realizes that the peritoneal cavity has not been entered. More gas is insufflated and the trocar is tried again.

Typically, the duller, reusable trocar pushes the leading edge of the peritoneum rather than penetrating it, further enlarging the properitoneal space and bringing the anterior and posterior peritoneal walls very close together.

In another scenario, the same set of circumstances exists except, rather than employing a reusable trocar, the surgeon selects a disposable device or even, after 2 failures to enter the peritoneal cavity with the reusable device, an extra-long (11-inch) disposable trocar (FIGURE 4).

 

 

In this scenario, an armed trocar enters the pseudospace—without the safety shield deployed—because no resistance was encountered during penetration of the incision, owing to the fact that two 10–12-mm trocars have previously traversed the same skin incision.

As the tip of the trocar comes into contact with the leading edge of the peritoneum, it encounters resistance, and the razor-sharp blade cuts through the anterior peritoneum, traverses the narrow peritoneal space, and cuts through the posterior peritoneum and the underlying great vessel.

Often, the trocar’s knife edge injures an artery by glancing off the curved surface of the vessels and embedding itself in the neighboring or underlying vein.

The best technique to manage a pseudo-pneumoperitoneal pocket is to abandon the subumbilical site, insert a Touhy needle in the left upper quadrant, and enter and overinflate the peritoneal cavity, thereby obliterating the properitoneal gas space.

When injury occurs: 7 recommended management steps

In the event of a vascular injury, early diagnosis and treatment are vital. Do not observe retroperitoneal hematomas. The following steps are recommended:

  1. Call for a vascular surgeon immediately and indicate that the situation is an emergency. Do not waste time trying to locate the injury before calling for help.
  2. Get emergency type and cross-match for at least 6 U of whole blood.
  3. Obtain baseline lab measurements, including hemoglobin, hematocrit, platelets, fibrinogen, and fibrin split products.
  4. Open the abdomen using a vertical incision for maximum access and visibility.
  5. Get accurate outputs and blood-loss estimates and have anesthesia keep careful records of fluids given.
  6. Advise anesthesia staff to obtain additional help. This will facilitate starting additional IV sites, rapidly infusing blood products, obtaining key samples for laboratory data, and maintaining accurate and detailed records of blood gases, blood loss, replacement fluids, and blood products.
  7. Use a circulator to manage urgent medications or laboratory tests.

The author reports no financial relationships relevant to this article.

References

1. Champault G, Cazacu F, Taffinader N. Serious trocar accidents in laparoscopic surgery: a French survey of 103,852 operations. Surg Laparosc Endosc. 1996;6:367.

2. Baadsgaard SE, Bille S, Egelblad K. Major vascular injury during gynecologic laparoscopy: report of a case and review of published cases. Acta Obstet Gynecol Scand. 1989;68:283.

3. Chamberlain G, Brown JD. Gynecologic laparoscopy: report of the working party of the confidential enquiry into gynecologic laparoscopy. Br J Obstet Gynaecol. 1978;85:401.

4. Mintz M. Risk and prophylaxis in laparoscopy: a survey of 100,000 cases. J Reprod Med. 1977;18:269.

5. Phillips JM, Hulka JF, Peterson HB. American Association of Gynecologic Laparoscopists’ 1982 Membership Survey. J Reprod Med. 1984;29:592.

6. Saidi MH, Vancaillie TG, White AJ, et al. Complications of major operative laparoscopy: a review of 452 cases. J Reprod Med. 1996;41:471.

7. Loffer F, Pent D. Indications, contraindications, and complications of laparoscopy. Obstet Gynecol Surv. 1975;30:407.

8. Härkki-Sirén P, Kurki T. A nationwide analysis of laparoscopic complications. Obstet Gynecol. 1997;89:108.

9. Chapron C, Querleu D, Bruhat MA, et al. Surgical complications of diagnostic and operative gynecologic laparoscopy: a series of 29,966 cases. Hum Reprod. 1998;13:867-872.

10. Bhoyrul S, Vierra MA, Nezhat CR, Krummel TM, Way LW. Trocar injuries in laparoscopic surgery. J Am Coll Surg. 2001;192:677-683.

11. Sharp HT, Dodson MK, Draper ML, Watts DA, Doucette RC, Hurd WW. Complications associated with optical-access laparoscopic trocars. Obstet Gynecol. 2002;99:553-555.

12. Jansen FW, Kapiteyn K, Trimbos-Kemper T, Herman J, Trimbos JB. Complications of laparoscopy: a prospective multi-center observational study. Br J Obstet Gynaecol. 1997;104:595-600.

13. Baggish MS. Analysis of 31 cases of major vessel injury associated with gynecologic laparoscopy operations. J Gynecol Surg. 2003;19:63-73.

14. Hurd WW, Bude RO, DeLancey JOL, Gauvin JM, Aisen AM. Abdominal wall characterization by MRI and CT imaging: the effect of obesity on laparoscopic approach. J Reprod Med. 1991;36:473.

15. Narendran M, Baggish MS. Mean distance between primary trocar insertion site and major retroperitoneal vessels during routine laparoscopy. J Gynecol Surg. 2002;18:121-127.

16. Baggish MS, Gandhi S, Kasper G. Force required by laparoscopic trocar devices to penetrate the human female’s anterior abdominal wall. J Gynecol Surg. 2003;19:1-11.

17. McDougall EM, Figenshau RS, Clayman RV, Monk TG, Smith DS. Laparoscopic pneumoperitoneum: impact of body habitus. J Laparosc Endosc Surg. 1994;4:385-391.

18. Hanney RM, Carmalt HL, Merrett N, Tait N. Use of Hassan cannula producing major vascular injury at laparoscopy. Surg Endosc. 1999;13:1238-1240.

References

1. Champault G, Cazacu F, Taffinader N. Serious trocar accidents in laparoscopic surgery: a French survey of 103,852 operations. Surg Laparosc Endosc. 1996;6:367.

2. Baadsgaard SE, Bille S, Egelblad K. Major vascular injury during gynecologic laparoscopy: report of a case and review of published cases. Acta Obstet Gynecol Scand. 1989;68:283.

3. Chamberlain G, Brown JD. Gynecologic laparoscopy: report of the working party of the confidential enquiry into gynecologic laparoscopy. Br J Obstet Gynaecol. 1978;85:401.

4. Mintz M. Risk and prophylaxis in laparoscopy: a survey of 100,000 cases. J Reprod Med. 1977;18:269.

5. Phillips JM, Hulka JF, Peterson HB. American Association of Gynecologic Laparoscopists’ 1982 Membership Survey. J Reprod Med. 1984;29:592.

6. Saidi MH, Vancaillie TG, White AJ, et al. Complications of major operative laparoscopy: a review of 452 cases. J Reprod Med. 1996;41:471.

7. Loffer F, Pent D. Indications, contraindications, and complications of laparoscopy. Obstet Gynecol Surv. 1975;30:407.

8. Härkki-Sirén P, Kurki T. A nationwide analysis of laparoscopic complications. Obstet Gynecol. 1997;89:108.

9. Chapron C, Querleu D, Bruhat MA, et al. Surgical complications of diagnostic and operative gynecologic laparoscopy: a series of 29,966 cases. Hum Reprod. 1998;13:867-872.

10. Bhoyrul S, Vierra MA, Nezhat CR, Krummel TM, Way LW. Trocar injuries in laparoscopic surgery. J Am Coll Surg. 2001;192:677-683.

11. Sharp HT, Dodson MK, Draper ML, Watts DA, Doucette RC, Hurd WW. Complications associated with optical-access laparoscopic trocars. Obstet Gynecol. 2002;99:553-555.

12. Jansen FW, Kapiteyn K, Trimbos-Kemper T, Herman J, Trimbos JB. Complications of laparoscopy: a prospective multi-center observational study. Br J Obstet Gynaecol. 1997;104:595-600.

13. Baggish MS. Analysis of 31 cases of major vessel injury associated with gynecologic laparoscopy operations. J Gynecol Surg. 2003;19:63-73.

14. Hurd WW, Bude RO, DeLancey JOL, Gauvin JM, Aisen AM. Abdominal wall characterization by MRI and CT imaging: the effect of obesity on laparoscopic approach. J Reprod Med. 1991;36:473.

15. Narendran M, Baggish MS. Mean distance between primary trocar insertion site and major retroperitoneal vessels during routine laparoscopy. J Gynecol Surg. 2002;18:121-127.

16. Baggish MS, Gandhi S, Kasper G. Force required by laparoscopic trocar devices to penetrate the human female’s anterior abdominal wall. J Gynecol Surg. 2003;19:1-11.

17. McDougall EM, Figenshau RS, Clayman RV, Monk TG, Smith DS. Laparoscopic pneumoperitoneum: impact of body habitus. J Laparosc Endosc Surg. 1994;4:385-391.

18. Hanney RM, Carmalt HL, Merrett N, Tait N. Use of Hassan cannula producing major vascular injury at laparoscopy. Surg Endosc. 1999;13:1238-1240.

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Subtotal vs total hysterectomy: Does the evidence support saving the cervix?

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Subtotal vs total hysterectomy: Does the evidence support saving the cervix?

KEY POINTS

  • Sexual function is not improved more with supracervical than with total hysterectomy.
  • Operative morbidity for supracervical and total hysterectomy are similar.
  • Pelvic-floor support and urinary incontinence do not seem to be improved with the supracervical approach.
  • Cyclic bleeding occurs in 5% to 20% of women after supracervical hysterectomy.
  • Reoperation rates for symptoms related to the retained cervix are significant—over 20% in the hands of highly skilled surgeons.
Thanks to the advent of minimally invasive, organ-preserving treatments such as endometrial ablation, progesterone-containing intrauterine delivery systems, and uterine fibroid embolization, today’s patients suffer less morbidity and enjoy better outcomes for a number of procedures. To take advantage of the potential for improved patient care, we try to use every new technology for every suitable candidate.

Hysterectomy is an obvious target. The number of hysterectomies performed has not declined substantially since these technologies were introduced, and persists at more than 550,000 per year in the United States. It is still the most widely performed major gynecological procedure.

Technological advances have made possible the use of laparoscopy to facilitate removal of the uterus without a major abdominal incision, with its inherent hazards. Many surgeons, seeking to make the most of new technology, have revisited laparoscopic subtotal hysterectomy, advocating preservation of the cervix to reduce surgical complications, sexual dysfunction, and pelvic-floor defects after hysterectomy.

New data, however—much of it released only in the last 12 to 18 months—tell us there is no difference in sexual function, pelvic floor support, or return to normal activities when the cervix is retained. What’s more, leaving the cervix in place puts the patient at greater risk of reoperation related to hysterectomy.

THEORY

Improved sexual function

EVIDENCE

Recent prospective analyses using validated measures of female sexual function have failed to demonstrate any advantage for supracervical hysterectomy.

Scientific study of sexual function is difficult at best. Many factors influence sexual behavior, and all must be considered when analyzing the effects of hysterectomy. To clearly understand the impact of hysterectomy on female sexual function, prospective studies in which women serve as their own controls provide the best quality evidence. That said, the contention that supracervical hysterectomy results in better sexual function than total hysterectomy stems from the research of a single group, which in 1983 retrospectively compared coital frequency, dyspareunia, libido, and orgasm after “supravaginal uterine amputation” with total hysterectomy.1,2

Simple hysterectomy causes minimal disruption of Frankenhauser’s plexus of autonomic nerves.

They theorized that supracervical operation preserves Frankenhauser’s plexus of autonomic nerves, resulting in better sexual function. However, careful anatomic assessment of the nerve content in the ligaments supporting the uterus has since demonstrated that the rich nerve supply to the uterosacral and cardinal ligaments occurs in the lateral two thirds of these structures. Simple hysterectomy causes minimal disruption of these autonomic nerves, ganglia, and extensions of the inferior hypogastric plexus.3

Thakar et al,4 in a pivotal multicenter, double-blind, randomized trial conducted in the United Kingdom, randomized 279 patients with benign disease to supracervical or total hysterectomy and followed them for 12 months. Surgical technique was standardized and the endocervix was coagulated in all patients.

The 2 groups were similar in measures of sexual function, including frequency of intercourse, orgasm, and rating of relationship with partner.

The Danish Hysterectomy Group5 randomized 319 patients with benign disease to total abdominal hysterectomy or subtotal abdominal hysterectomy, of whom 276 completed validated mailed questionnaires preoperatively, and at 2, 6, and 12 months postoperatively.

There was no change in sexual satisfaction in either group from their prehysterectomy levels. Overall quality of life improved significantly in both groups, in both mental and physical measures.

Roovers et al,6 in a multicenter, nonrandomized trial—powered well to detect 20% differences—compared vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy (technique chosen by the surgeon).

Of the 379 patients recruited (from 13 teaching and nonteaching hospitals in the Netherlands) who had a male partner, 93% completed a validated questionnaire before and 6 months after surgery.

The questionnaire—used to assess sexual pleasure, activity, and problems—specifically addressed lubrication, orgasm, pain, and arousal on a 5-point scale (“not bothered” to “severely bothered”). Their findings:

  • Sexual pleasure increased significantly in all groups regardless of type of hysterectomy.
  • There was no difference in the incidence of bothersome sexual problems, but a significant number were reported: 43% after vaginal, 41% after subtotal, and 39% after total abdominal hysterectomy (P =.88).
  • New sexual problems were reported in 9 patients (23%) after vaginal hysterectomy, 8 patients (24%) after subtotal hysterectomy, and 12 patients (19%) after total abdominal hysterectomy.
  • There was a nonsignificant trend toward higher prevalence of arousal and lubrication problems after subtotal hysterectomy and total abdominal hysterectomy, compared with vaginal hysterectomy.
 

 

Theory

Improved pelvic floor support, less incontinence

Evidence

Pelvic floor support and urinary incontinence do not seem to be improved with the supracervical approach.

Proponents of supracervical hysterectomy argue that preservation of the cardinal and uterosacral ligaments will reduce the incidence of apical prolapse. In addition, maintenance of the pubocervical ring should lead to less posthysterectomy urinary incontinence.

Our newfound understanding that the nerves are, for the most part, spared at simple hysterectomy should argue against allegations that bowel and urinary function are better preserved by retaining the cervix.

Clearly, long-term outcome studies are required to assess these issues. The randomized trials thus far comparing supracervical with total hysterectomy have not followed patients beyond 2 years.

Nevertheless, at 12 to 24 months, published trials5,7 report an increased incidence of urinary incontinence in patients randomized to supracervical hysterectomy. Prolapse was also reported in a larger number of the patients undergoing subtotal as compared with total hysterectomy (1 to 2% versus 0% at 12 months).

The Total or Supracervical Hysterectomy (TOSH) Research Group7 conducted a multi-center randomized trial with a diverse patient population (78% of women were African American). From January 1998 through April 2000, 135 patients at 4 centers were randomized to supracervical hysterectomy or total abdominal hysterectomy. All patients had benign disease. Surgical technique varied by surgeon as in the general community. Patients and researchers were not blinded as to the technique performed. Subjects were followed for 2 years.

Women undergoing supracervical hysterectomy had a greater incidence of urinary incontinence after surgery.

Both techniques resulted in significant decreases in complaints of urinary incontinence and voiding dysfunction

The Danish Hysterectomy Group5 found that patients who had supracervical hysterectomies had a statistically greater incidence of urinary incontinence after surgery than those undergoing total abdominal hysterectomy (18% versus 9% P = .04). The incidence of new incontinence symptoms was 2.1% in the total abdominal hysterectomy group compared with 7.6% in the subtotal group. There was no change in bowel function in either group.

Thakar et al4 found urinary frequency declined significantly in both groups.

Theory

Fewer injuries and complications, less blood loss

Evidence

Randomized trials have offered no evidence to support a reduction in complication rates or bleeding requiring transfusion.

Since the creation of a bladder flap and division of the cardinal ligaments is not required in supracervical hysterectomy, we might theoretically expect to see reduced rates of injury to the ureters and bladder. Without the need for colpotomy, blood loss should also be reduced.

Cyclic bleeding may occur after supracervical hysterectomy even when residual endocervical tissue is cored or coagulated.

Given the low incidence of these complications at total hysterectomy, however, a meta-analysis of published randomized trials would be required to properly evaluate this issue. Thus far, randomized trials have offered no evidence to support a reduction in complication rates or bleeding requiring transfusion.

Thakar et al4 found a significant reduction in operating time as well as a reduction in blood loss (422 mL versus 320 mL) for the supracervical group compared with the total hysterectomy group; however there were no differences in the need for transfusion (5% in each group).

Women who underwent total abdominal hysterectomy had a higher incidence of fever while in the hospital (27% versus 10%), but there was no difference in the rate of infectious morbidity.

Within 1 year of discharge, more patients undergoing supracervical hysterectomy experienced complications: 7% had cyclic bleeding; 2% had cervical prolapse.

The TOSH Research Group7 found no difference in the rate of complications, activity limitations, or symptom improvement between groups. During the first 3 months, there was no difference in missed work, restricting activities, or bed rest. Both techniques resulted in significant decreases in complaints of pelvic pain, pressure, and back pain.

Of women undergoing supracervical hysterectomy, 5% had cyclic vaginal bleeding (only half of the patients in this series had the endocervix ablated).

Further, there were more readmissions related to the hysterectomy in the supracervical group, though this was not statistically significant (relative risk 1.99; 95% confidence interval, 0.58 to 6.8).

Twenty percent of women in the Danish Hysterectomy Group study 5 had persistent vaginal bleeding after subtotal hysterectomy; 2 went on to have trachelectomy for cyclic bleeding.

Prolapse of the cervical stump occurred in 3/136 patients after subtotal hysterectomy, versus no prolapse after total abdominal hysterectomy.

A snapshot of key trials: Total vs subtotal hysterectomy

Outcomes after total versus subtotal abdominal hysterectomy. Thakar R, et al. N Engl J Med. 2002;347:1318–1325.4 Level I evidence

CONCLUSION Neither subtotal nor total abdominal hysterectomy adversely affected pelvic organ function at 12 months. Subtotal abdominal hysterectomy resulted in more rapid recovery and fewer short-term complications but infrequently caused cyclical bleeding or cervical prolapse.

  • Pivotal multicenter, double-blind, randomized trial conducted in the United Kingdom.
  • Randomized 279 patients with benign disease to supracervical or total hysterectomy and followed them for 12 months.
  • Surgical technique was standardized and the endocervix coagulated in all patients.

Randomized controlled trial of total compared with subtotal hysterectomy with 1-year follow-up results. The Danish Hysterectomy Group. Br J Obstet Gynaecol. 2003;110:1088–1098.5 Level I evidence

CONCLUSION A smaller proportion of women suffered from urinary incontinence after total abdominal hysterectomy than after subtotal abdominal hysterectomy 1 year postoperatively.

  • Multicenter, unblinded randomized trial conducted in Denmark.
  • Randomized 319 patients with benign disease to total abdominal hysterectomy or subtotal abdominal hysterectomy, of whom 276 completed validated mailed questionnaires preoperatively, and at 2, 6, and 12 months postoperatively.

Hysterectomy and sexual well being: Prospective observational study of vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy. Roovers JP, et al. Br Med J. 2003;327:774–779.6 Level II-1 evidence

CONCLUSION Sexual pleasure improved after vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy. The persistence and development of bothersome problems during sexual activity were similar for all 3 techniques.

  • Multicenter, nonrandomized trial conducted in the Netherlands.
  • Investigated sexual function only.
  • Compared vaginal, subtotal abdominal, and total abdominal hysterectomy (technique chosen by the surgeon).
  • Of the 379 patients with a male partner, 93% completed a validated questionnaire before and 6 months after surgery.

A randomized comparison of total or supracervical hysterectomy: Surgical complications and clinical outcomes. Total or Supracervical Hysterectomy Research Group, Obstet Gynecol. 2003;102:453–462.7 Level I evidence

CONCLUSION We found no statistically significant differences between supracervical hysterectomy and total abdominal hysterectomy in surgical complications and clinical outcomes during 2 years of follow-up.

  • Multicenter, unblinded randomized trial conducted in the United States.
  • Randomized 135 patients with benign disease to supracervical hysterectomy or total abdominal hysterectomy and followed them for 2 years.
  • Surgical technique varied by surgeon as in the general community.
  • Only half of the patients had the endocervix ablated.

Long term outcome following laparoscopic supracervical hysterectomy. Okaro EO, et al. Br J Obstet Gynecol. 2001;108:1017–1020.8 Level II-3 evidence

CONCLUSION Symptoms related to the cervical stump requiring further surgery frequently occur following a laparoscopic supracervical hysterectomy.

  • Retrospective analysis of case records for 70 patients.
  • All subjects were women who would have otherwise undergone abdominal hysterectomy, but agreed to laparoscopic supracervical hysterectomy.
  • All surgeries were performed by the same surgeon.
 

 

Long-term outcomes: the downside

For a mean of 66 months (range: 4 to 7 years), Okaro et al8 followed 70 patients undergoing laparoscopic supracervical hysterectomy by a single, highly skilled laparoscopic surgeon.

Their findings point out the downside of cervical preservation. Although all patients had the endocervical canal and transition zone cored out, over 24% reported symptoms related to the cervical stump—and all required further surgery. Further, cyclic vaginal bleeding occurred in 11% of women.

One patient developed cervical intraepithelial neoplasia. Dyspareunia and pelvic pain were significant complaints in 19% of the patients. (These women were more likely to have had hysterectomy for endometriosis.) Sixteen of the 17 patients with cervical complaints required trachelectomy within the follow-up time period.

“How empty is theory in the presence of fact!”
Mark Twain, A Connecticut Yankee in King Arthur’s Court

Practice recommendations

We, as clinicians, must accumulate evidence from basic science as well as clinical research, put it all together, and make recommendations based on these data. The data, tell us, in fact, that there is no difference in sexual dysfunction, pelvic floor support, or return to normal activity levels when the cervix is retained, and no evidence to support an advantage to supracervical hysterectomy.

My recommendation is for vaginal hysterectomy when possible. The theoretical advantages of retention of the cervix have driven many clinicians to abandon the vaginal approach in favor of laparoscopic supracervical hysterectomy; no data support this theory.

While not the focus of this article, ample data tell us that the vaginal approach, when technically feasible, is less invasive and carries fewer risks for our patients than laparoscopic or abdominal hysterectomy, and permits excellent access for support of the pelvic floor. I do think that patients who truly believe that their sex lives will be ruined after total hysterectomy or that they will do dramatically better if the cervix remains, may experience this self-fulfilling prophecy.

What I tell patients. I carefully review all the facts with patients in helping them select the appropriate surgical procedure.

I tell patients:

  • That overwhelming evidence suggests that sexual function improves in the vast majority of women after hysterectomy, whether or not the cervix is left.
  • That there is a real possibility that cyclic bleeding may occur after supracervical hysterectomy, even when the residual endocervical tissue is cored or coagulated. I stress this point to all women who elect hysterectomy.
  • That randomized trials demonstrate a significant incidence of reoperation for persistent bleeding.
The author serves on the Speakers Bureaus for Barr, Berlex, and Wyeth-Ayerst.
References

1. Kikku P. Supravaginal uterine amputation vs. hysterectomy: effects on coital frequency and dyspareunia. Acta Obstet Gynecol Scand. 1983;63:141-145.

2. Kikku P, Gronroos M, Hirvonen T, et al. Supravaginal uterine amputation vs. hysterectomy: effect on libido and orgasm. Acta Obstet Gynecol Scand. 1983;62:147-152.

3. Butler-Manuel SA, Buttery LD, A’Hern RP, et al. Pelvic nerve plexus trauma at radical hysterectomy and simple hysterectomy: the nerve content of the uterine supporting ligaments. Cancer. 2000;89:834-841.

4. Thakar R, Ayers S, Clarkson P, et al. Outcomes after total versus subtotal abdominal hysterectomy. N Engl J Med. 2002;347:1318-1325.

5. Gimbel H, Zobbe V, Andersen BM, et al. Randomized controlled trial of total compared with subtotal hysterectomy with 1-year follow-up results. Br J Obstet Gynaecol. 2003;110:1088-1098.

6. Roovers JP, van der Bom JG, van der Vaart CH, et al. Hysterectomy and sexual wellbeing: prospective observational study of vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy. Br Med J. 2003;327:774-779.

7. Learman LA, Summitt RL, Jr, Varner RE, et al. A randomized comparison of total or supracervical hysterectomy: surgical complications and clinical outcomes. Obstet Gynecol. 2003;102:453-462.

8. Okaro EO, Jones KD, Sutton C. Long term outcome following laparoscopic supracervical hysterectomy. Br J Obstet Gynecol. 2001;108:1017-1020.

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KEY POINTS

  • Sexual function is not improved more with supracervical than with total hysterectomy.
  • Operative morbidity for supracervical and total hysterectomy are similar.
  • Pelvic-floor support and urinary incontinence do not seem to be improved with the supracervical approach.
  • Cyclic bleeding occurs in 5% to 20% of women after supracervical hysterectomy.
  • Reoperation rates for symptoms related to the retained cervix are significant—over 20% in the hands of highly skilled surgeons.
Thanks to the advent of minimally invasive, organ-preserving treatments such as endometrial ablation, progesterone-containing intrauterine delivery systems, and uterine fibroid embolization, today’s patients suffer less morbidity and enjoy better outcomes for a number of procedures. To take advantage of the potential for improved patient care, we try to use every new technology for every suitable candidate.

Hysterectomy is an obvious target. The number of hysterectomies performed has not declined substantially since these technologies were introduced, and persists at more than 550,000 per year in the United States. It is still the most widely performed major gynecological procedure.

Technological advances have made possible the use of laparoscopy to facilitate removal of the uterus without a major abdominal incision, with its inherent hazards. Many surgeons, seeking to make the most of new technology, have revisited laparoscopic subtotal hysterectomy, advocating preservation of the cervix to reduce surgical complications, sexual dysfunction, and pelvic-floor defects after hysterectomy.

New data, however—much of it released only in the last 12 to 18 months—tell us there is no difference in sexual function, pelvic floor support, or return to normal activities when the cervix is retained. What’s more, leaving the cervix in place puts the patient at greater risk of reoperation related to hysterectomy.

THEORY

Improved sexual function

EVIDENCE

Recent prospective analyses using validated measures of female sexual function have failed to demonstrate any advantage for supracervical hysterectomy.

Scientific study of sexual function is difficult at best. Many factors influence sexual behavior, and all must be considered when analyzing the effects of hysterectomy. To clearly understand the impact of hysterectomy on female sexual function, prospective studies in which women serve as their own controls provide the best quality evidence. That said, the contention that supracervical hysterectomy results in better sexual function than total hysterectomy stems from the research of a single group, which in 1983 retrospectively compared coital frequency, dyspareunia, libido, and orgasm after “supravaginal uterine amputation” with total hysterectomy.1,2

Simple hysterectomy causes minimal disruption of Frankenhauser’s plexus of autonomic nerves.

They theorized that supracervical operation preserves Frankenhauser’s plexus of autonomic nerves, resulting in better sexual function. However, careful anatomic assessment of the nerve content in the ligaments supporting the uterus has since demonstrated that the rich nerve supply to the uterosacral and cardinal ligaments occurs in the lateral two thirds of these structures. Simple hysterectomy causes minimal disruption of these autonomic nerves, ganglia, and extensions of the inferior hypogastric plexus.3

Thakar et al,4 in a pivotal multicenter, double-blind, randomized trial conducted in the United Kingdom, randomized 279 patients with benign disease to supracervical or total hysterectomy and followed them for 12 months. Surgical technique was standardized and the endocervix was coagulated in all patients.

The 2 groups were similar in measures of sexual function, including frequency of intercourse, orgasm, and rating of relationship with partner.

The Danish Hysterectomy Group5 randomized 319 patients with benign disease to total abdominal hysterectomy or subtotal abdominal hysterectomy, of whom 276 completed validated mailed questionnaires preoperatively, and at 2, 6, and 12 months postoperatively.

There was no change in sexual satisfaction in either group from their prehysterectomy levels. Overall quality of life improved significantly in both groups, in both mental and physical measures.

Roovers et al,6 in a multicenter, nonrandomized trial—powered well to detect 20% differences—compared vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy (technique chosen by the surgeon).

Of the 379 patients recruited (from 13 teaching and nonteaching hospitals in the Netherlands) who had a male partner, 93% completed a validated questionnaire before and 6 months after surgery.

The questionnaire—used to assess sexual pleasure, activity, and problems—specifically addressed lubrication, orgasm, pain, and arousal on a 5-point scale (“not bothered” to “severely bothered”). Their findings:

  • Sexual pleasure increased significantly in all groups regardless of type of hysterectomy.
  • There was no difference in the incidence of bothersome sexual problems, but a significant number were reported: 43% after vaginal, 41% after subtotal, and 39% after total abdominal hysterectomy (P =.88).
  • New sexual problems were reported in 9 patients (23%) after vaginal hysterectomy, 8 patients (24%) after subtotal hysterectomy, and 12 patients (19%) after total abdominal hysterectomy.
  • There was a nonsignificant trend toward higher prevalence of arousal and lubrication problems after subtotal hysterectomy and total abdominal hysterectomy, compared with vaginal hysterectomy.
 

 

Theory

Improved pelvic floor support, less incontinence

Evidence

Pelvic floor support and urinary incontinence do not seem to be improved with the supracervical approach.

Proponents of supracervical hysterectomy argue that preservation of the cardinal and uterosacral ligaments will reduce the incidence of apical prolapse. In addition, maintenance of the pubocervical ring should lead to less posthysterectomy urinary incontinence.

Our newfound understanding that the nerves are, for the most part, spared at simple hysterectomy should argue against allegations that bowel and urinary function are better preserved by retaining the cervix.

Clearly, long-term outcome studies are required to assess these issues. The randomized trials thus far comparing supracervical with total hysterectomy have not followed patients beyond 2 years.

Nevertheless, at 12 to 24 months, published trials5,7 report an increased incidence of urinary incontinence in patients randomized to supracervical hysterectomy. Prolapse was also reported in a larger number of the patients undergoing subtotal as compared with total hysterectomy (1 to 2% versus 0% at 12 months).

The Total or Supracervical Hysterectomy (TOSH) Research Group7 conducted a multi-center randomized trial with a diverse patient population (78% of women were African American). From January 1998 through April 2000, 135 patients at 4 centers were randomized to supracervical hysterectomy or total abdominal hysterectomy. All patients had benign disease. Surgical technique varied by surgeon as in the general community. Patients and researchers were not blinded as to the technique performed. Subjects were followed for 2 years.

Women undergoing supracervical hysterectomy had a greater incidence of urinary incontinence after surgery.

Both techniques resulted in significant decreases in complaints of urinary incontinence and voiding dysfunction

The Danish Hysterectomy Group5 found that patients who had supracervical hysterectomies had a statistically greater incidence of urinary incontinence after surgery than those undergoing total abdominal hysterectomy (18% versus 9% P = .04). The incidence of new incontinence symptoms was 2.1% in the total abdominal hysterectomy group compared with 7.6% in the subtotal group. There was no change in bowel function in either group.

Thakar et al4 found urinary frequency declined significantly in both groups.

Theory

Fewer injuries and complications, less blood loss

Evidence

Randomized trials have offered no evidence to support a reduction in complication rates or bleeding requiring transfusion.

Since the creation of a bladder flap and division of the cardinal ligaments is not required in supracervical hysterectomy, we might theoretically expect to see reduced rates of injury to the ureters and bladder. Without the need for colpotomy, blood loss should also be reduced.

Cyclic bleeding may occur after supracervical hysterectomy even when residual endocervical tissue is cored or coagulated.

Given the low incidence of these complications at total hysterectomy, however, a meta-analysis of published randomized trials would be required to properly evaluate this issue. Thus far, randomized trials have offered no evidence to support a reduction in complication rates or bleeding requiring transfusion.

Thakar et al4 found a significant reduction in operating time as well as a reduction in blood loss (422 mL versus 320 mL) for the supracervical group compared with the total hysterectomy group; however there were no differences in the need for transfusion (5% in each group).

Women who underwent total abdominal hysterectomy had a higher incidence of fever while in the hospital (27% versus 10%), but there was no difference in the rate of infectious morbidity.

Within 1 year of discharge, more patients undergoing supracervical hysterectomy experienced complications: 7% had cyclic bleeding; 2% had cervical prolapse.

The TOSH Research Group7 found no difference in the rate of complications, activity limitations, or symptom improvement between groups. During the first 3 months, there was no difference in missed work, restricting activities, or bed rest. Both techniques resulted in significant decreases in complaints of pelvic pain, pressure, and back pain.

Of women undergoing supracervical hysterectomy, 5% had cyclic vaginal bleeding (only half of the patients in this series had the endocervix ablated).

Further, there were more readmissions related to the hysterectomy in the supracervical group, though this was not statistically significant (relative risk 1.99; 95% confidence interval, 0.58 to 6.8).

Twenty percent of women in the Danish Hysterectomy Group study 5 had persistent vaginal bleeding after subtotal hysterectomy; 2 went on to have trachelectomy for cyclic bleeding.

Prolapse of the cervical stump occurred in 3/136 patients after subtotal hysterectomy, versus no prolapse after total abdominal hysterectomy.

A snapshot of key trials: Total vs subtotal hysterectomy

Outcomes after total versus subtotal abdominal hysterectomy. Thakar R, et al. N Engl J Med. 2002;347:1318–1325.4 Level I evidence

CONCLUSION Neither subtotal nor total abdominal hysterectomy adversely affected pelvic organ function at 12 months. Subtotal abdominal hysterectomy resulted in more rapid recovery and fewer short-term complications but infrequently caused cyclical bleeding or cervical prolapse.

  • Pivotal multicenter, double-blind, randomized trial conducted in the United Kingdom.
  • Randomized 279 patients with benign disease to supracervical or total hysterectomy and followed them for 12 months.
  • Surgical technique was standardized and the endocervix coagulated in all patients.

Randomized controlled trial of total compared with subtotal hysterectomy with 1-year follow-up results. The Danish Hysterectomy Group. Br J Obstet Gynaecol. 2003;110:1088–1098.5 Level I evidence

CONCLUSION A smaller proportion of women suffered from urinary incontinence after total abdominal hysterectomy than after subtotal abdominal hysterectomy 1 year postoperatively.

  • Multicenter, unblinded randomized trial conducted in Denmark.
  • Randomized 319 patients with benign disease to total abdominal hysterectomy or subtotal abdominal hysterectomy, of whom 276 completed validated mailed questionnaires preoperatively, and at 2, 6, and 12 months postoperatively.

Hysterectomy and sexual well being: Prospective observational study of vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy. Roovers JP, et al. Br Med J. 2003;327:774–779.6 Level II-1 evidence

CONCLUSION Sexual pleasure improved after vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy. The persistence and development of bothersome problems during sexual activity were similar for all 3 techniques.

  • Multicenter, nonrandomized trial conducted in the Netherlands.
  • Investigated sexual function only.
  • Compared vaginal, subtotal abdominal, and total abdominal hysterectomy (technique chosen by the surgeon).
  • Of the 379 patients with a male partner, 93% completed a validated questionnaire before and 6 months after surgery.

A randomized comparison of total or supracervical hysterectomy: Surgical complications and clinical outcomes. Total or Supracervical Hysterectomy Research Group, Obstet Gynecol. 2003;102:453–462.7 Level I evidence

CONCLUSION We found no statistically significant differences between supracervical hysterectomy and total abdominal hysterectomy in surgical complications and clinical outcomes during 2 years of follow-up.

  • Multicenter, unblinded randomized trial conducted in the United States.
  • Randomized 135 patients with benign disease to supracervical hysterectomy or total abdominal hysterectomy and followed them for 2 years.
  • Surgical technique varied by surgeon as in the general community.
  • Only half of the patients had the endocervix ablated.

Long term outcome following laparoscopic supracervical hysterectomy. Okaro EO, et al. Br J Obstet Gynecol. 2001;108:1017–1020.8 Level II-3 evidence

CONCLUSION Symptoms related to the cervical stump requiring further surgery frequently occur following a laparoscopic supracervical hysterectomy.

  • Retrospective analysis of case records for 70 patients.
  • All subjects were women who would have otherwise undergone abdominal hysterectomy, but agreed to laparoscopic supracervical hysterectomy.
  • All surgeries were performed by the same surgeon.
 

 

Long-term outcomes: the downside

For a mean of 66 months (range: 4 to 7 years), Okaro et al8 followed 70 patients undergoing laparoscopic supracervical hysterectomy by a single, highly skilled laparoscopic surgeon.

Their findings point out the downside of cervical preservation. Although all patients had the endocervical canal and transition zone cored out, over 24% reported symptoms related to the cervical stump—and all required further surgery. Further, cyclic vaginal bleeding occurred in 11% of women.

One patient developed cervical intraepithelial neoplasia. Dyspareunia and pelvic pain were significant complaints in 19% of the patients. (These women were more likely to have had hysterectomy for endometriosis.) Sixteen of the 17 patients with cervical complaints required trachelectomy within the follow-up time period.

“How empty is theory in the presence of fact!”
Mark Twain, A Connecticut Yankee in King Arthur’s Court

Practice recommendations

We, as clinicians, must accumulate evidence from basic science as well as clinical research, put it all together, and make recommendations based on these data. The data, tell us, in fact, that there is no difference in sexual dysfunction, pelvic floor support, or return to normal activity levels when the cervix is retained, and no evidence to support an advantage to supracervical hysterectomy.

My recommendation is for vaginal hysterectomy when possible. The theoretical advantages of retention of the cervix have driven many clinicians to abandon the vaginal approach in favor of laparoscopic supracervical hysterectomy; no data support this theory.

While not the focus of this article, ample data tell us that the vaginal approach, when technically feasible, is less invasive and carries fewer risks for our patients than laparoscopic or abdominal hysterectomy, and permits excellent access for support of the pelvic floor. I do think that patients who truly believe that their sex lives will be ruined after total hysterectomy or that they will do dramatically better if the cervix remains, may experience this self-fulfilling prophecy.

What I tell patients. I carefully review all the facts with patients in helping them select the appropriate surgical procedure.

I tell patients:

  • That overwhelming evidence suggests that sexual function improves in the vast majority of women after hysterectomy, whether or not the cervix is left.
  • That there is a real possibility that cyclic bleeding may occur after supracervical hysterectomy, even when the residual endocervical tissue is cored or coagulated. I stress this point to all women who elect hysterectomy.
  • That randomized trials demonstrate a significant incidence of reoperation for persistent bleeding.
The author serves on the Speakers Bureaus for Barr, Berlex, and Wyeth-Ayerst.

KEY POINTS

  • Sexual function is not improved more with supracervical than with total hysterectomy.
  • Operative morbidity for supracervical and total hysterectomy are similar.
  • Pelvic-floor support and urinary incontinence do not seem to be improved with the supracervical approach.
  • Cyclic bleeding occurs in 5% to 20% of women after supracervical hysterectomy.
  • Reoperation rates for symptoms related to the retained cervix are significant—over 20% in the hands of highly skilled surgeons.
Thanks to the advent of minimally invasive, organ-preserving treatments such as endometrial ablation, progesterone-containing intrauterine delivery systems, and uterine fibroid embolization, today’s patients suffer less morbidity and enjoy better outcomes for a number of procedures. To take advantage of the potential for improved patient care, we try to use every new technology for every suitable candidate.

Hysterectomy is an obvious target. The number of hysterectomies performed has not declined substantially since these technologies were introduced, and persists at more than 550,000 per year in the United States. It is still the most widely performed major gynecological procedure.

Technological advances have made possible the use of laparoscopy to facilitate removal of the uterus without a major abdominal incision, with its inherent hazards. Many surgeons, seeking to make the most of new technology, have revisited laparoscopic subtotal hysterectomy, advocating preservation of the cervix to reduce surgical complications, sexual dysfunction, and pelvic-floor defects after hysterectomy.

New data, however—much of it released only in the last 12 to 18 months—tell us there is no difference in sexual function, pelvic floor support, or return to normal activities when the cervix is retained. What’s more, leaving the cervix in place puts the patient at greater risk of reoperation related to hysterectomy.

THEORY

Improved sexual function

EVIDENCE

Recent prospective analyses using validated measures of female sexual function have failed to demonstrate any advantage for supracervical hysterectomy.

Scientific study of sexual function is difficult at best. Many factors influence sexual behavior, and all must be considered when analyzing the effects of hysterectomy. To clearly understand the impact of hysterectomy on female sexual function, prospective studies in which women serve as their own controls provide the best quality evidence. That said, the contention that supracervical hysterectomy results in better sexual function than total hysterectomy stems from the research of a single group, which in 1983 retrospectively compared coital frequency, dyspareunia, libido, and orgasm after “supravaginal uterine amputation” with total hysterectomy.1,2

Simple hysterectomy causes minimal disruption of Frankenhauser’s plexus of autonomic nerves.

They theorized that supracervical operation preserves Frankenhauser’s plexus of autonomic nerves, resulting in better sexual function. However, careful anatomic assessment of the nerve content in the ligaments supporting the uterus has since demonstrated that the rich nerve supply to the uterosacral and cardinal ligaments occurs in the lateral two thirds of these structures. Simple hysterectomy causes minimal disruption of these autonomic nerves, ganglia, and extensions of the inferior hypogastric plexus.3

Thakar et al,4 in a pivotal multicenter, double-blind, randomized trial conducted in the United Kingdom, randomized 279 patients with benign disease to supracervical or total hysterectomy and followed them for 12 months. Surgical technique was standardized and the endocervix was coagulated in all patients.

The 2 groups were similar in measures of sexual function, including frequency of intercourse, orgasm, and rating of relationship with partner.

The Danish Hysterectomy Group5 randomized 319 patients with benign disease to total abdominal hysterectomy or subtotal abdominal hysterectomy, of whom 276 completed validated mailed questionnaires preoperatively, and at 2, 6, and 12 months postoperatively.

There was no change in sexual satisfaction in either group from their prehysterectomy levels. Overall quality of life improved significantly in both groups, in both mental and physical measures.

Roovers et al,6 in a multicenter, nonrandomized trial—powered well to detect 20% differences—compared vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy (technique chosen by the surgeon).

Of the 379 patients recruited (from 13 teaching and nonteaching hospitals in the Netherlands) who had a male partner, 93% completed a validated questionnaire before and 6 months after surgery.

The questionnaire—used to assess sexual pleasure, activity, and problems—specifically addressed lubrication, orgasm, pain, and arousal on a 5-point scale (“not bothered” to “severely bothered”). Their findings:

  • Sexual pleasure increased significantly in all groups regardless of type of hysterectomy.
  • There was no difference in the incidence of bothersome sexual problems, but a significant number were reported: 43% after vaginal, 41% after subtotal, and 39% after total abdominal hysterectomy (P =.88).
  • New sexual problems were reported in 9 patients (23%) after vaginal hysterectomy, 8 patients (24%) after subtotal hysterectomy, and 12 patients (19%) after total abdominal hysterectomy.
  • There was a nonsignificant trend toward higher prevalence of arousal and lubrication problems after subtotal hysterectomy and total abdominal hysterectomy, compared with vaginal hysterectomy.
 

 

Theory

Improved pelvic floor support, less incontinence

Evidence

Pelvic floor support and urinary incontinence do not seem to be improved with the supracervical approach.

Proponents of supracervical hysterectomy argue that preservation of the cardinal and uterosacral ligaments will reduce the incidence of apical prolapse. In addition, maintenance of the pubocervical ring should lead to less posthysterectomy urinary incontinence.

Our newfound understanding that the nerves are, for the most part, spared at simple hysterectomy should argue against allegations that bowel and urinary function are better preserved by retaining the cervix.

Clearly, long-term outcome studies are required to assess these issues. The randomized trials thus far comparing supracervical with total hysterectomy have not followed patients beyond 2 years.

Nevertheless, at 12 to 24 months, published trials5,7 report an increased incidence of urinary incontinence in patients randomized to supracervical hysterectomy. Prolapse was also reported in a larger number of the patients undergoing subtotal as compared with total hysterectomy (1 to 2% versus 0% at 12 months).

The Total or Supracervical Hysterectomy (TOSH) Research Group7 conducted a multi-center randomized trial with a diverse patient population (78% of women were African American). From January 1998 through April 2000, 135 patients at 4 centers were randomized to supracervical hysterectomy or total abdominal hysterectomy. All patients had benign disease. Surgical technique varied by surgeon as in the general community. Patients and researchers were not blinded as to the technique performed. Subjects were followed for 2 years.

Women undergoing supracervical hysterectomy had a greater incidence of urinary incontinence after surgery.

Both techniques resulted in significant decreases in complaints of urinary incontinence and voiding dysfunction

The Danish Hysterectomy Group5 found that patients who had supracervical hysterectomies had a statistically greater incidence of urinary incontinence after surgery than those undergoing total abdominal hysterectomy (18% versus 9% P = .04). The incidence of new incontinence symptoms was 2.1% in the total abdominal hysterectomy group compared with 7.6% in the subtotal group. There was no change in bowel function in either group.

Thakar et al4 found urinary frequency declined significantly in both groups.

Theory

Fewer injuries and complications, less blood loss

Evidence

Randomized trials have offered no evidence to support a reduction in complication rates or bleeding requiring transfusion.

Since the creation of a bladder flap and division of the cardinal ligaments is not required in supracervical hysterectomy, we might theoretically expect to see reduced rates of injury to the ureters and bladder. Without the need for colpotomy, blood loss should also be reduced.

Cyclic bleeding may occur after supracervical hysterectomy even when residual endocervical tissue is cored or coagulated.

Given the low incidence of these complications at total hysterectomy, however, a meta-analysis of published randomized trials would be required to properly evaluate this issue. Thus far, randomized trials have offered no evidence to support a reduction in complication rates or bleeding requiring transfusion.

Thakar et al4 found a significant reduction in operating time as well as a reduction in blood loss (422 mL versus 320 mL) for the supracervical group compared with the total hysterectomy group; however there were no differences in the need for transfusion (5% in each group).

Women who underwent total abdominal hysterectomy had a higher incidence of fever while in the hospital (27% versus 10%), but there was no difference in the rate of infectious morbidity.

Within 1 year of discharge, more patients undergoing supracervical hysterectomy experienced complications: 7% had cyclic bleeding; 2% had cervical prolapse.

The TOSH Research Group7 found no difference in the rate of complications, activity limitations, or symptom improvement between groups. During the first 3 months, there was no difference in missed work, restricting activities, or bed rest. Both techniques resulted in significant decreases in complaints of pelvic pain, pressure, and back pain.

Of women undergoing supracervical hysterectomy, 5% had cyclic vaginal bleeding (only half of the patients in this series had the endocervix ablated).

Further, there were more readmissions related to the hysterectomy in the supracervical group, though this was not statistically significant (relative risk 1.99; 95% confidence interval, 0.58 to 6.8).

Twenty percent of women in the Danish Hysterectomy Group study 5 had persistent vaginal bleeding after subtotal hysterectomy; 2 went on to have trachelectomy for cyclic bleeding.

Prolapse of the cervical stump occurred in 3/136 patients after subtotal hysterectomy, versus no prolapse after total abdominal hysterectomy.

A snapshot of key trials: Total vs subtotal hysterectomy

Outcomes after total versus subtotal abdominal hysterectomy. Thakar R, et al. N Engl J Med. 2002;347:1318–1325.4 Level I evidence

CONCLUSION Neither subtotal nor total abdominal hysterectomy adversely affected pelvic organ function at 12 months. Subtotal abdominal hysterectomy resulted in more rapid recovery and fewer short-term complications but infrequently caused cyclical bleeding or cervical prolapse.

  • Pivotal multicenter, double-blind, randomized trial conducted in the United Kingdom.
  • Randomized 279 patients with benign disease to supracervical or total hysterectomy and followed them for 12 months.
  • Surgical technique was standardized and the endocervix coagulated in all patients.

Randomized controlled trial of total compared with subtotal hysterectomy with 1-year follow-up results. The Danish Hysterectomy Group. Br J Obstet Gynaecol. 2003;110:1088–1098.5 Level I evidence

CONCLUSION A smaller proportion of women suffered from urinary incontinence after total abdominal hysterectomy than after subtotal abdominal hysterectomy 1 year postoperatively.

  • Multicenter, unblinded randomized trial conducted in Denmark.
  • Randomized 319 patients with benign disease to total abdominal hysterectomy or subtotal abdominal hysterectomy, of whom 276 completed validated mailed questionnaires preoperatively, and at 2, 6, and 12 months postoperatively.

Hysterectomy and sexual well being: Prospective observational study of vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy. Roovers JP, et al. Br Med J. 2003;327:774–779.6 Level II-1 evidence

CONCLUSION Sexual pleasure improved after vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy. The persistence and development of bothersome problems during sexual activity were similar for all 3 techniques.

  • Multicenter, nonrandomized trial conducted in the Netherlands.
  • Investigated sexual function only.
  • Compared vaginal, subtotal abdominal, and total abdominal hysterectomy (technique chosen by the surgeon).
  • Of the 379 patients with a male partner, 93% completed a validated questionnaire before and 6 months after surgery.

A randomized comparison of total or supracervical hysterectomy: Surgical complications and clinical outcomes. Total or Supracervical Hysterectomy Research Group, Obstet Gynecol. 2003;102:453–462.7 Level I evidence

CONCLUSION We found no statistically significant differences between supracervical hysterectomy and total abdominal hysterectomy in surgical complications and clinical outcomes during 2 years of follow-up.

  • Multicenter, unblinded randomized trial conducted in the United States.
  • Randomized 135 patients with benign disease to supracervical hysterectomy or total abdominal hysterectomy and followed them for 2 years.
  • Surgical technique varied by surgeon as in the general community.
  • Only half of the patients had the endocervix ablated.

Long term outcome following laparoscopic supracervical hysterectomy. Okaro EO, et al. Br J Obstet Gynecol. 2001;108:1017–1020.8 Level II-3 evidence

CONCLUSION Symptoms related to the cervical stump requiring further surgery frequently occur following a laparoscopic supracervical hysterectomy.

  • Retrospective analysis of case records for 70 patients.
  • All subjects were women who would have otherwise undergone abdominal hysterectomy, but agreed to laparoscopic supracervical hysterectomy.
  • All surgeries were performed by the same surgeon.
 

 

Long-term outcomes: the downside

For a mean of 66 months (range: 4 to 7 years), Okaro et al8 followed 70 patients undergoing laparoscopic supracervical hysterectomy by a single, highly skilled laparoscopic surgeon.

Their findings point out the downside of cervical preservation. Although all patients had the endocervical canal and transition zone cored out, over 24% reported symptoms related to the cervical stump—and all required further surgery. Further, cyclic vaginal bleeding occurred in 11% of women.

One patient developed cervical intraepithelial neoplasia. Dyspareunia and pelvic pain were significant complaints in 19% of the patients. (These women were more likely to have had hysterectomy for endometriosis.) Sixteen of the 17 patients with cervical complaints required trachelectomy within the follow-up time period.

“How empty is theory in the presence of fact!”
Mark Twain, A Connecticut Yankee in King Arthur’s Court

Practice recommendations

We, as clinicians, must accumulate evidence from basic science as well as clinical research, put it all together, and make recommendations based on these data. The data, tell us, in fact, that there is no difference in sexual dysfunction, pelvic floor support, or return to normal activity levels when the cervix is retained, and no evidence to support an advantage to supracervical hysterectomy.

My recommendation is for vaginal hysterectomy when possible. The theoretical advantages of retention of the cervix have driven many clinicians to abandon the vaginal approach in favor of laparoscopic supracervical hysterectomy; no data support this theory.

While not the focus of this article, ample data tell us that the vaginal approach, when technically feasible, is less invasive and carries fewer risks for our patients than laparoscopic or abdominal hysterectomy, and permits excellent access for support of the pelvic floor. I do think that patients who truly believe that their sex lives will be ruined after total hysterectomy or that they will do dramatically better if the cervix remains, may experience this self-fulfilling prophecy.

What I tell patients. I carefully review all the facts with patients in helping them select the appropriate surgical procedure.

I tell patients:

  • That overwhelming evidence suggests that sexual function improves in the vast majority of women after hysterectomy, whether or not the cervix is left.
  • That there is a real possibility that cyclic bleeding may occur after supracervical hysterectomy, even when the residual endocervical tissue is cored or coagulated. I stress this point to all women who elect hysterectomy.
  • That randomized trials demonstrate a significant incidence of reoperation for persistent bleeding.
The author serves on the Speakers Bureaus for Barr, Berlex, and Wyeth-Ayerst.
References

1. Kikku P. Supravaginal uterine amputation vs. hysterectomy: effects on coital frequency and dyspareunia. Acta Obstet Gynecol Scand. 1983;63:141-145.

2. Kikku P, Gronroos M, Hirvonen T, et al. Supravaginal uterine amputation vs. hysterectomy: effect on libido and orgasm. Acta Obstet Gynecol Scand. 1983;62:147-152.

3. Butler-Manuel SA, Buttery LD, A’Hern RP, et al. Pelvic nerve plexus trauma at radical hysterectomy and simple hysterectomy: the nerve content of the uterine supporting ligaments. Cancer. 2000;89:834-841.

4. Thakar R, Ayers S, Clarkson P, et al. Outcomes after total versus subtotal abdominal hysterectomy. N Engl J Med. 2002;347:1318-1325.

5. Gimbel H, Zobbe V, Andersen BM, et al. Randomized controlled trial of total compared with subtotal hysterectomy with 1-year follow-up results. Br J Obstet Gynaecol. 2003;110:1088-1098.

6. Roovers JP, van der Bom JG, van der Vaart CH, et al. Hysterectomy and sexual wellbeing: prospective observational study of vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy. Br Med J. 2003;327:774-779.

7. Learman LA, Summitt RL, Jr, Varner RE, et al. A randomized comparison of total or supracervical hysterectomy: surgical complications and clinical outcomes. Obstet Gynecol. 2003;102:453-462.

8. Okaro EO, Jones KD, Sutton C. Long term outcome following laparoscopic supracervical hysterectomy. Br J Obstet Gynecol. 2001;108:1017-1020.

References

1. Kikku P. Supravaginal uterine amputation vs. hysterectomy: effects on coital frequency and dyspareunia. Acta Obstet Gynecol Scand. 1983;63:141-145.

2. Kikku P, Gronroos M, Hirvonen T, et al. Supravaginal uterine amputation vs. hysterectomy: effect on libido and orgasm. Acta Obstet Gynecol Scand. 1983;62:147-152.

3. Butler-Manuel SA, Buttery LD, A’Hern RP, et al. Pelvic nerve plexus trauma at radical hysterectomy and simple hysterectomy: the nerve content of the uterine supporting ligaments. Cancer. 2000;89:834-841.

4. Thakar R, Ayers S, Clarkson P, et al. Outcomes after total versus subtotal abdominal hysterectomy. N Engl J Med. 2002;347:1318-1325.

5. Gimbel H, Zobbe V, Andersen BM, et al. Randomized controlled trial of total compared with subtotal hysterectomy with 1-year follow-up results. Br J Obstet Gynaecol. 2003;110:1088-1098.

6. Roovers JP, van der Bom JG, van der Vaart CH, et al. Hysterectomy and sexual wellbeing: prospective observational study of vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy. Br Med J. 2003;327:774-779.

7. Learman LA, Summitt RL, Jr, Varner RE, et al. A randomized comparison of total or supracervical hysterectomy: surgical complications and clinical outcomes. Obstet Gynecol. 2003;102:453-462.

8. Okaro EO, Jones KD, Sutton C. Long term outcome following laparoscopic supracervical hysterectomy. Br J Obstet Gynecol. 2001;108:1017-1020.

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Avoiding and repairing bowel injury in gynecologic surgery

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Avoiding and repairing bowel injury in gynecologic surgery

KEY POINTS

  • Although the optimal method is a matter of choice, preoperative bowel preparation is recommended to reduce bacteria, stool bulk, and infectious complications.
  • When entering the peritoneal cavity in patients with prior surgery, watch for adhesions between a loop of bowel and the abdominal wall.
  • In high-risk patients, enter the peritoneal cavity by extending the previous abdominal scar superiorly and inferiorly to minimize risk of injury.
  • Close small perforations in 2 layers, with the suture line always perpendicular to the long axis of the bowel.
  • For more extensive injury or compromised blood supply to the bowel wall, resection and anastomosis may be necessary. Obtain intraoperative general surgical consultation if not trained to perform this kind of repair.

This dreaded complication requires vigilance and skill to avoid, and adequate training and experience to manage and repair. In a perfect world, every gynecologist would be trained in techniques to prevent and repair inadvertent bowel injuries. Unfortunately, residency programs often do not provide such training.

Gynecologists routinely operate on patients with risk factors for bowel injury—obesity, endometriosis, multiple abdominal procedures, pelvic inflammatory disease, history of malignancy, and advanced age. A general surgeon is often called, however, for bowel repairs that can be performed by a gynecologist with sufficient training and experience. (There are instances, however, in which a general surgical consultation may not be readily available—another reason to master repair of bowel injuries encountered during gynecologic surgery.)

This article describes techniques to avert and manage intestinal injury. Topics include adhesiolysis, repair of bowel perforations, segmental bowel resection, and pre- and postoperative management. Vascular anatomy of the bowel is illustrated.

We emphasize the need for direct supervision by an experienced surgeon while mastering these techniques.

Bowel preparation: A useful tool to reduce infection, leakage

Isolated reports have questioned the need for mechanical bowel preparation,1,2 and some experts point to the recent success of primary repairs of gunshot and stab wounds to the colon as evidence that bowel preparation and preoperative oral antibiotics are unnecessary.

Other studies indicate potential benefits, namely reducing infectious complications and anastomotic leakage following repair of inadvertent enterotomy. Indeed, the vast majority of North American surgeons continue to use some form of bowel preparation,3,4 and it is the standard of care for elective intestinal surgery. For these reasons, bowel preparation is strongly encouraged for the gynecologic surgeon operating on a pelvic mass, endometriosis, or malignancy, or when difficult dissection is anticipated with the potential for inadvertent enterotomy and spillage of intestinal contents.

Bowel preparation consists of 2 phases: mechanical cleansing and antibiotic administration (TABLE). The postoperative infection rate can be reduced to well below 10% when these are properly performed.

Mechanical cleansing reduces the bulk of stool content within the lumen of the bowel, which also decreases the absolute amount of bacteria.5 Anaerobes are the predominant flora in the colon, with an estimated density of 1010 organisms per gram of stool. Perforation and spillage of colon contents contaminates the peritoneal cavity with more than 400 species of bacteria.

Perforation and spillage of colon contents contaminates the peritoneal cavity with more than 400 species of bacteria.

In the past, stool bulk was reduced via a low-residue or liquid diet combined with cathartics, enemas, or other agents given over 2 to 3 days. This regimen was time-consuming, patient compliance was poor, and nutritional intake was severely restricted prior to major surgery.

Today, polyethylene glycol and sodium phosphate are the 2 most popular methods of bowel preparation.

  • Polyethylene glycol (Golytely, Braintree Labs, Braintree, Mass) is a balanced electrolyte solution dispensed in a 4-L quantity that must be taken over 4 hours. Some patients find this volume difficult to consume; one option is administering the solution via a small nasogastric tube. Complications may include nausea/vomiting, abdominal cramping, and, rarely, fluid overload and electrolyte disturbances.
  • Sodium phosphate (Fleet Phosphosoda, C.B. Fleet Co, Lynchburg, Va) is administered in two 45-mL increments several hours apart. There is no consensus on which bowel-prep method is superior3,4; most surgeons prefer one or the other. Due to potential electrolyte abnormalities with the use of sodium phosphate, polyethylene glycol is favored for patients with significant renal, cardiac, or hepatic disease.
  • We recommend minimally absorbed oral antibiotics (1 g each of neomycin and erythromycin, given at 1 PM, 2 PM, and 11 PM the day before surgery) in combination with an intravenous second-generation cephalosporin (1 g if using cefotetan, 2 g if using cefoxitin; given immediately before surgery and continued postoperatively for 3 doses).
  • Timing of antibiotic administration is important, since postoperative antibiotics alone do not appear to be effective. If significant spillage occurs intraoperatively, parenteral antibiotics should be continued for 5 days.
 

 

TABLE

Bowel prep regimen

DAY BEFORE SURGERY
Morning
  Light breakfast
Noon
  Clear liquids
  Polyethylene glycol, 4L, to be consumed over 4 to 6 hours
1 PM
  Neomycin, 1 g orally
  Erythromycin, 1 g orally
2 PM
  Neomycin, 1 g orally
  Erythromycin, 1 g orally
Evening
  Clear liquids
11 PM
  Neomycin, 1 g orally
  Erythromycin, 1 g orally
DAY OF SURGERY
Morning
  Intravenous cephalosporin (1 g cefotetan or 2 g cefoxitin); 1 hour before incision, continued postoperatively for 3 doses
Thermal injury due to unipolar cautery is particularly ominous because the extent of injury exceeds what is grossly observed.

When injuries are most likely

Intestinal injuries during gynecologic surgery usually involve the small bowel and can be minor, such as a serosal tear or a small, full-thickness laceration—or major, involving a devitalized bowel loop or its mesentery.

Bowel injury may occur during a variety of surgical procedures. One study showed that most injuries occur during adhesiolysis or entry into the peritoneal cavity. A smaller but substantial number of cases occur during “less extensive” procedures such as uterine curettage and laparoscopy.6

Upon entering the peritoneal cavity, keep in mind the possibility of injuring an adherent loop of bowel. Because of its anatomical relationships to the pelvic viscera, portions of the bowel may become involved in adhesions, which can lead to extremely challenging pelvic dissections in conditions such as endometriosis or severe pelvic infection. Dissection of pelvic adhesions is a common cause of bowel injury, because bowel loops are retracted deeply downward by adhesive bands, and the limited pelvic space hampers visualization and gentle adhesiolysis.

At special risk for bowel injury are women who have undergone prior abdominal operations or who are obese. In a series of 270 general surgery patients undergoing reoperation,7 52 (19%) sustained inadvertent enterotomy. These patients had undergone a mean of 3.3 previous laparotomies and had a higher body mass index (mean of 25.5 versus 21.9).

Age may be another risk factor, since patients with enterotomies were 60 years or older.7

Injury during laparoscopy. Inadvertent bowel injuries may occur during laparoscopic procedures, especially at the time of trocar insertion or manipulation of pelvic structures.5 One device that helps prevent these injuries is the optical trocar (Visiport, US Surgical, Norwalk, Conn), which allows physicians to visualize the layers of the abdominal wall as penetration occurs.

We also routinely direct anesthesia personnel to insert a nasogastric tube at the beginning of laparoscopic procedures to facilitate decompression of the stomach and small bowel.

The risks of electrosurgery. Electrocautery used for tubal ligation, pelvic dissection, or hemostasis may injure the bowel if the surgeon is not careful. Thermal injury due to unipolar cautery is particularly ominous because the extent of injury is greater than what can be grossly observed. The incidence of this type of injury can be reduced using bipolar cautery devices, as well as clips or bands for tubal ligation.

Injury as a result of uterine perforation is unlikely, but can occur. If perforation occurs during dilation and curettage, bowel laceration may result, particularly adhesions are present between the uterus and bowel loops. In extremely rare instances, a loop of bowel may be pulled through a perforation into the uterine cavity or vagina, requiring laparotomy for reduction and repair. Caution is advised during curettage, especially in a gravid uterus, to prevent this potentially catastrophic event.

Avoid the temptation to lyse opaque adhesions using blunt dissection, as serosal tears and enterotomies may occur.

Adhesiolysis: Plan on a lengthy, meticulous procedure

Adhesions are a common cause of pelvic pain, infertility, and bowel obstruction, and their presence may make it difficult to carry out the intended surgical procedure. Adhesiolysis may be necessary to mobilize loops of bowel tightly adherent to pelvic structures, to provide sufficient exposure of the surgical field and prevent subsequent bowel obstruction.

The extent of adhesions does not necessarily correlate with clinical symptoms.

Adhesions may be of the thin, filmy, “friendly” variety or dense, thick bands.

How adhesions occur. When tissue is injured, fibrin is deposited on the peritoneal and serosal surfaces. The extent to which this fibrin is infiltrated with fibroblasts and the degree of subsequent fibrosis determine adhesion density. Any process that impairs fibrinolysis tends to delay resolution of adhesions.

Contributing factors. Adhesions are commonly encountered in pelvic surgery and may be observed in 50% to 90% of patients who have undergone previous surgery.8

Obese patients also are more susceptible to adhesions. Other contributing factors include pelvic infection, bleeding, irradiation, chemical irritants, and conditions such as endometriosis.

Lysis technique. Apply gentle, controlled traction—as well as countertraction—on the bowel loops to facilitate isolation and dissection with sharp Metzenbaum scissors or a scalpel. (Forceful traction or rough handling of bowel loops may cause a breach in the bowel wall with subsequent spillage of intestinal contents.)

 

 

Avoid the temptation to lyse adhesions using blunt dissection (serosal tears and enterotomies may occur)—except in the case of translucent adhesions. These may be lysed via gentle, blunt dissection by rubbing the index finger and thumb back and forth over tissue. They also may be sharply cut using the tip of the scissors to form a “window” in a portion of the adhesion and cutting the adhesive segments in increments.

A characteristic line of demarcation often appears between adhesions and their peritoneal attachment, denoting a safe dissection plane.

Technique for special challenges: Chronic pelvic disease, prior laparotomies. When operating on these patients, be prepared for a long, meticulous procedure. A hasty approach in such cases is perilous and increases the likelihood of postoperative complications.

First, dissect the anterior abdominal wall from the adherent bowel on either side of the incision. Then extend the dissection laterally on both sides until the ascending and descending colon are identified. Next, dissect the small bowel free and mobilize it out of the pelvis.

It often is helpful to move to another area when dissection becomes too difficult; dissection through easier planes often will clarify the relationship of pelvic structures and adherent bowel loops.

Once the small bowel has been mobilized from the pelvis, lyse adhesions between loops of bowel that are causing kinking or narrowing of the lumen, to reduce the risk of postoperative bowel obstruction. Next, carefully dissect pelvic structures from the sigmoid colon and rectum.

How and when to repair serosal injury

Serosal injury is a breach of integrity of the visceral peritoneum, the outermost covering of the bowel wall. This may occur when the serosa is cut during entry into the abdomen or when it is torn during blunt dissection of dense adhesions.

If the underlying muscular and mucosal layers remain intact, these small areas of “denuded” serosa need not be repaired, since most experts believe that suture placement increases the likelihood of future adhesions. The serosal and muscular layers should be repaired if the mucosa is exposed, however. Otherwise the bowel wall will weaken at the site, making it vulnerable to perforation. The seromuscular layers can be approximated easily using interrupted 4-0 silk on a small tapered needle. Be careful to avoid placing the stitch through the mucosa, which would violate the bowel lumen.

When the defect of the seromuscular layer is large (when a more extensive area is denuded during dissection of densely adherent bowel away from a tumor or endometriotic lesion), repair becomes more involved. This may require resection of the injured area with primary anastomosis.

Intestinal perforations: Early recognition is essential

This critical serious complication can become disastrous if not immediately recognized and repaired. Perforation of the small intestine (enterotomy) or large bowel (colotomy) often occurs upon entry into the peritoneal cavity or during a difficult dissection, particularly when extensive adhesions are present.

Exercise special caution when operating on patients who have undergone prior surgery, who are advanced in age, or both.

Reoperation technique. When entering the abdomen through an old scar, reduce the likelihood of bowel injury by extending the new incision to either side of the old scar. Then enter the peritoneal cavity in a virgin area of the abdominal wall, where adherent loops of bowel are less likely.

Carefully open the fascia and dissect the preperitoneal fat down to the peritoneum. Before entering the abdominal cavity, retract the peritoneum upward with smooth forceps and palpate it between the thumb and index finger to ensure that a bowel loop is not in harm’s way.

If the underlying muscular and mucosal layers remain intact, small areas of “denuded” serosa need not be repaired.

Examine the entire small and large bowel carefully after surgery, to rule out injury. It is not uncommon for more than 1 perforation to occur in a bowel segment during a difficult dissection.

Begin at the ligament of Treitz and continue to the ileocecal junction. This is “running” the bowel—ie, inspecting in hand-over-hand fashion.

In the small bowel, the division between the jejunum and ileum is arbitrary, with no sharply defined line of demarcation. However, the diameter of the lumen decreases as one moves from jejunum to ileum, the number of vascular arcades increases, and the number of windows of Deaver diminishes. Also, the wall of the jejunum is generally thicker than that of the ileum.

In addition, inspect the colon in its entirety, with special emphasis on the sigmoid and rectum. Besides its larger lumen, the large bowel is distinguished by 3 longitudinal muscular bands called taenia coli, out-pouching of the wall (sacculations), and epiploic appendages.

 

 

Also examine the mesentery to exclude vascular compromise to the bowel wall.

Repair perforations immediately to limit contamination of the peritoneal cavity. Prior to closure, inspect wound edges for devitalized tissue and, if found, promptly debride it.

If colotomy occurs in the setting of an unprepared bowel with significant spillage, follow closure with copious irrigation.

Small perforations can usually be closed in 2 layers, with an inner layer of 3-0 delayed synthetic absorbable suture (Dexon, Vicryl) through the full thickness of the bowel wall, ensuring mucosal approximation. It is vital that this layer be “waterproof,” allowing no leakage of intestinal contents. Then place a second row of suture in the seromuscular layer using 4-0 silk to imbricate the first suture line.

General surgical consultation is needed whenever the gynecologist is inexperienced with bowel resection and anastomosis.

It also is essential that the suture line be perpendicular to the long axis of the bowel, rather than parallel; otherwise, the bowel lumen would narrow. Even perforations extending along the longitudinal axis for several centimeters should be repaired in transverse fashion to provide a lumen of adequate diameter.

Resecting the small bowel: If inexperienced, obtain general surgery consultation

Bowel resection and anastomosis require a greater degree of skill than is attained in a typical gynecologic training program. For that reason, resection is addressed here only superficially. Our primary caveat: A general surgical consultation should be obtained whenever the gynecologist is inexperienced with bowel resection and anastomosis.

Indications for resection. Strongly consider resection and anastomosis if the perforation involves more than 50% of the circumference of the bowel wall, if multiple perforations occur in a short segment of bowel, or if there is vascular compromise to a segment of bowel. Adequate perfusion to the bowel usually is indicated by a pink serosal surface. If the serosa remains dark or dusky and fails to become pink after several minutes of observation, vascular compromise is likely and resection is preferred.

If there is doubt about the blood supply to the bowel, give 1 g fluorescein intravenously and inspect the bowel under ultraviolet light (Wood’s lamp). Normal vascularized bowel will have a homogenous yellow-green appearance. Patchy fluorescence or areas without any fluorescence are evidence of ischemia.

To drain or not to drain

Because perforation and resection both involve entry into the bowel lumen, some degree of spillage is inevitable. This is of greater concern when the large bowel is involved, because of the increased likelihood of bacterial contamination. Immediate copious irrigation of the peritoneal cavity is indicated. Also consider a pelvic drain, especially when dissection has been extensive or raw surfaces are oozing.

The combination of bacterial contamination and free peritoneal blood in the pelvis increases the risk for infection. A strategically placed, half-inch Jackson Pratt drain (or a similar device) may help prevent abscess. In the event of anastomotic leakage, a drain often allows for a controlled enterocutaneous fistula to be managed without reoperation.

Some surgeons have satisfactory results without these drainage techniques.

When to begin postop feeding: Depends on type of repair

Opinion varies about the appropriate time to commence feeding after major abdominal surgery, particularly bowel surgery. Over the past decade, with the pressure to discharge patients earlier, many physicians have opted for earlier timing.

Traditionally, feeding was withheld until bowel sounds were auscultated; then it progressed slowly. Today many surgeons advance the diet much more quickly, with little or no delay in recovery. Fanning and Andrews9 demonstrated that early feeding does not increase the incidence of anastomotic leakage, dehiscence, or aspiration pneumonia—although it is associated with increased emesis.

Patients undergoing surgery for relatively minor injuries can have their diet advanced as if there were no intestinal involvement.

Feeding after minor repairs. When the surgery has involved relatively minor injuries, such as isolated serosal tears and adhesiolysis, nasogastric tube placement is not required. These patients can have their diet advanced as if there were no intestinal involvement. Give clear liquids when bowel sounds are heard and, if tolerated, advance to solids. It is probably not necessary to await a bowel movement before discharging the patient; she can be released once flatus is passed.

Substantial repairs. When major injuries have been repaired, such as with a large perforation repair or bowel resection, it is prudent to proceed more slowly.

Place a nasogastric tube to minimize bowel distention and subsequent leakage from the repair site. Give the patient nothing by mouth until bowel sounds are clearly present and flatus is passed. Then clamp the nasogastric tube for 24 hours, remove it, and institute clear liquids, provided there is no nausea, vomiting, or distension. Advance to full liquids and then solids, tailoring this process to the patient. When she can tolerate a regular diet, with substantial passage of flatus or bowel movement, recovery is signaled.

 

 

Need for additional training

The techniques necessary to manage simple bowel injury are not difficult to master. However, Ob/Gyn residency programs need to extend training in this area. Additional rotations on the general surgery or trauma services as second- or third-year residents would be ideal, but the use of animal laboratories is a good alternative.

The authors report no financial relationships relevant to this article.

References

1. Burke P, Mealy K, Gillen P, Joyce W, Traynor O, Hyland J. Requirement for bowel preparation in colorectal surgery. Br J Surg. 1994;81:907-910.

2. Miettinen RPJ, Laitinen ST, Makela JT, Paakkonen ME. Bowel preparation with oral polyethylene glycol electrolyte solution vs. no preparation in elective open colorectal surgery. Dis Colon Rectum. 2000;43:669-677.

3. Zmora O, Pikarsky AJ, Wexner SD. Bowel preparation for colorectal surgery. Dis Colon Rectum. 2001;44:1537-1547.

4. Nichols RL, Smith JW, Garcia RY, Waterman RS, Holmes JWC. Current practices of preoperative bowel preparation among North American colorectal surgeons. Clin Infect Dis. 1997;24:609-619.

5. Rock JA, Jones HW. Intestinal tract in gynecologic surgery. In: TeLinde RW, Rock JA, Jones HW, eds. Telinde’s Operative Gynecology. 9th ed. Philadelphia: Lippincott Williams & Wilkins; 2003;1239-1272.

6. Krebs H. Intestinal injury in gynecologic surgery: a ten-year experience. Am J Obstet Gynecol. 1986;155:509-514.

7. Van Der Krabben AA, Dukstra FR, Nieuwenhuijzen M, Reijnen M, Schaapveld M, Van Der Goor H. Morbidity and mortality of inadvertent enterotomy during adhesiotomy. Br J Surg. 2000;87:467-471.

8. Monk BJ, Berman ML, Montz FJ. Adhesions after extensive gynecologic surgery: clinical significance, etiology, and prevention. Am J Obstet Gynecol. 1994;170:1396-1403.

9. Fanning J, Andrews S. Early postoperative feeding after major gynecologic surgery: evidence-based scientific medicine. Am J Obstet Gynecol. 2001;185:1-4.

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JAMES D. PERKINS, MD
LEON L. DENT, MD
Dr. Perkins is clinical instructor in obstetrics and gynecology, University of Mississippi Medical Center, Jackson, Miss, and Meharry Medical College School of Medicine, Nashville, Tenn. He practices at the Women’s Clinic, King’s Daughters Hospital, Greenville, Miss. Dr. Dent is assistant professor of surgery, Morehouse School of Medicine, and is a trauma surgeon at Grady Memorial Hospital, both in Atlanta, Ga. Dr. Perkins and Dr. Dent are members of the Society of Black Academic Surgeons. Both completed their training at Harlem Hospital Center in New York City.

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LEON L. DENT, MD
Dr. Perkins is clinical instructor in obstetrics and gynecology, University of Mississippi Medical Center, Jackson, Miss, and Meharry Medical College School of Medicine, Nashville, Tenn. He practices at the Women’s Clinic, King’s Daughters Hospital, Greenville, Miss. Dr. Dent is assistant professor of surgery, Morehouse School of Medicine, and is a trauma surgeon at Grady Memorial Hospital, both in Atlanta, Ga. Dr. Perkins and Dr. Dent are members of the Society of Black Academic Surgeons. Both completed their training at Harlem Hospital Center in New York City.

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JAMES D. PERKINS, MD
LEON L. DENT, MD
Dr. Perkins is clinical instructor in obstetrics and gynecology, University of Mississippi Medical Center, Jackson, Miss, and Meharry Medical College School of Medicine, Nashville, Tenn. He practices at the Women’s Clinic, King’s Daughters Hospital, Greenville, Miss. Dr. Dent is assistant professor of surgery, Morehouse School of Medicine, and is a trauma surgeon at Grady Memorial Hospital, both in Atlanta, Ga. Dr. Perkins and Dr. Dent are members of the Society of Black Academic Surgeons. Both completed their training at Harlem Hospital Center in New York City.

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KEY POINTS

  • Although the optimal method is a matter of choice, preoperative bowel preparation is recommended to reduce bacteria, stool bulk, and infectious complications.
  • When entering the peritoneal cavity in patients with prior surgery, watch for adhesions between a loop of bowel and the abdominal wall.
  • In high-risk patients, enter the peritoneal cavity by extending the previous abdominal scar superiorly and inferiorly to minimize risk of injury.
  • Close small perforations in 2 layers, with the suture line always perpendicular to the long axis of the bowel.
  • For more extensive injury or compromised blood supply to the bowel wall, resection and anastomosis may be necessary. Obtain intraoperative general surgical consultation if not trained to perform this kind of repair.

This dreaded complication requires vigilance and skill to avoid, and adequate training and experience to manage and repair. In a perfect world, every gynecologist would be trained in techniques to prevent and repair inadvertent bowel injuries. Unfortunately, residency programs often do not provide such training.

Gynecologists routinely operate on patients with risk factors for bowel injury—obesity, endometriosis, multiple abdominal procedures, pelvic inflammatory disease, history of malignancy, and advanced age. A general surgeon is often called, however, for bowel repairs that can be performed by a gynecologist with sufficient training and experience. (There are instances, however, in which a general surgical consultation may not be readily available—another reason to master repair of bowel injuries encountered during gynecologic surgery.)

This article describes techniques to avert and manage intestinal injury. Topics include adhesiolysis, repair of bowel perforations, segmental bowel resection, and pre- and postoperative management. Vascular anatomy of the bowel is illustrated.

We emphasize the need for direct supervision by an experienced surgeon while mastering these techniques.

Bowel preparation: A useful tool to reduce infection, leakage

Isolated reports have questioned the need for mechanical bowel preparation,1,2 and some experts point to the recent success of primary repairs of gunshot and stab wounds to the colon as evidence that bowel preparation and preoperative oral antibiotics are unnecessary.

Other studies indicate potential benefits, namely reducing infectious complications and anastomotic leakage following repair of inadvertent enterotomy. Indeed, the vast majority of North American surgeons continue to use some form of bowel preparation,3,4 and it is the standard of care for elective intestinal surgery. For these reasons, bowel preparation is strongly encouraged for the gynecologic surgeon operating on a pelvic mass, endometriosis, or malignancy, or when difficult dissection is anticipated with the potential for inadvertent enterotomy and spillage of intestinal contents.

Bowel preparation consists of 2 phases: mechanical cleansing and antibiotic administration (TABLE). The postoperative infection rate can be reduced to well below 10% when these are properly performed.

Mechanical cleansing reduces the bulk of stool content within the lumen of the bowel, which also decreases the absolute amount of bacteria.5 Anaerobes are the predominant flora in the colon, with an estimated density of 1010 organisms per gram of stool. Perforation and spillage of colon contents contaminates the peritoneal cavity with more than 400 species of bacteria.

Perforation and spillage of colon contents contaminates the peritoneal cavity with more than 400 species of bacteria.

In the past, stool bulk was reduced via a low-residue or liquid diet combined with cathartics, enemas, or other agents given over 2 to 3 days. This regimen was time-consuming, patient compliance was poor, and nutritional intake was severely restricted prior to major surgery.

Today, polyethylene glycol and sodium phosphate are the 2 most popular methods of bowel preparation.

  • Polyethylene glycol (Golytely, Braintree Labs, Braintree, Mass) is a balanced electrolyte solution dispensed in a 4-L quantity that must be taken over 4 hours. Some patients find this volume difficult to consume; one option is administering the solution via a small nasogastric tube. Complications may include nausea/vomiting, abdominal cramping, and, rarely, fluid overload and electrolyte disturbances.
  • Sodium phosphate (Fleet Phosphosoda, C.B. Fleet Co, Lynchburg, Va) is administered in two 45-mL increments several hours apart. There is no consensus on which bowel-prep method is superior3,4; most surgeons prefer one or the other. Due to potential electrolyte abnormalities with the use of sodium phosphate, polyethylene glycol is favored for patients with significant renal, cardiac, or hepatic disease.
  • We recommend minimally absorbed oral antibiotics (1 g each of neomycin and erythromycin, given at 1 PM, 2 PM, and 11 PM the day before surgery) in combination with an intravenous second-generation cephalosporin (1 g if using cefotetan, 2 g if using cefoxitin; given immediately before surgery and continued postoperatively for 3 doses).
  • Timing of antibiotic administration is important, since postoperative antibiotics alone do not appear to be effective. If significant spillage occurs intraoperatively, parenteral antibiotics should be continued for 5 days.
 

 

TABLE

Bowel prep regimen

DAY BEFORE SURGERY
Morning
  Light breakfast
Noon
  Clear liquids
  Polyethylene glycol, 4L, to be consumed over 4 to 6 hours
1 PM
  Neomycin, 1 g orally
  Erythromycin, 1 g orally
2 PM
  Neomycin, 1 g orally
  Erythromycin, 1 g orally
Evening
  Clear liquids
11 PM
  Neomycin, 1 g orally
  Erythromycin, 1 g orally
DAY OF SURGERY
Morning
  Intravenous cephalosporin (1 g cefotetan or 2 g cefoxitin); 1 hour before incision, continued postoperatively for 3 doses
Thermal injury due to unipolar cautery is particularly ominous because the extent of injury exceeds what is grossly observed.

When injuries are most likely

Intestinal injuries during gynecologic surgery usually involve the small bowel and can be minor, such as a serosal tear or a small, full-thickness laceration—or major, involving a devitalized bowel loop or its mesentery.

Bowel injury may occur during a variety of surgical procedures. One study showed that most injuries occur during adhesiolysis or entry into the peritoneal cavity. A smaller but substantial number of cases occur during “less extensive” procedures such as uterine curettage and laparoscopy.6

Upon entering the peritoneal cavity, keep in mind the possibility of injuring an adherent loop of bowel. Because of its anatomical relationships to the pelvic viscera, portions of the bowel may become involved in adhesions, which can lead to extremely challenging pelvic dissections in conditions such as endometriosis or severe pelvic infection. Dissection of pelvic adhesions is a common cause of bowel injury, because bowel loops are retracted deeply downward by adhesive bands, and the limited pelvic space hampers visualization and gentle adhesiolysis.

At special risk for bowel injury are women who have undergone prior abdominal operations or who are obese. In a series of 270 general surgery patients undergoing reoperation,7 52 (19%) sustained inadvertent enterotomy. These patients had undergone a mean of 3.3 previous laparotomies and had a higher body mass index (mean of 25.5 versus 21.9).

Age may be another risk factor, since patients with enterotomies were 60 years or older.7

Injury during laparoscopy. Inadvertent bowel injuries may occur during laparoscopic procedures, especially at the time of trocar insertion or manipulation of pelvic structures.5 One device that helps prevent these injuries is the optical trocar (Visiport, US Surgical, Norwalk, Conn), which allows physicians to visualize the layers of the abdominal wall as penetration occurs.

We also routinely direct anesthesia personnel to insert a nasogastric tube at the beginning of laparoscopic procedures to facilitate decompression of the stomach and small bowel.

The risks of electrosurgery. Electrocautery used for tubal ligation, pelvic dissection, or hemostasis may injure the bowel if the surgeon is not careful. Thermal injury due to unipolar cautery is particularly ominous because the extent of injury is greater than what can be grossly observed. The incidence of this type of injury can be reduced using bipolar cautery devices, as well as clips or bands for tubal ligation.

Injury as a result of uterine perforation is unlikely, but can occur. If perforation occurs during dilation and curettage, bowel laceration may result, particularly adhesions are present between the uterus and bowel loops. In extremely rare instances, a loop of bowel may be pulled through a perforation into the uterine cavity or vagina, requiring laparotomy for reduction and repair. Caution is advised during curettage, especially in a gravid uterus, to prevent this potentially catastrophic event.

Avoid the temptation to lyse opaque adhesions using blunt dissection, as serosal tears and enterotomies may occur.

Adhesiolysis: Plan on a lengthy, meticulous procedure

Adhesions are a common cause of pelvic pain, infertility, and bowel obstruction, and their presence may make it difficult to carry out the intended surgical procedure. Adhesiolysis may be necessary to mobilize loops of bowel tightly adherent to pelvic structures, to provide sufficient exposure of the surgical field and prevent subsequent bowel obstruction.

The extent of adhesions does not necessarily correlate with clinical symptoms.

Adhesions may be of the thin, filmy, “friendly” variety or dense, thick bands.

How adhesions occur. When tissue is injured, fibrin is deposited on the peritoneal and serosal surfaces. The extent to which this fibrin is infiltrated with fibroblasts and the degree of subsequent fibrosis determine adhesion density. Any process that impairs fibrinolysis tends to delay resolution of adhesions.

Contributing factors. Adhesions are commonly encountered in pelvic surgery and may be observed in 50% to 90% of patients who have undergone previous surgery.8

Obese patients also are more susceptible to adhesions. Other contributing factors include pelvic infection, bleeding, irradiation, chemical irritants, and conditions such as endometriosis.

Lysis technique. Apply gentle, controlled traction—as well as countertraction—on the bowel loops to facilitate isolation and dissection with sharp Metzenbaum scissors or a scalpel. (Forceful traction or rough handling of bowel loops may cause a breach in the bowel wall with subsequent spillage of intestinal contents.)

 

 

Avoid the temptation to lyse adhesions using blunt dissection (serosal tears and enterotomies may occur)—except in the case of translucent adhesions. These may be lysed via gentle, blunt dissection by rubbing the index finger and thumb back and forth over tissue. They also may be sharply cut using the tip of the scissors to form a “window” in a portion of the adhesion and cutting the adhesive segments in increments.

A characteristic line of demarcation often appears between adhesions and their peritoneal attachment, denoting a safe dissection plane.

Technique for special challenges: Chronic pelvic disease, prior laparotomies. When operating on these patients, be prepared for a long, meticulous procedure. A hasty approach in such cases is perilous and increases the likelihood of postoperative complications.

First, dissect the anterior abdominal wall from the adherent bowel on either side of the incision. Then extend the dissection laterally on both sides until the ascending and descending colon are identified. Next, dissect the small bowel free and mobilize it out of the pelvis.

It often is helpful to move to another area when dissection becomes too difficult; dissection through easier planes often will clarify the relationship of pelvic structures and adherent bowel loops.

Once the small bowel has been mobilized from the pelvis, lyse adhesions between loops of bowel that are causing kinking or narrowing of the lumen, to reduce the risk of postoperative bowel obstruction. Next, carefully dissect pelvic structures from the sigmoid colon and rectum.

How and when to repair serosal injury

Serosal injury is a breach of integrity of the visceral peritoneum, the outermost covering of the bowel wall. This may occur when the serosa is cut during entry into the abdomen or when it is torn during blunt dissection of dense adhesions.

If the underlying muscular and mucosal layers remain intact, these small areas of “denuded” serosa need not be repaired, since most experts believe that suture placement increases the likelihood of future adhesions. The serosal and muscular layers should be repaired if the mucosa is exposed, however. Otherwise the bowel wall will weaken at the site, making it vulnerable to perforation. The seromuscular layers can be approximated easily using interrupted 4-0 silk on a small tapered needle. Be careful to avoid placing the stitch through the mucosa, which would violate the bowel lumen.

When the defect of the seromuscular layer is large (when a more extensive area is denuded during dissection of densely adherent bowel away from a tumor or endometriotic lesion), repair becomes more involved. This may require resection of the injured area with primary anastomosis.

Intestinal perforations: Early recognition is essential

This critical serious complication can become disastrous if not immediately recognized and repaired. Perforation of the small intestine (enterotomy) or large bowel (colotomy) often occurs upon entry into the peritoneal cavity or during a difficult dissection, particularly when extensive adhesions are present.

Exercise special caution when operating on patients who have undergone prior surgery, who are advanced in age, or both.

Reoperation technique. When entering the abdomen through an old scar, reduce the likelihood of bowel injury by extending the new incision to either side of the old scar. Then enter the peritoneal cavity in a virgin area of the abdominal wall, where adherent loops of bowel are less likely.

Carefully open the fascia and dissect the preperitoneal fat down to the peritoneum. Before entering the abdominal cavity, retract the peritoneum upward with smooth forceps and palpate it between the thumb and index finger to ensure that a bowel loop is not in harm’s way.

If the underlying muscular and mucosal layers remain intact, small areas of “denuded” serosa need not be repaired.

Examine the entire small and large bowel carefully after surgery, to rule out injury. It is not uncommon for more than 1 perforation to occur in a bowel segment during a difficult dissection.

Begin at the ligament of Treitz and continue to the ileocecal junction. This is “running” the bowel—ie, inspecting in hand-over-hand fashion.

In the small bowel, the division between the jejunum and ileum is arbitrary, with no sharply defined line of demarcation. However, the diameter of the lumen decreases as one moves from jejunum to ileum, the number of vascular arcades increases, and the number of windows of Deaver diminishes. Also, the wall of the jejunum is generally thicker than that of the ileum.

In addition, inspect the colon in its entirety, with special emphasis on the sigmoid and rectum. Besides its larger lumen, the large bowel is distinguished by 3 longitudinal muscular bands called taenia coli, out-pouching of the wall (sacculations), and epiploic appendages.

 

 

Also examine the mesentery to exclude vascular compromise to the bowel wall.

Repair perforations immediately to limit contamination of the peritoneal cavity. Prior to closure, inspect wound edges for devitalized tissue and, if found, promptly debride it.

If colotomy occurs in the setting of an unprepared bowel with significant spillage, follow closure with copious irrigation.

Small perforations can usually be closed in 2 layers, with an inner layer of 3-0 delayed synthetic absorbable suture (Dexon, Vicryl) through the full thickness of the bowel wall, ensuring mucosal approximation. It is vital that this layer be “waterproof,” allowing no leakage of intestinal contents. Then place a second row of suture in the seromuscular layer using 4-0 silk to imbricate the first suture line.

General surgical consultation is needed whenever the gynecologist is inexperienced with bowel resection and anastomosis.

It also is essential that the suture line be perpendicular to the long axis of the bowel, rather than parallel; otherwise, the bowel lumen would narrow. Even perforations extending along the longitudinal axis for several centimeters should be repaired in transverse fashion to provide a lumen of adequate diameter.

Resecting the small bowel: If inexperienced, obtain general surgery consultation

Bowel resection and anastomosis require a greater degree of skill than is attained in a typical gynecologic training program. For that reason, resection is addressed here only superficially. Our primary caveat: A general surgical consultation should be obtained whenever the gynecologist is inexperienced with bowel resection and anastomosis.

Indications for resection. Strongly consider resection and anastomosis if the perforation involves more than 50% of the circumference of the bowel wall, if multiple perforations occur in a short segment of bowel, or if there is vascular compromise to a segment of bowel. Adequate perfusion to the bowel usually is indicated by a pink serosal surface. If the serosa remains dark or dusky and fails to become pink after several minutes of observation, vascular compromise is likely and resection is preferred.

If there is doubt about the blood supply to the bowel, give 1 g fluorescein intravenously and inspect the bowel under ultraviolet light (Wood’s lamp). Normal vascularized bowel will have a homogenous yellow-green appearance. Patchy fluorescence or areas without any fluorescence are evidence of ischemia.

To drain or not to drain

Because perforation and resection both involve entry into the bowel lumen, some degree of spillage is inevitable. This is of greater concern when the large bowel is involved, because of the increased likelihood of bacterial contamination. Immediate copious irrigation of the peritoneal cavity is indicated. Also consider a pelvic drain, especially when dissection has been extensive or raw surfaces are oozing.

The combination of bacterial contamination and free peritoneal blood in the pelvis increases the risk for infection. A strategically placed, half-inch Jackson Pratt drain (or a similar device) may help prevent abscess. In the event of anastomotic leakage, a drain often allows for a controlled enterocutaneous fistula to be managed without reoperation.

Some surgeons have satisfactory results without these drainage techniques.

When to begin postop feeding: Depends on type of repair

Opinion varies about the appropriate time to commence feeding after major abdominal surgery, particularly bowel surgery. Over the past decade, with the pressure to discharge patients earlier, many physicians have opted for earlier timing.

Traditionally, feeding was withheld until bowel sounds were auscultated; then it progressed slowly. Today many surgeons advance the diet much more quickly, with little or no delay in recovery. Fanning and Andrews9 demonstrated that early feeding does not increase the incidence of anastomotic leakage, dehiscence, or aspiration pneumonia—although it is associated with increased emesis.

Patients undergoing surgery for relatively minor injuries can have their diet advanced as if there were no intestinal involvement.

Feeding after minor repairs. When the surgery has involved relatively minor injuries, such as isolated serosal tears and adhesiolysis, nasogastric tube placement is not required. These patients can have their diet advanced as if there were no intestinal involvement. Give clear liquids when bowel sounds are heard and, if tolerated, advance to solids. It is probably not necessary to await a bowel movement before discharging the patient; she can be released once flatus is passed.

Substantial repairs. When major injuries have been repaired, such as with a large perforation repair or bowel resection, it is prudent to proceed more slowly.

Place a nasogastric tube to minimize bowel distention and subsequent leakage from the repair site. Give the patient nothing by mouth until bowel sounds are clearly present and flatus is passed. Then clamp the nasogastric tube for 24 hours, remove it, and institute clear liquids, provided there is no nausea, vomiting, or distension. Advance to full liquids and then solids, tailoring this process to the patient. When she can tolerate a regular diet, with substantial passage of flatus or bowel movement, recovery is signaled.

 

 

Need for additional training

The techniques necessary to manage simple bowel injury are not difficult to master. However, Ob/Gyn residency programs need to extend training in this area. Additional rotations on the general surgery or trauma services as second- or third-year residents would be ideal, but the use of animal laboratories is a good alternative.

The authors report no financial relationships relevant to this article.

KEY POINTS

  • Although the optimal method is a matter of choice, preoperative bowel preparation is recommended to reduce bacteria, stool bulk, and infectious complications.
  • When entering the peritoneal cavity in patients with prior surgery, watch for adhesions between a loop of bowel and the abdominal wall.
  • In high-risk patients, enter the peritoneal cavity by extending the previous abdominal scar superiorly and inferiorly to minimize risk of injury.
  • Close small perforations in 2 layers, with the suture line always perpendicular to the long axis of the bowel.
  • For more extensive injury or compromised blood supply to the bowel wall, resection and anastomosis may be necessary. Obtain intraoperative general surgical consultation if not trained to perform this kind of repair.

This dreaded complication requires vigilance and skill to avoid, and adequate training and experience to manage and repair. In a perfect world, every gynecologist would be trained in techniques to prevent and repair inadvertent bowel injuries. Unfortunately, residency programs often do not provide such training.

Gynecologists routinely operate on patients with risk factors for bowel injury—obesity, endometriosis, multiple abdominal procedures, pelvic inflammatory disease, history of malignancy, and advanced age. A general surgeon is often called, however, for bowel repairs that can be performed by a gynecologist with sufficient training and experience. (There are instances, however, in which a general surgical consultation may not be readily available—another reason to master repair of bowel injuries encountered during gynecologic surgery.)

This article describes techniques to avert and manage intestinal injury. Topics include adhesiolysis, repair of bowel perforations, segmental bowel resection, and pre- and postoperative management. Vascular anatomy of the bowel is illustrated.

We emphasize the need for direct supervision by an experienced surgeon while mastering these techniques.

Bowel preparation: A useful tool to reduce infection, leakage

Isolated reports have questioned the need for mechanical bowel preparation,1,2 and some experts point to the recent success of primary repairs of gunshot and stab wounds to the colon as evidence that bowel preparation and preoperative oral antibiotics are unnecessary.

Other studies indicate potential benefits, namely reducing infectious complications and anastomotic leakage following repair of inadvertent enterotomy. Indeed, the vast majority of North American surgeons continue to use some form of bowel preparation,3,4 and it is the standard of care for elective intestinal surgery. For these reasons, bowel preparation is strongly encouraged for the gynecologic surgeon operating on a pelvic mass, endometriosis, or malignancy, or when difficult dissection is anticipated with the potential for inadvertent enterotomy and spillage of intestinal contents.

Bowel preparation consists of 2 phases: mechanical cleansing and antibiotic administration (TABLE). The postoperative infection rate can be reduced to well below 10% when these are properly performed.

Mechanical cleansing reduces the bulk of stool content within the lumen of the bowel, which also decreases the absolute amount of bacteria.5 Anaerobes are the predominant flora in the colon, with an estimated density of 1010 organisms per gram of stool. Perforation and spillage of colon contents contaminates the peritoneal cavity with more than 400 species of bacteria.

Perforation and spillage of colon contents contaminates the peritoneal cavity with more than 400 species of bacteria.

In the past, stool bulk was reduced via a low-residue or liquid diet combined with cathartics, enemas, or other agents given over 2 to 3 days. This regimen was time-consuming, patient compliance was poor, and nutritional intake was severely restricted prior to major surgery.

Today, polyethylene glycol and sodium phosphate are the 2 most popular methods of bowel preparation.

  • Polyethylene glycol (Golytely, Braintree Labs, Braintree, Mass) is a balanced electrolyte solution dispensed in a 4-L quantity that must be taken over 4 hours. Some patients find this volume difficult to consume; one option is administering the solution via a small nasogastric tube. Complications may include nausea/vomiting, abdominal cramping, and, rarely, fluid overload and electrolyte disturbances.
  • Sodium phosphate (Fleet Phosphosoda, C.B. Fleet Co, Lynchburg, Va) is administered in two 45-mL increments several hours apart. There is no consensus on which bowel-prep method is superior3,4; most surgeons prefer one or the other. Due to potential electrolyte abnormalities with the use of sodium phosphate, polyethylene glycol is favored for patients with significant renal, cardiac, or hepatic disease.
  • We recommend minimally absorbed oral antibiotics (1 g each of neomycin and erythromycin, given at 1 PM, 2 PM, and 11 PM the day before surgery) in combination with an intravenous second-generation cephalosporin (1 g if using cefotetan, 2 g if using cefoxitin; given immediately before surgery and continued postoperatively for 3 doses).
  • Timing of antibiotic administration is important, since postoperative antibiotics alone do not appear to be effective. If significant spillage occurs intraoperatively, parenteral antibiotics should be continued for 5 days.
 

 

TABLE

Bowel prep regimen

DAY BEFORE SURGERY
Morning
  Light breakfast
Noon
  Clear liquids
  Polyethylene glycol, 4L, to be consumed over 4 to 6 hours
1 PM
  Neomycin, 1 g orally
  Erythromycin, 1 g orally
2 PM
  Neomycin, 1 g orally
  Erythromycin, 1 g orally
Evening
  Clear liquids
11 PM
  Neomycin, 1 g orally
  Erythromycin, 1 g orally
DAY OF SURGERY
Morning
  Intravenous cephalosporin (1 g cefotetan or 2 g cefoxitin); 1 hour before incision, continued postoperatively for 3 doses
Thermal injury due to unipolar cautery is particularly ominous because the extent of injury exceeds what is grossly observed.

When injuries are most likely

Intestinal injuries during gynecologic surgery usually involve the small bowel and can be minor, such as a serosal tear or a small, full-thickness laceration—or major, involving a devitalized bowel loop or its mesentery.

Bowel injury may occur during a variety of surgical procedures. One study showed that most injuries occur during adhesiolysis or entry into the peritoneal cavity. A smaller but substantial number of cases occur during “less extensive” procedures such as uterine curettage and laparoscopy.6

Upon entering the peritoneal cavity, keep in mind the possibility of injuring an adherent loop of bowel. Because of its anatomical relationships to the pelvic viscera, portions of the bowel may become involved in adhesions, which can lead to extremely challenging pelvic dissections in conditions such as endometriosis or severe pelvic infection. Dissection of pelvic adhesions is a common cause of bowel injury, because bowel loops are retracted deeply downward by adhesive bands, and the limited pelvic space hampers visualization and gentle adhesiolysis.

At special risk for bowel injury are women who have undergone prior abdominal operations or who are obese. In a series of 270 general surgery patients undergoing reoperation,7 52 (19%) sustained inadvertent enterotomy. These patients had undergone a mean of 3.3 previous laparotomies and had a higher body mass index (mean of 25.5 versus 21.9).

Age may be another risk factor, since patients with enterotomies were 60 years or older.7

Injury during laparoscopy. Inadvertent bowel injuries may occur during laparoscopic procedures, especially at the time of trocar insertion or manipulation of pelvic structures.5 One device that helps prevent these injuries is the optical trocar (Visiport, US Surgical, Norwalk, Conn), which allows physicians to visualize the layers of the abdominal wall as penetration occurs.

We also routinely direct anesthesia personnel to insert a nasogastric tube at the beginning of laparoscopic procedures to facilitate decompression of the stomach and small bowel.

The risks of electrosurgery. Electrocautery used for tubal ligation, pelvic dissection, or hemostasis may injure the bowel if the surgeon is not careful. Thermal injury due to unipolar cautery is particularly ominous because the extent of injury is greater than what can be grossly observed. The incidence of this type of injury can be reduced using bipolar cautery devices, as well as clips or bands for tubal ligation.

Injury as a result of uterine perforation is unlikely, but can occur. If perforation occurs during dilation and curettage, bowel laceration may result, particularly adhesions are present between the uterus and bowel loops. In extremely rare instances, a loop of bowel may be pulled through a perforation into the uterine cavity or vagina, requiring laparotomy for reduction and repair. Caution is advised during curettage, especially in a gravid uterus, to prevent this potentially catastrophic event.

Avoid the temptation to lyse opaque adhesions using blunt dissection, as serosal tears and enterotomies may occur.

Adhesiolysis: Plan on a lengthy, meticulous procedure

Adhesions are a common cause of pelvic pain, infertility, and bowel obstruction, and their presence may make it difficult to carry out the intended surgical procedure. Adhesiolysis may be necessary to mobilize loops of bowel tightly adherent to pelvic structures, to provide sufficient exposure of the surgical field and prevent subsequent bowel obstruction.

The extent of adhesions does not necessarily correlate with clinical symptoms.

Adhesions may be of the thin, filmy, “friendly” variety or dense, thick bands.

How adhesions occur. When tissue is injured, fibrin is deposited on the peritoneal and serosal surfaces. The extent to which this fibrin is infiltrated with fibroblasts and the degree of subsequent fibrosis determine adhesion density. Any process that impairs fibrinolysis tends to delay resolution of adhesions.

Contributing factors. Adhesions are commonly encountered in pelvic surgery and may be observed in 50% to 90% of patients who have undergone previous surgery.8

Obese patients also are more susceptible to adhesions. Other contributing factors include pelvic infection, bleeding, irradiation, chemical irritants, and conditions such as endometriosis.

Lysis technique. Apply gentle, controlled traction—as well as countertraction—on the bowel loops to facilitate isolation and dissection with sharp Metzenbaum scissors or a scalpel. (Forceful traction or rough handling of bowel loops may cause a breach in the bowel wall with subsequent spillage of intestinal contents.)

 

 

Avoid the temptation to lyse adhesions using blunt dissection (serosal tears and enterotomies may occur)—except in the case of translucent adhesions. These may be lysed via gentle, blunt dissection by rubbing the index finger and thumb back and forth over tissue. They also may be sharply cut using the tip of the scissors to form a “window” in a portion of the adhesion and cutting the adhesive segments in increments.

A characteristic line of demarcation often appears between adhesions and their peritoneal attachment, denoting a safe dissection plane.

Technique for special challenges: Chronic pelvic disease, prior laparotomies. When operating on these patients, be prepared for a long, meticulous procedure. A hasty approach in such cases is perilous and increases the likelihood of postoperative complications.

First, dissect the anterior abdominal wall from the adherent bowel on either side of the incision. Then extend the dissection laterally on both sides until the ascending and descending colon are identified. Next, dissect the small bowel free and mobilize it out of the pelvis.

It often is helpful to move to another area when dissection becomes too difficult; dissection through easier planes often will clarify the relationship of pelvic structures and adherent bowel loops.

Once the small bowel has been mobilized from the pelvis, lyse adhesions between loops of bowel that are causing kinking or narrowing of the lumen, to reduce the risk of postoperative bowel obstruction. Next, carefully dissect pelvic structures from the sigmoid colon and rectum.

How and when to repair serosal injury

Serosal injury is a breach of integrity of the visceral peritoneum, the outermost covering of the bowel wall. This may occur when the serosa is cut during entry into the abdomen or when it is torn during blunt dissection of dense adhesions.

If the underlying muscular and mucosal layers remain intact, these small areas of “denuded” serosa need not be repaired, since most experts believe that suture placement increases the likelihood of future adhesions. The serosal and muscular layers should be repaired if the mucosa is exposed, however. Otherwise the bowel wall will weaken at the site, making it vulnerable to perforation. The seromuscular layers can be approximated easily using interrupted 4-0 silk on a small tapered needle. Be careful to avoid placing the stitch through the mucosa, which would violate the bowel lumen.

When the defect of the seromuscular layer is large (when a more extensive area is denuded during dissection of densely adherent bowel away from a tumor or endometriotic lesion), repair becomes more involved. This may require resection of the injured area with primary anastomosis.

Intestinal perforations: Early recognition is essential

This critical serious complication can become disastrous if not immediately recognized and repaired. Perforation of the small intestine (enterotomy) or large bowel (colotomy) often occurs upon entry into the peritoneal cavity or during a difficult dissection, particularly when extensive adhesions are present.

Exercise special caution when operating on patients who have undergone prior surgery, who are advanced in age, or both.

Reoperation technique. When entering the abdomen through an old scar, reduce the likelihood of bowel injury by extending the new incision to either side of the old scar. Then enter the peritoneal cavity in a virgin area of the abdominal wall, where adherent loops of bowel are less likely.

Carefully open the fascia and dissect the preperitoneal fat down to the peritoneum. Before entering the abdominal cavity, retract the peritoneum upward with smooth forceps and palpate it between the thumb and index finger to ensure that a bowel loop is not in harm’s way.

If the underlying muscular and mucosal layers remain intact, small areas of “denuded” serosa need not be repaired.

Examine the entire small and large bowel carefully after surgery, to rule out injury. It is not uncommon for more than 1 perforation to occur in a bowel segment during a difficult dissection.

Begin at the ligament of Treitz and continue to the ileocecal junction. This is “running” the bowel—ie, inspecting in hand-over-hand fashion.

In the small bowel, the division between the jejunum and ileum is arbitrary, with no sharply defined line of demarcation. However, the diameter of the lumen decreases as one moves from jejunum to ileum, the number of vascular arcades increases, and the number of windows of Deaver diminishes. Also, the wall of the jejunum is generally thicker than that of the ileum.

In addition, inspect the colon in its entirety, with special emphasis on the sigmoid and rectum. Besides its larger lumen, the large bowel is distinguished by 3 longitudinal muscular bands called taenia coli, out-pouching of the wall (sacculations), and epiploic appendages.

 

 

Also examine the mesentery to exclude vascular compromise to the bowel wall.

Repair perforations immediately to limit contamination of the peritoneal cavity. Prior to closure, inspect wound edges for devitalized tissue and, if found, promptly debride it.

If colotomy occurs in the setting of an unprepared bowel with significant spillage, follow closure with copious irrigation.

Small perforations can usually be closed in 2 layers, with an inner layer of 3-0 delayed synthetic absorbable suture (Dexon, Vicryl) through the full thickness of the bowel wall, ensuring mucosal approximation. It is vital that this layer be “waterproof,” allowing no leakage of intestinal contents. Then place a second row of suture in the seromuscular layer using 4-0 silk to imbricate the first suture line.

General surgical consultation is needed whenever the gynecologist is inexperienced with bowel resection and anastomosis.

It also is essential that the suture line be perpendicular to the long axis of the bowel, rather than parallel; otherwise, the bowel lumen would narrow. Even perforations extending along the longitudinal axis for several centimeters should be repaired in transverse fashion to provide a lumen of adequate diameter.

Resecting the small bowel: If inexperienced, obtain general surgery consultation

Bowel resection and anastomosis require a greater degree of skill than is attained in a typical gynecologic training program. For that reason, resection is addressed here only superficially. Our primary caveat: A general surgical consultation should be obtained whenever the gynecologist is inexperienced with bowel resection and anastomosis.

Indications for resection. Strongly consider resection and anastomosis if the perforation involves more than 50% of the circumference of the bowel wall, if multiple perforations occur in a short segment of bowel, or if there is vascular compromise to a segment of bowel. Adequate perfusion to the bowel usually is indicated by a pink serosal surface. If the serosa remains dark or dusky and fails to become pink after several minutes of observation, vascular compromise is likely and resection is preferred.

If there is doubt about the blood supply to the bowel, give 1 g fluorescein intravenously and inspect the bowel under ultraviolet light (Wood’s lamp). Normal vascularized bowel will have a homogenous yellow-green appearance. Patchy fluorescence or areas without any fluorescence are evidence of ischemia.

To drain or not to drain

Because perforation and resection both involve entry into the bowel lumen, some degree of spillage is inevitable. This is of greater concern when the large bowel is involved, because of the increased likelihood of bacterial contamination. Immediate copious irrigation of the peritoneal cavity is indicated. Also consider a pelvic drain, especially when dissection has been extensive or raw surfaces are oozing.

The combination of bacterial contamination and free peritoneal blood in the pelvis increases the risk for infection. A strategically placed, half-inch Jackson Pratt drain (or a similar device) may help prevent abscess. In the event of anastomotic leakage, a drain often allows for a controlled enterocutaneous fistula to be managed without reoperation.

Some surgeons have satisfactory results without these drainage techniques.

When to begin postop feeding: Depends on type of repair

Opinion varies about the appropriate time to commence feeding after major abdominal surgery, particularly bowel surgery. Over the past decade, with the pressure to discharge patients earlier, many physicians have opted for earlier timing.

Traditionally, feeding was withheld until bowel sounds were auscultated; then it progressed slowly. Today many surgeons advance the diet much more quickly, with little or no delay in recovery. Fanning and Andrews9 demonstrated that early feeding does not increase the incidence of anastomotic leakage, dehiscence, or aspiration pneumonia—although it is associated with increased emesis.

Patients undergoing surgery for relatively minor injuries can have their diet advanced as if there were no intestinal involvement.

Feeding after minor repairs. When the surgery has involved relatively minor injuries, such as isolated serosal tears and adhesiolysis, nasogastric tube placement is not required. These patients can have their diet advanced as if there were no intestinal involvement. Give clear liquids when bowel sounds are heard and, if tolerated, advance to solids. It is probably not necessary to await a bowel movement before discharging the patient; she can be released once flatus is passed.

Substantial repairs. When major injuries have been repaired, such as with a large perforation repair or bowel resection, it is prudent to proceed more slowly.

Place a nasogastric tube to minimize bowel distention and subsequent leakage from the repair site. Give the patient nothing by mouth until bowel sounds are clearly present and flatus is passed. Then clamp the nasogastric tube for 24 hours, remove it, and institute clear liquids, provided there is no nausea, vomiting, or distension. Advance to full liquids and then solids, tailoring this process to the patient. When she can tolerate a regular diet, with substantial passage of flatus or bowel movement, recovery is signaled.

 

 

Need for additional training

The techniques necessary to manage simple bowel injury are not difficult to master. However, Ob/Gyn residency programs need to extend training in this area. Additional rotations on the general surgery or trauma services as second- or third-year residents would be ideal, but the use of animal laboratories is a good alternative.

The authors report no financial relationships relevant to this article.

References

1. Burke P, Mealy K, Gillen P, Joyce W, Traynor O, Hyland J. Requirement for bowel preparation in colorectal surgery. Br J Surg. 1994;81:907-910.

2. Miettinen RPJ, Laitinen ST, Makela JT, Paakkonen ME. Bowel preparation with oral polyethylene glycol electrolyte solution vs. no preparation in elective open colorectal surgery. Dis Colon Rectum. 2000;43:669-677.

3. Zmora O, Pikarsky AJ, Wexner SD. Bowel preparation for colorectal surgery. Dis Colon Rectum. 2001;44:1537-1547.

4. Nichols RL, Smith JW, Garcia RY, Waterman RS, Holmes JWC. Current practices of preoperative bowel preparation among North American colorectal surgeons. Clin Infect Dis. 1997;24:609-619.

5. Rock JA, Jones HW. Intestinal tract in gynecologic surgery. In: TeLinde RW, Rock JA, Jones HW, eds. Telinde’s Operative Gynecology. 9th ed. Philadelphia: Lippincott Williams & Wilkins; 2003;1239-1272.

6. Krebs H. Intestinal injury in gynecologic surgery: a ten-year experience. Am J Obstet Gynecol. 1986;155:509-514.

7. Van Der Krabben AA, Dukstra FR, Nieuwenhuijzen M, Reijnen M, Schaapveld M, Van Der Goor H. Morbidity and mortality of inadvertent enterotomy during adhesiotomy. Br J Surg. 2000;87:467-471.

8. Monk BJ, Berman ML, Montz FJ. Adhesions after extensive gynecologic surgery: clinical significance, etiology, and prevention. Am J Obstet Gynecol. 1994;170:1396-1403.

9. Fanning J, Andrews S. Early postoperative feeding after major gynecologic surgery: evidence-based scientific medicine. Am J Obstet Gynecol. 2001;185:1-4.

References

1. Burke P, Mealy K, Gillen P, Joyce W, Traynor O, Hyland J. Requirement for bowel preparation in colorectal surgery. Br J Surg. 1994;81:907-910.

2. Miettinen RPJ, Laitinen ST, Makela JT, Paakkonen ME. Bowel preparation with oral polyethylene glycol electrolyte solution vs. no preparation in elective open colorectal surgery. Dis Colon Rectum. 2000;43:669-677.

3. Zmora O, Pikarsky AJ, Wexner SD. Bowel preparation for colorectal surgery. Dis Colon Rectum. 2001;44:1537-1547.

4. Nichols RL, Smith JW, Garcia RY, Waterman RS, Holmes JWC. Current practices of preoperative bowel preparation among North American colorectal surgeons. Clin Infect Dis. 1997;24:609-619.

5. Rock JA, Jones HW. Intestinal tract in gynecologic surgery. In: TeLinde RW, Rock JA, Jones HW, eds. Telinde’s Operative Gynecology. 9th ed. Philadelphia: Lippincott Williams & Wilkins; 2003;1239-1272.

6. Krebs H. Intestinal injury in gynecologic surgery: a ten-year experience. Am J Obstet Gynecol. 1986;155:509-514.

7. Van Der Krabben AA, Dukstra FR, Nieuwenhuijzen M, Reijnen M, Schaapveld M, Van Der Goor H. Morbidity and mortality of inadvertent enterotomy during adhesiotomy. Br J Surg. 2000;87:467-471.

8. Monk BJ, Berman ML, Montz FJ. Adhesions after extensive gynecologic surgery: clinical significance, etiology, and prevention. Am J Obstet Gynecol. 1994;170:1396-1403.

9. Fanning J, Andrews S. Early postoperative feeding after major gynecologic surgery: evidence-based scientific medicine. Am J Obstet Gynecol. 2001;185:1-4.

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4 global ablation devices: Efficacy, indications, and technique

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4 global ablation devices: Efficacy, indications, and technique

KEY POINTS

  • These techniques are easy to learn and use, and offer results comparable to rollerball procedures. Selected patients can be treated successfully in the office setting.
  • It is is vital that the patient have a reliable and permanent form of contraception, such as tubal ligation or vasectomy.
  • Long-term complications, though rare, include endometrial hyperplasia and occult endometrial carcinoma.
Endometrial tissues have amazing regenerative properties, with a controlled growth rate exceeding that of all known tumors. Within days of onset of menses, under appropriate estrogen stimulation, the endometrial surface “repairs” and “rebuilds”—from the basalis layer on up—rapidly achieving a thickness of 8 to 10 mm.

Thus, attempts to destroy it and achieve amenorrhea have met with limited success.

Hysterectomy is still the definitive treatment for excessive uterine bleeding, but a more conservative treatment, ablation, uses surgical or chemical means to obliterate the endometrial surface. Newer devices (FDA approved since 1997) allow office-based or same-day surgery; recovery time is shorter, and complication rates are lower than for hysterectomy.

This approach has gained popularity as instrumentation has improved; yet, because the endometrial surface is so resilient, success rates fall well shy of 100%. This article summaries the data on efficacy, and describes the indications, preoperative evaluation, and technique for 4 ablation options:

  • thermal balloon ablation
  • thermal fluid ablation
  • cryotherapy
  • impedance-controlled ablation

Other modalities include microwave, laser, and a progestin-releasing intrauterine contraception system.

Each uses a different energy-transfer technique to destroy the endometrium ( TABLE).

TABLE

4 global ablation devices at a glance

 THERMAL BALLOON (THERMACHOICE)THERMAL FLUID (HYDROTHERMABLATOR)CRYOTHERAPY (HER OPTION)IMPEDANCE-CONTROLLED (NOVASURE)
PretreatmentYesYesYesNo
Time of energy delivery8 minutes10 minutes10–12 minutes90–120 seconds
Cornual ablationNoYesUser-dependentYes
PrincipleBalloon filled with fluid (5% dextrose in water) at 87°CHydrothermal circulation of saline at 90°CProbe with transfer media creates ice ball at –100 to –120°CBipolar, radiofrequency ablation at 100°C
Direct visualizationNoneHysteroscopyUltrasound guidanceNone
Safety featuresPressure and temperature-sensing cutoffsFluid loss detection systemUltrasound guidanceUterine cavity integrity assessment system

Indications

The typical candidate for endometrial ablation has heavy menses requiring excessive sanitary protection (eg, tampon and pad simultaneously); her daily activity frequently is limited. The patient may have tried such management as nonsteroidal anti-inflammatory agents, oral contraceptives, or surgical dilatation and curettage (D&C) without success.

Excessive or abnormal uterine bleeding is defined as blood loss exceeding 80 mL per menses or a menstrual flow longer than 7 days. Abnormal uterine bleeding affects 22% of women of reproductive age.1 Each year in the United States, approximately 180,000 women undergo hysterectomy for this indication.2

The optimal patient for endometrial ablation has a history of regular menses without excessive dysmenorrhea, which could suggest an underlying diagnosis of adenomyosis. (Findings suggestive of this difficult-to-diagnose condition include a tender, soft, boggy uterus at the time of menses.) Many women with adenomyosis fail to achieve adequate pain relief with endometrial ablation alone and eventually require a hysterectomy.

The patient should have completed childbearing and have a permanent method of contraception in place—endometrial ablation only reduces fertility, it does not eliminate it.

Preoperative evaluation

Laboratory studies include a complete blood count and urine human chorionic gonadotropin level, as well as screening for bleeding disorders when indicated.

A bleeding diary helps quantify symptoms. Its use should be encouraged.

Other tests and examinations. Also recommended are endometrial biopsy, a Pap test, and assessment of the endometrial cavity via hysteroscopy or sonohysterography.

Biopsy should reflect histologically normal tissue. The patient should have:

  • regular menstrual cycles lasting 25 to 34 days
  • no uterine anomaly or potential myometrial wall defect from a previous classical cesarean or transmural myomectomy
Preparing the endometrium. After careful patient selection and appropriate counseling for the procedure, preoperative preparation of the endometrium may be required, depending on the technique chosen. For example, thermal fluid ablation requires pretreatment with a gonadotropin-releasing hormone (GnRH) agonist or suction curettage. The most widely used preparation methods are hormonal treatment with GnRH agonists over 2 menstrual cycles, and suction D&C.

Contraindications

Anovulatory patients may not be good candidates because islands of endometrial tissue can remain after ablation. These tissue “nests” may spontaneously change to hyperplasia or endometrial carcinoma (due to unopposed estrogen). Further, uterine bleeding may not always occur when hyperplasia is present after endometrial ablation, delaying this serious diagnosis.

Relative contraindications include intramural or submucosal uterine myomas.

Earlier techniques: Hysteroscopic ablation

Techniques developed earlier require expert operative hysteroscopic skills and should be performed by experienced gynecologic surgeons to minimize complications.

For example, the first treatment of menorrhagia using a hysteroscopic approach with a Nd:YAG laser power source, reported in 1981 by Goldrath et al,3 utilized 55 watts of power with a 600-micron fiber dragged across the endometrium. Later, other surgeons used a rollerball unipolar electrode that coagulated the surface with continuous contact.4,5

 

 

Modifications of this technique included a loop electrode that used monopolar electrical energy to “shave” the thicker portions of endometrium. In some reports, the rollerball electrode was used to reach the uterine cornu and endocoagulate the lower uterine segments. The most successful reports of this approach used a loop electrode to shave the endometrium followed by rollerball coagulation of the shaved areas. Amenorrhea rates with these techniques approached 60%.

Thermal balloon ablation

ThermaChoice (Gynecare, Somerville, NJ), the first global-ablation device to be marketed, was FDA-approved in 1997.6,7 It is a single-use balloon that is filled with fluid (5% dextrose and water) and inflated to a pressure of 180 mm Hg.

Technique. After general or regional anesthesia and prior to balloon insertion, remove the superficial endometrium by suction curettage.

The balloon contains a central heating element that warms the fluid to 87°C for 8 minutes via electronic control. Pressure within the balloon must be stabilized within the uterine cavity.

Safety features include a pressure shut-off device that activates at 210 mm Hg or higher and 45 mm Hg or below. The procedure is terminated if the temperature exceeds 95°C or falls below 75°C.

Caveats. The device may not function optimally if the cavity is irregular. In addition, it may not destroy residual and endometrial tissue in cornual regions of the uterus.

Postoperative response. Patients have reported increased uterine pain secondary to release of prostaglandins and other tissue factors that may increase uterine contractility.

What the data show. In a series of 296 patients followed for 1 year, 88% reported decreased flow and 14% achieved amenorrhea.6 Meyer et al7 compared thermal balloon ablation with the rollerball technique and found an amenorrhea rate of 27% with rollerball and 15% with the balloon. Patient satisfaction remained high in both groups: 87% for rollerball versus 86% with the balloon.

More recently, 5- and 7-year follow-up studies have been published. At 5-year follow-up, Loffer and Grainger8 concluded that thermal balloon ablation therapy was an effective treatment of menorrhagia in premenopausal women, with clinical outcomes similar to rollerball ablation. Patient satisfaction was noted in 93% of women treated with thermal balloon ablation and 100% of those treated with rollerball ablation. A 7-year multicenter follow-up study of thermal balloon therapy defined avoidance of hysterectomy as the primary outcome.9 Overall, the probability of avoiding any surgery was 75% at 6.5 or 7 years.

Thermal fluid ablation

The HydroThermAblator (Boston Scientific, Natick, Mass) is similar to the balloon. It delivers heated saline at 90°C directly to the uterine cavity under hysteroscopic guidance.10 This solution is circulated at gravity pressure so that it remains in the uterine cavity and does not flow out the fallopian tubes into the peritoneal cavity. Approximately 10 minutes is required for the procedure.

Preparation is via GnRH-agonist hormonal suppression or a suction D&C.

Technique. Following regional or general anesthesia, the uterus is sounded and the endocervical canal dilated sufficiently to insert the operative hysteroscope. After inspection of the uterine cavity by direct visualization via the hysteroscope/TV monitor, the tubing that delivers the heated saline is connected to the operative hysteroscope to perform the ablation. The procedure takes place under direct visualization.

Safety features include automatic shutdown if there is a 10-mL fluid loss or an increase in fluid accumulation in excess of 20 mL.

What the data show. At 12 months, 1 trial reported an amenorrhea rate of 50%, hypomenorrhea of 39%, and eumenorrhea of 5.5%.11

Cryotherapy

The Her Option cryoablation system (American Medical Systems, Minnetonka, Minn) involves insertion of a cryoprobe into the uterine cavity, cooling it to –100 to –120°C to form an ice ball, and destroying adjacent endometrium.

Preparation is via preoperative hormonal suppression with a GnRH agonist.

Abdominal ultrasound monitoring is necessary for insertion of the cryoprobe and ice ball formation.

Technique. In some patients, multiple ice balls may be needed to thoroughly ablate the endometrial cavity, which can prolong the procedure.

What the data show. A multicenter randomized trial comparing durability of treatment effects after endometrial cryoablation versus rollerball electroablation for abnormal uterine bleeding found 94% of patients (n = 94) free of abnormal uterine bleeding at 24 months of follow-up, compared to 93% of rollerball electroablation patients (n = 43).12

Impedance-controlled endometrial ablation

The NovaSure device (Novacept, Palo Alto, Calif) consists of a hand-held, disposable, 3-dimensional ablation wand that functions as a bipolar electrode. It is constructed of gold-plated fabric mesh mounted on a metal wire frame.

Treatment time. The procedure can be completed in less than 120 seconds. Because it is so quick, this technique can be accomplished with paracervical blockade and conscious sedation in suitable patients.

 

 

Pretreatment is not necessary. The procedure can be performed any time during the menstrual cycle.

Technique. After measuring the uterine cavity with a sound, insert and deploy the wand. Because it is flexible, it will make contact with and conform to the shape of the uterine cavity. Ablation depth is controlled by tissue impedance (electrical resistance).

As the wand makes contact with the endometrial surface, tissue is vaporized, and vapors are evacuated from the uterine cavity by continuous suction—which also brings additional endometrial tissue layers into contact with the bipolar electrode. As the device reaches myometrial tissue, resistance increases to a preset threshold and the device automatically shuts down.

The ablation electrode is configured so that the ablation zone in the lower uterine segment and corneal region will not exceed 2 mm; in the miduterine cavity, meanwhile, it reaches a depth of 5 to 7 mm.

Safety features. If inadvertent perforation occurs before the treatment cycle begins, the device will not activate.

What the data show. In a large multicenter clinical trial of 265 patients followed for 12 months, 41% reported amenorrhea and 88% eumenorrhea or hypomenorrhea.13

Other techniques

Microwave. Novel endometrial ablation techniques include use of microwave energies delivered to the uterine cavity via an 8-mm probe (Microsoulis, Waterloo, UK).14

Laser. A procedure known as endometrial laser intrauterine thermal therapy, or ELITT,15 delivers laser energy via a tri-fibershaped intrauterine device.

Progestin-releasing intrauterine system. Recently, the medical treatment of excessive uterine bleeding has been advanced by the levonorgestrel-releasing intrauterine device, approved by the FDA in 2000 for intrauterine contraception. The Mirena device (Berlex, Montville, NJ) has a Pearl index of 0.11 and is more reliable than tubal ligation. It can induce endometrial thinning and reduce menstrual blood loss by as much as 90%. When Mirena was compared with rollerball endometrial ablation, it was more effective in reducing menstrual blood loss and had similar satisfaction rates.16 No doubt future trials will compare Mirena with the newer ablation devices.

Complications and long-term considerations

Short-term complications, which are rare, include uterine perforation, low-grade endometritis, cervical stenosis, hematometra, and pelvic infection. These problems can be minimized by giving preoperative antibiotics and reducing tissue destruction in the lower uterine segment and cervix.

Long-term complications. Development of occult endometrial carcinoma in islands of endometrial tissue is a remote possibility. The likelihood of this rare occurrence remains low if the patient is ovulatory. Once a woman transitions into menopause and desires hormone therapy, a progestin should be included in treatment to reduce the risk of endometrial hyperplasia.

Pregnancy after endometrial ablation has been reported even in the absence of significant amounts of normal endometrial tissue.17 Thus, it is vital that the patient have a reliable and permanent form of contraception, such as tubal ligation or vasectomy.

Failure rates. Long-term failure rates in women undergoing ablation are not known, but clinical trials exploring the issue are under way.18

Dr. Brzozowski is a speaker for Novasure. Dr. Liu reports no financial relationships relevant to this article.

References

1. Shah A, Grainger D. Contemporary concepts in managing menorrhagia. Medscape General Medicine. December 24, 1996. Available at http://www.medscape.com/Medscape/viewarticle/408831. Accessed June 16, 2004.

2. Sculpher M, Bryan S, Dwyer N, Hutton J, Stirrat G. An economic evaluation of transcervical endometrial resection versus abdominal hysterectomy for the treatment of menorrhagia. Br J Obstet Gynecol. 1993;100:244-252.

3. Goldrath MH, Fuller TA, Segal S. Laser photo vaporization of the endometrium for the treatment of menorrhagia. Am J Obstet Gynecol. 1981;140:14-19.

4. Vancaillie TG. Electrocoagulation of the endometrium with the ball-end resectoscope. Obstet Gynecol. 1989;74:425-427.

5. Townsend DE, Richart RM, Paskowitz RA, Woolfork RE. “Rollerball” coagulation of the endometrium. Obstet Gynecol. 1990;76:310-313.

6. Amso NN, Stabinsky SA, McFaul P, Blanc B, Pendley L, Neuwirth R. Uterine thermal balloon therapy for the treatment of menorrhagia: the first 300 patients from a multi-centered study. Br J Obstet Gynaecol. 1998;105:517-523.

7. Meyer WR, Walsh BW, Grainger DA, Peacock LM, Loffer FD, Steege JF. Thermal balloon and rollerball to treat menorrhagia: a multicenter comparison. Obstet Gynecol. 1998;92:98-103.

8. Loffer FD, Grainger D. Five-year follow-up of patients participating in a randomized trial of uterine balloon therapy versus rollerball ablation for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9:429-435.

9. Amso NN, Fernandez H, Vilos G, et al. Uterine endometrial thermal balloon therapy for the treatment of menorrhagia: long-term multicenter follow-up study. Hum Reprod. 2003;18:1082-1087.

10. Corson S. A multicenter evaluation of endometrial ablation by HydroThermAblator and rollerball for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2001;8:359-367.

11. Romer T, Muller J. A simple method of coagulating endometrium in patients with therapy-resistant recurring hypermenorrhea. J Am Assoc Gynecol Laparosc. 1999;6:265-268.

12. Townsend DE, Duleba AJ, Wilkes MM. Durability of treatment effects after endometrial cryoablation versus rollerball electroablation for abnormal uterine bleeding: two-year results of a multicenter randomized trial. Am J Obstet Gynecol. 2003;188:699-701.

13. Cooper J, Gimpelson R, Laberge P, et al. A randomized, multicenter trial of safety and efficacy of the NovaSure System in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9:418-428.

14. Bain C, Cooper K, Parkin D. Microwave endometrial ablation versus endometrial resection: a randomized controlled trial. Obstet Gynecol. 2002;99:983-987.

15. Donnez J, Polet R, Rabinovitz R, Ak M, Squiffler J, Nisolle M. Endometrial laser intrauterine thermotherapy: the first series of 100 patients observed for 1 year. Fertil Steril. 2000;74:791-796.

16. Lethaby A, Cooke I, Rees M. Progesterone/progestogen releasing intrauterine systems versus either placebo or any other medications for heavy menstrual bleeding. Cochrane Database System Rev. 2000;CD002126.-

17. Cook JR, Seman EI. Pregnancy following endometrial ablation: case history and literature review. Obstet Gynecol Survey. 2003;58:551-556.

18. Dickersin K, Munro M, Langenberg P, et al. Surgical treatments outcomes project for dysfunctional uterine bleeding (STOP-DUB): design and methods. Clinical Trials. 2003;24:591-609.

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PHILLIP BRZOZOWSKI, MD
JAMES H. LIU, MD
Dr. Brzozowski is clinical assistant professor and Dr. Liu is the Arthur H. Bill Professor and Chair, department of reproductive biology, Case Western Reserve University, department of obstetrics and gynecology, MacDonald Womens Hospital, University Hospitals of Cleveland, Ohio.

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JAMES H. LIU, MD
Dr. Brzozowski is clinical assistant professor and Dr. Liu is the Arthur H. Bill Professor and Chair, department of reproductive biology, Case Western Reserve University, department of obstetrics and gynecology, MacDonald Womens Hospital, University Hospitals of Cleveland, Ohio.

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KEY POINTS

  • These techniques are easy to learn and use, and offer results comparable to rollerball procedures. Selected patients can be treated successfully in the office setting.
  • It is is vital that the patient have a reliable and permanent form of contraception, such as tubal ligation or vasectomy.
  • Long-term complications, though rare, include endometrial hyperplasia and occult endometrial carcinoma.
Endometrial tissues have amazing regenerative properties, with a controlled growth rate exceeding that of all known tumors. Within days of onset of menses, under appropriate estrogen stimulation, the endometrial surface “repairs” and “rebuilds”—from the basalis layer on up—rapidly achieving a thickness of 8 to 10 mm.

Thus, attempts to destroy it and achieve amenorrhea have met with limited success.

Hysterectomy is still the definitive treatment for excessive uterine bleeding, but a more conservative treatment, ablation, uses surgical or chemical means to obliterate the endometrial surface. Newer devices (FDA approved since 1997) allow office-based or same-day surgery; recovery time is shorter, and complication rates are lower than for hysterectomy.

This approach has gained popularity as instrumentation has improved; yet, because the endometrial surface is so resilient, success rates fall well shy of 100%. This article summaries the data on efficacy, and describes the indications, preoperative evaluation, and technique for 4 ablation options:

  • thermal balloon ablation
  • thermal fluid ablation
  • cryotherapy
  • impedance-controlled ablation

Other modalities include microwave, laser, and a progestin-releasing intrauterine contraception system.

Each uses a different energy-transfer technique to destroy the endometrium ( TABLE).

TABLE

4 global ablation devices at a glance

 THERMAL BALLOON (THERMACHOICE)THERMAL FLUID (HYDROTHERMABLATOR)CRYOTHERAPY (HER OPTION)IMPEDANCE-CONTROLLED (NOVASURE)
PretreatmentYesYesYesNo
Time of energy delivery8 minutes10 minutes10–12 minutes90–120 seconds
Cornual ablationNoYesUser-dependentYes
PrincipleBalloon filled with fluid (5% dextrose in water) at 87°CHydrothermal circulation of saline at 90°CProbe with transfer media creates ice ball at –100 to –120°CBipolar, radiofrequency ablation at 100°C
Direct visualizationNoneHysteroscopyUltrasound guidanceNone
Safety featuresPressure and temperature-sensing cutoffsFluid loss detection systemUltrasound guidanceUterine cavity integrity assessment system

Indications

The typical candidate for endometrial ablation has heavy menses requiring excessive sanitary protection (eg, tampon and pad simultaneously); her daily activity frequently is limited. The patient may have tried such management as nonsteroidal anti-inflammatory agents, oral contraceptives, or surgical dilatation and curettage (D&C) without success.

Excessive or abnormal uterine bleeding is defined as blood loss exceeding 80 mL per menses or a menstrual flow longer than 7 days. Abnormal uterine bleeding affects 22% of women of reproductive age.1 Each year in the United States, approximately 180,000 women undergo hysterectomy for this indication.2

The optimal patient for endometrial ablation has a history of regular menses without excessive dysmenorrhea, which could suggest an underlying diagnosis of adenomyosis. (Findings suggestive of this difficult-to-diagnose condition include a tender, soft, boggy uterus at the time of menses.) Many women with adenomyosis fail to achieve adequate pain relief with endometrial ablation alone and eventually require a hysterectomy.

The patient should have completed childbearing and have a permanent method of contraception in place—endometrial ablation only reduces fertility, it does not eliminate it.

Preoperative evaluation

Laboratory studies include a complete blood count and urine human chorionic gonadotropin level, as well as screening for bleeding disorders when indicated.

A bleeding diary helps quantify symptoms. Its use should be encouraged.

Other tests and examinations. Also recommended are endometrial biopsy, a Pap test, and assessment of the endometrial cavity via hysteroscopy or sonohysterography.

Biopsy should reflect histologically normal tissue. The patient should have:

  • regular menstrual cycles lasting 25 to 34 days
  • no uterine anomaly or potential myometrial wall defect from a previous classical cesarean or transmural myomectomy
Preparing the endometrium. After careful patient selection and appropriate counseling for the procedure, preoperative preparation of the endometrium may be required, depending on the technique chosen. For example, thermal fluid ablation requires pretreatment with a gonadotropin-releasing hormone (GnRH) agonist or suction curettage. The most widely used preparation methods are hormonal treatment with GnRH agonists over 2 menstrual cycles, and suction D&C.

Contraindications

Anovulatory patients may not be good candidates because islands of endometrial tissue can remain after ablation. These tissue “nests” may spontaneously change to hyperplasia or endometrial carcinoma (due to unopposed estrogen). Further, uterine bleeding may not always occur when hyperplasia is present after endometrial ablation, delaying this serious diagnosis.

Relative contraindications include intramural or submucosal uterine myomas.

Earlier techniques: Hysteroscopic ablation

Techniques developed earlier require expert operative hysteroscopic skills and should be performed by experienced gynecologic surgeons to minimize complications.

For example, the first treatment of menorrhagia using a hysteroscopic approach with a Nd:YAG laser power source, reported in 1981 by Goldrath et al,3 utilized 55 watts of power with a 600-micron fiber dragged across the endometrium. Later, other surgeons used a rollerball unipolar electrode that coagulated the surface with continuous contact.4,5

 

 

Modifications of this technique included a loop electrode that used monopolar electrical energy to “shave” the thicker portions of endometrium. In some reports, the rollerball electrode was used to reach the uterine cornu and endocoagulate the lower uterine segments. The most successful reports of this approach used a loop electrode to shave the endometrium followed by rollerball coagulation of the shaved areas. Amenorrhea rates with these techniques approached 60%.

Thermal balloon ablation

ThermaChoice (Gynecare, Somerville, NJ), the first global-ablation device to be marketed, was FDA-approved in 1997.6,7 It is a single-use balloon that is filled with fluid (5% dextrose and water) and inflated to a pressure of 180 mm Hg.

Technique. After general or regional anesthesia and prior to balloon insertion, remove the superficial endometrium by suction curettage.

The balloon contains a central heating element that warms the fluid to 87°C for 8 minutes via electronic control. Pressure within the balloon must be stabilized within the uterine cavity.

Safety features include a pressure shut-off device that activates at 210 mm Hg or higher and 45 mm Hg or below. The procedure is terminated if the temperature exceeds 95°C or falls below 75°C.

Caveats. The device may not function optimally if the cavity is irregular. In addition, it may not destroy residual and endometrial tissue in cornual regions of the uterus.

Postoperative response. Patients have reported increased uterine pain secondary to release of prostaglandins and other tissue factors that may increase uterine contractility.

What the data show. In a series of 296 patients followed for 1 year, 88% reported decreased flow and 14% achieved amenorrhea.6 Meyer et al7 compared thermal balloon ablation with the rollerball technique and found an amenorrhea rate of 27% with rollerball and 15% with the balloon. Patient satisfaction remained high in both groups: 87% for rollerball versus 86% with the balloon.

More recently, 5- and 7-year follow-up studies have been published. At 5-year follow-up, Loffer and Grainger8 concluded that thermal balloon ablation therapy was an effective treatment of menorrhagia in premenopausal women, with clinical outcomes similar to rollerball ablation. Patient satisfaction was noted in 93% of women treated with thermal balloon ablation and 100% of those treated with rollerball ablation. A 7-year multicenter follow-up study of thermal balloon therapy defined avoidance of hysterectomy as the primary outcome.9 Overall, the probability of avoiding any surgery was 75% at 6.5 or 7 years.

Thermal fluid ablation

The HydroThermAblator (Boston Scientific, Natick, Mass) is similar to the balloon. It delivers heated saline at 90°C directly to the uterine cavity under hysteroscopic guidance.10 This solution is circulated at gravity pressure so that it remains in the uterine cavity and does not flow out the fallopian tubes into the peritoneal cavity. Approximately 10 minutes is required for the procedure.

Preparation is via GnRH-agonist hormonal suppression or a suction D&C.

Technique. Following regional or general anesthesia, the uterus is sounded and the endocervical canal dilated sufficiently to insert the operative hysteroscope. After inspection of the uterine cavity by direct visualization via the hysteroscope/TV monitor, the tubing that delivers the heated saline is connected to the operative hysteroscope to perform the ablation. The procedure takes place under direct visualization.

Safety features include automatic shutdown if there is a 10-mL fluid loss or an increase in fluid accumulation in excess of 20 mL.

What the data show. At 12 months, 1 trial reported an amenorrhea rate of 50%, hypomenorrhea of 39%, and eumenorrhea of 5.5%.11

Cryotherapy

The Her Option cryoablation system (American Medical Systems, Minnetonka, Minn) involves insertion of a cryoprobe into the uterine cavity, cooling it to –100 to –120°C to form an ice ball, and destroying adjacent endometrium.

Preparation is via preoperative hormonal suppression with a GnRH agonist.

Abdominal ultrasound monitoring is necessary for insertion of the cryoprobe and ice ball formation.

Technique. In some patients, multiple ice balls may be needed to thoroughly ablate the endometrial cavity, which can prolong the procedure.

What the data show. A multicenter randomized trial comparing durability of treatment effects after endometrial cryoablation versus rollerball electroablation for abnormal uterine bleeding found 94% of patients (n = 94) free of abnormal uterine bleeding at 24 months of follow-up, compared to 93% of rollerball electroablation patients (n = 43).12

Impedance-controlled endometrial ablation

The NovaSure device (Novacept, Palo Alto, Calif) consists of a hand-held, disposable, 3-dimensional ablation wand that functions as a bipolar electrode. It is constructed of gold-plated fabric mesh mounted on a metal wire frame.

Treatment time. The procedure can be completed in less than 120 seconds. Because it is so quick, this technique can be accomplished with paracervical blockade and conscious sedation in suitable patients.

 

 

Pretreatment is not necessary. The procedure can be performed any time during the menstrual cycle.

Technique. After measuring the uterine cavity with a sound, insert and deploy the wand. Because it is flexible, it will make contact with and conform to the shape of the uterine cavity. Ablation depth is controlled by tissue impedance (electrical resistance).

As the wand makes contact with the endometrial surface, tissue is vaporized, and vapors are evacuated from the uterine cavity by continuous suction—which also brings additional endometrial tissue layers into contact with the bipolar electrode. As the device reaches myometrial tissue, resistance increases to a preset threshold and the device automatically shuts down.

The ablation electrode is configured so that the ablation zone in the lower uterine segment and corneal region will not exceed 2 mm; in the miduterine cavity, meanwhile, it reaches a depth of 5 to 7 mm.

Safety features. If inadvertent perforation occurs before the treatment cycle begins, the device will not activate.

What the data show. In a large multicenter clinical trial of 265 patients followed for 12 months, 41% reported amenorrhea and 88% eumenorrhea or hypomenorrhea.13

Other techniques

Microwave. Novel endometrial ablation techniques include use of microwave energies delivered to the uterine cavity via an 8-mm probe (Microsoulis, Waterloo, UK).14

Laser. A procedure known as endometrial laser intrauterine thermal therapy, or ELITT,15 delivers laser energy via a tri-fibershaped intrauterine device.

Progestin-releasing intrauterine system. Recently, the medical treatment of excessive uterine bleeding has been advanced by the levonorgestrel-releasing intrauterine device, approved by the FDA in 2000 for intrauterine contraception. The Mirena device (Berlex, Montville, NJ) has a Pearl index of 0.11 and is more reliable than tubal ligation. It can induce endometrial thinning and reduce menstrual blood loss by as much as 90%. When Mirena was compared with rollerball endometrial ablation, it was more effective in reducing menstrual blood loss and had similar satisfaction rates.16 No doubt future trials will compare Mirena with the newer ablation devices.

Complications and long-term considerations

Short-term complications, which are rare, include uterine perforation, low-grade endometritis, cervical stenosis, hematometra, and pelvic infection. These problems can be minimized by giving preoperative antibiotics and reducing tissue destruction in the lower uterine segment and cervix.

Long-term complications. Development of occult endometrial carcinoma in islands of endometrial tissue is a remote possibility. The likelihood of this rare occurrence remains low if the patient is ovulatory. Once a woman transitions into menopause and desires hormone therapy, a progestin should be included in treatment to reduce the risk of endometrial hyperplasia.

Pregnancy after endometrial ablation has been reported even in the absence of significant amounts of normal endometrial tissue.17 Thus, it is vital that the patient have a reliable and permanent form of contraception, such as tubal ligation or vasectomy.

Failure rates. Long-term failure rates in women undergoing ablation are not known, but clinical trials exploring the issue are under way.18

Dr. Brzozowski is a speaker for Novasure. Dr. Liu reports no financial relationships relevant to this article.

KEY POINTS

  • These techniques are easy to learn and use, and offer results comparable to rollerball procedures. Selected patients can be treated successfully in the office setting.
  • It is is vital that the patient have a reliable and permanent form of contraception, such as tubal ligation or vasectomy.
  • Long-term complications, though rare, include endometrial hyperplasia and occult endometrial carcinoma.
Endometrial tissues have amazing regenerative properties, with a controlled growth rate exceeding that of all known tumors. Within days of onset of menses, under appropriate estrogen stimulation, the endometrial surface “repairs” and “rebuilds”—from the basalis layer on up—rapidly achieving a thickness of 8 to 10 mm.

Thus, attempts to destroy it and achieve amenorrhea have met with limited success.

Hysterectomy is still the definitive treatment for excessive uterine bleeding, but a more conservative treatment, ablation, uses surgical or chemical means to obliterate the endometrial surface. Newer devices (FDA approved since 1997) allow office-based or same-day surgery; recovery time is shorter, and complication rates are lower than for hysterectomy.

This approach has gained popularity as instrumentation has improved; yet, because the endometrial surface is so resilient, success rates fall well shy of 100%. This article summaries the data on efficacy, and describes the indications, preoperative evaluation, and technique for 4 ablation options:

  • thermal balloon ablation
  • thermal fluid ablation
  • cryotherapy
  • impedance-controlled ablation

Other modalities include microwave, laser, and a progestin-releasing intrauterine contraception system.

Each uses a different energy-transfer technique to destroy the endometrium ( TABLE).

TABLE

4 global ablation devices at a glance

 THERMAL BALLOON (THERMACHOICE)THERMAL FLUID (HYDROTHERMABLATOR)CRYOTHERAPY (HER OPTION)IMPEDANCE-CONTROLLED (NOVASURE)
PretreatmentYesYesYesNo
Time of energy delivery8 minutes10 minutes10–12 minutes90–120 seconds
Cornual ablationNoYesUser-dependentYes
PrincipleBalloon filled with fluid (5% dextrose in water) at 87°CHydrothermal circulation of saline at 90°CProbe with transfer media creates ice ball at –100 to –120°CBipolar, radiofrequency ablation at 100°C
Direct visualizationNoneHysteroscopyUltrasound guidanceNone
Safety featuresPressure and temperature-sensing cutoffsFluid loss detection systemUltrasound guidanceUterine cavity integrity assessment system

Indications

The typical candidate for endometrial ablation has heavy menses requiring excessive sanitary protection (eg, tampon and pad simultaneously); her daily activity frequently is limited. The patient may have tried such management as nonsteroidal anti-inflammatory agents, oral contraceptives, or surgical dilatation and curettage (D&C) without success.

Excessive or abnormal uterine bleeding is defined as blood loss exceeding 80 mL per menses or a menstrual flow longer than 7 days. Abnormal uterine bleeding affects 22% of women of reproductive age.1 Each year in the United States, approximately 180,000 women undergo hysterectomy for this indication.2

The optimal patient for endometrial ablation has a history of regular menses without excessive dysmenorrhea, which could suggest an underlying diagnosis of adenomyosis. (Findings suggestive of this difficult-to-diagnose condition include a tender, soft, boggy uterus at the time of menses.) Many women with adenomyosis fail to achieve adequate pain relief with endometrial ablation alone and eventually require a hysterectomy.

The patient should have completed childbearing and have a permanent method of contraception in place—endometrial ablation only reduces fertility, it does not eliminate it.

Preoperative evaluation

Laboratory studies include a complete blood count and urine human chorionic gonadotropin level, as well as screening for bleeding disorders when indicated.

A bleeding diary helps quantify symptoms. Its use should be encouraged.

Other tests and examinations. Also recommended are endometrial biopsy, a Pap test, and assessment of the endometrial cavity via hysteroscopy or sonohysterography.

Biopsy should reflect histologically normal tissue. The patient should have:

  • regular menstrual cycles lasting 25 to 34 days
  • no uterine anomaly or potential myometrial wall defect from a previous classical cesarean or transmural myomectomy
Preparing the endometrium. After careful patient selection and appropriate counseling for the procedure, preoperative preparation of the endometrium may be required, depending on the technique chosen. For example, thermal fluid ablation requires pretreatment with a gonadotropin-releasing hormone (GnRH) agonist or suction curettage. The most widely used preparation methods are hormonal treatment with GnRH agonists over 2 menstrual cycles, and suction D&C.

Contraindications

Anovulatory patients may not be good candidates because islands of endometrial tissue can remain after ablation. These tissue “nests” may spontaneously change to hyperplasia or endometrial carcinoma (due to unopposed estrogen). Further, uterine bleeding may not always occur when hyperplasia is present after endometrial ablation, delaying this serious diagnosis.

Relative contraindications include intramural or submucosal uterine myomas.

Earlier techniques: Hysteroscopic ablation

Techniques developed earlier require expert operative hysteroscopic skills and should be performed by experienced gynecologic surgeons to minimize complications.

For example, the first treatment of menorrhagia using a hysteroscopic approach with a Nd:YAG laser power source, reported in 1981 by Goldrath et al,3 utilized 55 watts of power with a 600-micron fiber dragged across the endometrium. Later, other surgeons used a rollerball unipolar electrode that coagulated the surface with continuous contact.4,5

 

 

Modifications of this technique included a loop electrode that used monopolar electrical energy to “shave” the thicker portions of endometrium. In some reports, the rollerball electrode was used to reach the uterine cornu and endocoagulate the lower uterine segments. The most successful reports of this approach used a loop electrode to shave the endometrium followed by rollerball coagulation of the shaved areas. Amenorrhea rates with these techniques approached 60%.

Thermal balloon ablation

ThermaChoice (Gynecare, Somerville, NJ), the first global-ablation device to be marketed, was FDA-approved in 1997.6,7 It is a single-use balloon that is filled with fluid (5% dextrose and water) and inflated to a pressure of 180 mm Hg.

Technique. After general or regional anesthesia and prior to balloon insertion, remove the superficial endometrium by suction curettage.

The balloon contains a central heating element that warms the fluid to 87°C for 8 minutes via electronic control. Pressure within the balloon must be stabilized within the uterine cavity.

Safety features include a pressure shut-off device that activates at 210 mm Hg or higher and 45 mm Hg or below. The procedure is terminated if the temperature exceeds 95°C or falls below 75°C.

Caveats. The device may not function optimally if the cavity is irregular. In addition, it may not destroy residual and endometrial tissue in cornual regions of the uterus.

Postoperative response. Patients have reported increased uterine pain secondary to release of prostaglandins and other tissue factors that may increase uterine contractility.

What the data show. In a series of 296 patients followed for 1 year, 88% reported decreased flow and 14% achieved amenorrhea.6 Meyer et al7 compared thermal balloon ablation with the rollerball technique and found an amenorrhea rate of 27% with rollerball and 15% with the balloon. Patient satisfaction remained high in both groups: 87% for rollerball versus 86% with the balloon.

More recently, 5- and 7-year follow-up studies have been published. At 5-year follow-up, Loffer and Grainger8 concluded that thermal balloon ablation therapy was an effective treatment of menorrhagia in premenopausal women, with clinical outcomes similar to rollerball ablation. Patient satisfaction was noted in 93% of women treated with thermal balloon ablation and 100% of those treated with rollerball ablation. A 7-year multicenter follow-up study of thermal balloon therapy defined avoidance of hysterectomy as the primary outcome.9 Overall, the probability of avoiding any surgery was 75% at 6.5 or 7 years.

Thermal fluid ablation

The HydroThermAblator (Boston Scientific, Natick, Mass) is similar to the balloon. It delivers heated saline at 90°C directly to the uterine cavity under hysteroscopic guidance.10 This solution is circulated at gravity pressure so that it remains in the uterine cavity and does not flow out the fallopian tubes into the peritoneal cavity. Approximately 10 minutes is required for the procedure.

Preparation is via GnRH-agonist hormonal suppression or a suction D&C.

Technique. Following regional or general anesthesia, the uterus is sounded and the endocervical canal dilated sufficiently to insert the operative hysteroscope. After inspection of the uterine cavity by direct visualization via the hysteroscope/TV monitor, the tubing that delivers the heated saline is connected to the operative hysteroscope to perform the ablation. The procedure takes place under direct visualization.

Safety features include automatic shutdown if there is a 10-mL fluid loss or an increase in fluid accumulation in excess of 20 mL.

What the data show. At 12 months, 1 trial reported an amenorrhea rate of 50%, hypomenorrhea of 39%, and eumenorrhea of 5.5%.11

Cryotherapy

The Her Option cryoablation system (American Medical Systems, Minnetonka, Minn) involves insertion of a cryoprobe into the uterine cavity, cooling it to –100 to –120°C to form an ice ball, and destroying adjacent endometrium.

Preparation is via preoperative hormonal suppression with a GnRH agonist.

Abdominal ultrasound monitoring is necessary for insertion of the cryoprobe and ice ball formation.

Technique. In some patients, multiple ice balls may be needed to thoroughly ablate the endometrial cavity, which can prolong the procedure.

What the data show. A multicenter randomized trial comparing durability of treatment effects after endometrial cryoablation versus rollerball electroablation for abnormal uterine bleeding found 94% of patients (n = 94) free of abnormal uterine bleeding at 24 months of follow-up, compared to 93% of rollerball electroablation patients (n = 43).12

Impedance-controlled endometrial ablation

The NovaSure device (Novacept, Palo Alto, Calif) consists of a hand-held, disposable, 3-dimensional ablation wand that functions as a bipolar electrode. It is constructed of gold-plated fabric mesh mounted on a metal wire frame.

Treatment time. The procedure can be completed in less than 120 seconds. Because it is so quick, this technique can be accomplished with paracervical blockade and conscious sedation in suitable patients.

 

 

Pretreatment is not necessary. The procedure can be performed any time during the menstrual cycle.

Technique. After measuring the uterine cavity with a sound, insert and deploy the wand. Because it is flexible, it will make contact with and conform to the shape of the uterine cavity. Ablation depth is controlled by tissue impedance (electrical resistance).

As the wand makes contact with the endometrial surface, tissue is vaporized, and vapors are evacuated from the uterine cavity by continuous suction—which also brings additional endometrial tissue layers into contact with the bipolar electrode. As the device reaches myometrial tissue, resistance increases to a preset threshold and the device automatically shuts down.

The ablation electrode is configured so that the ablation zone in the lower uterine segment and corneal region will not exceed 2 mm; in the miduterine cavity, meanwhile, it reaches a depth of 5 to 7 mm.

Safety features. If inadvertent perforation occurs before the treatment cycle begins, the device will not activate.

What the data show. In a large multicenter clinical trial of 265 patients followed for 12 months, 41% reported amenorrhea and 88% eumenorrhea or hypomenorrhea.13

Other techniques

Microwave. Novel endometrial ablation techniques include use of microwave energies delivered to the uterine cavity via an 8-mm probe (Microsoulis, Waterloo, UK).14

Laser. A procedure known as endometrial laser intrauterine thermal therapy, or ELITT,15 delivers laser energy via a tri-fibershaped intrauterine device.

Progestin-releasing intrauterine system. Recently, the medical treatment of excessive uterine bleeding has been advanced by the levonorgestrel-releasing intrauterine device, approved by the FDA in 2000 for intrauterine contraception. The Mirena device (Berlex, Montville, NJ) has a Pearl index of 0.11 and is more reliable than tubal ligation. It can induce endometrial thinning and reduce menstrual blood loss by as much as 90%. When Mirena was compared with rollerball endometrial ablation, it was more effective in reducing menstrual blood loss and had similar satisfaction rates.16 No doubt future trials will compare Mirena with the newer ablation devices.

Complications and long-term considerations

Short-term complications, which are rare, include uterine perforation, low-grade endometritis, cervical stenosis, hematometra, and pelvic infection. These problems can be minimized by giving preoperative antibiotics and reducing tissue destruction in the lower uterine segment and cervix.

Long-term complications. Development of occult endometrial carcinoma in islands of endometrial tissue is a remote possibility. The likelihood of this rare occurrence remains low if the patient is ovulatory. Once a woman transitions into menopause and desires hormone therapy, a progestin should be included in treatment to reduce the risk of endometrial hyperplasia.

Pregnancy after endometrial ablation has been reported even in the absence of significant amounts of normal endometrial tissue.17 Thus, it is vital that the patient have a reliable and permanent form of contraception, such as tubal ligation or vasectomy.

Failure rates. Long-term failure rates in women undergoing ablation are not known, but clinical trials exploring the issue are under way.18

Dr. Brzozowski is a speaker for Novasure. Dr. Liu reports no financial relationships relevant to this article.

References

1. Shah A, Grainger D. Contemporary concepts in managing menorrhagia. Medscape General Medicine. December 24, 1996. Available at http://www.medscape.com/Medscape/viewarticle/408831. Accessed June 16, 2004.

2. Sculpher M, Bryan S, Dwyer N, Hutton J, Stirrat G. An economic evaluation of transcervical endometrial resection versus abdominal hysterectomy for the treatment of menorrhagia. Br J Obstet Gynecol. 1993;100:244-252.

3. Goldrath MH, Fuller TA, Segal S. Laser photo vaporization of the endometrium for the treatment of menorrhagia. Am J Obstet Gynecol. 1981;140:14-19.

4. Vancaillie TG. Electrocoagulation of the endometrium with the ball-end resectoscope. Obstet Gynecol. 1989;74:425-427.

5. Townsend DE, Richart RM, Paskowitz RA, Woolfork RE. “Rollerball” coagulation of the endometrium. Obstet Gynecol. 1990;76:310-313.

6. Amso NN, Stabinsky SA, McFaul P, Blanc B, Pendley L, Neuwirth R. Uterine thermal balloon therapy for the treatment of menorrhagia: the first 300 patients from a multi-centered study. Br J Obstet Gynaecol. 1998;105:517-523.

7. Meyer WR, Walsh BW, Grainger DA, Peacock LM, Loffer FD, Steege JF. Thermal balloon and rollerball to treat menorrhagia: a multicenter comparison. Obstet Gynecol. 1998;92:98-103.

8. Loffer FD, Grainger D. Five-year follow-up of patients participating in a randomized trial of uterine balloon therapy versus rollerball ablation for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9:429-435.

9. Amso NN, Fernandez H, Vilos G, et al. Uterine endometrial thermal balloon therapy for the treatment of menorrhagia: long-term multicenter follow-up study. Hum Reprod. 2003;18:1082-1087.

10. Corson S. A multicenter evaluation of endometrial ablation by HydroThermAblator and rollerball for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2001;8:359-367.

11. Romer T, Muller J. A simple method of coagulating endometrium in patients with therapy-resistant recurring hypermenorrhea. J Am Assoc Gynecol Laparosc. 1999;6:265-268.

12. Townsend DE, Duleba AJ, Wilkes MM. Durability of treatment effects after endometrial cryoablation versus rollerball electroablation for abnormal uterine bleeding: two-year results of a multicenter randomized trial. Am J Obstet Gynecol. 2003;188:699-701.

13. Cooper J, Gimpelson R, Laberge P, et al. A randomized, multicenter trial of safety and efficacy of the NovaSure System in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9:418-428.

14. Bain C, Cooper K, Parkin D. Microwave endometrial ablation versus endometrial resection: a randomized controlled trial. Obstet Gynecol. 2002;99:983-987.

15. Donnez J, Polet R, Rabinovitz R, Ak M, Squiffler J, Nisolle M. Endometrial laser intrauterine thermotherapy: the first series of 100 patients observed for 1 year. Fertil Steril. 2000;74:791-796.

16. Lethaby A, Cooke I, Rees M. Progesterone/progestogen releasing intrauterine systems versus either placebo or any other medications for heavy menstrual bleeding. Cochrane Database System Rev. 2000;CD002126.-

17. Cook JR, Seman EI. Pregnancy following endometrial ablation: case history and literature review. Obstet Gynecol Survey. 2003;58:551-556.

18. Dickersin K, Munro M, Langenberg P, et al. Surgical treatments outcomes project for dysfunctional uterine bleeding (STOP-DUB): design and methods. Clinical Trials. 2003;24:591-609.

References

1. Shah A, Grainger D. Contemporary concepts in managing menorrhagia. Medscape General Medicine. December 24, 1996. Available at http://www.medscape.com/Medscape/viewarticle/408831. Accessed June 16, 2004.

2. Sculpher M, Bryan S, Dwyer N, Hutton J, Stirrat G. An economic evaluation of transcervical endometrial resection versus abdominal hysterectomy for the treatment of menorrhagia. Br J Obstet Gynecol. 1993;100:244-252.

3. Goldrath MH, Fuller TA, Segal S. Laser photo vaporization of the endometrium for the treatment of menorrhagia. Am J Obstet Gynecol. 1981;140:14-19.

4. Vancaillie TG. Electrocoagulation of the endometrium with the ball-end resectoscope. Obstet Gynecol. 1989;74:425-427.

5. Townsend DE, Richart RM, Paskowitz RA, Woolfork RE. “Rollerball” coagulation of the endometrium. Obstet Gynecol. 1990;76:310-313.

6. Amso NN, Stabinsky SA, McFaul P, Blanc B, Pendley L, Neuwirth R. Uterine thermal balloon therapy for the treatment of menorrhagia: the first 300 patients from a multi-centered study. Br J Obstet Gynaecol. 1998;105:517-523.

7. Meyer WR, Walsh BW, Grainger DA, Peacock LM, Loffer FD, Steege JF. Thermal balloon and rollerball to treat menorrhagia: a multicenter comparison. Obstet Gynecol. 1998;92:98-103.

8. Loffer FD, Grainger D. Five-year follow-up of patients participating in a randomized trial of uterine balloon therapy versus rollerball ablation for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9:429-435.

9. Amso NN, Fernandez H, Vilos G, et al. Uterine endometrial thermal balloon therapy for the treatment of menorrhagia: long-term multicenter follow-up study. Hum Reprod. 2003;18:1082-1087.

10. Corson S. A multicenter evaluation of endometrial ablation by HydroThermAblator and rollerball for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2001;8:359-367.

11. Romer T, Muller J. A simple method of coagulating endometrium in patients with therapy-resistant recurring hypermenorrhea. J Am Assoc Gynecol Laparosc. 1999;6:265-268.

12. Townsend DE, Duleba AJ, Wilkes MM. Durability of treatment effects after endometrial cryoablation versus rollerball electroablation for abnormal uterine bleeding: two-year results of a multicenter randomized trial. Am J Obstet Gynecol. 2003;188:699-701.

13. Cooper J, Gimpelson R, Laberge P, et al. A randomized, multicenter trial of safety and efficacy of the NovaSure System in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9:418-428.

14. Bain C, Cooper K, Parkin D. Microwave endometrial ablation versus endometrial resection: a randomized controlled trial. Obstet Gynecol. 2002;99:983-987.

15. Donnez J, Polet R, Rabinovitz R, Ak M, Squiffler J, Nisolle M. Endometrial laser intrauterine thermotherapy: the first series of 100 patients observed for 1 year. Fertil Steril. 2000;74:791-796.

16. Lethaby A, Cooke I, Rees M. Progesterone/progestogen releasing intrauterine systems versus either placebo or any other medications for heavy menstrual bleeding. Cochrane Database System Rev. 2000;CD002126.-

17. Cook JR, Seman EI. Pregnancy following endometrial ablation: case history and literature review. Obstet Gynecol Survey. 2003;58:551-556.

18. Dickersin K, Munro M, Langenberg P, et al. Surgical treatments outcomes project for dysfunctional uterine bleeding (STOP-DUB): design and methods. Clinical Trials. 2003;24:591-609.

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