Surgical Techniques

When the suburethral sling was first described in 1907 by von Giordano, it entailed placing autologous tissue underneath the bladder neck and suspending it superiorly. Complications including urethral erosion, infection, bleeding, and fistula formation led many surgeons to use it sparingly.

Fast forward to the 21st century: Synthetic materials and new techniques were introduced, simplifying the sling procedures and raising the long-term success rates to 84%.¹ As a result, slings now stand at the forefront of stress urinary incontinence (SUI) treatment. Among advances are the tension-free vaginal tape (TVT) sling (Gynecare, a division of Ethicon Inc., Somerville, NJ) and the SPARC sling (American Medical Systems, Inc., Minnetonka, Minn). The former, approved in the U.S. in 1998, calls for another look due to of the recent publication of a Cochrane review of outcomes studies, while the latter, approved by the FDA in August 2001, is the newest technique deserving examination. Clearly, with 83,010 incontinence procedures performed in the U.S. in 1999,² a detailed look at the suburethral sling is warranted. Here, we review materials, indications, techniques, complications, and outcomes.

Materials

The choice of material—either organic or synthetic—depends on several factors: availability, cost, patient and surgeon preference, and clinical variables. (TABLE 1) outlines the advantages and disadvantages of each material type. Organic slings include autologous tissues (rectus fascia and fascia lata graft), and allografts or xenografts (cadaveric fascia lata graft, human dermal graft, or porcine small intestine and dermal graft). Synthetic slings are made of polyethylene terephthalate, expanded polytetrafluoroethylene, and polypropylene.

While sling procedures utilizing organic materials do have their benefits, synthetic slings, particularly the polypropylene mesh used in TVT and SPARC, have proven to be a stable material unlikely to deteriorate with time. Further, increased collagen metabolism around this synthetic sling promotes an ingrowth of tissue through the mesh.

TABLE 1

Slings: advantages and disadvantages of various materials

Indications

Suburethral sling procedures are typically used for the treatment of genuine stress urinary incontinence (GSUI), in which the urethra becomes either hypermobile and unstable or its intrinsic sphincter becomes incompetent. In fact, slings are technically easier to place in patients with anatomic urethrovesical junction hypermobility compared to those with fixed urethras. Several authors also have suggested the sling’s advantage in patients with low-pressure urethras.³

Use urodynamic criteria to diagnose intrinsic sphincter deficiency (ISD), which is defined as a Valsalva leak point pressure of less than 60 cm water or maximal urethral closure pressure of less than 20 cm water. (Bear in mind, however, that these cut-off criteria are controversial.^4,5)

Also, consider slings in patients with recurrent GSUI, inherited collagen deficiency, and increased abdominal pressure (e.g., women with chronic obstructive pulmonary disease, obesity, or high-impact physical activity). The sling also can be used as an adjunct to other transvaginal surgeries (e.g., hysterectomy or prolapse repair).

Autologous slings may be a better choice than synthetic slings in cases of severe urogenital atrophy, previous radiation, or extensive scarring from previous repairs. In these instances, the patient may be at-risk for postoperative vaginal necrosis or erosion.⁶ Due to their biocompatibility, autologous slings are more likely to heal over a vaginal erosion and less likely to infect or erode into the urethra. In any event, urogenital atrophy should be treated with local estrogen preoperatively to prevent some of these complications.

Technique

Conventionally, suburethral slings were placed via a combined vaginal and abdominal approach into the retropubic space of Retzius. Alternatively, the procedure could be performed abdominally by creating a suburethral tunnel via pelvic incisions, but this is the most difficult route.

Most recently, technological advances have simplified the vaginal approach, which utilizes minimal suburethral dissection and small suprapubic incisions. This technique is subdivided into “bottom-up” and “top-down” approaches. In the bottom-up TVT, the sling is inserted into a vaginal incision and threaded up through the patient’s pelvis, exiting from a small suprapubic incision. The topdown SPARC entails a reverse approach, starting from a suprapubic incision and exiting from a vaginal incision. New modifications allow for an abdominal TVT approach, as well, which we describe in detail in a later section.

Surgeons who are familiar with traditional needle suspensions may be more comfortable with the top-down approach. The need for concomitant surgery (e.g., hysterectomy or prolapse repair) not only determines the type of incontinence procedure, but also dictates the approach.

Preparing the patient. Place the patient under regional or local anesthesia with sedation so that an intraoperative cough stress test can be performed. Then administer an intravenous dose of a broad-spectrum antibiotic. Insert a 16 to 18 French Foley catheter into the urethra. Mark the suprapubic region 1 cm above and 1 cm lateral to the pubic symphsis on the left and right sides of the patient. Inject approximately 20 cc of a 1:1 mixture of local anesthetic and normal saline into the marked areas. We typically use 60 cc of 0.25% bupivicaine with epinephrine, diluted 1:1 with 60 cc of normal saline. After administering the local anesthetic suprapubically, inject a similar solution into the anterior vaginal wall suburethrally in the midline and laterally toward the retropubic tunnels.

Making the incisions. Both the TVT and SPARC techniques utilize the same type and location of incisions. As such, make a 0.5-cm incision into the abdominal skin on each side of the midline, approximately 1 cm lateral to midline and 1 cm above the pubic symphsis. Next, make a 1.5- to 2-cm vertical incision in the vaginal mucosa, starting 1.5 cm from the urethral meatus (FIGURE 1). Use Metzenbaum scissors to dissect the vaginal mucosa from the pubocervical fascia sub- and para-urethrally on both sides (FIGURE 2). Insert a Foley catheter guide (similar to the Lowsley retractor) into the catheter and deviate it to the ipsilateral side, thereby retracting the bladder neck to the contralateral side. Proceed with the placement of either the TVT or SPARC sling.

Placing the TVT sling. Attach the TVT introducer to the curved needle trocar on 1 end of the polypropylene sling. Insert the trocar with the tape attached into the vaginal incision and push through the retropubic space, keeping the trocar in close contact with the posterior surface of the pubic bone (FIGURES 3 and 4). Continue pushing the trocar through the urogenital diaphragm until its tip comes through the suprapubic incision on the ipsilateral side (FIGURE 5). It is important to not deviate too laterally, medially, or cephalad during trocar insertion to prevent vessel, bladder, or bowel injury. Perform a cystoscopy to rule out cystotomy. Place the second trocar in a similar manner on the opposite side. After both trocars have been pulled through their respective incisions, perform a tension test.

Placing the SPARC/abdominal TVT sling. Guide the abdominal needles through the previously marked suprapubic incision and the patient’s retropubic cavity (keeping the needle behind the pubic bone), to a finger placed in the vaginal incision (FIGURE 6). Snap the abdominal needle guides with the attached polypropylene mesh to the sling connectors (FIGURE 7). Bring the abdominal needles through the suprapubic incisions. Perform a tension test. As with the TVT sling, perform a cystoscopy after each needle placement to rule out cystotomy. Then pass the sling through the tunnel.

Testing for continence. Once the sling is in place, fill the bladder with 250 cc of water and perform a cough stress test. Adjust sling tension by pulling up on both sling arms until only a few drops of leakage are noted. It is important not to secure the sling too tightly as this may lead to urinary retention, detrusor instability, or urethral erosion. We prefer placing a hemostat between the sling tape and the urethra to avoid over tightening.

Suspending the sling arms. Remove the plastic sheaths after tension adjustment and cut the sling flush with the skin (FIGURE 8). Compared to the conventional bone-anchored slings, the newer tension-free sling devices are not anchored but instead suspended through the retropubic space. At first, the sling is held in place by friction from the opposing tissues. Over time, collagen formation fixes the mesh more strongly within the suburethral and paravaginal tissues.

Finally, close the suprapubic and vaginal incisions with absorbable sutures.

Placing autologous or allogenic slings. Fashion the graft, typically 2 cm wide and 10 to 12 cm long, with permanent sutures at the edges. Make a 1-cm incision into the suprapubic rectus fascia. Use either a Stamey-type needle trocar or uterine packing forceps and guide the instrument “top down” from the retropubic incision to the vaginal tunnel. The tunnel is made directly into the retropubic space from the vaginal incision. Bring the sling arms up on each side. Attach the arms to the rectus fascia and tie them down once cystoscopy and the tension test are complete.

The sling also can be performed with bone anchors placed through the vaginal incision into the pubic bone. Placement requires vaginal dissection into the retropubic space with no suprapubic incision. Once anchored, the sutures are then passed through the chosen graft materials and tied down. Bear in mind that anchoring into the periosteum of the pubic bone may cause severe osteomyelitis or osteitis pubis, though the actual incidence is unknown.⁷

FIGURE 1 Surgical steps for tension-free vaginal tape (TVT)

Place a Sims speculum into the vagina and make a vertical incision 1.5 cm from the external urethra meatus.

FIGURE 2

Use Metzenbaum scissors to dissect the vaginal mucosa from the underlying fascia bilaterally. Insert a Foley catheter with guide.

FIGURE 3

Place TVT trocars through the vaginal incision. Place abdominal guides suprapubically and attach them to the TVT trocar tip.

FIGURE 4

Push the tape through the retropubic space, keeping the trocar in close contact with the posterior surface of the pubic bone.

FIGURE 5

Continue pushing the trocar through the urogenital diaphragm until its tip comes through the suprapubic incision on the ipsilateral side.

FIGURE 6 Surgical steps for SPARC

Guide the needle down the posterior side of the pubic bone, keeping the needle tip in contact with the pubic bone.

FIGURE 7

Snap the needle guide and sling onto the sling connectors and pull through the suprapubic incision.

FIGURE 8

Perform a tension test. Remove the plastic sheaths and cut the sling flush with the skin.

Complications

Intraoperative and immediate postoperative complications include bladder perforation, vaginal or retropubic bleeding, wound or urinary tract infection (UTI), and short-term urinary retention. Possible long-term problems include urethral or vaginal erosion, mesh infection, prolonged voiding dysfunction, fistula formation, or de novo urge incontinence (TABLE 2).

Specifically, the TVT sling, which has been placed in more than 50,000 women in the U.S. and 200,000 worldwide, carries the potential for significant vascular injury and bowel perforation. In addition, the Food and Drug Administration (FDA) reported 4 deaths (2 from unrecognized bowel injuries, 1 from retropubic bleeding in a patient with a bleeding disorder, and 1 from a heart attack more than 1 week after an incontinence repair procedure complicated by a vascular injury); 168 device malfunctions (mostly tape or sheath detachment from the trocar); and 128 other injuries, including bowel perforations and major vascular injuries to the obturator, external iliac, femoral, or inferior epigastrics (TABLE 3).⁸ In a review of 1,455 TVT sling cases at 38 hospitals, Kuuva and Nilsson⁹ found bladder perforation in 3.8% of the patients and retropubic hematoma in 1.9%, along with 1 case of vesicovaginal fistula, 1 obturator nerve injury, and 1 epigastric vessel injury.

According to the FDA, there have been 2 complications reported with the SPARC sling system. Both involved vaginal erosion subsequently repaired by oversewing the vaginal mucosa. One of these complications occurred in a woman undergoing her fourth vaginal procedure who was therefore deemed to have “poor tissue.”⁸

TABLE 2

Suburethral sling complications¹

TABLE 3

TVT complications in 200,000 procedures worldwide

Outcomes studies

Unfortunately, most of the published clinical studies on the surgical management of stress urinary incontinence suffer from inadequate follow-up and sample size, unclear patient selection criteria, and poor postoperative documentation, especially with respect to quality of life. However, multiple studies to assess the effectiveness and safety of TVT slings have been published. The following is an outline of these preliminary yet important findings.

In 2002, the Cochrane Database evaluated 7 randomized and quasi-randomized trials of suburethral slings for the treatment of urinary incontinence.¹⁰ Of 682 women evaluated, 457 had some type of suburethral sling procedure. Four trials compared slings to retropubic urethropexies, 1 compared slings to Stamey needle suspensions, and 2 compared the use of different sling materials. The results indicated that the data were insufficient to suggest that slings were more effective than other incontinence procedures or that slings were associated with fewer postoperative complications. While TVT slings did provide similar cure rates as open retropubic urethropexy, research is still lacking with respect to other types of slings. More studies comparing TVT slings to traditional pubovaginal slings also are needed before the 2 can be deemed equivalent.

In Sweden and Finland, where the TVT procedure was developed,¹¹ 85 patients who had undergone the procedure were evaluated at 48 to 70 months. Of those, 84.7% were completely cured of stress incontinence, 10.6% had significantly improved symptoms, and 4.7% were regarded as failures.

A recent well-designed, multicenter, randomized, prospective trial in the U.K. and Ireland compared 146 open Burch colposuspensions to 170 TVTs. Similar cure rates (57% and 66%, respectively) were reported.¹² Although these rates are low compared to the Nordic nonrandomized TVT studies mentioned, the U.K./Ireland outcome criteria were particularly stringent and included a negative cystometrogram for stress incontinence and negative pad test. These differences in reported success rates highlight the importance of clearly defining objective outcomes criteria from randomized trials.

Nonetheless, the U.K./Ireland study showed that TVT is less invasive than the Burch procedure and is associated with shorter recovery periods and greater cost savings. Follow-up on complications (bladder perforation and hematoma in TVTs and incisional hernia formation in Burch colposuspensions) will be the most crucial aspect of this study.¹³

Clearly, the question of whether a Burch retropubic urethropexy or a suburethral sling procedure is better for SUI needs to be further investigated. Weber and Walters sought to answer this question by developing a decision analytical model (without the aid of randomized, controlled trials) and discovered similar cure rates.¹⁴ However, there were higher rates of urinary retention and detrusor instability associated with the traditional pubovaginal sling. But, most importantly, sensitivity analyses proved that if the rate of permanent urinary retention after a sling procedure was less than 9%—as in most sling series—the overall effectiveness of slings was higher than that of the Burch.

Conclusion

The suburethral sling procedure has undergone many modifications since its first description nearly a century ago. As such, Ob/Gyns need to familiarize themselves with the current options. Typically, we perform up to 6 suburethral sling procedures per month. Of those, 50% are referrals from failed incontinence procedures. Recently, we have made the switch from using autologous slings to tension-free type slings due to ease and good outcomes. While more data from randomized, prospective, multicenter trials are needed to determine the best approach for individual patients, surgeons should become comfortable with the technique that works best for them.

The authors report no financial relationship with any companies whose products are mentioned in this article.

When the suburethral sling was first described in 1907 by von Giordano, it entailed placing autologous tissue underneath the bladder neck and suspending it superiorly. Complications including urethral erosion, infection, bleeding, and fistula formation led many surgeons to use it sparingly.

Fast forward to the 21st century: Synthetic materials and new techniques were introduced, simplifying the sling procedures and raising the long-term success rates to 84%.¹ As a result, slings now stand at the forefront of stress urinary incontinence (SUI) treatment. Among advances are the tension-free vaginal tape (TVT) sling (Gynecare, a division of Ethicon Inc., Somerville, NJ) and the SPARC sling (American Medical Systems, Inc., Minnetonka, Minn). The former, approved in the U.S. in 1998, calls for another look due to of the recent publication of a Cochrane review of outcomes studies, while the latter, approved by the FDA in August 2001, is the newest technique deserving examination. Clearly, with 83,010 incontinence procedures performed in the U.S. in 1999,² a detailed look at the suburethral sling is warranted. Here, we review materials, indications, techniques, complications, and outcomes.

Materials

The choice of material—either organic or synthetic—depends on several factors: availability, cost, patient and surgeon preference, and clinical variables. (TABLE 1) outlines the advantages and disadvantages of each material type. Organic slings include autologous tissues (rectus fascia and fascia lata graft), and allografts or xenografts (cadaveric fascia lata graft, human dermal graft, or porcine small intestine and dermal graft). Synthetic slings are made of polyethylene terephthalate, expanded polytetrafluoroethylene, and polypropylene.

While sling procedures utilizing organic materials do have their benefits, synthetic slings, particularly the polypropylene mesh used in TVT and SPARC, have proven to be a stable material unlikely to deteriorate with time. Further, increased collagen metabolism around this synthetic sling promotes an ingrowth of tissue through the mesh.

TABLE 1

Slings: advantages and disadvantages of various materials

Indications

Suburethral sling procedures are typically used for the treatment of genuine stress urinary incontinence (GSUI), in which the urethra becomes either hypermobile and unstable or its intrinsic sphincter becomes incompetent. In fact, slings are technically easier to place in patients with anatomic urethrovesical junction hypermobility compared to those with fixed urethras. Several authors also have suggested the sling’s advantage in patients with low-pressure urethras.³

Use urodynamic criteria to diagnose intrinsic sphincter deficiency (ISD), which is defined as a Valsalva leak point pressure of less than 60 cm water or maximal urethral closure pressure of less than 20 cm water. (Bear in mind, however, that these cut-off criteria are controversial.^4,5)

Also, consider slings in patients with recurrent GSUI, inherited collagen deficiency, and increased abdominal pressure (e.g., women with chronic obstructive pulmonary disease, obesity, or high-impact physical activity). The sling also can be used as an adjunct to other transvaginal surgeries (e.g., hysterectomy or prolapse repair).

Autologous slings may be a better choice than synthetic slings in cases of severe urogenital atrophy, previous radiation, or extensive scarring from previous repairs. In these instances, the patient may be at-risk for postoperative vaginal necrosis or erosion.⁶ Due to their biocompatibility, autologous slings are more likely to heal over a vaginal erosion and less likely to infect or erode into the urethra. In any event, urogenital atrophy should be treated with local estrogen preoperatively to prevent some of these complications.

Technique

Conventionally, suburethral slings were placed via a combined vaginal and abdominal approach into the retropubic space of Retzius. Alternatively, the procedure could be performed abdominally by creating a suburethral tunnel via pelvic incisions, but this is the most difficult route.

Most recently, technological advances have simplified the vaginal approach, which utilizes minimal suburethral dissection and small suprapubic incisions. This technique is subdivided into “bottom-up” and “top-down” approaches. In the bottom-up TVT, the sling is inserted into a vaginal incision and threaded up through the patient’s pelvis, exiting from a small suprapubic incision. The topdown SPARC entails a reverse approach, starting from a suprapubic incision and exiting from a vaginal incision. New modifications allow for an abdominal TVT approach, as well, which we describe in detail in a later section.

Surgeons who are familiar with traditional needle suspensions may be more comfortable with the top-down approach. The need for concomitant surgery (e.g., hysterectomy or prolapse repair) not only determines the type of incontinence procedure, but also dictates the approach.

Preparing the patient. Place the patient under regional or local anesthesia with sedation so that an intraoperative cough stress test can be performed. Then administer an intravenous dose of a broad-spectrum antibiotic. Insert a 16 to 18 French Foley catheter into the urethra. Mark the suprapubic region 1 cm above and 1 cm lateral to the pubic symphsis on the left and right sides of the patient. Inject approximately 20 cc of a 1:1 mixture of local anesthetic and normal saline into the marked areas. We typically use 60 cc of 0.25% bupivicaine with epinephrine, diluted 1:1 with 60 cc of normal saline. After administering the local anesthetic suprapubically, inject a similar solution into the anterior vaginal wall suburethrally in the midline and laterally toward the retropubic tunnels.

Making the incisions. Both the TVT and SPARC techniques utilize the same type and location of incisions. As such, make a 0.5-cm incision into the abdominal skin on each side of the midline, approximately 1 cm lateral to midline and 1 cm above the pubic symphsis. Next, make a 1.5- to 2-cm vertical incision in the vaginal mucosa, starting 1.5 cm from the urethral meatus (FIGURE 1). Use Metzenbaum scissors to dissect the vaginal mucosa from the pubocervical fascia sub- and para-urethrally on both sides (FIGURE 2). Insert a Foley catheter guide (similar to the Lowsley retractor) into the catheter and deviate it to the ipsilateral side, thereby retracting the bladder neck to the contralateral side. Proceed with the placement of either the TVT or SPARC sling.

Placing the TVT sling. Attach the TVT introducer to the curved needle trocar on 1 end of the polypropylene sling. Insert the trocar with the tape attached into the vaginal incision and push through the retropubic space, keeping the trocar in close contact with the posterior surface of the pubic bone (FIGURES 3 and 4). Continue pushing the trocar through the urogenital diaphragm until its tip comes through the suprapubic incision on the ipsilateral side (FIGURE 5). It is important to not deviate too laterally, medially, or cephalad during trocar insertion to prevent vessel, bladder, or bowel injury. Perform a cystoscopy to rule out cystotomy. Place the second trocar in a similar manner on the opposite side. After both trocars have been pulled through their respective incisions, perform a tension test.

Placing the SPARC/abdominal TVT sling. Guide the abdominal needles through the previously marked suprapubic incision and the patient’s retropubic cavity (keeping the needle behind the pubic bone), to a finger placed in the vaginal incision (FIGURE 6). Snap the abdominal needle guides with the attached polypropylene mesh to the sling connectors (FIGURE 7). Bring the abdominal needles through the suprapubic incisions. Perform a tension test. As with the TVT sling, perform a cystoscopy after each needle placement to rule out cystotomy. Then pass the sling through the tunnel.

Testing for continence. Once the sling is in place, fill the bladder with 250 cc of water and perform a cough stress test. Adjust sling tension by pulling up on both sling arms until only a few drops of leakage are noted. It is important not to secure the sling too tightly as this may lead to urinary retention, detrusor instability, or urethral erosion. We prefer placing a hemostat between the sling tape and the urethra to avoid over tightening.

Suspending the sling arms. Remove the plastic sheaths after tension adjustment and cut the sling flush with the skin (FIGURE 8). Compared to the conventional bone-anchored slings, the newer tension-free sling devices are not anchored but instead suspended through the retropubic space. At first, the sling is held in place by friction from the opposing tissues. Over time, collagen formation fixes the mesh more strongly within the suburethral and paravaginal tissues.

Finally, close the suprapubic and vaginal incisions with absorbable sutures.

Placing autologous or allogenic slings. Fashion the graft, typically 2 cm wide and 10 to 12 cm long, with permanent sutures at the edges. Make a 1-cm incision into the suprapubic rectus fascia. Use either a Stamey-type needle trocar or uterine packing forceps and guide the instrument “top down” from the retropubic incision to the vaginal tunnel. The tunnel is made directly into the retropubic space from the vaginal incision. Bring the sling arms up on each side. Attach the arms to the rectus fascia and tie them down once cystoscopy and the tension test are complete.

The sling also can be performed with bone anchors placed through the vaginal incision into the pubic bone. Placement requires vaginal dissection into the retropubic space with no suprapubic incision. Once anchored, the sutures are then passed through the chosen graft materials and tied down. Bear in mind that anchoring into the periosteum of the pubic bone may cause severe osteomyelitis or osteitis pubis, though the actual incidence is unknown.⁷

FIGURE 1 Surgical steps for tension-free vaginal tape (TVT)

Place a Sims speculum into the vagina and make a vertical incision 1.5 cm from the external urethra meatus.

FIGURE 2

Use Metzenbaum scissors to dissect the vaginal mucosa from the underlying fascia bilaterally. Insert a Foley catheter with guide.

FIGURE 3

Place TVT trocars through the vaginal incision. Place abdominal guides suprapubically and attach them to the TVT trocar tip.

FIGURE 4

Push the tape through the retropubic space, keeping the trocar in close contact with the posterior surface of the pubic bone.

FIGURE 5

Continue pushing the trocar through the urogenital diaphragm until its tip comes through the suprapubic incision on the ipsilateral side.

FIGURE 6 Surgical steps for SPARC

Guide the needle down the posterior side of the pubic bone, keeping the needle tip in contact with the pubic bone.

FIGURE 7

Snap the needle guide and sling onto the sling connectors and pull through the suprapubic incision.

FIGURE 8

Perform a tension test. Remove the plastic sheaths and cut the sling flush with the skin.

Complications

Intraoperative and immediate postoperative complications include bladder perforation, vaginal or retropubic bleeding, wound or urinary tract infection (UTI), and short-term urinary retention. Possible long-term problems include urethral or vaginal erosion, mesh infection, prolonged voiding dysfunction, fistula formation, or de novo urge incontinence (TABLE 2).

Specifically, the TVT sling, which has been placed in more than 50,000 women in the U.S. and 200,000 worldwide, carries the potential for significant vascular injury and bowel perforation. In addition, the Food and Drug Administration (FDA) reported 4 deaths (2 from unrecognized bowel injuries, 1 from retropubic bleeding in a patient with a bleeding disorder, and 1 from a heart attack more than 1 week after an incontinence repair procedure complicated by a vascular injury); 168 device malfunctions (mostly tape or sheath detachment from the trocar); and 128 other injuries, including bowel perforations and major vascular injuries to the obturator, external iliac, femoral, or inferior epigastrics (TABLE 3).⁸ In a review of 1,455 TVT sling cases at 38 hospitals, Kuuva and Nilsson⁹ found bladder perforation in 3.8% of the patients and retropubic hematoma in 1.9%, along with 1 case of vesicovaginal fistula, 1 obturator nerve injury, and 1 epigastric vessel injury.

According to the FDA, there have been 2 complications reported with the SPARC sling system. Both involved vaginal erosion subsequently repaired by oversewing the vaginal mucosa. One of these complications occurred in a woman undergoing her fourth vaginal procedure who was therefore deemed to have “poor tissue.”⁸

TABLE 2

Suburethral sling complications¹

TABLE 3

TVT complications in 200,000 procedures worldwide

Outcomes studies

Unfortunately, most of the published clinical studies on the surgical management of stress urinary incontinence suffer from inadequate follow-up and sample size, unclear patient selection criteria, and poor postoperative documentation, especially with respect to quality of life. However, multiple studies to assess the effectiveness and safety of TVT slings have been published. The following is an outline of these preliminary yet important findings.

In 2002, the Cochrane Database evaluated 7 randomized and quasi-randomized trials of suburethral slings for the treatment of urinary incontinence.¹⁰ Of 682 women evaluated, 457 had some type of suburethral sling procedure. Four trials compared slings to retropubic urethropexies, 1 compared slings to Stamey needle suspensions, and 2 compared the use of different sling materials. The results indicated that the data were insufficient to suggest that slings were more effective than other incontinence procedures or that slings were associated with fewer postoperative complications. While TVT slings did provide similar cure rates as open retropubic urethropexy, research is still lacking with respect to other types of slings. More studies comparing TVT slings to traditional pubovaginal slings also are needed before the 2 can be deemed equivalent.

In Sweden and Finland, where the TVT procedure was developed,¹¹ 85 patients who had undergone the procedure were evaluated at 48 to 70 months. Of those, 84.7% were completely cured of stress incontinence, 10.6% had significantly improved symptoms, and 4.7% were regarded as failures.

A recent well-designed, multicenter, randomized, prospective trial in the U.K. and Ireland compared 146 open Burch colposuspensions to 170 TVTs. Similar cure rates (57% and 66%, respectively) were reported.¹² Although these rates are low compared to the Nordic nonrandomized TVT studies mentioned, the U.K./Ireland outcome criteria were particularly stringent and included a negative cystometrogram for stress incontinence and negative pad test. These differences in reported success rates highlight the importance of clearly defining objective outcomes criteria from randomized trials.

Nonetheless, the U.K./Ireland study showed that TVT is less invasive than the Burch procedure and is associated with shorter recovery periods and greater cost savings. Follow-up on complications (bladder perforation and hematoma in TVTs and incisional hernia formation in Burch colposuspensions) will be the most crucial aspect of this study.¹³

Clearly, the question of whether a Burch retropubic urethropexy or a suburethral sling procedure is better for SUI needs to be further investigated. Weber and Walters sought to answer this question by developing a decision analytical model (without the aid of randomized, controlled trials) and discovered similar cure rates.¹⁴ However, there were higher rates of urinary retention and detrusor instability associated with the traditional pubovaginal sling. But, most importantly, sensitivity analyses proved that if the rate of permanent urinary retention after a sling procedure was less than 9%—as in most sling series—the overall effectiveness of slings was higher than that of the Burch.

Conclusion

The suburethral sling procedure has undergone many modifications since its first description nearly a century ago. As such, Ob/Gyns need to familiarize themselves with the current options. Typically, we perform up to 6 suburethral sling procedures per month. Of those, 50% are referrals from failed incontinence procedures. Recently, we have made the switch from using autologous slings to tension-free type slings due to ease and good outcomes. While more data from randomized, prospective, multicenter trials are needed to determine the best approach for individual patients, surgeons should become comfortable with the technique that works best for them.

The authors report no financial relationship with any companies whose products are mentioned in this article.

When the suburethral sling was first described in 1907 by von Giordano, it entailed placing autologous tissue underneath the bladder neck and suspending it superiorly. Complications including urethral erosion, infection, bleeding, and fistula formation led many surgeons to use it sparingly.

Fast forward to the 21st century: Synthetic materials and new techniques were introduced, simplifying the sling procedures and raising the long-term success rates to 84%.¹ As a result, slings now stand at the forefront of stress urinary incontinence (SUI) treatment. Among advances are the tension-free vaginal tape (TVT) sling (Gynecare, a division of Ethicon Inc., Somerville, NJ) and the SPARC sling (American Medical Systems, Inc., Minnetonka, Minn). The former, approved in the U.S. in 1998, calls for another look due to of the recent publication of a Cochrane review of outcomes studies, while the latter, approved by the FDA in August 2001, is the newest technique deserving examination. Clearly, with 83,010 incontinence procedures performed in the U.S. in 1999,² a detailed look at the suburethral sling is warranted. Here, we review materials, indications, techniques, complications, and outcomes.

Materials

The choice of material—either organic or synthetic—depends on several factors: availability, cost, patient and surgeon preference, and clinical variables. (TABLE 1) outlines the advantages and disadvantages of each material type. Organic slings include autologous tissues (rectus fascia and fascia lata graft), and allografts or xenografts (cadaveric fascia lata graft, human dermal graft, or porcine small intestine and dermal graft). Synthetic slings are made of polyethylene terephthalate, expanded polytetrafluoroethylene, and polypropylene.

While sling procedures utilizing organic materials do have their benefits, synthetic slings, particularly the polypropylene mesh used in TVT and SPARC, have proven to be a stable material unlikely to deteriorate with time. Further, increased collagen metabolism around this synthetic sling promotes an ingrowth of tissue through the mesh.

TABLE 1

Slings: advantages and disadvantages of various materials

Indications

Suburethral sling procedures are typically used for the treatment of genuine stress urinary incontinence (GSUI), in which the urethra becomes either hypermobile and unstable or its intrinsic sphincter becomes incompetent. In fact, slings are technically easier to place in patients with anatomic urethrovesical junction hypermobility compared to those with fixed urethras. Several authors also have suggested the sling’s advantage in patients with low-pressure urethras.³

Use urodynamic criteria to diagnose intrinsic sphincter deficiency (ISD), which is defined as a Valsalva leak point pressure of less than 60 cm water or maximal urethral closure pressure of less than 20 cm water. (Bear in mind, however, that these cut-off criteria are controversial.^4,5)

Also, consider slings in patients with recurrent GSUI, inherited collagen deficiency, and increased abdominal pressure (e.g., women with chronic obstructive pulmonary disease, obesity, or high-impact physical activity). The sling also can be used as an adjunct to other transvaginal surgeries (e.g., hysterectomy or prolapse repair).

Autologous slings may be a better choice than synthetic slings in cases of severe urogenital atrophy, previous radiation, or extensive scarring from previous repairs. In these instances, the patient may be at-risk for postoperative vaginal necrosis or erosion.⁶ Due to their biocompatibility, autologous slings are more likely to heal over a vaginal erosion and less likely to infect or erode into the urethra. In any event, urogenital atrophy should be treated with local estrogen preoperatively to prevent some of these complications.

Technique

Conventionally, suburethral slings were placed via a combined vaginal and abdominal approach into the retropubic space of Retzius. Alternatively, the procedure could be performed abdominally by creating a suburethral tunnel via pelvic incisions, but this is the most difficult route.

Most recently, technological advances have simplified the vaginal approach, which utilizes minimal suburethral dissection and small suprapubic incisions. This technique is subdivided into “bottom-up” and “top-down” approaches. In the bottom-up TVT, the sling is inserted into a vaginal incision and threaded up through the patient’s pelvis, exiting from a small suprapubic incision. The topdown SPARC entails a reverse approach, starting from a suprapubic incision and exiting from a vaginal incision. New modifications allow for an abdominal TVT approach, as well, which we describe in detail in a later section.

Surgeons who are familiar with traditional needle suspensions may be more comfortable with the top-down approach. The need for concomitant surgery (e.g., hysterectomy or prolapse repair) not only determines the type of incontinence procedure, but also dictates the approach.

Preparing the patient. Place the patient under regional or local anesthesia with sedation so that an intraoperative cough stress test can be performed. Then administer an intravenous dose of a broad-spectrum antibiotic. Insert a 16 to 18 French Foley catheter into the urethra. Mark the suprapubic region 1 cm above and 1 cm lateral to the pubic symphsis on the left and right sides of the patient. Inject approximately 20 cc of a 1:1 mixture of local anesthetic and normal saline into the marked areas. We typically use 60 cc of 0.25% bupivicaine with epinephrine, diluted 1:1 with 60 cc of normal saline. After administering the local anesthetic suprapubically, inject a similar solution into the anterior vaginal wall suburethrally in the midline and laterally toward the retropubic tunnels.

Making the incisions. Both the TVT and SPARC techniques utilize the same type and location of incisions. As such, make a 0.5-cm incision into the abdominal skin on each side of the midline, approximately 1 cm lateral to midline and 1 cm above the pubic symphsis. Next, make a 1.5- to 2-cm vertical incision in the vaginal mucosa, starting 1.5 cm from the urethral meatus (FIGURE 1). Use Metzenbaum scissors to dissect the vaginal mucosa from the pubocervical fascia sub- and para-urethrally on both sides (FIGURE 2). Insert a Foley catheter guide (similar to the Lowsley retractor) into the catheter and deviate it to the ipsilateral side, thereby retracting the bladder neck to the contralateral side. Proceed with the placement of either the TVT or SPARC sling.

Placing the TVT sling. Attach the TVT introducer to the curved needle trocar on 1 end of the polypropylene sling. Insert the trocar with the tape attached into the vaginal incision and push through the retropubic space, keeping the trocar in close contact with the posterior surface of the pubic bone (FIGURES 3 and 4). Continue pushing the trocar through the urogenital diaphragm until its tip comes through the suprapubic incision on the ipsilateral side (FIGURE 5). It is important to not deviate too laterally, medially, or cephalad during trocar insertion to prevent vessel, bladder, or bowel injury. Perform a cystoscopy to rule out cystotomy. Place the second trocar in a similar manner on the opposite side. After both trocars have been pulled through their respective incisions, perform a tension test.

Placing the SPARC/abdominal TVT sling. Guide the abdominal needles through the previously marked suprapubic incision and the patient’s retropubic cavity (keeping the needle behind the pubic bone), to a finger placed in the vaginal incision (FIGURE 6). Snap the abdominal needle guides with the attached polypropylene mesh to the sling connectors (FIGURE 7). Bring the abdominal needles through the suprapubic incisions. Perform a tension test. As with the TVT sling, perform a cystoscopy after each needle placement to rule out cystotomy. Then pass the sling through the tunnel.

Testing for continence. Once the sling is in place, fill the bladder with 250 cc of water and perform a cough stress test. Adjust sling tension by pulling up on both sling arms until only a few drops of leakage are noted. It is important not to secure the sling too tightly as this may lead to urinary retention, detrusor instability, or urethral erosion. We prefer placing a hemostat between the sling tape and the urethra to avoid over tightening.

Suspending the sling arms. Remove the plastic sheaths after tension adjustment and cut the sling flush with the skin (FIGURE 8). Compared to the conventional bone-anchored slings, the newer tension-free sling devices are not anchored but instead suspended through the retropubic space. At first, the sling is held in place by friction from the opposing tissues. Over time, collagen formation fixes the mesh more strongly within the suburethral and paravaginal tissues.

Finally, close the suprapubic and vaginal incisions with absorbable sutures.

Placing autologous or allogenic slings. Fashion the graft, typically 2 cm wide and 10 to 12 cm long, with permanent sutures at the edges. Make a 1-cm incision into the suprapubic rectus fascia. Use either a Stamey-type needle trocar or uterine packing forceps and guide the instrument “top down” from the retropubic incision to the vaginal tunnel. The tunnel is made directly into the retropubic space from the vaginal incision. Bring the sling arms up on each side. Attach the arms to the rectus fascia and tie them down once cystoscopy and the tension test are complete.

The sling also can be performed with bone anchors placed through the vaginal incision into the pubic bone. Placement requires vaginal dissection into the retropubic space with no suprapubic incision. Once anchored, the sutures are then passed through the chosen graft materials and tied down. Bear in mind that anchoring into the periosteum of the pubic bone may cause severe osteomyelitis or osteitis pubis, though the actual incidence is unknown.⁷

FIGURE 1 Surgical steps for tension-free vaginal tape (TVT)

Place a Sims speculum into the vagina and make a vertical incision 1.5 cm from the external urethra meatus.

FIGURE 2

Use Metzenbaum scissors to dissect the vaginal mucosa from the underlying fascia bilaterally. Insert a Foley catheter with guide.

FIGURE 3

Place TVT trocars through the vaginal incision. Place abdominal guides suprapubically and attach them to the TVT trocar tip.

FIGURE 4

Push the tape through the retropubic space, keeping the trocar in close contact with the posterior surface of the pubic bone.

FIGURE 5

Continue pushing the trocar through the urogenital diaphragm until its tip comes through the suprapubic incision on the ipsilateral side.

FIGURE 6 Surgical steps for SPARC

Guide the needle down the posterior side of the pubic bone, keeping the needle tip in contact with the pubic bone.

FIGURE 7

Snap the needle guide and sling onto the sling connectors and pull through the suprapubic incision.

FIGURE 8

Perform a tension test. Remove the plastic sheaths and cut the sling flush with the skin.

Complications

Intraoperative and immediate postoperative complications include bladder perforation, vaginal or retropubic bleeding, wound or urinary tract infection (UTI), and short-term urinary retention. Possible long-term problems include urethral or vaginal erosion, mesh infection, prolonged voiding dysfunction, fistula formation, or de novo urge incontinence (TABLE 2).

Specifically, the TVT sling, which has been placed in more than 50,000 women in the U.S. and 200,000 worldwide, carries the potential for significant vascular injury and bowel perforation. In addition, the Food and Drug Administration (FDA) reported 4 deaths (2 from unrecognized bowel injuries, 1 from retropubic bleeding in a patient with a bleeding disorder, and 1 from a heart attack more than 1 week after an incontinence repair procedure complicated by a vascular injury); 168 device malfunctions (mostly tape or sheath detachment from the trocar); and 128 other injuries, including bowel perforations and major vascular injuries to the obturator, external iliac, femoral, or inferior epigastrics (TABLE 3).⁸ In a review of 1,455 TVT sling cases at 38 hospitals, Kuuva and Nilsson⁹ found bladder perforation in 3.8% of the patients and retropubic hematoma in 1.9%, along with 1 case of vesicovaginal fistula, 1 obturator nerve injury, and 1 epigastric vessel injury.

According to the FDA, there have been 2 complications reported with the SPARC sling system. Both involved vaginal erosion subsequently repaired by oversewing the vaginal mucosa. One of these complications occurred in a woman undergoing her fourth vaginal procedure who was therefore deemed to have “poor tissue.”⁸

TABLE 2

Suburethral sling complications¹

TABLE 3

TVT complications in 200,000 procedures worldwide

Outcomes studies

Unfortunately, most of the published clinical studies on the surgical management of stress urinary incontinence suffer from inadequate follow-up and sample size, unclear patient selection criteria, and poor postoperative documentation, especially with respect to quality of life. However, multiple studies to assess the effectiveness and safety of TVT slings have been published. The following is an outline of these preliminary yet important findings.

In 2002, the Cochrane Database evaluated 7 randomized and quasi-randomized trials of suburethral slings for the treatment of urinary incontinence.¹⁰ Of 682 women evaluated, 457 had some type of suburethral sling procedure. Four trials compared slings to retropubic urethropexies, 1 compared slings to Stamey needle suspensions, and 2 compared the use of different sling materials. The results indicated that the data were insufficient to suggest that slings were more effective than other incontinence procedures or that slings were associated with fewer postoperative complications. While TVT slings did provide similar cure rates as open retropubic urethropexy, research is still lacking with respect to other types of slings. More studies comparing TVT slings to traditional pubovaginal slings also are needed before the 2 can be deemed equivalent.

In Sweden and Finland, where the TVT procedure was developed,¹¹ 85 patients who had undergone the procedure were evaluated at 48 to 70 months. Of those, 84.7% were completely cured of stress incontinence, 10.6% had significantly improved symptoms, and 4.7% were regarded as failures.

A recent well-designed, multicenter, randomized, prospective trial in the U.K. and Ireland compared 146 open Burch colposuspensions to 170 TVTs. Similar cure rates (57% and 66%, respectively) were reported.¹² Although these rates are low compared to the Nordic nonrandomized TVT studies mentioned, the U.K./Ireland outcome criteria were particularly stringent and included a negative cystometrogram for stress incontinence and negative pad test. These differences in reported success rates highlight the importance of clearly defining objective outcomes criteria from randomized trials.

Nonetheless, the U.K./Ireland study showed that TVT is less invasive than the Burch procedure and is associated with shorter recovery periods and greater cost savings. Follow-up on complications (bladder perforation and hematoma in TVTs and incisional hernia formation in Burch colposuspensions) will be the most crucial aspect of this study.¹³

Clearly, the question of whether a Burch retropubic urethropexy or a suburethral sling procedure is better for SUI needs to be further investigated. Weber and Walters sought to answer this question by developing a decision analytical model (without the aid of randomized, controlled trials) and discovered similar cure rates.¹⁴ However, there were higher rates of urinary retention and detrusor instability associated with the traditional pubovaginal sling. But, most importantly, sensitivity analyses proved that if the rate of permanent urinary retention after a sling procedure was less than 9%—as in most sling series—the overall effectiveness of slings was higher than that of the Burch.

Conclusion

The suburethral sling procedure has undergone many modifications since its first description nearly a century ago. As such, Ob/Gyns need to familiarize themselves with the current options. Typically, we perform up to 6 suburethral sling procedures per month. Of those, 50% are referrals from failed incontinence procedures. Recently, we have made the switch from using autologous slings to tension-free type slings due to ease and good outcomes. While more data from randomized, prospective, multicenter trials are needed to determine the best approach for individual patients, surgeons should become comfortable with the technique that works best for them.

The authors report no financial relationship with any companies whose products are mentioned in this article.

Even with its recent decline in occurrence, cesarean delivery remains the most frequently performed surgical procedure in the United States, accounting for approximately 21.5% of all deliveries. Here, obstetricians from across the country share pearls on various aspects of cesarean birth.

The difficult cesarean. When a difficult cesarean is predicted and the threat of obstetrical hemorrhage is imminent, I recommend that clinicians position the patient in low Allen stirrups, using a drape that provides vaginal access. This allows for proper elevation of the fetal head and better assessment of potential blood loss. Make sure a hysterectomy instrument tray is nearby and an experienced gynecologic scrub nurse is available. These steps should eliminate occult hemorrhage and allow for rapid response to any changes in the patient’s clinical status. —Richard Hill, MD, Kansas City, Mo

Cranial dystocia. A cesarean is often required when labor-arrest disorders occur. Cranial dystocia is sometimes found in these cases, making for a difficult delivery. When manual extraction of the fetal head fails, the surgeon typically has an assistant place a hand in the vagina to elevate and disengage the head. In these cases, I instead suggest surgeons remove their delivering hand from the uterine incision, cup the fetal head outside the lower uterine segment and bladder, and then pull upward. This will break the vacuum that spontaneously occurs, liberating the fetal head and allowing for successful cesarean delivery. —Peter Napolitano, MD, Tacoma, Wash

Intact membranes. When a patient with unruptured membranes presents for a cesarean, avoid breaching the amniotic sac sharply or with a clamp. Instead, first approach the uterine muscle sharply through the outer layers, then bluntly dissect the remaining fibers with your fingertip, allowing the amniotic sac to bulge out through the incision. Complete the uterine incision sharply with bandage scissors prior to rupturing the membranes, then open the bulging membranes either bluntly or with an Allis clamp. These steps ensure that the fetus will not experience trauma from sharp surgical objects. —Scott Resnick, MD, Taos, NM

Lowering the cesarean rate. To reduce the number of cesarean deliveries, try inducing labor of the unscarred uterus as follows:

• 8 AM: Insert 50 μg of misoprostol deep in the vagina.
  
• Noon: If the cervix is dilated, rupture membranes regardless of the Bishop score. Labor will almost invariably ensue within 1 to 2 hours. If the cervix is still closed at this time, insert another dose of misoprostol.
  
• Noon to 5 PM: Observe for cervical dilation. If this does not occur, augment labor with oxytocin.
  

Some patients will achieve vaginal delivery by 5 PM, and most will deliver by midnight.

With this technique, selecting patients for induction prior to their due date and before macrosomia or fetal stress develop is key to successfully keeping the cesarean rate low. —Susan Vicente, MD, Kailua, Hawaii

Even with its recent decline in occurrence, cesarean delivery remains the most frequently performed surgical procedure in the United States, accounting for approximately 21.5% of all deliveries. Here, obstetricians from across the country share pearls on various aspects of cesarean birth.

The difficult cesarean. When a difficult cesarean is predicted and the threat of obstetrical hemorrhage is imminent, I recommend that clinicians position the patient in low Allen stirrups, using a drape that provides vaginal access. This allows for proper elevation of the fetal head and better assessment of potential blood loss. Make sure a hysterectomy instrument tray is nearby and an experienced gynecologic scrub nurse is available. These steps should eliminate occult hemorrhage and allow for rapid response to any changes in the patient’s clinical status. —Richard Hill, MD, Kansas City, Mo

Cranial dystocia. A cesarean is often required when labor-arrest disorders occur. Cranial dystocia is sometimes found in these cases, making for a difficult delivery. When manual extraction of the fetal head fails, the surgeon typically has an assistant place a hand in the vagina to elevate and disengage the head. In these cases, I instead suggest surgeons remove their delivering hand from the uterine incision, cup the fetal head outside the lower uterine segment and bladder, and then pull upward. This will break the vacuum that spontaneously occurs, liberating the fetal head and allowing for successful cesarean delivery. —Peter Napolitano, MD, Tacoma, Wash

Intact membranes. When a patient with unruptured membranes presents for a cesarean, avoid breaching the amniotic sac sharply or with a clamp. Instead, first approach the uterine muscle sharply through the outer layers, then bluntly dissect the remaining fibers with your fingertip, allowing the amniotic sac to bulge out through the incision. Complete the uterine incision sharply with bandage scissors prior to rupturing the membranes, then open the bulging membranes either bluntly or with an Allis clamp. These steps ensure that the fetus will not experience trauma from sharp surgical objects. —Scott Resnick, MD, Taos, NM

Lowering the cesarean rate. To reduce the number of cesarean deliveries, try inducing labor of the unscarred uterus as follows:

• 8 AM: Insert 50 μg of misoprostol deep in the vagina.
  
• Noon: If the cervix is dilated, rupture membranes regardless of the Bishop score. Labor will almost invariably ensue within 1 to 2 hours. If the cervix is still closed at this time, insert another dose of misoprostol.
  
• Noon to 5 PM: Observe for cervical dilation. If this does not occur, augment labor with oxytocin.
  

Some patients will achieve vaginal delivery by 5 PM, and most will deliver by midnight.

With this technique, selecting patients for induction prior to their due date and before macrosomia or fetal stress develop is key to successfully keeping the cesarean rate low. —Susan Vicente, MD, Kailua, Hawaii

Even with its recent decline in occurrence, cesarean delivery remains the most frequently performed surgical procedure in the United States, accounting for approximately 21.5% of all deliveries. Here, obstetricians from across the country share pearls on various aspects of cesarean birth.

The difficult cesarean. When a difficult cesarean is predicted and the threat of obstetrical hemorrhage is imminent, I recommend that clinicians position the patient in low Allen stirrups, using a drape that provides vaginal access. This allows for proper elevation of the fetal head and better assessment of potential blood loss. Make sure a hysterectomy instrument tray is nearby and an experienced gynecologic scrub nurse is available. These steps should eliminate occult hemorrhage and allow for rapid response to any changes in the patient’s clinical status. —Richard Hill, MD, Kansas City, Mo

Cranial dystocia. A cesarean is often required when labor-arrest disorders occur. Cranial dystocia is sometimes found in these cases, making for a difficult delivery. When manual extraction of the fetal head fails, the surgeon typically has an assistant place a hand in the vagina to elevate and disengage the head. In these cases, I instead suggest surgeons remove their delivering hand from the uterine incision, cup the fetal head outside the lower uterine segment and bladder, and then pull upward. This will break the vacuum that spontaneously occurs, liberating the fetal head and allowing for successful cesarean delivery. —Peter Napolitano, MD, Tacoma, Wash

Intact membranes. When a patient with unruptured membranes presents for a cesarean, avoid breaching the amniotic sac sharply or with a clamp. Instead, first approach the uterine muscle sharply through the outer layers, then bluntly dissect the remaining fibers with your fingertip, allowing the amniotic sac to bulge out through the incision. Complete the uterine incision sharply with bandage scissors prior to rupturing the membranes, then open the bulging membranes either bluntly or with an Allis clamp. These steps ensure that the fetus will not experience trauma from sharp surgical objects. —Scott Resnick, MD, Taos, NM

Lowering the cesarean rate. To reduce the number of cesarean deliveries, try inducing labor of the unscarred uterus as follows:

• 8 AM: Insert 50 μg of misoprostol deep in the vagina.
  
• Noon: If the cervix is dilated, rupture membranes regardless of the Bishop score. Labor will almost invariably ensue within 1 to 2 hours. If the cervix is still closed at this time, insert another dose of misoprostol.
  
• Noon to 5 PM: Observe for cervical dilation. If this does not occur, augment labor with oxytocin.
  

Some patients will achieve vaginal delivery by 5 PM, and most will deliver by midnight.

With this technique, selecting patients for induction prior to their due date and before macrosomia or fetal stress develop is key to successfully keeping the cesarean rate low. —Susan Vicente, MD, Kailua, Hawaii

When cervical intraepithelial neoplasia (CIN) requires treatment, loop electrosurgical excision procedure (LEEP) is the most frequently used modality, although cold-knife conization (CKC) of the cervical transformation zone still is preferred in select cases. Since excisional techniques are used with CKC, margin status is known and clinical decisions may be based on this information.

This article reviews current indications for excisional biopsy and presents evidence to direct management and follow-up of patients with positive and negative margins.

Selecting a technique

Several large randomized and prospective studies have demonstrated that LEEP is similar in efficacy to CKC and may even remove less of the normal cervical stroma.^1-3 In general, LEEP is used to excise high-grade and recurrent squamous dysplasia, as it is similar to CKC in its rates of incomplete excision and residual disease.^1,4 However, when adenocarcinoma in situ (AIS) is present, CKC is preferred for diagnosis and treatment, since it results in a lower incidence of involved margins and a lower recurrence rate.^3,5-7

CKC also is preferred when histologic confirmation of the margin status is crucial, such as when invasion with squamous lesions is suspected. This is because thermal artifacts that may result from LEEP will interfere with interpretation, further complicating treatment planning.^1,4,8,9 In cases of microinvasion, the ability to confirm margins makes conservative treatment possible; if the depth of invasion cannot be determined from the specimen, radical surgery may be necessary.

In the hands of an experienced clinician, however, thermal artifact from the LEEP technique generally is not a significant problem. Series reporting high rates of uninterpretable margins have been attributed to operator inexperience.¹⁰ In general, thermal artifact is reduced by limiting the number of sections taken. In ideal cases, only a single-piece specimen is obtained, similar to that achieved using CKC.^8,10,11 Newer loops, such as the cone biopsy excision loop, may decrease the number of sections and further improve margin interpretation.⁸

I use CKC in cases of suspected squamous invasion and in the evaluation of glandular lesions, but feel that in other cases LEEP is efficacious and quicker.

Identifying residual disease

When both the endocervical margin and endocervical curettage (ECC) are positive for squamous dysplasia at the time of excision, there is an increased risk of residual disease (TABLE 1).^12-14 However, it is not clear whether ECC alone is an independent predictor of residual disease. Although 1 study suggests an increased risk of invasive cancer in women over 50 years of age with a positive ECC at the time of conization, other series have failed to demonstrate a difference in treatment failure rates based on ECC.^15-17 Thus, the utility of ECC in directing further therapy at the time of excisional biopsy is unclear. I generally do not perform an ECC with LEEP for squamous dysplasia.

In AIS, a positive ECC is a strong predictor of residual disease, while a negative ECC is of limited significance.¹⁸ I am more likely to perform an ECC with glandular lesions. If it is negative, close follow-up still is indicated. If it is positive, repeat excision may be necessary.

TABLE 1

Residual disease and margin status: squamous dysplasia

Follow-up of squamous lesions

Considerable clinical uncertainty remains over the relative strengths of cytologic, colposcopic, and histologic evaluation for residual or recurrent disease following excisional biopsy. Conservative management includes Papanicolaou smears alone or in combination with ECC and/or colposcopy.

Negative margins. If margins are negative, the success rate of excisional biopsy is high (90%-100%), and careful observation is the preferred follow-up. Repeat cytologic testing will identify the majority of patients with residual high-grade disease. A prospective randomized trial of cytologic surveillance showed that the detection rate was only 1.9% higher for histology.¹⁹ Although 1 report suggests that colposcopy can expedite the diagnosis of recurrent dysplasia, it is unclear from this report whether colposcopy identified significant high-grade dysplasia that cytology missed.²⁰

Positive margins. In most series involving CIN with positive margins, treatment success rates do not differ significantly between patients who undergo repeat surgical procedures and those who have close follow-up. However, endocervical margin involvement appears to carry a higher treatment failure rate than ectocervical margin involvement. Data are conflicting on the proper method of conservative follow-up. Some authors propose only frequent cytologic testing, while others recommend that colposcopy be performed.^19-21

For patients with positive margins, I perform both cytology and colposcopy in 4 to 6 months. If an endocervical margin was positive, I also perform an ECC. If this evaluation is negative, I repeat cytologic testing every 6 months until 3 consecutive Pap smears are normal and satisfactory. In cases of recurrent high-grade dysplasia with positive margins, hysterectomy may be indicated, depending on the patient’s age and desire for continued fertility.^14,21

Squamous microinvasion

There is a significant risk (50%-80%) of residual disease or true invasion when margins or an ECC are positive and microinvasion is present.^2,5-7 In these cases, a repeat excisional biopsy should be performed to determine the true extent of disease prior to deciding on definitive therapy.²² As previously mentioned, CKC is preferred to limit artifact that could obscure interpretation. If the patient has completed her childbearing, hysterectomy remains the standard treatment for microinvasive squamous cell carcinoma. When the woman wishes to preserve fertility, conservative follow-up appears to be safe if the final pathologic specimen has negative margins. A follow-up protocol including cytologic, colposcopic, and ECC monitoring in the first post-conization visit is recommended.^2,6

Glandular lesions

AIS with involved margins requires further surgery due to the possibility of residual AIS or invasion (TABLES 2 and 3).^2,5-7 In these cases, CKC is preferable to LEEP.^3,5-7 Hysterectomy remains the standard therapy for AIS. Conservative management is an option if fertility is desired and margin status is negative. Patients should be informed that persistent disease or recurrence is possible and that there is a risk of invasive disease.¹⁵

Counseling, thorough documentation, and second surgical and pathologic opinions may be helpful in conservative management. Colposcopy, ECC, and cytology are indicated at the first follow-up visit, with cytology repeated every 6 months until 4 consecutive Paps are normal. More frequent colposcopy and liberal use of ECC also may be considered.

TABLE 2

Residual disease and margin status: adenocarcinoma in situ

TABLE 3

Follow-up recommendations

When further excision is necessary

As noted earlier, repeat excision is necessary in cases of squamous microinvasion or AIS with positive margins. CKC is generally preferred to allow for optimal pathologic interpretation. For squamous intraepithelial lesions, excisional biopsy with close follow-up has a significant cure rate, and hysterectomy usually is not indicated. However, hysterectomy still should be considered part of the treatment continuum for CIN, particularly for patients who have completed childbearing.

Conclusion

Although the risk of recurrence is correlated with a patient’s margin status in cases of squamous dysplasia, conservative follow-up is possible and has a high success rate. Cytology is sufficient surveillance for cases involving negative margins. When margins are positive, colposcopy and ECC also may be useful. Microinvasive lesions with positive margins require further surgical evaluation to determine treatment. For glandular lesions, CKC is preferred for both diagnosis and treatment.

Dr. Dunton reports no affiliation or financial arrangement with any of the companies that manufacture drugs or devices in any of the product classes mentioned in this article.

When cervical intraepithelial neoplasia (CIN) requires treatment, loop electrosurgical excision procedure (LEEP) is the most frequently used modality, although cold-knife conization (CKC) of the cervical transformation zone still is preferred in select cases. Since excisional techniques are used with CKC, margin status is known and clinical decisions may be based on this information.

This article reviews current indications for excisional biopsy and presents evidence to direct management and follow-up of patients with positive and negative margins.

Selecting a technique

Several large randomized and prospective studies have demonstrated that LEEP is similar in efficacy to CKC and may even remove less of the normal cervical stroma.^1-3 In general, LEEP is used to excise high-grade and recurrent squamous dysplasia, as it is similar to CKC in its rates of incomplete excision and residual disease.^1,4 However, when adenocarcinoma in situ (AIS) is present, CKC is preferred for diagnosis and treatment, since it results in a lower incidence of involved margins and a lower recurrence rate.^3,5-7

CKC also is preferred when histologic confirmation of the margin status is crucial, such as when invasion with squamous lesions is suspected. This is because thermal artifacts that may result from LEEP will interfere with interpretation, further complicating treatment planning.^1,4,8,9 In cases of microinvasion, the ability to confirm margins makes conservative treatment possible; if the depth of invasion cannot be determined from the specimen, radical surgery may be necessary.

In the hands of an experienced clinician, however, thermal artifact from the LEEP technique generally is not a significant problem. Series reporting high rates of uninterpretable margins have been attributed to operator inexperience.¹⁰ In general, thermal artifact is reduced by limiting the number of sections taken. In ideal cases, only a single-piece specimen is obtained, similar to that achieved using CKC.^8,10,11 Newer loops, such as the cone biopsy excision loop, may decrease the number of sections and further improve margin interpretation.⁸

I use CKC in cases of suspected squamous invasion and in the evaluation of glandular lesions, but feel that in other cases LEEP is efficacious and quicker.

Identifying residual disease

When both the endocervical margin and endocervical curettage (ECC) are positive for squamous dysplasia at the time of excision, there is an increased risk of residual disease (TABLE 1).^12-14 However, it is not clear whether ECC alone is an independent predictor of residual disease. Although 1 study suggests an increased risk of invasive cancer in women over 50 years of age with a positive ECC at the time of conization, other series have failed to demonstrate a difference in treatment failure rates based on ECC.^15-17 Thus, the utility of ECC in directing further therapy at the time of excisional biopsy is unclear. I generally do not perform an ECC with LEEP for squamous dysplasia.

In AIS, a positive ECC is a strong predictor of residual disease, while a negative ECC is of limited significance.¹⁸ I am more likely to perform an ECC with glandular lesions. If it is negative, close follow-up still is indicated. If it is positive, repeat excision may be necessary.

TABLE 1

Residual disease and margin status: squamous dysplasia

Follow-up of squamous lesions

Considerable clinical uncertainty remains over the relative strengths of cytologic, colposcopic, and histologic evaluation for residual or recurrent disease following excisional biopsy. Conservative management includes Papanicolaou smears alone or in combination with ECC and/or colposcopy.

Negative margins. If margins are negative, the success rate of excisional biopsy is high (90%-100%), and careful observation is the preferred follow-up. Repeat cytologic testing will identify the majority of patients with residual high-grade disease. A prospective randomized trial of cytologic surveillance showed that the detection rate was only 1.9% higher for histology.¹⁹ Although 1 report suggests that colposcopy can expedite the diagnosis of recurrent dysplasia, it is unclear from this report whether colposcopy identified significant high-grade dysplasia that cytology missed.²⁰

Positive margins. In most series involving CIN with positive margins, treatment success rates do not differ significantly between patients who undergo repeat surgical procedures and those who have close follow-up. However, endocervical margin involvement appears to carry a higher treatment failure rate than ectocervical margin involvement. Data are conflicting on the proper method of conservative follow-up. Some authors propose only frequent cytologic testing, while others recommend that colposcopy be performed.^19-21

For patients with positive margins, I perform both cytology and colposcopy in 4 to 6 months. If an endocervical margin was positive, I also perform an ECC. If this evaluation is negative, I repeat cytologic testing every 6 months until 3 consecutive Pap smears are normal and satisfactory. In cases of recurrent high-grade dysplasia with positive margins, hysterectomy may be indicated, depending on the patient’s age and desire for continued fertility.^14,21

Squamous microinvasion

There is a significant risk (50%-80%) of residual disease or true invasion when margins or an ECC are positive and microinvasion is present.^2,5-7 In these cases, a repeat excisional biopsy should be performed to determine the true extent of disease prior to deciding on definitive therapy.²² As previously mentioned, CKC is preferred to limit artifact that could obscure interpretation. If the patient has completed her childbearing, hysterectomy remains the standard treatment for microinvasive squamous cell carcinoma. When the woman wishes to preserve fertility, conservative follow-up appears to be safe if the final pathologic specimen has negative margins. A follow-up protocol including cytologic, colposcopic, and ECC monitoring in the first post-conization visit is recommended.^2,6

Glandular lesions

AIS with involved margins requires further surgery due to the possibility of residual AIS or invasion (TABLES 2 and 3).^2,5-7 In these cases, CKC is preferable to LEEP.^3,5-7 Hysterectomy remains the standard therapy for AIS. Conservative management is an option if fertility is desired and margin status is negative. Patients should be informed that persistent disease or recurrence is possible and that there is a risk of invasive disease.¹⁵

Counseling, thorough documentation, and second surgical and pathologic opinions may be helpful in conservative management. Colposcopy, ECC, and cytology are indicated at the first follow-up visit, with cytology repeated every 6 months until 4 consecutive Paps are normal. More frequent colposcopy and liberal use of ECC also may be considered.

TABLE 2

Residual disease and margin status: adenocarcinoma in situ

TABLE 3

Follow-up recommendations

When further excision is necessary

As noted earlier, repeat excision is necessary in cases of squamous microinvasion or AIS with positive margins. CKC is generally preferred to allow for optimal pathologic interpretation. For squamous intraepithelial lesions, excisional biopsy with close follow-up has a significant cure rate, and hysterectomy usually is not indicated. However, hysterectomy still should be considered part of the treatment continuum for CIN, particularly for patients who have completed childbearing.

Conclusion

Although the risk of recurrence is correlated with a patient’s margin status in cases of squamous dysplasia, conservative follow-up is possible and has a high success rate. Cytology is sufficient surveillance for cases involving negative margins. When margins are positive, colposcopy and ECC also may be useful. Microinvasive lesions with positive margins require further surgical evaluation to determine treatment. For glandular lesions, CKC is preferred for both diagnosis and treatment.

Dr. Dunton reports no affiliation or financial arrangement with any of the companies that manufacture drugs or devices in any of the product classes mentioned in this article.

When cervical intraepithelial neoplasia (CIN) requires treatment, loop electrosurgical excision procedure (LEEP) is the most frequently used modality, although cold-knife conization (CKC) of the cervical transformation zone still is preferred in select cases. Since excisional techniques are used with CKC, margin status is known and clinical decisions may be based on this information.

This article reviews current indications for excisional biopsy and presents evidence to direct management and follow-up of patients with positive and negative margins.

Selecting a technique

Several large randomized and prospective studies have demonstrated that LEEP is similar in efficacy to CKC and may even remove less of the normal cervical stroma.^1-3 In general, LEEP is used to excise high-grade and recurrent squamous dysplasia, as it is similar to CKC in its rates of incomplete excision and residual disease.^1,4 However, when adenocarcinoma in situ (AIS) is present, CKC is preferred for diagnosis and treatment, since it results in a lower incidence of involved margins and a lower recurrence rate.^3,5-7

CKC also is preferred when histologic confirmation of the margin status is crucial, such as when invasion with squamous lesions is suspected. This is because thermal artifacts that may result from LEEP will interfere with interpretation, further complicating treatment planning.^1,4,8,9 In cases of microinvasion, the ability to confirm margins makes conservative treatment possible; if the depth of invasion cannot be determined from the specimen, radical surgery may be necessary.

In the hands of an experienced clinician, however, thermal artifact from the LEEP technique generally is not a significant problem. Series reporting high rates of uninterpretable margins have been attributed to operator inexperience.¹⁰ In general, thermal artifact is reduced by limiting the number of sections taken. In ideal cases, only a single-piece specimen is obtained, similar to that achieved using CKC.^8,10,11 Newer loops, such as the cone biopsy excision loop, may decrease the number of sections and further improve margin interpretation.⁸

I use CKC in cases of suspected squamous invasion and in the evaluation of glandular lesions, but feel that in other cases LEEP is efficacious and quicker.

Identifying residual disease

When both the endocervical margin and endocervical curettage (ECC) are positive for squamous dysplasia at the time of excision, there is an increased risk of residual disease (TABLE 1).^12-14 However, it is not clear whether ECC alone is an independent predictor of residual disease. Although 1 study suggests an increased risk of invasive cancer in women over 50 years of age with a positive ECC at the time of conization, other series have failed to demonstrate a difference in treatment failure rates based on ECC.^15-17 Thus, the utility of ECC in directing further therapy at the time of excisional biopsy is unclear. I generally do not perform an ECC with LEEP for squamous dysplasia.

In AIS, a positive ECC is a strong predictor of residual disease, while a negative ECC is of limited significance.¹⁸ I am more likely to perform an ECC with glandular lesions. If it is negative, close follow-up still is indicated. If it is positive, repeat excision may be necessary.

TABLE 1

Residual disease and margin status: squamous dysplasia

Follow-up of squamous lesions

Considerable clinical uncertainty remains over the relative strengths of cytologic, colposcopic, and histologic evaluation for residual or recurrent disease following excisional biopsy. Conservative management includes Papanicolaou smears alone or in combination with ECC and/or colposcopy.

Negative margins. If margins are negative, the success rate of excisional biopsy is high (90%-100%), and careful observation is the preferred follow-up. Repeat cytologic testing will identify the majority of patients with residual high-grade disease. A prospective randomized trial of cytologic surveillance showed that the detection rate was only 1.9% higher for histology.¹⁹ Although 1 report suggests that colposcopy can expedite the diagnosis of recurrent dysplasia, it is unclear from this report whether colposcopy identified significant high-grade dysplasia that cytology missed.²⁰

Positive margins. In most series involving CIN with positive margins, treatment success rates do not differ significantly between patients who undergo repeat surgical procedures and those who have close follow-up. However, endocervical margin involvement appears to carry a higher treatment failure rate than ectocervical margin involvement. Data are conflicting on the proper method of conservative follow-up. Some authors propose only frequent cytologic testing, while others recommend that colposcopy be performed.^19-21

For patients with positive margins, I perform both cytology and colposcopy in 4 to 6 months. If an endocervical margin was positive, I also perform an ECC. If this evaluation is negative, I repeat cytologic testing every 6 months until 3 consecutive Pap smears are normal and satisfactory. In cases of recurrent high-grade dysplasia with positive margins, hysterectomy may be indicated, depending on the patient’s age and desire for continued fertility.^14,21

Squamous microinvasion

There is a significant risk (50%-80%) of residual disease or true invasion when margins or an ECC are positive and microinvasion is present.^2,5-7 In these cases, a repeat excisional biopsy should be performed to determine the true extent of disease prior to deciding on definitive therapy.²² As previously mentioned, CKC is preferred to limit artifact that could obscure interpretation. If the patient has completed her childbearing, hysterectomy remains the standard treatment for microinvasive squamous cell carcinoma. When the woman wishes to preserve fertility, conservative follow-up appears to be safe if the final pathologic specimen has negative margins. A follow-up protocol including cytologic, colposcopic, and ECC monitoring in the first post-conization visit is recommended.^2,6

Glandular lesions

AIS with involved margins requires further surgery due to the possibility of residual AIS or invasion (TABLES 2 and 3).^2,5-7 In these cases, CKC is preferable to LEEP.^3,5-7 Hysterectomy remains the standard therapy for AIS. Conservative management is an option if fertility is desired and margin status is negative. Patients should be informed that persistent disease or recurrence is possible and that there is a risk of invasive disease.¹⁵

Counseling, thorough documentation, and second surgical and pathologic opinions may be helpful in conservative management. Colposcopy, ECC, and cytology are indicated at the first follow-up visit, with cytology repeated every 6 months until 4 consecutive Paps are normal. More frequent colposcopy and liberal use of ECC also may be considered.

TABLE 2

Residual disease and margin status: adenocarcinoma in situ

TABLE 3

Follow-up recommendations

When further excision is necessary

As noted earlier, repeat excision is necessary in cases of squamous microinvasion or AIS with positive margins. CKC is generally preferred to allow for optimal pathologic interpretation. For squamous intraepithelial lesions, excisional biopsy with close follow-up has a significant cure rate, and hysterectomy usually is not indicated. However, hysterectomy still should be considered part of the treatment continuum for CIN, particularly for patients who have completed childbearing.

Conclusion

Although the risk of recurrence is correlated with a patient’s margin status in cases of squamous dysplasia, conservative follow-up is possible and has a high success rate. Cytology is sufficient surveillance for cases involving negative margins. When margins are positive, colposcopy and ECC also may be useful. Microinvasive lesions with positive margins require further surgical evaluation to determine treatment. For glandular lesions, CKC is preferred for both diagnosis and treatment.

Dr. Dunton reports no affiliation or financial arrangement with any of the companies that manufacture drugs or devices in any of the product classes mentioned in this article.

While hysterectomy is one of the most frequently performed operations in gynecology, how to perform it—abdominally, vaginally, or laparoscopically—is less evident. Numerous studies have been published in an attempt to shed some light on this controversy.

Individualize the approach for each patient rather than rely on a dogmatic assignment of technique.

Prior to the introduction of the laparoscopic-assisted vaginal hysterectomy (LAVH) by Reich et al in 1989,¹ several large studies were published that compared the abdominal and vaginal routes for hysterectomy. The largest was the Collaborative Review of Sterilization (CREST) study conducted by the Centers for Disease Control (CDC).² This report included 1,856 women aged 15 to 44 who underwent non-emergency, non-radical hysterectomies at 9 institutions between 1978 and 1981. Fewer complications were associated with vaginal hysterectomy (VH) than abdominal hysterectomy (AH) (Table 1).

Now, several trials have included LAVH in the comparison of hysterectomy routes. In the most comprehensive study to date, Johns et al reviewed 2,563 hysterectomies performed for nonmalignant indications by 37 private gynecologists from a single institution.³ The researchers found that bowel, bladder, and ureteral injuries were uncommon, and the rates of each were similar among LAVH, abdominal hysterectomy, and vaginal hysterectomy (Table 2). In addition, a review of the literature between 1989 and 1995 revealed that LAVH is associated with a shorter hospital stay, decreased recovery time, and less analgesia compared with AH.⁴

However, since most of the data on route for hysterectomy are from retrospective and uncontrolled trials, one must interpret the findings carefully. For example, many studies do not control for additional procedures performed at the time of hysterectomy (e.g., enterocele, rectocele, and cystocele repairs). In addition, information on how researchers categorized unsuccessful attempts at VH or LAVH—which then had to be converted to AH—often is excluded. Also, physicians usually select the technique based on personal preference, practice style, and traditional dogma such as uterine size rather than a standard protocol.^5,6 Therefore, the increased incidence of postoperative morbidity associated with AH is difficult to decipher. Is it due to the increased number of obese and nulliparous women undergoing AH, the surgeon’s experience, pelvic pathology or operative indication, or is it related to the actual opening of the abdomen and intraperitoneal manipulation? Most likely, it is a combination of these factors.

Overall, hysterectomy is a relatively safe procedure with a mortality rate of 1 to 2 per 1,000.⁷ Morbidity, however, remains high. Fortunately, most complications are minor and easily remedied with little clinical consequence. Since certain aspects of postoperative morbidity are related to the route for hysterectomy, the surgeon must individualize the approach for each patient and not rely on a dogmatic assignment of technique. Here, we will review the patient selection for and provide pearls on abdominal, vaginal, and laparoscopic-assisted vaginal hysterectomy, as well as look at the advantages and disadvantages of each method.

TABLE 1

CREST^*study results

TABLE 2

Complications at hysterectomy

Abdominal hysterectomy

Patient selection. Choose the abdominal route when extensive intraperitoneal surgery and/or exploration are required in addition to the hysterectomy, i.e., in cases of pelvic organ carcinoma. Severe pelvic adhesive disease from documented severe endometriosis, salpingitis, or significant adnexal pathology and a considerably enlarged uterus also are best approached abdominally (Figure 1). In addition, use the abdominal route for obstetric emergencies such as postpartum hemorrhage.

Technique. First, determine the type of incision based on the following factors: Which one will allow completion of the procedure in a safe and efficient manner, minimize complications, expedite recovery, and offer a favorable cosmetic result? A vertical midline incision is the most adaptable to unsuspected pathology, especially if found in the upper abdomen. It is the quickest to perform and is associated with the least blood loss, an important advantage when operating emergently on an anemic or hemorrhaging patient. However, bear in mind that vertical incisions that have been extended into the upper abdomen are accompanied by increased postoperative pulmonary morbidity, pain, and risk of hernia formation.^8,9

Transverse incisions such as the commonly used Pfannenstiel, Cherney, and Maylard compromise upper abdominal exposure but are more cosmetically appealing than vertical incisions. Each of these involves a lower abdominal transverse skin incision and a transverse fascial incision. With the Pfannenstiel technique, the rectus fascia is separated from the rectus muscles, and the muscles are split vertically in the midline, allowing access to the peritoneal cavity. This is the quickest transverse incision to make but provides the least exposure.

If a Pfannenstiel incision has been made and additional lateral pelvic exposure is needed, convert the incision to a Cherney. Both the Cherney and Maylard incisions provide additional exposure to the pelvis, especially laterally, which is advantageous when complex pathology is limited to the pelvis. The Cherney incision involves dividing the rectus muscles from the pubic symphysis, whereas the Maylard incision entails horizontal transection of the rectus muscles at the level of the fascial incision. With the Maylard technique, the rectus fascia is not separated from the underlying muscles as it is in the Cherney incision. If upper abdominal exposure becomes necessary, all of these incisions can be extended upward from their lateral margin, creating a “J.” Alternatively, a second incision can be made in the upper abdomen.

Another option is mini-laparotomy (an incision less than 6 cm). Hoffman and Lynch reported success with this technique for hysterectomy in select patients.¹⁰ Most of the procedures were completed with minimal use of retractors by exteriorizing the uterus via one of the aforementioned incisions. They found this approach to be safe and effective in nonobese women in whom a vaginal approach was precluded due to anatomy.

Use the mini-laparotomy approach when there is a suspicious adnexal mass that can be removed through a small abdominal incision.¹¹ In addition, a large benign-appearing cystic adnexal mass can be drained, and the procedure then completed through this incision. Proceed cautiously, however, since an occasional unanticipated carcinoma will be encountered, and the act of drainage will result in the need for chemotherapy in a woman with otherwise early-stage disease. If cancer is suspected, consider a vertical minilaparotomy, which allows easy extension into the upper abdomen should surgical staging or debulking become necessary.

Advantages and disadvantages. The abdominal approach offers the best exposure of the pelvic and upper abdominal cavity but is associated with a high rate of complications, including fever and excessive blood loss. We surmise that postoperative recovery with a mini-laparotomy is likely to be improved compared with the traditional abdominal technique.

Figure 1

Opt for abdominal hysterectomy when a considerably enlarged uterus due to numerous fibroids is encountered.

Vaginal hysterectomy

Patient selection. Choose the vaginal route when pelvic support defects are present (Figure 2), but bear in mind that the course of the ureter changes with worsening degrees of uterine prolapse. We have found the ureter to be palpable in the bladder pillar in most women undergoing VH for prolapse, which helps avoid intraoperative ureteral injury.

The ovaries can be safely removed through the vagina in a large percentage of patients.

Obese, elderly, and otherwise medically debilitated patients also will benefit from the vaginal approach. Avoiding an abdominal wound in these women has obvious advantages. Also, vaginal surgery is associated with a reduction in postoperative pulmonary complications when compared with AH.^6,12

Vaginal accessibility inevitably influences the decision to proceed vaginally with a hysterectomy. An inadequate bony pelvis is reason to forgo a VH. Orthopedic conditions and muscular contractures of the lower extremities, which prevent safe positioning, also inhibit this approach. Some surgeons also consider prior abdominal or pelvic surgery a reason to avoid vaginal hysterectomy, while others find this route a means of eluding potential adhesions.

We are strong advocates of vaginal surgery and do not consider nulliparity, lack of uterine descent, or prior abdominopelvic surgery to be strict contraindications for VH. A Schuchardt incision may overcome a small introitus, and a mobile uterus often will descend as the uterosacral and cardinal ligaments are divided.

In women with a prior cesarean delivery, it may be easier to enter the vesicouterine space by approaching it from the less-scarred vaginal side. In a study of more than 200 patients with a previous cesarean who underwent VH, Sheth and Malpani found no increase in complications and concluded that VH is the route of choice in this patient population.¹³ When unsuspected pelvic adhesions are encountered, carefully dissect them transvaginally and complete the procedure.

Besides accessibility, uterine size must be considered. However, size alone should present a dilemma in only about 15% of patients since most hysterectomy specimens are 12 weeks’ gestational size or smaller.¹⁴

Technique. Large uteri can be removed vaginally, depending on the surgeon’s technical ability and experience. A familiarity with the various methods of morcellation—hemisection, posterior fundal morcellation, intramyometrial coring, and myomectomy—is mandatory. It often is beneficial to use a combination of these techniques to accomplish the procedure vaginally, as opposed to a single means of morcellation. With any morcellation procedure, maintain a midline orientation to avoid dissection into the broad ligament. Continued caudal traction also is helpful in eliminating excessive blood loss during this prolonged procedure. Do not morcellate a uterus when endometrial carcinoma is suspected.

In a prospective observational study comparing vaginal morcellation to AH, Hoffman et al¹⁵ found the former to be safer. Other researchers also have demonstrated the procedure’s safety in retrospective reports^16-18 and as subgroups in other series.¹⁴ Alternatively, preoperative treatment with a gonadotropin-releasing hor-Surgical Techniques mone (GnRH) agonist can reduce uterine size and result in a technically less challenging VH in some women.^19,20

Also, whether or not the ovaries will be resected may influence the decision to perform a VH. While some surgeons believe that oophorectomy precludes the vaginal approach, the ovaries can be safely removed through the vagina in a large percentage of patients.^21-23 In fact, Sheth²⁴ and Kovac¹⁴ have published 95% and 97% success rates in 2 separate series in which vaginal oophorectomy was attempted in 740 and 142 women, respectively. However, do not attempt adnexal removal without adequate transvaginal access and visibility, as it increases the risk of hemorrhage and ureteral injury. In these cases, LAVH or mini-laparotomy AH may be preferable if oophorectomy is mandatory, i.e., in women who are predisposed to ovarian malignancies because of genetic mutations. However, when patients are appropriately selected, there are essentially no disadvantages to VH.

Advantages and disadvantages.VH has many advantages over AH. Minimal intraperitoneal manipulation and the avoidance of an abdominal wound lead to a shorter hospital stay and decreased recovery time, which is coupled with less cost. Patients also find the lack of an abdominal scar to be an attractive feature of VH. A disadvantage is reduced operative exposure, making it difficult to manipulate pelvic pathology and resect the adnexa.

Figure 2

Choose the vaginal route when pelvic support defects are present, but bear in mind that the course of the ureter changes due to prolapse.

Laparoscopic-assisted vaginal hysterectomy

Patient selection. When in doubt about which approach to use, turn to LAVH. The laparoscope allows the surgeon to thoroughly assess intra-abdominal pathology, which aids in the appropriate selection of a hysterectomy route. For example, if cancer is suspected based on the visual inspection, opt for an AH. On the other hand, if only extensive adhesions are noted, laparoscopic adhesiolysis can be performed to allow the hysterectomy to be completed vaginally. As previously noted, LAVH is appropriate in patients undergoing hysterectomy with prophylactic oophorectomy due to genetic or familial risk factors.

Technique. Bear in mind that the laparoscope does not permit all patients to undergo a VH. In fact, about 10% of attempted LAVHs will be unsuccessful.^25,26 Some authors have reported failure during the laparoscopic portion,^25,26 while others have attributed the lack of success to the vaginal portion of the procedure.²⁷ Thus, it is important to be skilled at both laparoscopic and vaginal surgery in order to be successful with an LAVH.

LAVH requires three to five 5-to 10-mm abdominal incisions for port sites. An umbilical port is commonly used for the camera, and the remaining ports are used for operating. We typically use 3 ports and avoid most disposable instruments by using cautery on vascular pedicles, which helps minimize costs.³ Other alternatives include the use of endoscopic staplers, the Harmonic Scalpel (Ethicon Endo-Surgery, a Johnson & Johnson company, Cincinnati, Ohio), and suture ligatures with extra-or intracorporeal knot tying. Whichever instrument is used, familiarize yourself with all available equipment given the occasional malfunction encountered during laparoscopy.

Advantages and disadvantages. LAVH requires special equipment and expertise beyond that needed for an abdominal or vaginal hysterectomy. Additionally, this procedure increases operative time, cost, and morbidity (depending on the surgeon’s experience),^4,27,28 while the postoperative recovery is similar to that of VH.

Although we use the laparoscope infrequently and believe there is little need to perform excessive laparoscopy at the time of routine hysterectomy, we do not wish to understate the role of the laparoscope. Its use in specific instances can certainly avoid a laparotomy or help determine when an AH is more appropriate.

Conclusion

Emergent situations and patients with excessively enlarged uteri, significant pelvic pathology, or cancer are obvious candidates for AH. On the other hand, VH is frequently chosen for the small uterus in a multiparous woman with a large pelvis and no prior pelvic inflammatory disease or surgery. The dilemma arises when determining the approach for those patients with moderately enlarged uteri or presumptive risk factors for serious pelvic disease.

Kovac reported a standard protocol for selecting the route for hysterectomy. Uterine size, other pelvic pathology (endometriosis, adnexal disease, chronic pain, etc.), and uterine and adnexal accessibility (bony architecture, uterine support, and vaginal diameter) were each considered in the decision-making. A simplification of Kovac’s guidelines applicable to women undergoing hysterectomy for benign indications is summarized in Figure 3. Using these guidelines, Kovac reported a 99% (608/611) success rate for women assigned to VH or LAVH. The laparoscope was deemed necessary in only 19% of those assigned to the LAVH group, and ultimately only 9 patients required AH, yielding a 1:68 ratio for AH to VH.¹⁴

Gynecologists should seek alternatives to AH given its less favorable outcome in terms of morbidity and recovery. However, the surgeon who is competent with AH better serves the patient by performing the procedure via this route than by attempting an alternative procedure without the necessary proficiency. In other words, pelvic surgeons must be cognizant of their abilities and practice within that realm. Ultimately, the final selection of hysterectomy route should be based on the surgeon’s experience, the indication for surgery, and the patient’s anatomy.

FIGURE 3Guidelines to determine route of hysterectomy.

While hysterectomy is one of the most frequently performed operations in gynecology, how to perform it—abdominally, vaginally, or laparoscopically—is less evident. Numerous studies have been published in an attempt to shed some light on this controversy.

Individualize the approach for each patient rather than rely on a dogmatic assignment of technique.

Prior to the introduction of the laparoscopic-assisted vaginal hysterectomy (LAVH) by Reich et al in 1989,¹ several large studies were published that compared the abdominal and vaginal routes for hysterectomy. The largest was the Collaborative Review of Sterilization (CREST) study conducted by the Centers for Disease Control (CDC).² This report included 1,856 women aged 15 to 44 who underwent non-emergency, non-radical hysterectomies at 9 institutions between 1978 and 1981. Fewer complications were associated with vaginal hysterectomy (VH) than abdominal hysterectomy (AH) (Table 1).

Now, several trials have included LAVH in the comparison of hysterectomy routes. In the most comprehensive study to date, Johns et al reviewed 2,563 hysterectomies performed for nonmalignant indications by 37 private gynecologists from a single institution.³ The researchers found that bowel, bladder, and ureteral injuries were uncommon, and the rates of each were similar among LAVH, abdominal hysterectomy, and vaginal hysterectomy (Table 2). In addition, a review of the literature between 1989 and 1995 revealed that LAVH is associated with a shorter hospital stay, decreased recovery time, and less analgesia compared with AH.⁴

However, since most of the data on route for hysterectomy are from retrospective and uncontrolled trials, one must interpret the findings carefully. For example, many studies do not control for additional procedures performed at the time of hysterectomy (e.g., enterocele, rectocele, and cystocele repairs). In addition, information on how researchers categorized unsuccessful attempts at VH or LAVH—which then had to be converted to AH—often is excluded. Also, physicians usually select the technique based on personal preference, practice style, and traditional dogma such as uterine size rather than a standard protocol.^5,6 Therefore, the increased incidence of postoperative morbidity associated with AH is difficult to decipher. Is it due to the increased number of obese and nulliparous women undergoing AH, the surgeon’s experience, pelvic pathology or operative indication, or is it related to the actual opening of the abdomen and intraperitoneal manipulation? Most likely, it is a combination of these factors.

Overall, hysterectomy is a relatively safe procedure with a mortality rate of 1 to 2 per 1,000.⁷ Morbidity, however, remains high. Fortunately, most complications are minor and easily remedied with little clinical consequence. Since certain aspects of postoperative morbidity are related to the route for hysterectomy, the surgeon must individualize the approach for each patient and not rely on a dogmatic assignment of technique. Here, we will review the patient selection for and provide pearls on abdominal, vaginal, and laparoscopic-assisted vaginal hysterectomy, as well as look at the advantages and disadvantages of each method.

TABLE 1

CREST^*study results

TABLE 2

Complications at hysterectomy

Abdominal hysterectomy

Patient selection. Choose the abdominal route when extensive intraperitoneal surgery and/or exploration are required in addition to the hysterectomy, i.e., in cases of pelvic organ carcinoma. Severe pelvic adhesive disease from documented severe endometriosis, salpingitis, or significant adnexal pathology and a considerably enlarged uterus also are best approached abdominally (Figure 1). In addition, use the abdominal route for obstetric emergencies such as postpartum hemorrhage.

Technique. First, determine the type of incision based on the following factors: Which one will allow completion of the procedure in a safe and efficient manner, minimize complications, expedite recovery, and offer a favorable cosmetic result? A vertical midline incision is the most adaptable to unsuspected pathology, especially if found in the upper abdomen. It is the quickest to perform and is associated with the least blood loss, an important advantage when operating emergently on an anemic or hemorrhaging patient. However, bear in mind that vertical incisions that have been extended into the upper abdomen are accompanied by increased postoperative pulmonary morbidity, pain, and risk of hernia formation.^8,9

Transverse incisions such as the commonly used Pfannenstiel, Cherney, and Maylard compromise upper abdominal exposure but are more cosmetically appealing than vertical incisions. Each of these involves a lower abdominal transverse skin incision and a transverse fascial incision. With the Pfannenstiel technique, the rectus fascia is separated from the rectus muscles, and the muscles are split vertically in the midline, allowing access to the peritoneal cavity. This is the quickest transverse incision to make but provides the least exposure.

If a Pfannenstiel incision has been made and additional lateral pelvic exposure is needed, convert the incision to a Cherney. Both the Cherney and Maylard incisions provide additional exposure to the pelvis, especially laterally, which is advantageous when complex pathology is limited to the pelvis. The Cherney incision involves dividing the rectus muscles from the pubic symphysis, whereas the Maylard incision entails horizontal transection of the rectus muscles at the level of the fascial incision. With the Maylard technique, the rectus fascia is not separated from the underlying muscles as it is in the Cherney incision. If upper abdominal exposure becomes necessary, all of these incisions can be extended upward from their lateral margin, creating a “J.” Alternatively, a second incision can be made in the upper abdomen.

Another option is mini-laparotomy (an incision less than 6 cm). Hoffman and Lynch reported success with this technique for hysterectomy in select patients.¹⁰ Most of the procedures were completed with minimal use of retractors by exteriorizing the uterus via one of the aforementioned incisions. They found this approach to be safe and effective in nonobese women in whom a vaginal approach was precluded due to anatomy.

Use the mini-laparotomy approach when there is a suspicious adnexal mass that can be removed through a small abdominal incision.¹¹ In addition, a large benign-appearing cystic adnexal mass can be drained, and the procedure then completed through this incision. Proceed cautiously, however, since an occasional unanticipated carcinoma will be encountered, and the act of drainage will result in the need for chemotherapy in a woman with otherwise early-stage disease. If cancer is suspected, consider a vertical minilaparotomy, which allows easy extension into the upper abdomen should surgical staging or debulking become necessary.

Advantages and disadvantages. The abdominal approach offers the best exposure of the pelvic and upper abdominal cavity but is associated with a high rate of complications, including fever and excessive blood loss. We surmise that postoperative recovery with a mini-laparotomy is likely to be improved compared with the traditional abdominal technique.

Figure 1

Opt for abdominal hysterectomy when a considerably enlarged uterus due to numerous fibroids is encountered.

Vaginal hysterectomy

Patient selection. Choose the vaginal route when pelvic support defects are present (Figure 2), but bear in mind that the course of the ureter changes with worsening degrees of uterine prolapse. We have found the ureter to be palpable in the bladder pillar in most women undergoing VH for prolapse, which helps avoid intraoperative ureteral injury.

The ovaries can be safely removed through the vagina in a large percentage of patients.

Obese, elderly, and otherwise medically debilitated patients also will benefit from the vaginal approach. Avoiding an abdominal wound in these women has obvious advantages. Also, vaginal surgery is associated with a reduction in postoperative pulmonary complications when compared with AH.^6,12

Vaginal accessibility inevitably influences the decision to proceed vaginally with a hysterectomy. An inadequate bony pelvis is reason to forgo a VH. Orthopedic conditions and muscular contractures of the lower extremities, which prevent safe positioning, also inhibit this approach. Some surgeons also consider prior abdominal or pelvic surgery a reason to avoid vaginal hysterectomy, while others find this route a means of eluding potential adhesions.

We are strong advocates of vaginal surgery and do not consider nulliparity, lack of uterine descent, or prior abdominopelvic surgery to be strict contraindications for VH. A Schuchardt incision may overcome a small introitus, and a mobile uterus often will descend as the uterosacral and cardinal ligaments are divided.

In women with a prior cesarean delivery, it may be easier to enter the vesicouterine space by approaching it from the less-scarred vaginal side. In a study of more than 200 patients with a previous cesarean who underwent VH, Sheth and Malpani found no increase in complications and concluded that VH is the route of choice in this patient population.¹³ When unsuspected pelvic adhesions are encountered, carefully dissect them transvaginally and complete the procedure.

Besides accessibility, uterine size must be considered. However, size alone should present a dilemma in only about 15% of patients since most hysterectomy specimens are 12 weeks’ gestational size or smaller.¹⁴

Technique. Large uteri can be removed vaginally, depending on the surgeon’s technical ability and experience. A familiarity with the various methods of morcellation—hemisection, posterior fundal morcellation, intramyometrial coring, and myomectomy—is mandatory. It often is beneficial to use a combination of these techniques to accomplish the procedure vaginally, as opposed to a single means of morcellation. With any morcellation procedure, maintain a midline orientation to avoid dissection into the broad ligament. Continued caudal traction also is helpful in eliminating excessive blood loss during this prolonged procedure. Do not morcellate a uterus when endometrial carcinoma is suspected.

In a prospective observational study comparing vaginal morcellation to AH, Hoffman et al¹⁵ found the former to be safer. Other researchers also have demonstrated the procedure’s safety in retrospective reports^16-18 and as subgroups in other series.¹⁴ Alternatively, preoperative treatment with a gonadotropin-releasing hor-Surgical Techniques mone (GnRH) agonist can reduce uterine size and result in a technically less challenging VH in some women.^19,20

Also, whether or not the ovaries will be resected may influence the decision to perform a VH. While some surgeons believe that oophorectomy precludes the vaginal approach, the ovaries can be safely removed through the vagina in a large percentage of patients.^21-23 In fact, Sheth²⁴ and Kovac¹⁴ have published 95% and 97% success rates in 2 separate series in which vaginal oophorectomy was attempted in 740 and 142 women, respectively. However, do not attempt adnexal removal without adequate transvaginal access and visibility, as it increases the risk of hemorrhage and ureteral injury. In these cases, LAVH or mini-laparotomy AH may be preferable if oophorectomy is mandatory, i.e., in women who are predisposed to ovarian malignancies because of genetic mutations. However, when patients are appropriately selected, there are essentially no disadvantages to VH.

Advantages and disadvantages.VH has many advantages over AH. Minimal intraperitoneal manipulation and the avoidance of an abdominal wound lead to a shorter hospital stay and decreased recovery time, which is coupled with less cost. Patients also find the lack of an abdominal scar to be an attractive feature of VH. A disadvantage is reduced operative exposure, making it difficult to manipulate pelvic pathology and resect the adnexa.

Figure 2

Choose the vaginal route when pelvic support defects are present, but bear in mind that the course of the ureter changes due to prolapse.

Laparoscopic-assisted vaginal hysterectomy

Patient selection. When in doubt about which approach to use, turn to LAVH. The laparoscope allows the surgeon to thoroughly assess intra-abdominal pathology, which aids in the appropriate selection of a hysterectomy route. For example, if cancer is suspected based on the visual inspection, opt for an AH. On the other hand, if only extensive adhesions are noted, laparoscopic adhesiolysis can be performed to allow the hysterectomy to be completed vaginally. As previously noted, LAVH is appropriate in patients undergoing hysterectomy with prophylactic oophorectomy due to genetic or familial risk factors.

Technique. Bear in mind that the laparoscope does not permit all patients to undergo a VH. In fact, about 10% of attempted LAVHs will be unsuccessful.^25,26 Some authors have reported failure during the laparoscopic portion,^25,26 while others have attributed the lack of success to the vaginal portion of the procedure.²⁷ Thus, it is important to be skilled at both laparoscopic and vaginal surgery in order to be successful with an LAVH.

LAVH requires three to five 5-to 10-mm abdominal incisions for port sites. An umbilical port is commonly used for the camera, and the remaining ports are used for operating. We typically use 3 ports and avoid most disposable instruments by using cautery on vascular pedicles, which helps minimize costs.³ Other alternatives include the use of endoscopic staplers, the Harmonic Scalpel (Ethicon Endo-Surgery, a Johnson & Johnson company, Cincinnati, Ohio), and suture ligatures with extra-or intracorporeal knot tying. Whichever instrument is used, familiarize yourself with all available equipment given the occasional malfunction encountered during laparoscopy.

Advantages and disadvantages. LAVH requires special equipment and expertise beyond that needed for an abdominal or vaginal hysterectomy. Additionally, this procedure increases operative time, cost, and morbidity (depending on the surgeon’s experience),^4,27,28 while the postoperative recovery is similar to that of VH.

Although we use the laparoscope infrequently and believe there is little need to perform excessive laparoscopy at the time of routine hysterectomy, we do not wish to understate the role of the laparoscope. Its use in specific instances can certainly avoid a laparotomy or help determine when an AH is more appropriate.

Conclusion

Emergent situations and patients with excessively enlarged uteri, significant pelvic pathology, or cancer are obvious candidates for AH. On the other hand, VH is frequently chosen for the small uterus in a multiparous woman with a large pelvis and no prior pelvic inflammatory disease or surgery. The dilemma arises when determining the approach for those patients with moderately enlarged uteri or presumptive risk factors for serious pelvic disease.

Kovac reported a standard protocol for selecting the route for hysterectomy. Uterine size, other pelvic pathology (endometriosis, adnexal disease, chronic pain, etc.), and uterine and adnexal accessibility (bony architecture, uterine support, and vaginal diameter) were each considered in the decision-making. A simplification of Kovac’s guidelines applicable to women undergoing hysterectomy for benign indications is summarized in Figure 3. Using these guidelines, Kovac reported a 99% (608/611) success rate for women assigned to VH or LAVH. The laparoscope was deemed necessary in only 19% of those assigned to the LAVH group, and ultimately only 9 patients required AH, yielding a 1:68 ratio for AH to VH.¹⁴

Gynecologists should seek alternatives to AH given its less favorable outcome in terms of morbidity and recovery. However, the surgeon who is competent with AH better serves the patient by performing the procedure via this route than by attempting an alternative procedure without the necessary proficiency. In other words, pelvic surgeons must be cognizant of their abilities and practice within that realm. Ultimately, the final selection of hysterectomy route should be based on the surgeon’s experience, the indication for surgery, and the patient’s anatomy.

FIGURE 3Guidelines to determine route of hysterectomy.

While hysterectomy is one of the most frequently performed operations in gynecology, how to perform it—abdominally, vaginally, or laparoscopically—is less evident. Numerous studies have been published in an attempt to shed some light on this controversy.

Individualize the approach for each patient rather than rely on a dogmatic assignment of technique.

Prior to the introduction of the laparoscopic-assisted vaginal hysterectomy (LAVH) by Reich et al in 1989,¹ several large studies were published that compared the abdominal and vaginal routes for hysterectomy. The largest was the Collaborative Review of Sterilization (CREST) study conducted by the Centers for Disease Control (CDC).² This report included 1,856 women aged 15 to 44 who underwent non-emergency, non-radical hysterectomies at 9 institutions between 1978 and 1981. Fewer complications were associated with vaginal hysterectomy (VH) than abdominal hysterectomy (AH) (Table 1).

Now, several trials have included LAVH in the comparison of hysterectomy routes. In the most comprehensive study to date, Johns et al reviewed 2,563 hysterectomies performed for nonmalignant indications by 37 private gynecologists from a single institution.³ The researchers found that bowel, bladder, and ureteral injuries were uncommon, and the rates of each were similar among LAVH, abdominal hysterectomy, and vaginal hysterectomy (Table 2). In addition, a review of the literature between 1989 and 1995 revealed that LAVH is associated with a shorter hospital stay, decreased recovery time, and less analgesia compared with AH.⁴

However, since most of the data on route for hysterectomy are from retrospective and uncontrolled trials, one must interpret the findings carefully. For example, many studies do not control for additional procedures performed at the time of hysterectomy (e.g., enterocele, rectocele, and cystocele repairs). In addition, information on how researchers categorized unsuccessful attempts at VH or LAVH—which then had to be converted to AH—often is excluded. Also, physicians usually select the technique based on personal preference, practice style, and traditional dogma such as uterine size rather than a standard protocol.^5,6 Therefore, the increased incidence of postoperative morbidity associated with AH is difficult to decipher. Is it due to the increased number of obese and nulliparous women undergoing AH, the surgeon’s experience, pelvic pathology or operative indication, or is it related to the actual opening of the abdomen and intraperitoneal manipulation? Most likely, it is a combination of these factors.

Overall, hysterectomy is a relatively safe procedure with a mortality rate of 1 to 2 per 1,000.⁷ Morbidity, however, remains high. Fortunately, most complications are minor and easily remedied with little clinical consequence. Since certain aspects of postoperative morbidity are related to the route for hysterectomy, the surgeon must individualize the approach for each patient and not rely on a dogmatic assignment of technique. Here, we will review the patient selection for and provide pearls on abdominal, vaginal, and laparoscopic-assisted vaginal hysterectomy, as well as look at the advantages and disadvantages of each method.

TABLE 1

CREST^*study results

TABLE 2

Complications at hysterectomy

Abdominal hysterectomy

Patient selection. Choose the abdominal route when extensive intraperitoneal surgery and/or exploration are required in addition to the hysterectomy, i.e., in cases of pelvic organ carcinoma. Severe pelvic adhesive disease from documented severe endometriosis, salpingitis, or significant adnexal pathology and a considerably enlarged uterus also are best approached abdominally (Figure 1). In addition, use the abdominal route for obstetric emergencies such as postpartum hemorrhage.

Technique. First, determine the type of incision based on the following factors: Which one will allow completion of the procedure in a safe and efficient manner, minimize complications, expedite recovery, and offer a favorable cosmetic result? A vertical midline incision is the most adaptable to unsuspected pathology, especially if found in the upper abdomen. It is the quickest to perform and is associated with the least blood loss, an important advantage when operating emergently on an anemic or hemorrhaging patient. However, bear in mind that vertical incisions that have been extended into the upper abdomen are accompanied by increased postoperative pulmonary morbidity, pain, and risk of hernia formation.^8,9

Transverse incisions such as the commonly used Pfannenstiel, Cherney, and Maylard compromise upper abdominal exposure but are more cosmetically appealing than vertical incisions. Each of these involves a lower abdominal transverse skin incision and a transverse fascial incision. With the Pfannenstiel technique, the rectus fascia is separated from the rectus muscles, and the muscles are split vertically in the midline, allowing access to the peritoneal cavity. This is the quickest transverse incision to make but provides the least exposure.

If a Pfannenstiel incision has been made and additional lateral pelvic exposure is needed, convert the incision to a Cherney. Both the Cherney and Maylard incisions provide additional exposure to the pelvis, especially laterally, which is advantageous when complex pathology is limited to the pelvis. The Cherney incision involves dividing the rectus muscles from the pubic symphysis, whereas the Maylard incision entails horizontal transection of the rectus muscles at the level of the fascial incision. With the Maylard technique, the rectus fascia is not separated from the underlying muscles as it is in the Cherney incision. If upper abdominal exposure becomes necessary, all of these incisions can be extended upward from their lateral margin, creating a “J.” Alternatively, a second incision can be made in the upper abdomen.

Another option is mini-laparotomy (an incision less than 6 cm). Hoffman and Lynch reported success with this technique for hysterectomy in select patients.¹⁰ Most of the procedures were completed with minimal use of retractors by exteriorizing the uterus via one of the aforementioned incisions. They found this approach to be safe and effective in nonobese women in whom a vaginal approach was precluded due to anatomy.

Use the mini-laparotomy approach when there is a suspicious adnexal mass that can be removed through a small abdominal incision.¹¹ In addition, a large benign-appearing cystic adnexal mass can be drained, and the procedure then completed through this incision. Proceed cautiously, however, since an occasional unanticipated carcinoma will be encountered, and the act of drainage will result in the need for chemotherapy in a woman with otherwise early-stage disease. If cancer is suspected, consider a vertical minilaparotomy, which allows easy extension into the upper abdomen should surgical staging or debulking become necessary.

Advantages and disadvantages. The abdominal approach offers the best exposure of the pelvic and upper abdominal cavity but is associated with a high rate of complications, including fever and excessive blood loss. We surmise that postoperative recovery with a mini-laparotomy is likely to be improved compared with the traditional abdominal technique.

Figure 1

Opt for abdominal hysterectomy when a considerably enlarged uterus due to numerous fibroids is encountered.

Vaginal hysterectomy

Patient selection. Choose the vaginal route when pelvic support defects are present (Figure 2), but bear in mind that the course of the ureter changes with worsening degrees of uterine prolapse. We have found the ureter to be palpable in the bladder pillar in most women undergoing VH for prolapse, which helps avoid intraoperative ureteral injury.

The ovaries can be safely removed through the vagina in a large percentage of patients.

Obese, elderly, and otherwise medically debilitated patients also will benefit from the vaginal approach. Avoiding an abdominal wound in these women has obvious advantages. Also, vaginal surgery is associated with a reduction in postoperative pulmonary complications when compared with AH.^6,12

Vaginal accessibility inevitably influences the decision to proceed vaginally with a hysterectomy. An inadequate bony pelvis is reason to forgo a VH. Orthopedic conditions and muscular contractures of the lower extremities, which prevent safe positioning, also inhibit this approach. Some surgeons also consider prior abdominal or pelvic surgery a reason to avoid vaginal hysterectomy, while others find this route a means of eluding potential adhesions.

We are strong advocates of vaginal surgery and do not consider nulliparity, lack of uterine descent, or prior abdominopelvic surgery to be strict contraindications for VH. A Schuchardt incision may overcome a small introitus, and a mobile uterus often will descend as the uterosacral and cardinal ligaments are divided.

In women with a prior cesarean delivery, it may be easier to enter the vesicouterine space by approaching it from the less-scarred vaginal side. In a study of more than 200 patients with a previous cesarean who underwent VH, Sheth and Malpani found no increase in complications and concluded that VH is the route of choice in this patient population.¹³ When unsuspected pelvic adhesions are encountered, carefully dissect them transvaginally and complete the procedure.

Besides accessibility, uterine size must be considered. However, size alone should present a dilemma in only about 15% of patients since most hysterectomy specimens are 12 weeks’ gestational size or smaller.¹⁴

Technique. Large uteri can be removed vaginally, depending on the surgeon’s technical ability and experience. A familiarity with the various methods of morcellation—hemisection, posterior fundal morcellation, intramyometrial coring, and myomectomy—is mandatory. It often is beneficial to use a combination of these techniques to accomplish the procedure vaginally, as opposed to a single means of morcellation. With any morcellation procedure, maintain a midline orientation to avoid dissection into the broad ligament. Continued caudal traction also is helpful in eliminating excessive blood loss during this prolonged procedure. Do not morcellate a uterus when endometrial carcinoma is suspected.

In a prospective observational study comparing vaginal morcellation to AH, Hoffman et al¹⁵ found the former to be safer. Other researchers also have demonstrated the procedure’s safety in retrospective reports^16-18 and as subgroups in other series.¹⁴ Alternatively, preoperative treatment with a gonadotropin-releasing hor-Surgical Techniques mone (GnRH) agonist can reduce uterine size and result in a technically less challenging VH in some women.^19,20

Also, whether or not the ovaries will be resected may influence the decision to perform a VH. While some surgeons believe that oophorectomy precludes the vaginal approach, the ovaries can be safely removed through the vagina in a large percentage of patients.^21-23 In fact, Sheth²⁴ and Kovac¹⁴ have published 95% and 97% success rates in 2 separate series in which vaginal oophorectomy was attempted in 740 and 142 women, respectively. However, do not attempt adnexal removal without adequate transvaginal access and visibility, as it increases the risk of hemorrhage and ureteral injury. In these cases, LAVH or mini-laparotomy AH may be preferable if oophorectomy is mandatory, i.e., in women who are predisposed to ovarian malignancies because of genetic mutations. However, when patients are appropriately selected, there are essentially no disadvantages to VH.

Advantages and disadvantages.VH has many advantages over AH. Minimal intraperitoneal manipulation and the avoidance of an abdominal wound lead to a shorter hospital stay and decreased recovery time, which is coupled with less cost. Patients also find the lack of an abdominal scar to be an attractive feature of VH. A disadvantage is reduced operative exposure, making it difficult to manipulate pelvic pathology and resect the adnexa.

Figure 2

Choose the vaginal route when pelvic support defects are present, but bear in mind that the course of the ureter changes due to prolapse.

Laparoscopic-assisted vaginal hysterectomy

Patient selection. When in doubt about which approach to use, turn to LAVH. The laparoscope allows the surgeon to thoroughly assess intra-abdominal pathology, which aids in the appropriate selection of a hysterectomy route. For example, if cancer is suspected based on the visual inspection, opt for an AH. On the other hand, if only extensive adhesions are noted, laparoscopic adhesiolysis can be performed to allow the hysterectomy to be completed vaginally. As previously noted, LAVH is appropriate in patients undergoing hysterectomy with prophylactic oophorectomy due to genetic or familial risk factors.

Technique. Bear in mind that the laparoscope does not permit all patients to undergo a VH. In fact, about 10% of attempted LAVHs will be unsuccessful.^25,26 Some authors have reported failure during the laparoscopic portion,^25,26 while others have attributed the lack of success to the vaginal portion of the procedure.²⁷ Thus, it is important to be skilled at both laparoscopic and vaginal surgery in order to be successful with an LAVH.

LAVH requires three to five 5-to 10-mm abdominal incisions for port sites. An umbilical port is commonly used for the camera, and the remaining ports are used for operating. We typically use 3 ports and avoid most disposable instruments by using cautery on vascular pedicles, which helps minimize costs.³ Other alternatives include the use of endoscopic staplers, the Harmonic Scalpel (Ethicon Endo-Surgery, a Johnson & Johnson company, Cincinnati, Ohio), and suture ligatures with extra-or intracorporeal knot tying. Whichever instrument is used, familiarize yourself with all available equipment given the occasional malfunction encountered during laparoscopy.

Advantages and disadvantages. LAVH requires special equipment and expertise beyond that needed for an abdominal or vaginal hysterectomy. Additionally, this procedure increases operative time, cost, and morbidity (depending on the surgeon’s experience),^4,27,28 while the postoperative recovery is similar to that of VH.

Although we use the laparoscope infrequently and believe there is little need to perform excessive laparoscopy at the time of routine hysterectomy, we do not wish to understate the role of the laparoscope. Its use in specific instances can certainly avoid a laparotomy or help determine when an AH is more appropriate.

Conclusion

Emergent situations and patients with excessively enlarged uteri, significant pelvic pathology, or cancer are obvious candidates for AH. On the other hand, VH is frequently chosen for the small uterus in a multiparous woman with a large pelvis and no prior pelvic inflammatory disease or surgery. The dilemma arises when determining the approach for those patients with moderately enlarged uteri or presumptive risk factors for serious pelvic disease.

Kovac reported a standard protocol for selecting the route for hysterectomy. Uterine size, other pelvic pathology (endometriosis, adnexal disease, chronic pain, etc.), and uterine and adnexal accessibility (bony architecture, uterine support, and vaginal diameter) were each considered in the decision-making. A simplification of Kovac’s guidelines applicable to women undergoing hysterectomy for benign indications is summarized in Figure 3. Using these guidelines, Kovac reported a 99% (608/611) success rate for women assigned to VH or LAVH. The laparoscope was deemed necessary in only 19% of those assigned to the LAVH group, and ultimately only 9 patients required AH, yielding a 1:68 ratio for AH to VH.¹⁴

Gynecologists should seek alternatives to AH given its less favorable outcome in terms of morbidity and recovery. However, the surgeon who is competent with AH better serves the patient by performing the procedure via this route than by attempting an alternative procedure without the necessary proficiency. In other words, pelvic surgeons must be cognizant of their abilities and practice within that realm. Ultimately, the final selection of hysterectomy route should be based on the surgeon’s experience, the indication for surgery, and the patient’s anatomy.

FIGURE 3Guidelines to determine route of hysterectomy.

Surgery traditionally has been a mainstay in the treatment of endometriosis, one of the most common and debilitating diseases in benign gynecology. Surgeons were the first to attack the disease, and surgery remained the primary therapy through the 1970s. Only recently, with the development of drugs to combat endometriosis and techniques to circumvent the pelvic damage associated with the disease, has surgery begun to take a back seat to other therapeutic approaches.

The magnification afforded by laparoscopy frequently facilitates a more precise technique.

This review discusses the various surgical techniques available, including their advantages and disadvantages. An evidence-based review of the therapeutic value of surgery also is provided, along with recommendations for the application of surgery to different presentations of the disease.

One difficulty in reviewing the treatment of endometriosis lies in the heterogeneity of the disease itself. There are many physical manifestations of endometriosis, ranging from superficial peritoneal implants to deep, nodular lesions. Pelvic adhesions with fibrosis and distortion also are common, as are ovarian cysts (endometriomas) and involvement of organs such as the bladder and bowel. This wide range of presentations results in a variety of symptoms, with pelvic/abdominal pain and infertility being the most prominent. Although I will attempt to subdivide the data among these many “forms” of endometriosis, I would like to emphasize that, to some degree, the disease is unique in each woman. Of necessity, the recommendations here will be painted with broad strokes. Nevertheless, it is my belief that such generalizations retain their value in the quest to optimize therapy for individual patients.

Surgical methods

Conservative versus definitive surgery. When treating endometriosis, the surgeon is confronted with a number of technical considerations. The first is whether conservative or definitive surgery is advisable.

If a conservative approach is taken, the physician should assess the desired method of access, the method of treating implants, and the type of surgery done for endometriomas. The surgeon also should assess the need for ancillary procedures such as lysis of adhesions, appendectomy, and nerve interruption.

In conservative surgery, the patient’s fertility is preserved, while definitive surgery generally involves removal of the ovaries, a hysterectomy, or a combination of the 2 procedures. Definitive surgery is thought to be more effective over time, but must be reserved for patients whose fertility or continued endocrine function is deemed less important than the relief of pain.

Unfortunately, hysterectomy and ooph-orectomy do not guarantee the relief of pain. A study from Johns Hopkins suggests that the incidence of persistent or recurrent pain following hysterectomy and bilateral oophorectomy is 10%¹. One explanation for persistence/recurrence may be the presence of ovarian remnants, a common finding among such patients. One method of checking for postoperative remnants is checking serum FSH levels.

Method of access. When conservative surgery is desired, the surgeon must select a method of access. Although laparotomy traditionally has been used, most surgeons performing extensive surgery for endometriosis now favor a laparoscopic approach. There are several reasons for this. First, laparoscopy is less invasive, with a much more rapid recovery time. In addition, a laparoscopic procedure costs less than major surgery. Finally, the magnification afforded by laparoscopy frequently facilitates a more precise technique.

There are limited data comparing laparoscopic surgery to laparotomy for the conservative treatment of endometriosis, and all derive from observational cohort studies.^2-5 Despite the relatively poor quality of these studies, the evidence suggests little difference in pain relief via major or minor surgery. When the desired outcome is enhanced fertility, 3-year cumulative life-table pregnancy rates for the 2 techniques are equivalent.⁶

Destruction of implants. The surgical destruction of endometriotic lesions can be accomplished in a variety of ways: excision, vaporization, and fulguration/desiccation. Excision is generally thought to be the most complete of these techniques. It can be performed with a variety of instruments, ranging from the laser to monopolar needles to scissors. The technique is straightforward: The lesion margins are identified by close inspection of the peritoneum, and the cutting instrument is used to outline the area to be excised. The implant then is lifted with atraumatic forceps and separated from the underlying normal tissue by careful dissection. This procedure may be simple or extremely difficult, depending upon the location, thickness, and size of the implant. Many surgeons favor hydrodissection, a technique of irrigating under pressure the tissue near the lesion, in an attempt to separate normal tissue from abnormal. However, 2 dangers exist. First, fluid below the peritoneum frequently distorts anatomy, making a difficult dissection even more challenging. Second, structures fibrotically adherent to endometriosis will not separate and can be damaged if care is not taken to ensure their safety during excision of the lesion.

Implants may be vaporized using high-power-density energy over a short time. This induces a rapid increase in water temperature, resulting in vaporization and tissue destruction. If carbonization can be avoided, this method is very precise. It requires a focused, extremely high-power density, such as that achieved with the superpulse or ultra-pulse CO₂laser.

Coagulation occurs with lower energies and results in lower temperatures at the tissue level. At 60° to 80°C, there is a loss of intracellular water and coagulation of protein, resulting in cell destruction. Because the depth of penetration is not always predictable, this technique is considerably less precise than vaporization. In addition, while lasers are a rapid means of performing this method, bipolar electrical current or even monopolar techniques can be used.

No randomized comparisons of these approaches have been conducted. Only 1 retrospective, comparative trial exists. Winkel and Bray reported the results of a 24-month follow-up of 240 women with endometriosis and pelvic pain who underwent surgical treatment in the form of excision alone, laser coagulation alone, or laser coagulation plus medical therapy.⁷ Twelve months after surgery, 96% of excision patients were pain-free compared with 69% of those undergoing coagulation. At 2 years, the corresponding figures were 69% and 23%, respectively. While this seems to indicate that excision is superior to coagulation, the retrospective study design makes such a conclusion suggestive at best. For example, excision may have been used in easier, less risky situations, whereas in difficult cases, only coagulation may have been performed. The resulting success rates would thus reflect the amount of disease discovered, not the type of surgery. To truly clarify this issue, a randomized trial is needed.

Only 40% of patients surgically treated for endometriosis experience pain relief as a direct result of surgery.

As mentioned earlier, numerous weapons have been employed to destroy endometriosis lesions: the CO₂, KTP, Nd:YAG, and argon lasers; ultrasonic shears; monopolar electrical energy; and bipolar electrical energy. No comparisons of the efficacy of these instruments have been conducted.

Treating endometriomas. Ovarian cysts are common in the endometriosis patient, and the method by which they are surgically treated may be vital to the outcome. The goals of treating ovarian endometriomas are removing all ectopic endometrium in the ovary, reducing ovarian trauma, preserving follicles, and minimizing postoperative adhesion formation.⁸

Two types of endometriomas are recognized. The least common is contained entirely within the ovary. More widespread is an inverted anterior ovarian cortex with adhesions and implants on the surface, which is frequently adherent to the broad ligament. The latter type represents more than 90% of ovarian endometriomas.⁹

Before operating, the ovaries should be freed of all adhesions. The endometrioma may open spontaneously during this process; if not, incision and drainage are warranted. At this point, the cyst wall may be stripped, excised, or drained as indicated. Stripping involves separating the cyst wall from the ovary and slowly peeling them apart. In the Putman-Redwine technique, the opening to the endometrioma is circumscribed with a laser or electrosurgery, followed by dissection down to the cyst wall. The cyst wall and ovary then are separated sharply and bluntly until the cyst wall is removed, frequently intact. Excision also can be accomplished in a manner similar to a wedge resection. However, while removal of the endometrioma is invariably complete with this method, the potential for adhesion formation is higher.¹⁰

The vaporization or coagulation of cyst walls also has been described. A randomized trial comparing removal of the cyst wall versus fenestration and aspiration of cyst contents clearly demonstrates improved results with removal, whether the desired outcome is pain relief, fertility, or a lower rate of reoperation.¹¹

The value of closing the ovary after endometrioma removal has been greatly debated, with no consensus among surgeons. Data suggest more adhesions form with suturing of the ovary than without closure, but it is unclear whether this applies to all sizes of defects.¹²

Ancillary procedures. Adhesiolysis is an important step in the restoration of normal pelvic and abdominal anatomy. While simple lysis of adhesions is adequate if they were formed following infection, most experts believe a more complete approach is required for the endometriosis-induced adhesion. This is because of the relatively high incidence of endometriosis present within the adhesion itself. Thus, removal of the adhesion by lysing both boundaries of the scar tissue and connecting structures is preferable. The instrumentation is of little consequence as long as precision and hemostasis are maintained.

To minimize adhesion reformation, adhesion-prevention adjuvants should be used. Four are presently available, including Interceed (Ethicon Inc, Somerville, NJ), a cellulose based barrier; Seprafilm (Genzyme Corp, Cambridge, Mass), a hyaluronidase-impregnated barrier; Preclude (W.L. Gore and Associates Inc, Newark, Del), a non-absorbable barrier composed of the proprietary Gore-Tex; and Intergel (Lifecore Biomedical Inc, Chaska, Minn), a thick solution placed within the peritoneal cavity that provides widespread adhesion prophylaxis. All adjuvants currently available have been associated with decreased adhesion reformation in randomized clinical trials.¹³ They can be applied either laparoscopically or abdominally.

Appendectomy. Endometriosis of the appendix has been described in 17% of patients with bowel involvement.¹⁴ In all endometriosis surgeries, the appendix should be carefully inspected and removed if it appears abnormal. In patients who experience endometriosis-associated pelvic pain, it may be desirable to electively remove the appendix at the time of laparoscopy. This will prevent future confusion. Otherwise, emergency room physicians would have to differentiate the symptoms of chronic pelvic/abdominal pain from those of appendicitis in the event the patient presents with a complaint of pelvic pain.

Nerve interruption procedures. Two surgical procedures were designed to help reduce pain transmission in the endometriosis patient: uterosacral nerve ablation/resection and presacral neurectomy. Both involve interruption of the major efferent nerve fibers from the uterus, thus diminishing uterine and central pelvic pain. These procedures can be performed via laparoscopy or laparotomy. Unfortunately, neither has been shown to provide pain relief beyond that achieved with surgery directed against the disease itself.^15-18

Outcomes

Pain relief. Although there have been many investigations of the effect of endometriosis surgery on pelvic pain, the vast majority are of low quality. No randomized, controlled trials (RCTs) have compared surgery to medical therapy, and only 1 has investigated surgery versus sham surgery. Sutton and colleagues assessed the efficacy of laser laparoscopic surgery in the treatment of pain associated with minimal, mild, or moderate endometriosis.¹⁹ They found no difference in pain at 3 months follow-up. However, by 6 months, a clear-cut advantage was seen for surgery (Figure 1). Pain relief also was maintained for at least 1 year in patients undergoing laser surgery. These patients underwent ablation of endometriosis and of the uterosacral nerve (although, as noted earlier, the latter procedure provides no additional pain relief).

Most disconcerting is the finding that only 40% of patients surgically treated for endometriosis experience pain relief as a direct result of the surgery. (The number of patients who need to be treated to reduce pain in 1 patient is 2.5.)

It remains unclear whether excision of the disease will produce better results than coagulation with the CO₂ laser. Nor have the duration of pain relief and rate of reoperation been properly examined. Thus, although many surgeons feel quite strongly about the value of surgery to treat endometriosis-associated pain, there are few data to support their clinical impression of efficacy.

Fertility enhancement. Conservative surgery has been used extensively in an attempt to enhance fertility. Unfortunately, most studies on the subject are uncontrolled and of poor quality. In women who have early-stage disease, surgical therapy has resulted in pregnancy rates of 40% to 75%; in severe disease, the rates are lower, ranging from 20% to 50%.²⁰

A meta-analysis encompassing studies from 1982 through 1994 showed that either no treatment or surgery alone is superior to medical treatment for early-stage endometriosis-associated infertility.⁶

A separate meta-analysis of 25 RCTs and cohort studies examined the same issue.²¹ It found a possible treatment benefit from laparoscopic conservative surgery, but concluded that medical treatment of the disease was ineffective.

A multicenter randomized trial (ENDOCAN) assessed the value of surgery for early-stage endometriosis in the infertile patient. In this study, 341 infertile women with minimal or mild endometriosis were randomized to diagnostic laparoscopy or resection/ablation of disease.²² They then were followed for 36 weeks. The pregnancy rates were 31% for the treated group and 18% for the diagnostic group, demonstrating a clear advantage to surgery. The data also imply that to achieve 1 additional pregnancy in 9 months, 7.7 women must be surgically treated.

Adding confusion, a second randomized trial—this one from Italy—failed to demonstrate an improvement in fertility among those treated for early-stage endometriosis.²³ Nevertheless, when the studies are combined into meta-analysis, surgical treatment of early-stage endometriosis appears to provide a significant improvement in pregnancy rates (odds ratio [OR], 1.66; 95% confidence limits [CL], 1.09-2.51) (Figure 2).

The surgical treatment of endometriosis probably enhances fertility when the disease is advanced, although no high-quality studies specifically address this issue. For early-stage disease, the data are conflicting but suggest that a small effect may exist. Further studies are needed to assess the value of surgery for this disorder.

FIGURE 1 Rate of pain relief with operative versus diagnostic laparoscopy

Adapted from: Sutton CJG, Ewen SP, Whitelaw N, Haines P. Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, or moderate endometriosis. Fertil Steril. 1994;62:696.

FIGURE 2 Pregnancy rate with surgical treatment versus diagnostic laparoscopy for early-stage endometriosis

Conclusion

The role of surgery in the treatment of endometriosis is controversial. The procedure can be highly demanding technically and may involve a number of ancillary procedures besides destruction of lesions. Many questions remain unanswered. For example, we do not know the best surgical technique or ancillary procedures, or the best instruments for these procedures. While there appears to be value in treating pain and infertility, that value may be far less than anticipated. Moreover, the relative value of surgery in the treatment of endometriosis—when compared with medical therapy for pain relief or assisted reproduction for fertility enhancement—has yet to be adequately evaluated. Given this level of uncertainty and confusion, surgery should be undertaken with caution and restraint.

Dr. Olive reports that he is a consultant to TAP Pharmaceuticals. He also serves on the company’s speakers’ bureau.

Surgery traditionally has been a mainstay in the treatment of endometriosis, one of the most common and debilitating diseases in benign gynecology. Surgeons were the first to attack the disease, and surgery remained the primary therapy through the 1970s. Only recently, with the development of drugs to combat endometriosis and techniques to circumvent the pelvic damage associated with the disease, has surgery begun to take a back seat to other therapeutic approaches.

The magnification afforded by laparoscopy frequently facilitates a more precise technique.

This review discusses the various surgical techniques available, including their advantages and disadvantages. An evidence-based review of the therapeutic value of surgery also is provided, along with recommendations for the application of surgery to different presentations of the disease.

One difficulty in reviewing the treatment of endometriosis lies in the heterogeneity of the disease itself. There are many physical manifestations of endometriosis, ranging from superficial peritoneal implants to deep, nodular lesions. Pelvic adhesions with fibrosis and distortion also are common, as are ovarian cysts (endometriomas) and involvement of organs such as the bladder and bowel. This wide range of presentations results in a variety of symptoms, with pelvic/abdominal pain and infertility being the most prominent. Although I will attempt to subdivide the data among these many “forms” of endometriosis, I would like to emphasize that, to some degree, the disease is unique in each woman. Of necessity, the recommendations here will be painted with broad strokes. Nevertheless, it is my belief that such generalizations retain their value in the quest to optimize therapy for individual patients.

Surgical methods

Conservative versus definitive surgery. When treating endometriosis, the surgeon is confronted with a number of technical considerations. The first is whether conservative or definitive surgery is advisable.

If a conservative approach is taken, the physician should assess the desired method of access, the method of treating implants, and the type of surgery done for endometriomas. The surgeon also should assess the need for ancillary procedures such as lysis of adhesions, appendectomy, and nerve interruption.

In conservative surgery, the patient’s fertility is preserved, while definitive surgery generally involves removal of the ovaries, a hysterectomy, or a combination of the 2 procedures. Definitive surgery is thought to be more effective over time, but must be reserved for patients whose fertility or continued endocrine function is deemed less important than the relief of pain.

Unfortunately, hysterectomy and ooph-orectomy do not guarantee the relief of pain. A study from Johns Hopkins suggests that the incidence of persistent or recurrent pain following hysterectomy and bilateral oophorectomy is 10%¹. One explanation for persistence/recurrence may be the presence of ovarian remnants, a common finding among such patients. One method of checking for postoperative remnants is checking serum FSH levels.

Method of access. When conservative surgery is desired, the surgeon must select a method of access. Although laparotomy traditionally has been used, most surgeons performing extensive surgery for endometriosis now favor a laparoscopic approach. There are several reasons for this. First, laparoscopy is less invasive, with a much more rapid recovery time. In addition, a laparoscopic procedure costs less than major surgery. Finally, the magnification afforded by laparoscopy frequently facilitates a more precise technique.

There are limited data comparing laparoscopic surgery to laparotomy for the conservative treatment of endometriosis, and all derive from observational cohort studies.^2-5 Despite the relatively poor quality of these studies, the evidence suggests little difference in pain relief via major or minor surgery. When the desired outcome is enhanced fertility, 3-year cumulative life-table pregnancy rates for the 2 techniques are equivalent.⁶

Destruction of implants. The surgical destruction of endometriotic lesions can be accomplished in a variety of ways: excision, vaporization, and fulguration/desiccation. Excision is generally thought to be the most complete of these techniques. It can be performed with a variety of instruments, ranging from the laser to monopolar needles to scissors. The technique is straightforward: The lesion margins are identified by close inspection of the peritoneum, and the cutting instrument is used to outline the area to be excised. The implant then is lifted with atraumatic forceps and separated from the underlying normal tissue by careful dissection. This procedure may be simple or extremely difficult, depending upon the location, thickness, and size of the implant. Many surgeons favor hydrodissection, a technique of irrigating under pressure the tissue near the lesion, in an attempt to separate normal tissue from abnormal. However, 2 dangers exist. First, fluid below the peritoneum frequently distorts anatomy, making a difficult dissection even more challenging. Second, structures fibrotically adherent to endometriosis will not separate and can be damaged if care is not taken to ensure their safety during excision of the lesion.

Implants may be vaporized using high-power-density energy over a short time. This induces a rapid increase in water temperature, resulting in vaporization and tissue destruction. If carbonization can be avoided, this method is very precise. It requires a focused, extremely high-power density, such as that achieved with the superpulse or ultra-pulse CO₂laser.

Coagulation occurs with lower energies and results in lower temperatures at the tissue level. At 60° to 80°C, there is a loss of intracellular water and coagulation of protein, resulting in cell destruction. Because the depth of penetration is not always predictable, this technique is considerably less precise than vaporization. In addition, while lasers are a rapid means of performing this method, bipolar electrical current or even monopolar techniques can be used.

No randomized comparisons of these approaches have been conducted. Only 1 retrospective, comparative trial exists. Winkel and Bray reported the results of a 24-month follow-up of 240 women with endometriosis and pelvic pain who underwent surgical treatment in the form of excision alone, laser coagulation alone, or laser coagulation plus medical therapy.⁷ Twelve months after surgery, 96% of excision patients were pain-free compared with 69% of those undergoing coagulation. At 2 years, the corresponding figures were 69% and 23%, respectively. While this seems to indicate that excision is superior to coagulation, the retrospective study design makes such a conclusion suggestive at best. For example, excision may have been used in easier, less risky situations, whereas in difficult cases, only coagulation may have been performed. The resulting success rates would thus reflect the amount of disease discovered, not the type of surgery. To truly clarify this issue, a randomized trial is needed.

Only 40% of patients surgically treated for endometriosis experience pain relief as a direct result of surgery.

As mentioned earlier, numerous weapons have been employed to destroy endometriosis lesions: the CO₂, KTP, Nd:YAG, and argon lasers; ultrasonic shears; monopolar electrical energy; and bipolar electrical energy. No comparisons of the efficacy of these instruments have been conducted.

Treating endometriomas. Ovarian cysts are common in the endometriosis patient, and the method by which they are surgically treated may be vital to the outcome. The goals of treating ovarian endometriomas are removing all ectopic endometrium in the ovary, reducing ovarian trauma, preserving follicles, and minimizing postoperative adhesion formation.⁸

Two types of endometriomas are recognized. The least common is contained entirely within the ovary. More widespread is an inverted anterior ovarian cortex with adhesions and implants on the surface, which is frequently adherent to the broad ligament. The latter type represents more than 90% of ovarian endometriomas.⁹

Before operating, the ovaries should be freed of all adhesions. The endometrioma may open spontaneously during this process; if not, incision and drainage are warranted. At this point, the cyst wall may be stripped, excised, or drained as indicated. Stripping involves separating the cyst wall from the ovary and slowly peeling them apart. In the Putman-Redwine technique, the opening to the endometrioma is circumscribed with a laser or electrosurgery, followed by dissection down to the cyst wall. The cyst wall and ovary then are separated sharply and bluntly until the cyst wall is removed, frequently intact. Excision also can be accomplished in a manner similar to a wedge resection. However, while removal of the endometrioma is invariably complete with this method, the potential for adhesion formation is higher.¹⁰

The vaporization or coagulation of cyst walls also has been described. A randomized trial comparing removal of the cyst wall versus fenestration and aspiration of cyst contents clearly demonstrates improved results with removal, whether the desired outcome is pain relief, fertility, or a lower rate of reoperation.¹¹

The value of closing the ovary after endometrioma removal has been greatly debated, with no consensus among surgeons. Data suggest more adhesions form with suturing of the ovary than without closure, but it is unclear whether this applies to all sizes of defects.¹²

Ancillary procedures. Adhesiolysis is an important step in the restoration of normal pelvic and abdominal anatomy. While simple lysis of adhesions is adequate if they were formed following infection, most experts believe a more complete approach is required for the endometriosis-induced adhesion. This is because of the relatively high incidence of endometriosis present within the adhesion itself. Thus, removal of the adhesion by lysing both boundaries of the scar tissue and connecting structures is preferable. The instrumentation is of little consequence as long as precision and hemostasis are maintained.

To minimize adhesion reformation, adhesion-prevention adjuvants should be used. Four are presently available, including Interceed (Ethicon Inc, Somerville, NJ), a cellulose based barrier; Seprafilm (Genzyme Corp, Cambridge, Mass), a hyaluronidase-impregnated barrier; Preclude (W.L. Gore and Associates Inc, Newark, Del), a non-absorbable barrier composed of the proprietary Gore-Tex; and Intergel (Lifecore Biomedical Inc, Chaska, Minn), a thick solution placed within the peritoneal cavity that provides widespread adhesion prophylaxis. All adjuvants currently available have been associated with decreased adhesion reformation in randomized clinical trials.¹³ They can be applied either laparoscopically or abdominally.

Appendectomy. Endometriosis of the appendix has been described in 17% of patients with bowel involvement.¹⁴ In all endometriosis surgeries, the appendix should be carefully inspected and removed if it appears abnormal. In patients who experience endometriosis-associated pelvic pain, it may be desirable to electively remove the appendix at the time of laparoscopy. This will prevent future confusion. Otherwise, emergency room physicians would have to differentiate the symptoms of chronic pelvic/abdominal pain from those of appendicitis in the event the patient presents with a complaint of pelvic pain.

Nerve interruption procedures. Two surgical procedures were designed to help reduce pain transmission in the endometriosis patient: uterosacral nerve ablation/resection and presacral neurectomy. Both involve interruption of the major efferent nerve fibers from the uterus, thus diminishing uterine and central pelvic pain. These procedures can be performed via laparoscopy or laparotomy. Unfortunately, neither has been shown to provide pain relief beyond that achieved with surgery directed against the disease itself.^15-18

Outcomes

Pain relief. Although there have been many investigations of the effect of endometriosis surgery on pelvic pain, the vast majority are of low quality. No randomized, controlled trials (RCTs) have compared surgery to medical therapy, and only 1 has investigated surgery versus sham surgery. Sutton and colleagues assessed the efficacy of laser laparoscopic surgery in the treatment of pain associated with minimal, mild, or moderate endometriosis.¹⁹ They found no difference in pain at 3 months follow-up. However, by 6 months, a clear-cut advantage was seen for surgery (Figure 1). Pain relief also was maintained for at least 1 year in patients undergoing laser surgery. These patients underwent ablation of endometriosis and of the uterosacral nerve (although, as noted earlier, the latter procedure provides no additional pain relief).

Most disconcerting is the finding that only 40% of patients surgically treated for endometriosis experience pain relief as a direct result of the surgery. (The number of patients who need to be treated to reduce pain in 1 patient is 2.5.)

It remains unclear whether excision of the disease will produce better results than coagulation with the CO₂ laser. Nor have the duration of pain relief and rate of reoperation been properly examined. Thus, although many surgeons feel quite strongly about the value of surgery to treat endometriosis-associated pain, there are few data to support their clinical impression of efficacy.

Fertility enhancement. Conservative surgery has been used extensively in an attempt to enhance fertility. Unfortunately, most studies on the subject are uncontrolled and of poor quality. In women who have early-stage disease, surgical therapy has resulted in pregnancy rates of 40% to 75%; in severe disease, the rates are lower, ranging from 20% to 50%.²⁰

A meta-analysis encompassing studies from 1982 through 1994 showed that either no treatment or surgery alone is superior to medical treatment for early-stage endometriosis-associated infertility.⁶

A separate meta-analysis of 25 RCTs and cohort studies examined the same issue.²¹ It found a possible treatment benefit from laparoscopic conservative surgery, but concluded that medical treatment of the disease was ineffective.

A multicenter randomized trial (ENDOCAN) assessed the value of surgery for early-stage endometriosis in the infertile patient. In this study, 341 infertile women with minimal or mild endometriosis were randomized to diagnostic laparoscopy or resection/ablation of disease.²² They then were followed for 36 weeks. The pregnancy rates were 31% for the treated group and 18% for the diagnostic group, demonstrating a clear advantage to surgery. The data also imply that to achieve 1 additional pregnancy in 9 months, 7.7 women must be surgically treated.

Adding confusion, a second randomized trial—this one from Italy—failed to demonstrate an improvement in fertility among those treated for early-stage endometriosis.²³ Nevertheless, when the studies are combined into meta-analysis, surgical treatment of early-stage endometriosis appears to provide a significant improvement in pregnancy rates (odds ratio [OR], 1.66; 95% confidence limits [CL], 1.09-2.51) (Figure 2).

The surgical treatment of endometriosis probably enhances fertility when the disease is advanced, although no high-quality studies specifically address this issue. For early-stage disease, the data are conflicting but suggest that a small effect may exist. Further studies are needed to assess the value of surgery for this disorder.

FIGURE 1 Rate of pain relief with operative versus diagnostic laparoscopy

Adapted from: Sutton CJG, Ewen SP, Whitelaw N, Haines P. Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, or moderate endometriosis. Fertil Steril. 1994;62:696.

FIGURE 2 Pregnancy rate with surgical treatment versus diagnostic laparoscopy for early-stage endometriosis

Conclusion

The role of surgery in the treatment of endometriosis is controversial. The procedure can be highly demanding technically and may involve a number of ancillary procedures besides destruction of lesions. Many questions remain unanswered. For example, we do not know the best surgical technique or ancillary procedures, or the best instruments for these procedures. While there appears to be value in treating pain and infertility, that value may be far less than anticipated. Moreover, the relative value of surgery in the treatment of endometriosis—when compared with medical therapy for pain relief or assisted reproduction for fertility enhancement—has yet to be adequately evaluated. Given this level of uncertainty and confusion, surgery should be undertaken with caution and restraint.

Dr. Olive reports that he is a consultant to TAP Pharmaceuticals. He also serves on the company’s speakers’ bureau.

Surgery traditionally has been a mainstay in the treatment of endometriosis, one of the most common and debilitating diseases in benign gynecology. Surgeons were the first to attack the disease, and surgery remained the primary therapy through the 1970s. Only recently, with the development of drugs to combat endometriosis and techniques to circumvent the pelvic damage associated with the disease, has surgery begun to take a back seat to other therapeutic approaches.

The magnification afforded by laparoscopy frequently facilitates a more precise technique.

This review discusses the various surgical techniques available, including their advantages and disadvantages. An evidence-based review of the therapeutic value of surgery also is provided, along with recommendations for the application of surgery to different presentations of the disease.

One difficulty in reviewing the treatment of endometriosis lies in the heterogeneity of the disease itself. There are many physical manifestations of endometriosis, ranging from superficial peritoneal implants to deep, nodular lesions. Pelvic adhesions with fibrosis and distortion also are common, as are ovarian cysts (endometriomas) and involvement of organs such as the bladder and bowel. This wide range of presentations results in a variety of symptoms, with pelvic/abdominal pain and infertility being the most prominent. Although I will attempt to subdivide the data among these many “forms” of endometriosis, I would like to emphasize that, to some degree, the disease is unique in each woman. Of necessity, the recommendations here will be painted with broad strokes. Nevertheless, it is my belief that such generalizations retain their value in the quest to optimize therapy for individual patients.

Surgical methods

Conservative versus definitive surgery. When treating endometriosis, the surgeon is confronted with a number of technical considerations. The first is whether conservative or definitive surgery is advisable.

If a conservative approach is taken, the physician should assess the desired method of access, the method of treating implants, and the type of surgery done for endometriomas. The surgeon also should assess the need for ancillary procedures such as lysis of adhesions, appendectomy, and nerve interruption.

In conservative surgery, the patient’s fertility is preserved, while definitive surgery generally involves removal of the ovaries, a hysterectomy, or a combination of the 2 procedures. Definitive surgery is thought to be more effective over time, but must be reserved for patients whose fertility or continued endocrine function is deemed less important than the relief of pain.

Unfortunately, hysterectomy and ooph-orectomy do not guarantee the relief of pain. A study from Johns Hopkins suggests that the incidence of persistent or recurrent pain following hysterectomy and bilateral oophorectomy is 10%¹. One explanation for persistence/recurrence may be the presence of ovarian remnants, a common finding among such patients. One method of checking for postoperative remnants is checking serum FSH levels.

Method of access. When conservative surgery is desired, the surgeon must select a method of access. Although laparotomy traditionally has been used, most surgeons performing extensive surgery for endometriosis now favor a laparoscopic approach. There are several reasons for this. First, laparoscopy is less invasive, with a much more rapid recovery time. In addition, a laparoscopic procedure costs less than major surgery. Finally, the magnification afforded by laparoscopy frequently facilitates a more precise technique.

There are limited data comparing laparoscopic surgery to laparotomy for the conservative treatment of endometriosis, and all derive from observational cohort studies.^2-5 Despite the relatively poor quality of these studies, the evidence suggests little difference in pain relief via major or minor surgery. When the desired outcome is enhanced fertility, 3-year cumulative life-table pregnancy rates for the 2 techniques are equivalent.⁶

Destruction of implants. The surgical destruction of endometriotic lesions can be accomplished in a variety of ways: excision, vaporization, and fulguration/desiccation. Excision is generally thought to be the most complete of these techniques. It can be performed with a variety of instruments, ranging from the laser to monopolar needles to scissors. The technique is straightforward: The lesion margins are identified by close inspection of the peritoneum, and the cutting instrument is used to outline the area to be excised. The implant then is lifted with atraumatic forceps and separated from the underlying normal tissue by careful dissection. This procedure may be simple or extremely difficult, depending upon the location, thickness, and size of the implant. Many surgeons favor hydrodissection, a technique of irrigating under pressure the tissue near the lesion, in an attempt to separate normal tissue from abnormal. However, 2 dangers exist. First, fluid below the peritoneum frequently distorts anatomy, making a difficult dissection even more challenging. Second, structures fibrotically adherent to endometriosis will not separate and can be damaged if care is not taken to ensure their safety during excision of the lesion.

Implants may be vaporized using high-power-density energy over a short time. This induces a rapid increase in water temperature, resulting in vaporization and tissue destruction. If carbonization can be avoided, this method is very precise. It requires a focused, extremely high-power density, such as that achieved with the superpulse or ultra-pulse CO₂laser.

Coagulation occurs with lower energies and results in lower temperatures at the tissue level. At 60° to 80°C, there is a loss of intracellular water and coagulation of protein, resulting in cell destruction. Because the depth of penetration is not always predictable, this technique is considerably less precise than vaporization. In addition, while lasers are a rapid means of performing this method, bipolar electrical current or even monopolar techniques can be used.

No randomized comparisons of these approaches have been conducted. Only 1 retrospective, comparative trial exists. Winkel and Bray reported the results of a 24-month follow-up of 240 women with endometriosis and pelvic pain who underwent surgical treatment in the form of excision alone, laser coagulation alone, or laser coagulation plus medical therapy.⁷ Twelve months after surgery, 96% of excision patients were pain-free compared with 69% of those undergoing coagulation. At 2 years, the corresponding figures were 69% and 23%, respectively. While this seems to indicate that excision is superior to coagulation, the retrospective study design makes such a conclusion suggestive at best. For example, excision may have been used in easier, less risky situations, whereas in difficult cases, only coagulation may have been performed. The resulting success rates would thus reflect the amount of disease discovered, not the type of surgery. To truly clarify this issue, a randomized trial is needed.

Only 40% of patients surgically treated for endometriosis experience pain relief as a direct result of surgery.

As mentioned earlier, numerous weapons have been employed to destroy endometriosis lesions: the CO₂, KTP, Nd:YAG, and argon lasers; ultrasonic shears; monopolar electrical energy; and bipolar electrical energy. No comparisons of the efficacy of these instruments have been conducted.

Treating endometriomas. Ovarian cysts are common in the endometriosis patient, and the method by which they are surgically treated may be vital to the outcome. The goals of treating ovarian endometriomas are removing all ectopic endometrium in the ovary, reducing ovarian trauma, preserving follicles, and minimizing postoperative adhesion formation.⁸

Two types of endometriomas are recognized. The least common is contained entirely within the ovary. More widespread is an inverted anterior ovarian cortex with adhesions and implants on the surface, which is frequently adherent to the broad ligament. The latter type represents more than 90% of ovarian endometriomas.⁹

Before operating, the ovaries should be freed of all adhesions. The endometrioma may open spontaneously during this process; if not, incision and drainage are warranted. At this point, the cyst wall may be stripped, excised, or drained as indicated. Stripping involves separating the cyst wall from the ovary and slowly peeling them apart. In the Putman-Redwine technique, the opening to the endometrioma is circumscribed with a laser or electrosurgery, followed by dissection down to the cyst wall. The cyst wall and ovary then are separated sharply and bluntly until the cyst wall is removed, frequently intact. Excision also can be accomplished in a manner similar to a wedge resection. However, while removal of the endometrioma is invariably complete with this method, the potential for adhesion formation is higher.¹⁰

The vaporization or coagulation of cyst walls also has been described. A randomized trial comparing removal of the cyst wall versus fenestration and aspiration of cyst contents clearly demonstrates improved results with removal, whether the desired outcome is pain relief, fertility, or a lower rate of reoperation.¹¹

The value of closing the ovary after endometrioma removal has been greatly debated, with no consensus among surgeons. Data suggest more adhesions form with suturing of the ovary than without closure, but it is unclear whether this applies to all sizes of defects.¹²

Ancillary procedures. Adhesiolysis is an important step in the restoration of normal pelvic and abdominal anatomy. While simple lysis of adhesions is adequate if they were formed following infection, most experts believe a more complete approach is required for the endometriosis-induced adhesion. This is because of the relatively high incidence of endometriosis present within the adhesion itself. Thus, removal of the adhesion by lysing both boundaries of the scar tissue and connecting structures is preferable. The instrumentation is of little consequence as long as precision and hemostasis are maintained.

To minimize adhesion reformation, adhesion-prevention adjuvants should be used. Four are presently available, including Interceed (Ethicon Inc, Somerville, NJ), a cellulose based barrier; Seprafilm (Genzyme Corp, Cambridge, Mass), a hyaluronidase-impregnated barrier; Preclude (W.L. Gore and Associates Inc, Newark, Del), a non-absorbable barrier composed of the proprietary Gore-Tex; and Intergel (Lifecore Biomedical Inc, Chaska, Minn), a thick solution placed within the peritoneal cavity that provides widespread adhesion prophylaxis. All adjuvants currently available have been associated with decreased adhesion reformation in randomized clinical trials.¹³ They can be applied either laparoscopically or abdominally.

Appendectomy. Endometriosis of the appendix has been described in 17% of patients with bowel involvement.¹⁴ In all endometriosis surgeries, the appendix should be carefully inspected and removed if it appears abnormal. In patients who experience endometriosis-associated pelvic pain, it may be desirable to electively remove the appendix at the time of laparoscopy. This will prevent future confusion. Otherwise, emergency room physicians would have to differentiate the symptoms of chronic pelvic/abdominal pain from those of appendicitis in the event the patient presents with a complaint of pelvic pain.

Nerve interruption procedures. Two surgical procedures were designed to help reduce pain transmission in the endometriosis patient: uterosacral nerve ablation/resection and presacral neurectomy. Both involve interruption of the major efferent nerve fibers from the uterus, thus diminishing uterine and central pelvic pain. These procedures can be performed via laparoscopy or laparotomy. Unfortunately, neither has been shown to provide pain relief beyond that achieved with surgery directed against the disease itself.^15-18

Outcomes

Pain relief. Although there have been many investigations of the effect of endometriosis surgery on pelvic pain, the vast majority are of low quality. No randomized, controlled trials (RCTs) have compared surgery to medical therapy, and only 1 has investigated surgery versus sham surgery. Sutton and colleagues assessed the efficacy of laser laparoscopic surgery in the treatment of pain associated with minimal, mild, or moderate endometriosis.¹⁹ They found no difference in pain at 3 months follow-up. However, by 6 months, a clear-cut advantage was seen for surgery (Figure 1). Pain relief also was maintained for at least 1 year in patients undergoing laser surgery. These patients underwent ablation of endometriosis and of the uterosacral nerve (although, as noted earlier, the latter procedure provides no additional pain relief).

Most disconcerting is the finding that only 40% of patients surgically treated for endometriosis experience pain relief as a direct result of the surgery. (The number of patients who need to be treated to reduce pain in 1 patient is 2.5.)

It remains unclear whether excision of the disease will produce better results than coagulation with the CO₂ laser. Nor have the duration of pain relief and rate of reoperation been properly examined. Thus, although many surgeons feel quite strongly about the value of surgery to treat endometriosis-associated pain, there are few data to support their clinical impression of efficacy.

Fertility enhancement. Conservative surgery has been used extensively in an attempt to enhance fertility. Unfortunately, most studies on the subject are uncontrolled and of poor quality. In women who have early-stage disease, surgical therapy has resulted in pregnancy rates of 40% to 75%; in severe disease, the rates are lower, ranging from 20% to 50%.²⁰

A meta-analysis encompassing studies from 1982 through 1994 showed that either no treatment or surgery alone is superior to medical treatment for early-stage endometriosis-associated infertility.⁶

A separate meta-analysis of 25 RCTs and cohort studies examined the same issue.²¹ It found a possible treatment benefit from laparoscopic conservative surgery, but concluded that medical treatment of the disease was ineffective.

A multicenter randomized trial (ENDOCAN) assessed the value of surgery for early-stage endometriosis in the infertile patient. In this study, 341 infertile women with minimal or mild endometriosis were randomized to diagnostic laparoscopy or resection/ablation of disease.²² They then were followed for 36 weeks. The pregnancy rates were 31% for the treated group and 18% for the diagnostic group, demonstrating a clear advantage to surgery. The data also imply that to achieve 1 additional pregnancy in 9 months, 7.7 women must be surgically treated.

Adding confusion, a second randomized trial—this one from Italy—failed to demonstrate an improvement in fertility among those treated for early-stage endometriosis.²³ Nevertheless, when the studies are combined into meta-analysis, surgical treatment of early-stage endometriosis appears to provide a significant improvement in pregnancy rates (odds ratio [OR], 1.66; 95% confidence limits [CL], 1.09-2.51) (Figure 2).

The surgical treatment of endometriosis probably enhances fertility when the disease is advanced, although no high-quality studies specifically address this issue. For early-stage disease, the data are conflicting but suggest that a small effect may exist. Further studies are needed to assess the value of surgery for this disorder.

FIGURE 1 Rate of pain relief with operative versus diagnostic laparoscopy

Adapted from: Sutton CJG, Ewen SP, Whitelaw N, Haines P. Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, or moderate endometriosis. Fertil Steril. 1994;62:696.

FIGURE 2 Pregnancy rate with surgical treatment versus diagnostic laparoscopy for early-stage endometriosis

Conclusion

The role of surgery in the treatment of endometriosis is controversial. The procedure can be highly demanding technically and may involve a number of ancillary procedures besides destruction of lesions. Many questions remain unanswered. For example, we do not know the best surgical technique or ancillary procedures, or the best instruments for these procedures. While there appears to be value in treating pain and infertility, that value may be far less than anticipated. Moreover, the relative value of surgery in the treatment of endometriosis—when compared with medical therapy for pain relief or assisted reproduction for fertility enhancement—has yet to be adequately evaluated. Given this level of uncertainty and confusion, surgery should be undertaken with caution and restraint.

Dr. Olive reports that he is a consultant to TAP Pharmaceuticals. He also serves on the company’s speakers’ bureau.

While the mean age at which cervical cancer is diagnosed is 51, approximately 10% to 15% of women will develop cervical cancer in their reproductive years.¹ Traditionally, early-stage cervical cancers in young women have been treated by radical hysterectomy, resulting in permanent sterility. Now, these patients have an alternative: radical vaginal trachelectomy. This entails the excision of the majority of the cervix and parametria, with preservation of the uppermost portion of the cervix and uterus, allowing the possibility of future childbearing (Figure 1).

The rate of second trimester loss is elevated in radical vaginal trachelectomy patients.

A conservative approach for the treatment of early-stage cervical cancer was first proposed approximately 20 years ago by Aburel, a Romanian gynecologist.² He reported his experience with the abdominal “subfundic radical hysterectomy.” However, subsequent successful pregnancies did not occur, and the procedure was abandoned. In 1987, the French gynecologist Dargent began performing radical vaginal trachelectomy in concert with laparoscopic pelvic lymphadenectomy. He published his initial results in 1994.³ Thereafter, researchers in Quebec,⁴ Toronto,⁵ and London⁶ have reported their experiences with this procedure. Currently, almost 200 cases are reported in the literature. After describing patient selection and the technique, I will review the data regarding complications and oncologic and reproductive outcomes.

Figure 1

The shaded area indicates the portion of the cervix and upper vagina that will be resected during the procedure.

Patient selection

Although the potential benefit—preservation of fertility—is profound, the percentage of patients with cervical cancer who are candidates for radical vaginal trachelectomy is relatively small. The indications are the presence of an invasive cervical cancer (stage Ia2, Ib1, or IIa), the desire for future childbearing, no involvement of the upper endocervical canal, and no evidence of metastases on preoperative chest radiography and physical exam. Lesions 2 cm or smaller are ideal. While masses up to 3 cm can be resected, the recurrence rate is higher (similar to that after radical hysterectomy). Further, the absence of lymph-vascular space involvement (LVSI) is preferred, but its presence is not an absolute contraindication to the surgery.

Technique

Prior to the radical vaginal trachelectomy, perform a pelvic lymphadenectomy either transperitoneally or retroperitoneally, depending on the surgeon’s preference. If immediate histopathologic analysis of the lymph nodes is negative for metastases, proceed with the trachelectomy.

With the patient in the dorsal lithotomy position, grasp the vagina approximately 3 cm from the cervix and inject it with lidocaine. Then, using a scalpel, incise the vagina at the 12 o’clock position. After developing the vaginal cuff, suture it over the tumor using an absorbable suture in a figure-of-eight stitch, which provides traction to help identify proper surgical planes. Using the technique for a vaginal hysterectomy, create the vesicovaginal space. Then grasp the vagina at the 9 o’clock and 11 o’clock positions and sharply develop the paravesical space. Access to this space is located at approximately the 10 o’clock position. Repeat the same procedure on the contralateral side. (In this case, grasp the vagina at the 3 o’clock and 1 o’clock positions; access to this space is located at the 2 o’clock position.)

In the hands of an experienced surgeon, the complication rate is comparable to that of radical hysterectomy.

Place retractors in the paravesical spaces and retract the bladder anteriorly. The bladder pillars, which contain the ureters and are located in between the vesicovaginal and paravesical spaces, are now fully exposed (Figure 2). Palpate the ureter in each bladder pillar, then sharply divide each pillar, using cautery for hemostasis as needed. The ureters are now visible, as are the descending branches of the uterine artery.

At this point, the posterior cul-de-sac and the pararectal spaces can be accessed. Divide the uterosacral and cardinal ligaments 2 cm from the cervix (Figure 3). Retract the ureters and clamp the descending branch of the uterine artery. Finally, resect the cervix 0.5 to 1 cm distal to the isthmus and send the specimen to pathology (Figure 4). If the proximal (deep) incision margin has cleared the cancer, close the peritoneum and place a cerclage using a strong nonabsorbable suture (Figure 5). I prefer a double cerclage of No. 1 polyester or polypropylene. Then suture the vaginal mucosa to the cervical stump, not to the mucosa, to help prevent postoperative stenosis (Figure 6).

Prior to discharge, attempt a bladder challenge (usually postoperative day 2). In the rare instance the woman is unable to void, discharge the patient and repeat the bladder challenge in 1 week.

Figure 2

After dividing the bladder pillar, located between the vesicovaginal and paravesical spaces, identify the ureter (the tubular structure at 12 o’clock).

Figure 3

Access the posterior cul-de-sac and the pararectal spaces, and then divide the uterosacral and cardinal ligaments 2 cm from the cervix.

Figure 4

After retracting the ureters and clamping the descending branch of the uterine artery, resect the cervix 0.5 to 1 cm distal to the isthmus.

Figure 5

If the proximal incision margin has cleared the cancer, close the peritoneum and place a cerclage using a strong nonabsorbable suture.

Figure 6

Finally, suture the vaginal mucosa to the cervical stump, not to the mucosa, to help prevent postoperative stenosis.

Complications

The rate of morbidity associated with this procedure varies from 13% to 25%.^3-5 (In the hands of an experienced surgeon, the complication rate is comparable to that of radical hysterectomy.) Dargent et al reported complications in 7 of 47 women (1 required reoperation for sidewall hemorrhage, 5 had postoperative hematomas, and 1 had prolonged urinary retention).³ Similarly, Roy and Plante reported 2 external iliac artery injuries, 1 conversion to laparotomy for hemostasis, and 1 cystotomy among 30 patients who underwent the procedure.⁴ Covens et al encountered complications in 8 of 32 women, including 6 cystotomies, 1 enterotomy, and 1 external iliac artery injury.⁵ It is important to note that the vascular injuries most commonly occurred during the lymphadenectomy. To date, no operative mortalities have been reported in association with radical trachelectomy.

Oncologic outcome

Roy recently summarized the oncologic outcome of women undergoing radical vaginal trachelectomy for early-stage cervical cancer at medical centers in Lyon, Quebec, and Toronto.⁷ This data, as well as that from London and the Women’s Hospital in Los Angeles, are shown in Table 1. (Women who underwent radical trachelectomy followed by hysterectomy due to lack of lesion clearance are excluded.)

Among the almost 200 cases, the cancer recurrence rate is low, and viable pregnancies are clearly possible.

Seven of 197 women (3.5%) had positive lymph nodes discovered postoperatively. However, all of them have remained disease-free. (Most of the women received pelvic radiotherapy postoperatively.) To date, there have been 6 recurrences (3%) reported, 2 of which have been in women with neuroendocrine tumors (a histology associated with an especially poor prognosis). Excluding the 2 neuroendocrine tumors, the recurrence rate drops to 2.1%. All of the 4 remaining women had negative lymph nodes and LVSI, and 2 had lesions larger than 2 cm (Table 2).

Of the 92 women whose cervical cancers did not invade the lymph-vascular space, none experienced a recurrence. Similarly, smaller tumors were associated with a low recurrence rate; in women with lesions 2 cm or smaller, only 1.6% had a recurrence. Women with lesions larger than 2 cm or with LVSI had a somewhat higher recurrence rate (10.5% and 11.1%, respectively), as would be expected based on our knowledge of recurrence risk after radical hysterectomy (Table 3).^8,9

There are no prospective randomized trials that have analyzed oncologic outcome in women undergoing radical vaginal trachelectomy as compared to radical hysterectomy. Clearly, such a trial would not be feasible. However, the results of a 1999 retrospective case-control study are promising. In this trial, Covens compared the outcome of 32 women who underwent radical vaginal trachelectomy (all of whom had negative nodes and none of whom received radiation) to that of 30 women who underwent radical hystererctomy (matched for age, tumor size, histology, depth of invasion, and presence of LVSI).⁵ A second, unmatched, control group consisted of all women who had undergone radical hysterectomy for tumors 2 cm or smaller, had negative nodes, and had not received postoperative pelvic radiation. After a median follow-up of 23.4 months for the study patients, 46.5 months for the matched control patients, and 50.3 months for the unmatched control group, the 2-year actuarial recurrence-free survival was 95%, 97%, and 100%, respectively. These differences were not statistically significant.

TABLE 1

Oncologic outcome

TABLE 2

Recurrences after radical vaginal trachelectomy*

TABLE 3

Site recurrence by size and LVSI*

Reproductive outcome

Most researchers have reported that the majority of women attempting to conceive have been successful, and that most pregnancies result in a live birth (Table 4). The rate of second-trimester loss is clearly elevated in women who have undergone radical vaginal trachelectomy. The likely reason: the development of subclinical chorioamnionitis due to an inadequate mucus plug and exposure of the membranes to vaginal flora. To combat this problem, Dargent began performing the Saling procedure at 14 weeks’ gestation.² This entails approximating the vaginal mucosa over the cervix to provide a barrier to ascending infections. Since performing this technique, Dargent has not observed any cases of second-trimester loss. To date, this technique has not been adopted by other medical centers.

TABLE 4

Reproductive outcome

Conclusion

Based on the available data, the recurrence rate for women with squamous and adenocarcinomas appears to be low and comparable to that observed in women undergoing radical hysterectomy. Women with lesions larger than 2 cm or whose tumors have invaded the lymph-vascular space have a higher rate of recurrence, though not necessarily higher than if they had undergone radical hysterectomy.^8,9

However, this data must be interpreted with caution. The majority of recurrences reported have been located in the pelvis, raising the concern that the parametrial resection at the time of radical trachelectomy may be inadequate. Yet, recurrences after radical hysterectomy also tend to be local rather than distant in non-irradiated patients.^9,10 Also, the follow-up for women undergoing radical trachelectomy has been relatively short, and the number of women with lesions larger than 2 cm who have undergone this procedure is small. Thus, it is difficult to draw conclusions about the safety and efficacy of radical vaginal trachelectomy in this group.

Nonetheless, this technique appears to be a reasonable option for women with early-stage cervical cancer who desire future fertility. Among the almost 200 cases reported, the cancer recurrence rate is low, and viable pregnancies are clearly possible. However, longer follow-up is desirable. To meet this need, centers performing the procedure are forming a registry to better track both oncologic and reproductive outcomes. Further, more research is needed as to whether the Saling procedure will improve reproductive outcome and whether women with lesions larger than 2 cm and/or tumors invading the lymph-vascular space are at greater risk of recurrence with radical trachelectomy than if they had undergone radical hysterectomy.

At present, I offer radical vaginal trachelectomy to reproductive-age women with lesions 2 cm or smaller who are extremely desirous of future fertility. If the lesion is larger than 2 cm but is distal so that clearance appears feasible, I inform patients that there is limited data available regarding outcome, especially if LVSI is present.

The author reports no financial relationship with any companies whose products are mentioned in this article.

While the mean age at which cervical cancer is diagnosed is 51, approximately 10% to 15% of women will develop cervical cancer in their reproductive years.¹ Traditionally, early-stage cervical cancers in young women have been treated by radical hysterectomy, resulting in permanent sterility. Now, these patients have an alternative: radical vaginal trachelectomy. This entails the excision of the majority of the cervix and parametria, with preservation of the uppermost portion of the cervix and uterus, allowing the possibility of future childbearing (Figure 1).

The rate of second trimester loss is elevated in radical vaginal trachelectomy patients.

A conservative approach for the treatment of early-stage cervical cancer was first proposed approximately 20 years ago by Aburel, a Romanian gynecologist.² He reported his experience with the abdominal “subfundic radical hysterectomy.” However, subsequent successful pregnancies did not occur, and the procedure was abandoned. In 1987, the French gynecologist Dargent began performing radical vaginal trachelectomy in concert with laparoscopic pelvic lymphadenectomy. He published his initial results in 1994.³ Thereafter, researchers in Quebec,⁴ Toronto,⁵ and London⁶ have reported their experiences with this procedure. Currently, almost 200 cases are reported in the literature. After describing patient selection and the technique, I will review the data regarding complications and oncologic and reproductive outcomes.

Figure 1

The shaded area indicates the portion of the cervix and upper vagina that will be resected during the procedure.

Patient selection

Although the potential benefit—preservation of fertility—is profound, the percentage of patients with cervical cancer who are candidates for radical vaginal trachelectomy is relatively small. The indications are the presence of an invasive cervical cancer (stage Ia2, Ib1, or IIa), the desire for future childbearing, no involvement of the upper endocervical canal, and no evidence of metastases on preoperative chest radiography and physical exam. Lesions 2 cm or smaller are ideal. While masses up to 3 cm can be resected, the recurrence rate is higher (similar to that after radical hysterectomy). Further, the absence of lymph-vascular space involvement (LVSI) is preferred, but its presence is not an absolute contraindication to the surgery.

Technique

Prior to the radical vaginal trachelectomy, perform a pelvic lymphadenectomy either transperitoneally or retroperitoneally, depending on the surgeon’s preference. If immediate histopathologic analysis of the lymph nodes is negative for metastases, proceed with the trachelectomy.

With the patient in the dorsal lithotomy position, grasp the vagina approximately 3 cm from the cervix and inject it with lidocaine. Then, using a scalpel, incise the vagina at the 12 o’clock position. After developing the vaginal cuff, suture it over the tumor using an absorbable suture in a figure-of-eight stitch, which provides traction to help identify proper surgical planes. Using the technique for a vaginal hysterectomy, create the vesicovaginal space. Then grasp the vagina at the 9 o’clock and 11 o’clock positions and sharply develop the paravesical space. Access to this space is located at approximately the 10 o’clock position. Repeat the same procedure on the contralateral side. (In this case, grasp the vagina at the 3 o’clock and 1 o’clock positions; access to this space is located at the 2 o’clock position.)

In the hands of an experienced surgeon, the complication rate is comparable to that of radical hysterectomy.

Place retractors in the paravesical spaces and retract the bladder anteriorly. The bladder pillars, which contain the ureters and are located in between the vesicovaginal and paravesical spaces, are now fully exposed (Figure 2). Palpate the ureter in each bladder pillar, then sharply divide each pillar, using cautery for hemostasis as needed. The ureters are now visible, as are the descending branches of the uterine artery.

At this point, the posterior cul-de-sac and the pararectal spaces can be accessed. Divide the uterosacral and cardinal ligaments 2 cm from the cervix (Figure 3). Retract the ureters and clamp the descending branch of the uterine artery. Finally, resect the cervix 0.5 to 1 cm distal to the isthmus and send the specimen to pathology (Figure 4). If the proximal (deep) incision margin has cleared the cancer, close the peritoneum and place a cerclage using a strong nonabsorbable suture (Figure 5). I prefer a double cerclage of No. 1 polyester or polypropylene. Then suture the vaginal mucosa to the cervical stump, not to the mucosa, to help prevent postoperative stenosis (Figure 6).

Prior to discharge, attempt a bladder challenge (usually postoperative day 2). In the rare instance the woman is unable to void, discharge the patient and repeat the bladder challenge in 1 week.

Figure 2

After dividing the bladder pillar, located between the vesicovaginal and paravesical spaces, identify the ureter (the tubular structure at 12 o’clock).

Figure 3

Access the posterior cul-de-sac and the pararectal spaces, and then divide the uterosacral and cardinal ligaments 2 cm from the cervix.

Figure 4

After retracting the ureters and clamping the descending branch of the uterine artery, resect the cervix 0.5 to 1 cm distal to the isthmus.

Figure 5

If the proximal incision margin has cleared the cancer, close the peritoneum and place a cerclage using a strong nonabsorbable suture.

Figure 6

Finally, suture the vaginal mucosa to the cervical stump, not to the mucosa, to help prevent postoperative stenosis.

Complications

The rate of morbidity associated with this procedure varies from 13% to 25%.^3-5 (In the hands of an experienced surgeon, the complication rate is comparable to that of radical hysterectomy.) Dargent et al reported complications in 7 of 47 women (1 required reoperation for sidewall hemorrhage, 5 had postoperative hematomas, and 1 had prolonged urinary retention).³ Similarly, Roy and Plante reported 2 external iliac artery injuries, 1 conversion to laparotomy for hemostasis, and 1 cystotomy among 30 patients who underwent the procedure.⁴ Covens et al encountered complications in 8 of 32 women, including 6 cystotomies, 1 enterotomy, and 1 external iliac artery injury.⁵ It is important to note that the vascular injuries most commonly occurred during the lymphadenectomy. To date, no operative mortalities have been reported in association with radical trachelectomy.

Oncologic outcome

Roy recently summarized the oncologic outcome of women undergoing radical vaginal trachelectomy for early-stage cervical cancer at medical centers in Lyon, Quebec, and Toronto.⁷ This data, as well as that from London and the Women’s Hospital in Los Angeles, are shown in Table 1. (Women who underwent radical trachelectomy followed by hysterectomy due to lack of lesion clearance are excluded.)

Among the almost 200 cases, the cancer recurrence rate is low, and viable pregnancies are clearly possible.

Seven of 197 women (3.5%) had positive lymph nodes discovered postoperatively. However, all of them have remained disease-free. (Most of the women received pelvic radiotherapy postoperatively.) To date, there have been 6 recurrences (3%) reported, 2 of which have been in women with neuroendocrine tumors (a histology associated with an especially poor prognosis). Excluding the 2 neuroendocrine tumors, the recurrence rate drops to 2.1%. All of the 4 remaining women had negative lymph nodes and LVSI, and 2 had lesions larger than 2 cm (Table 2).

Of the 92 women whose cervical cancers did not invade the lymph-vascular space, none experienced a recurrence. Similarly, smaller tumors were associated with a low recurrence rate; in women with lesions 2 cm or smaller, only 1.6% had a recurrence. Women with lesions larger than 2 cm or with LVSI had a somewhat higher recurrence rate (10.5% and 11.1%, respectively), as would be expected based on our knowledge of recurrence risk after radical hysterectomy (Table 3).^8,9

There are no prospective randomized trials that have analyzed oncologic outcome in women undergoing radical vaginal trachelectomy as compared to radical hysterectomy. Clearly, such a trial would not be feasible. However, the results of a 1999 retrospective case-control study are promising. In this trial, Covens compared the outcome of 32 women who underwent radical vaginal trachelectomy (all of whom had negative nodes and none of whom received radiation) to that of 30 women who underwent radical hystererctomy (matched for age, tumor size, histology, depth of invasion, and presence of LVSI).⁵ A second, unmatched, control group consisted of all women who had undergone radical hysterectomy for tumors 2 cm or smaller, had negative nodes, and had not received postoperative pelvic radiation. After a median follow-up of 23.4 months for the study patients, 46.5 months for the matched control patients, and 50.3 months for the unmatched control group, the 2-year actuarial recurrence-free survival was 95%, 97%, and 100%, respectively. These differences were not statistically significant.

TABLE 1

Oncologic outcome

TABLE 2

Recurrences after radical vaginal trachelectomy*

TABLE 3

Site recurrence by size and LVSI*

Reproductive outcome

Most researchers have reported that the majority of women attempting to conceive have been successful, and that most pregnancies result in a live birth (Table 4). The rate of second-trimester loss is clearly elevated in women who have undergone radical vaginal trachelectomy. The likely reason: the development of subclinical chorioamnionitis due to an inadequate mucus plug and exposure of the membranes to vaginal flora. To combat this problem, Dargent began performing the Saling procedure at 14 weeks’ gestation.² This entails approximating the vaginal mucosa over the cervix to provide a barrier to ascending infections. Since performing this technique, Dargent has not observed any cases of second-trimester loss. To date, this technique has not been adopted by other medical centers.

TABLE 4

Reproductive outcome

Conclusion

Based on the available data, the recurrence rate for women with squamous and adenocarcinomas appears to be low and comparable to that observed in women undergoing radical hysterectomy. Women with lesions larger than 2 cm or whose tumors have invaded the lymph-vascular space have a higher rate of recurrence, though not necessarily higher than if they had undergone radical hysterectomy.^8,9

However, this data must be interpreted with caution. The majority of recurrences reported have been located in the pelvis, raising the concern that the parametrial resection at the time of radical trachelectomy may be inadequate. Yet, recurrences after radical hysterectomy also tend to be local rather than distant in non-irradiated patients.^9,10 Also, the follow-up for women undergoing radical trachelectomy has been relatively short, and the number of women with lesions larger than 2 cm who have undergone this procedure is small. Thus, it is difficult to draw conclusions about the safety and efficacy of radical vaginal trachelectomy in this group.

Nonetheless, this technique appears to be a reasonable option for women with early-stage cervical cancer who desire future fertility. Among the almost 200 cases reported, the cancer recurrence rate is low, and viable pregnancies are clearly possible. However, longer follow-up is desirable. To meet this need, centers performing the procedure are forming a registry to better track both oncologic and reproductive outcomes. Further, more research is needed as to whether the Saling procedure will improve reproductive outcome and whether women with lesions larger than 2 cm and/or tumors invading the lymph-vascular space are at greater risk of recurrence with radical trachelectomy than if they had undergone radical hysterectomy.

At present, I offer radical vaginal trachelectomy to reproductive-age women with lesions 2 cm or smaller who are extremely desirous of future fertility. If the lesion is larger than 2 cm but is distal so that clearance appears feasible, I inform patients that there is limited data available regarding outcome, especially if LVSI is present.

The author reports no financial relationship with any companies whose products are mentioned in this article.

While the mean age at which cervical cancer is diagnosed is 51, approximately 10% to 15% of women will develop cervical cancer in their reproductive years.¹ Traditionally, early-stage cervical cancers in young women have been treated by radical hysterectomy, resulting in permanent sterility. Now, these patients have an alternative: radical vaginal trachelectomy. This entails the excision of the majority of the cervix and parametria, with preservation of the uppermost portion of the cervix and uterus, allowing the possibility of future childbearing (Figure 1).

The rate of second trimester loss is elevated in radical vaginal trachelectomy patients.

A conservative approach for the treatment of early-stage cervical cancer was first proposed approximately 20 years ago by Aburel, a Romanian gynecologist.² He reported his experience with the abdominal “subfundic radical hysterectomy.” However, subsequent successful pregnancies did not occur, and the procedure was abandoned. In 1987, the French gynecologist Dargent began performing radical vaginal trachelectomy in concert with laparoscopic pelvic lymphadenectomy. He published his initial results in 1994.³ Thereafter, researchers in Quebec,⁴ Toronto,⁵ and London⁶ have reported their experiences with this procedure. Currently, almost 200 cases are reported in the literature. After describing patient selection and the technique, I will review the data regarding complications and oncologic and reproductive outcomes.

Figure 1

The shaded area indicates the portion of the cervix and upper vagina that will be resected during the procedure.

Patient selection

Although the potential benefit—preservation of fertility—is profound, the percentage of patients with cervical cancer who are candidates for radical vaginal trachelectomy is relatively small. The indications are the presence of an invasive cervical cancer (stage Ia2, Ib1, or IIa), the desire for future childbearing, no involvement of the upper endocervical canal, and no evidence of metastases on preoperative chest radiography and physical exam. Lesions 2 cm or smaller are ideal. While masses up to 3 cm can be resected, the recurrence rate is higher (similar to that after radical hysterectomy). Further, the absence of lymph-vascular space involvement (LVSI) is preferred, but its presence is not an absolute contraindication to the surgery.

Technique

Prior to the radical vaginal trachelectomy, perform a pelvic lymphadenectomy either transperitoneally or retroperitoneally, depending on the surgeon’s preference. If immediate histopathologic analysis of the lymph nodes is negative for metastases, proceed with the trachelectomy.

With the patient in the dorsal lithotomy position, grasp the vagina approximately 3 cm from the cervix and inject it with lidocaine. Then, using a scalpel, incise the vagina at the 12 o’clock position. After developing the vaginal cuff, suture it over the tumor using an absorbable suture in a figure-of-eight stitch, which provides traction to help identify proper surgical planes. Using the technique for a vaginal hysterectomy, create the vesicovaginal space. Then grasp the vagina at the 9 o’clock and 11 o’clock positions and sharply develop the paravesical space. Access to this space is located at approximately the 10 o’clock position. Repeat the same procedure on the contralateral side. (In this case, grasp the vagina at the 3 o’clock and 1 o’clock positions; access to this space is located at the 2 o’clock position.)

In the hands of an experienced surgeon, the complication rate is comparable to that of radical hysterectomy.

Place retractors in the paravesical spaces and retract the bladder anteriorly. The bladder pillars, which contain the ureters and are located in between the vesicovaginal and paravesical spaces, are now fully exposed (Figure 2). Palpate the ureter in each bladder pillar, then sharply divide each pillar, using cautery for hemostasis as needed. The ureters are now visible, as are the descending branches of the uterine artery.

At this point, the posterior cul-de-sac and the pararectal spaces can be accessed. Divide the uterosacral and cardinal ligaments 2 cm from the cervix (Figure 3). Retract the ureters and clamp the descending branch of the uterine artery. Finally, resect the cervix 0.5 to 1 cm distal to the isthmus and send the specimen to pathology (Figure 4). If the proximal (deep) incision margin has cleared the cancer, close the peritoneum and place a cerclage using a strong nonabsorbable suture (Figure 5). I prefer a double cerclage of No. 1 polyester or polypropylene. Then suture the vaginal mucosa to the cervical stump, not to the mucosa, to help prevent postoperative stenosis (Figure 6).

Prior to discharge, attempt a bladder challenge (usually postoperative day 2). In the rare instance the woman is unable to void, discharge the patient and repeat the bladder challenge in 1 week.

Figure 2

After dividing the bladder pillar, located between the vesicovaginal and paravesical spaces, identify the ureter (the tubular structure at 12 o’clock).

Figure 3

Access the posterior cul-de-sac and the pararectal spaces, and then divide the uterosacral and cardinal ligaments 2 cm from the cervix.

Figure 4

After retracting the ureters and clamping the descending branch of the uterine artery, resect the cervix 0.5 to 1 cm distal to the isthmus.

Figure 5

If the proximal incision margin has cleared the cancer, close the peritoneum and place a cerclage using a strong nonabsorbable suture.

Figure 6

Finally, suture the vaginal mucosa to the cervical stump, not to the mucosa, to help prevent postoperative stenosis.

Complications

The rate of morbidity associated with this procedure varies from 13% to 25%.^3-5 (In the hands of an experienced surgeon, the complication rate is comparable to that of radical hysterectomy.) Dargent et al reported complications in 7 of 47 women (1 required reoperation for sidewall hemorrhage, 5 had postoperative hematomas, and 1 had prolonged urinary retention).³ Similarly, Roy and Plante reported 2 external iliac artery injuries, 1 conversion to laparotomy for hemostasis, and 1 cystotomy among 30 patients who underwent the procedure.⁴ Covens et al encountered complications in 8 of 32 women, including 6 cystotomies, 1 enterotomy, and 1 external iliac artery injury.⁵ It is important to note that the vascular injuries most commonly occurred during the lymphadenectomy. To date, no operative mortalities have been reported in association with radical trachelectomy.

Oncologic outcome

Roy recently summarized the oncologic outcome of women undergoing radical vaginal trachelectomy for early-stage cervical cancer at medical centers in Lyon, Quebec, and Toronto.⁷ This data, as well as that from London and the Women’s Hospital in Los Angeles, are shown in Table 1. (Women who underwent radical trachelectomy followed by hysterectomy due to lack of lesion clearance are excluded.)

Among the almost 200 cases, the cancer recurrence rate is low, and viable pregnancies are clearly possible.

Seven of 197 women (3.5%) had positive lymph nodes discovered postoperatively. However, all of them have remained disease-free. (Most of the women received pelvic radiotherapy postoperatively.) To date, there have been 6 recurrences (3%) reported, 2 of which have been in women with neuroendocrine tumors (a histology associated with an especially poor prognosis). Excluding the 2 neuroendocrine tumors, the recurrence rate drops to 2.1%. All of the 4 remaining women had negative lymph nodes and LVSI, and 2 had lesions larger than 2 cm (Table 2).

Of the 92 women whose cervical cancers did not invade the lymph-vascular space, none experienced a recurrence. Similarly, smaller tumors were associated with a low recurrence rate; in women with lesions 2 cm or smaller, only 1.6% had a recurrence. Women with lesions larger than 2 cm or with LVSI had a somewhat higher recurrence rate (10.5% and 11.1%, respectively), as would be expected based on our knowledge of recurrence risk after radical hysterectomy (Table 3).^8,9

There are no prospective randomized trials that have analyzed oncologic outcome in women undergoing radical vaginal trachelectomy as compared to radical hysterectomy. Clearly, such a trial would not be feasible. However, the results of a 1999 retrospective case-control study are promising. In this trial, Covens compared the outcome of 32 women who underwent radical vaginal trachelectomy (all of whom had negative nodes and none of whom received radiation) to that of 30 women who underwent radical hystererctomy (matched for age, tumor size, histology, depth of invasion, and presence of LVSI).⁵ A second, unmatched, control group consisted of all women who had undergone radical hysterectomy for tumors 2 cm or smaller, had negative nodes, and had not received postoperative pelvic radiation. After a median follow-up of 23.4 months for the study patients, 46.5 months for the matched control patients, and 50.3 months for the unmatched control group, the 2-year actuarial recurrence-free survival was 95%, 97%, and 100%, respectively. These differences were not statistically significant.

TABLE 1

Oncologic outcome

TABLE 2

Recurrences after radical vaginal trachelectomy*

TABLE 3

Site recurrence by size and LVSI*

Reproductive outcome

Most researchers have reported that the majority of women attempting to conceive have been successful, and that most pregnancies result in a live birth (Table 4). The rate of second-trimester loss is clearly elevated in women who have undergone radical vaginal trachelectomy. The likely reason: the development of subclinical chorioamnionitis due to an inadequate mucus plug and exposure of the membranes to vaginal flora. To combat this problem, Dargent began performing the Saling procedure at 14 weeks’ gestation.² This entails approximating the vaginal mucosa over the cervix to provide a barrier to ascending infections. Since performing this technique, Dargent has not observed any cases of second-trimester loss. To date, this technique has not been adopted by other medical centers.

TABLE 4

Reproductive outcome

Conclusion

Based on the available data, the recurrence rate for women with squamous and adenocarcinomas appears to be low and comparable to that observed in women undergoing radical hysterectomy. Women with lesions larger than 2 cm or whose tumors have invaded the lymph-vascular space have a higher rate of recurrence, though not necessarily higher than if they had undergone radical hysterectomy.^8,9

However, this data must be interpreted with caution. The majority of recurrences reported have been located in the pelvis, raising the concern that the parametrial resection at the time of radical trachelectomy may be inadequate. Yet, recurrences after radical hysterectomy also tend to be local rather than distant in non-irradiated patients.^9,10 Also, the follow-up for women undergoing radical trachelectomy has been relatively short, and the number of women with lesions larger than 2 cm who have undergone this procedure is small. Thus, it is difficult to draw conclusions about the safety and efficacy of radical vaginal trachelectomy in this group.

Nonetheless, this technique appears to be a reasonable option for women with early-stage cervical cancer who desire future fertility. Among the almost 200 cases reported, the cancer recurrence rate is low, and viable pregnancies are clearly possible. However, longer follow-up is desirable. To meet this need, centers performing the procedure are forming a registry to better track both oncologic and reproductive outcomes. Further, more research is needed as to whether the Saling procedure will improve reproductive outcome and whether women with lesions larger than 2 cm and/or tumors invading the lymph-vascular space are at greater risk of recurrence with radical trachelectomy than if they had undergone radical hysterectomy.

At present, I offer radical vaginal trachelectomy to reproductive-age women with lesions 2 cm or smaller who are extremely desirous of future fertility. If the lesion is larger than 2 cm but is distal so that clearance appears feasible, I inform patients that there is limited data available regarding outcome, especially if LVSI is present.

The author reports no financial relationship with any companies whose products are mentioned in this article.

Although more than 50% of all women who undergo pelvic or abdominal surgery will develop adhesions, the condition garners limited attention in the literature and from physicians. And, yet, the problems—infertility, chronic pelvic pain, and bowel obstruction, to name a few—with which patients present to Ob/Gyns every day often can be attributed to pelvic adhesions. In short, the quality of life of a significant number of women is affected by this condition, warranting a detailed look at the laparoscopic technique of adhesiolysis.

Assessing etiology

Any injury to the peritoneum has the potential to cause a pelvic adhesion, including endometriosis, pelvic inflammatory disease (PID), infection with a sexually transmitted disease, bleeding, and prior surgery. When the peritoneum is injured, the superficial mesothelial cells are disrupted allowing leakage of fibrinogen and cells into the pelvic cavity. Fibrinogen is then converted to fibrin, which covers all injured surfaces. When excess fibrin is present, it binds one organ to another. During normal healing, plasmin (which is formed from plasminogen) breaks down these fibrin bridges. But when plasmin production is inhibited, the bridges between organs remain intact. Within 7 to 10 days after the initial injury, mesothelial cells infiltrate the fibrin bridges, causing adhesions to become more solid.

Consider the presence of adhesions in patients who present with pelvic pain or infertility, especially if they have had prior pelvic or abdominal surgery.

Salpingitis following chlamydia or gonorrhea is another common etiology of pelvic adhesions. The spread of the infection through the fallopian tubes and into the peritoneal cavity sets the stage for the condition, as do ulcerative colitis, appendicitis, and diverticulitis.

Endometriosis is one of the most common etiologies because peritoneal lesions activate a chronic extensive inflammatory process, leading to dense adhesions. In fact, endometriosis-related adhesions are so common that the American Society for Reproductive Medicine (ASRM) assigns more points to adhesions for the staging of endometriosis than it does to the disease itself.^1-2

Making the diagnosis

After reviewing the patient’s medical history, perform a physical exam. In some patients, an area of tenderness may be encountered when one palpates a prior incision, indicating that a loop of bowel may be adhered to this area. In addition, in women with adhesions, the uterus often is fixed either to the posterior pelvis or to the anterior abdominal wall, and the adnexa may be thickened and fixed to the uterus or pelvic sidewall. On rectal exam, the anterior wall of the rectum may be adhered to the uterus, or the rectum may be pulled to one side of the pelvis. Radiologic studies, with the exception of the hysterosalpingogram, do not usually aid in the diagnosis of pelvic adhesions.

Figure 1

Carefully inspect the pelvic cavity after placing the trocars. In this case, the woman was found to have adhesions on the left ovary.

Figure 2

Grasp the adhesion from the side contralateral to where you plan to make the first cut. Use laparoscopic scissors to divide and remove the tissue.

Figure 3

After completing adhesiolysis on the left ovary, check the contralateral organ. In this case, adhesions were found on the distal right tube and ovary.

Figure 4

Begin by excising superficial adhesions. This ensures unimpeded access to deeper adhesions in case bleeding occurs.

Figure 5

After all adhesions have been resected and removed, stop all bleeding and lavishly irrigate the pelvis with saline.

Figure 6

Just prior to closure, place oxidized regenerated cellulose (ORC) around both ovaries to help prevent recurrent adhesions.

Preparing the patient

After making the diagnosis and determining that surgery is the optimal treatment (see “Patient selection”), consider the approach. With rare exception, the procedure of choice is laparoscopy and is the method I prefer for adhesiolysis. Regardless of the route, prep the bowel either via an enema or an oral solution, as it decreases distention, making the operation safer and easier. In addition, evacuate the stomach contents via an oral gastric tube.

Placing the trocars

Correct trocar placement facilitates any laparoscopic procedure, especially when dense adhesions are present. First determine the insertion sites, then select the type of entry technique and the length of the trocars.