Surgical Techniques

CASE: Leaking fluid causes intraoperative burns

G.S. is a 45-year-old mother of three who is admitted for surgery for persistent menorrhagia. She has experienced at least two menstrual periods every month for several months, each of them associated with heavy bleeding. She has a history of hypothyroidism and hypertension, but no serious disease or surgery, and considers herself to be in good physical and mental health.

G.S. undergoes endometrial hydrothermablation (HTA) under general inhalation anesthesia. After the HTA mechanism is primed, the heating cycle is started, with a good seal and no fluid leaking from the cervix.

Approximately 8 minutes into the procedure, a 5-mL fluid deficit is noted, and a small amount of hot fluid is observed to be leaking from the cervical os. Examination reveals a thermal injury to the cervix and anterior vaginal wall. The wound is irrigated with cool, sterile saline, and silver sulfadiazine cream is applied. The patient is discharged.

Could this injury have been avoided? Is further treatment warranted?

A minimally invasive operation does not necessarily translate to minimal risk of serious complications. Although few studies of nonhysteroscopic endometrial ablation techniques report any complications,^1,2 Baggish and Savells³ found a number of injuries when they searched hospital records and the Food and Drug Administration (FDA) database (TABLE). They identified serious complications associated with the following devices:

• HydroThermablator (Boston Scientific), which utilizes a modified operating hysteroscope to deliver 10 to 12 mL of preheated saline into the uterus under low pressure.⁴ Complications: 16 adverse events were reported to the FDA, 13 of which involved the retrograde leakage of hot water, causing burns to the cervix, vagina, and vulva. Six additional injuries not reported to the FDA were identified at a single institution.
• Novasure (Cytyc), which employs bipolar electrodes that cover a porous bag.^5,6 Complications: 32 injuries, 26 of them uterine perforations.
• Thermachoice (Gynecare), a fluid-distended balloon ablator.⁷ Complications: 22 injuries included retrograde leakage of hot water after balloon failure and transmural thermal injury, with spread to, and injury of, proximal structures. One death was reported.
• Microsulis (MEA), which uses microwave energy to ablate the endometrium.^8-10 Complications: 19 injuries, including 13 thermal injuries to the intestines.

Baggish and Savells³ initiated this study after discovering six adverse events within their own hospital system utilizing a single device (HTA). Because these injuries were not reported to the FDA, the overall number of complications is likely higher than the figures given here.

This article describes the proper use of nonhysteroscopic endometrial ablation devices, the best ways to avert serious injury, and optimal treatment when complication occurs.

TABLE

Complications associated with 4 endometrial ablation devices

COMPLICATION	HYDRO THERMABLATOR*	THERMACHOICE	NOVASURE	MICROSULIS
Uterine perforation	2	3	26	19
Intestinal injury	1†	1†	–	13†
Retrograde leakage burn	19	6	–	–
Infection/sepsis	–	1†	2	1
Fistula/sinus	–	1†	1	–
Transmural uterine burn	–	1	–	–
Cervical stenosis	–	8	1	–
Cardiac arrest	1	–	1	–
Death	–	1	–	–
Other major	–	3	1	4†
Total	22	22	32	20
* Includes author’s data; 6 retrograde leaks
† Collateral injury

CASE continued: Patient opts for hysterectomy

In the case just described, G.S. was examined 1 week after surgery and found to have an exophytic burn over the entire right half of the cervix, extending into the vagina. She was readmitted for 3 days of intravenous (IV) antibiotic treatment and wound care. Computed tomography imaging showed gas formation within the damaged cervix.

Six weeks after surgery, the patient was still menstruating heavily, but her cervix and vagina had healed. Six months later, she underwent total abdominal hysterectomy for continued menorrhagia.

When is endometrial ablation an option?

Indications for endometrial ablation using a nonhysteroscopic, minimally invasive technique are no different from those for hysteroscopic ablation.¹¹ Abnormal, or dysfunctional, uterine bleeding is the principal reason for this operation. Dysfunctional bleeding is heavy or prolonged menses over 6 months or longer that fail to respond to conservative measures and occur in the absence of tumor, pregnancy, or inflammation (ie, infection).

A woman who meets these criteria should have a desire to retain her uterus if she is to be a candidate for a nonhysteroscopic, minimally invasive technique. She also should understand that ablation can render pregnancy unlikely and even pathologic. Her understanding of this consequence should be documented in the chart! Last, she should be informed that ablation will not necessarily render her sterile, so contraception or sterilization will be required to avoid pregnancy. This should also be clearly documented in the medical record.

 

Endometrial ablation may also be an alternative to hysterectomy for a mentally retarded woman who is unable to manage menses. Abnormal uterine bleeding in conjunction with bleeding diathesis, significant obesity, or serious medical disorders can also be treated by endometrial ablation.

Avoid endometrial ablation in certain circumstances

These circumstances include the presence of endometrial hyperplasia, endometrial cancer, endocervical neoplasia, cervical stenosis, an undiagnosed adnexal mass, moderate to severe dysmenorrhea, adenomyosis, or a uterine cavity larger than 10 cm.^12-15

Valle and Baggish¹⁵ reported eight cases in which women developed endometrial carcinoma following ablation, and identified the following major risk factors for postablation cancer:

• endometrial hyperplasia unresponsive to progesterone or progestin therapy
• complex endometrial hyperplasia
• atypical hyperplasia.

These conditions are contraindications to endometrial ablation.

Avoid a rush to ablation

The growing popularity of office-based, minimally invasive, nonhysteroscopic techniques, coupled with an increasing desire for and acceptance of elective cessation of menses, may stretch the indications listed above and cut short the discovery of contraindications. Clearly, thorough endometrial sampling and precise histopathologic interpretation are required before embarking on any type of endometrial ablation, to minimize the risk of complications.

How to prevent injury

Reduce the risk of perforation

Uterine perforation occurs for a variety of reasons:

• position of the uterus is unknown
• uterus has not been gently and carefully sounded
• cervix is insufficiently dilated to permit passage of the probe
• device is too long (large) to be accommodated in an individual patient’s uterus
• uterine cavity is distorted by pathology, such as adhesions, myomas, etc.

Attention to these details before surgery can prevent perforation.

When uterine injury occurs, the bowel is also at risk

The intestines can be injured following perforation or transmural injury of the uterus. Bowel injury has been reported with hysteroscopic ablation and resection as well as with Nd-YAG laser ablation.^16-18

Do not activate hot water or electrosurgical energy unless you are 100% certain that the device is within the uterine cavity.

Ideally, manufacturers’ safety studies should guarantee no risk of transtubal spillage of hot liquid.

Hot fluid adds to risk of burns

Devices that permit retrograde leakage of hot fluid, such as the HTA, should be modified to ensure sealing at the level of the external and internal cervical os. The Enable device (Innerdyne), no longer marketed in the United States, had such a sealing mechanism, which minimized retrograde leakage of hot water.

Balloon failure may be an unavoidable injury, but pretesting of the device and careful attention to pressure readings—particularly in a small uterus—may mitigate the risk.

Be alert for electrical leakage

The microwave device operates at the megahertz range of frequency. At this high frequency, the risk of leakage is much greater than with devices that operate in the kilohertz range. Therefore, it is important to pay close attention to grounding sites, such as cardiovascular-monitoring electrodes.

High-power monopolar devices, prolonged application of energy to tissue, and high generator frequency are all associated with leakage and subsequent burns.

Early recognition and treatment are vital to ensure the patient’s safety and reduce the risk of medicolegal liability. I recommend the following steps:

• Stop the procedure immediately if perforation is suspected. If you suspect that hot water has been dispersed within the abdominal cavity, switch to laparotomy and consult a general surgeon to inspect the entire intestine for injury. If perforation occurs during the use of electrosurgical energy, the same action is warranted. If uterine perforation occurs in isolation (ie, there is no thermal energy compounding the problem), admit the patient for careful observation, appropriate blood chemistries and hematologic studies, and radiologic examination.
• When hot liquids are spilled, switch to retrograde flow immediately and generously flush the vulva, vagina, and cervix with cold water. Cleanse the entire area with a soapless detergent, and apply clindamycin cream to the vagina and silver sulfadiazine cream to the vulva. Admit the patient for application of cold compresses, ice packs, and burn therapy, and obtain baseline cultures and hematologic studies and a plastic surgery consult. If third-degree (full thickness) burns are suspected, treat any suspected wound infection aggressively after obtaining cultures. Severe and inordinate pain should be investigated as a possible sign of necrotizing fasciitis. After discharge, follow the patient’s progress at weekly intervals.
• Talk to the patient and her family. It is a good idea to explain the complication in very clear terms. I believe it is reasonable to explain how the complication occurred, without speculation or theatrical explanations. Also be sure to document this conversation, including date and time. It may be useful to have a neutral witness present during the conversation. By and large, the patient and her family are likely to appreciate an honest account of how the complication occurred. Hiding data or attempting to cover up the injury may motivate the patient to seek legal representation.

 

What the future holds

The long-term success of endometrial ablation devices as a whole depends on several conditions. Foremost, the entire class of devices should demonstrate efficacy on par with hysteroscopic ablation. Currently, efficacy ranges from 80% to 95% (short-term follow-up).¹¹ The goal of minimally invasive procedures should be a sustainable 92% rate of amenorrhea, hypomenorrhea, or light, periodic menses. A long-term failure rate of 25% is unacceptable.^22-24 If the devices can, by their simplicity, be adapted to more or less universal office application and attain a 5-year success rate of 90% or higher, they will become the standard of care.

One size does not really fit all

Serious complications from endometrial ablation devices occur with regular frequency and must be eliminated or greatly reduced. Perforation is a significant problem and may be related to the “one-size-fits-all” design of the device. Perhaps a range of sizes needs to be produced and fitted to the individual uterine cavity.

If such complications as perforation and burns to the bowel, cervix, vagina, and vulva can be eliminated or relegated to rarity, then a happy future for these procedures lies beyond the horizon.

Price ceiling should be set at $1,000

If an operation can consistently be performed for less than $1,000 total cost—the cost of in-hospital endometrial ablation—it will gain mass appeal. In hospitals and so-called surgicenters, ablations are expensive and, therefore, less attractive to self- or third-party payers. If fees are based on the volume of cases, then a procedure may be price-efficient.

Outcome depends on patient selection

Poorly screened patients who have underlying hyperplasia may develop postablation carcinoma. Women who have dysmenorrhea before the procedure can be predicted to suffer from it afterward. Older women (ie, 40 years or older) will have better long-term success than younger women. And women with a large uterus or myomas will have a higher failure rate than women with smaller cavities (ie, less than 10 cm in length).

What this means for the individual surgeon

Although minimally invasive techniques are relatively easy to perform and simple to learn, each part of the procedure requires careful application and great attention to detail. Perforation of the uterus and leakage of scalding hot liquid must be avoided. If these complications occur, prompt diagnosis and appropriate treatment are critical. The removal of these procedures from the operating room to the office as well as competitive pricing of instrumentation will make nonhysteroscopic, minimally invasive endometrial ablation more cost-effective.

CASE: Leaking fluid causes intraoperative burns

G.S. is a 45-year-old mother of three who is admitted for surgery for persistent menorrhagia. She has experienced at least two menstrual periods every month for several months, each of them associated with heavy bleeding. She has a history of hypothyroidism and hypertension, but no serious disease or surgery, and considers herself to be in good physical and mental health.

G.S. undergoes endometrial hydrothermablation (HTA) under general inhalation anesthesia. After the HTA mechanism is primed, the heating cycle is started, with a good seal and no fluid leaking from the cervix.

Approximately 8 minutes into the procedure, a 5-mL fluid deficit is noted, and a small amount of hot fluid is observed to be leaking from the cervical os. Examination reveals a thermal injury to the cervix and anterior vaginal wall. The wound is irrigated with cool, sterile saline, and silver sulfadiazine cream is applied. The patient is discharged.

Could this injury have been avoided? Is further treatment warranted?

A minimally invasive operation does not necessarily translate to minimal risk of serious complications. Although few studies of nonhysteroscopic endometrial ablation techniques report any complications,^1,2 Baggish and Savells³ found a number of injuries when they searched hospital records and the Food and Drug Administration (FDA) database (TABLE). They identified serious complications associated with the following devices:

• HydroThermablator (Boston Scientific), which utilizes a modified operating hysteroscope to deliver 10 to 12 mL of preheated saline into the uterus under low pressure.⁴ Complications: 16 adverse events were reported to the FDA, 13 of which involved the retrograde leakage of hot water, causing burns to the cervix, vagina, and vulva. Six additional injuries not reported to the FDA were identified at a single institution.
• Novasure (Cytyc), which employs bipolar electrodes that cover a porous bag.^5,6 Complications: 32 injuries, 26 of them uterine perforations.
• Thermachoice (Gynecare), a fluid-distended balloon ablator.⁷ Complications: 22 injuries included retrograde leakage of hot water after balloon failure and transmural thermal injury, with spread to, and injury of, proximal structures. One death was reported.
• Microsulis (MEA), which uses microwave energy to ablate the endometrium.^8-10 Complications: 19 injuries, including 13 thermal injuries to the intestines.

Baggish and Savells³ initiated this study after discovering six adverse events within their own hospital system utilizing a single device (HTA). Because these injuries were not reported to the FDA, the overall number of complications is likely higher than the figures given here.

This article describes the proper use of nonhysteroscopic endometrial ablation devices, the best ways to avert serious injury, and optimal treatment when complication occurs.

TABLE

Complications associated with 4 endometrial ablation devices

COMPLICATION	HYDRO THERMABLATOR*	THERMACHOICE	NOVASURE	MICROSULIS
Uterine perforation	2	3	26	19
Intestinal injury	1†	1†	–	13†
Retrograde leakage burn	19	6	–	–
Infection/sepsis	–	1†	2	1
Fistula/sinus	–	1†	1	–
Transmural uterine burn	–	1	–	–
Cervical stenosis	–	8	1	–
Cardiac arrest	1	–	1	–
Death	–	1	–	–
Other major	–	3	1	4†
Total	22	22	32	20
* Includes author’s data; 6 retrograde leaks
† Collateral injury

CASE continued: Patient opts for hysterectomy

In the case just described, G.S. was examined 1 week after surgery and found to have an exophytic burn over the entire right half of the cervix, extending into the vagina. She was readmitted for 3 days of intravenous (IV) antibiotic treatment and wound care. Computed tomography imaging showed gas formation within the damaged cervix.

Six weeks after surgery, the patient was still menstruating heavily, but her cervix and vagina had healed. Six months later, she underwent total abdominal hysterectomy for continued menorrhagia.

When is endometrial ablation an option?

Indications for endometrial ablation using a nonhysteroscopic, minimally invasive technique are no different from those for hysteroscopic ablation.¹¹ Abnormal, or dysfunctional, uterine bleeding is the principal reason for this operation. Dysfunctional bleeding is heavy or prolonged menses over 6 months or longer that fail to respond to conservative measures and occur in the absence of tumor, pregnancy, or inflammation (ie, infection).

A woman who meets these criteria should have a desire to retain her uterus if she is to be a candidate for a nonhysteroscopic, minimally invasive technique. She also should understand that ablation can render pregnancy unlikely and even pathologic. Her understanding of this consequence should be documented in the chart! Last, she should be informed that ablation will not necessarily render her sterile, so contraception or sterilization will be required to avoid pregnancy. This should also be clearly documented in the medical record.

 

Endometrial ablation may also be an alternative to hysterectomy for a mentally retarded woman who is unable to manage menses. Abnormal uterine bleeding in conjunction with bleeding diathesis, significant obesity, or serious medical disorders can also be treated by endometrial ablation.

Avoid endometrial ablation in certain circumstances

These circumstances include the presence of endometrial hyperplasia, endometrial cancer, endocervical neoplasia, cervical stenosis, an undiagnosed adnexal mass, moderate to severe dysmenorrhea, adenomyosis, or a uterine cavity larger than 10 cm.^12-15

Valle and Baggish¹⁵ reported eight cases in which women developed endometrial carcinoma following ablation, and identified the following major risk factors for postablation cancer:

• endometrial hyperplasia unresponsive to progesterone or progestin therapy
• complex endometrial hyperplasia
• atypical hyperplasia.

These conditions are contraindications to endometrial ablation.

Avoid a rush to ablation

The growing popularity of office-based, minimally invasive, nonhysteroscopic techniques, coupled with an increasing desire for and acceptance of elective cessation of menses, may stretch the indications listed above and cut short the discovery of contraindications. Clearly, thorough endometrial sampling and precise histopathologic interpretation are required before embarking on any type of endometrial ablation, to minimize the risk of complications.

How to prevent injury

Reduce the risk of perforation

Uterine perforation occurs for a variety of reasons:

• position of the uterus is unknown
• uterus has not been gently and carefully sounded
• cervix is insufficiently dilated to permit passage of the probe
• device is too long (large) to be accommodated in an individual patient’s uterus
• uterine cavity is distorted by pathology, such as adhesions, myomas, etc.

Attention to these details before surgery can prevent perforation.

When uterine injury occurs, the bowel is also at risk

The intestines can be injured following perforation or transmural injury of the uterus. Bowel injury has been reported with hysteroscopic ablation and resection as well as with Nd-YAG laser ablation.^16-18

Do not activate hot water or electrosurgical energy unless you are 100% certain that the device is within the uterine cavity.

Ideally, manufacturers’ safety studies should guarantee no risk of transtubal spillage of hot liquid.

Hot fluid adds to risk of burns

Devices that permit retrograde leakage of hot fluid, such as the HTA, should be modified to ensure sealing at the level of the external and internal cervical os. The Enable device (Innerdyne), no longer marketed in the United States, had such a sealing mechanism, which minimized retrograde leakage of hot water.

Balloon failure may be an unavoidable injury, but pretesting of the device and careful attention to pressure readings—particularly in a small uterus—may mitigate the risk.

Be alert for electrical leakage

The microwave device operates at the megahertz range of frequency. At this high frequency, the risk of leakage is much greater than with devices that operate in the kilohertz range. Therefore, it is important to pay close attention to grounding sites, such as cardiovascular-monitoring electrodes.

High-power monopolar devices, prolonged application of energy to tissue, and high generator frequency are all associated with leakage and subsequent burns.

Early recognition and treatment are vital to ensure the patient’s safety and reduce the risk of medicolegal liability. I recommend the following steps:

• Stop the procedure immediately if perforation is suspected. If you suspect that hot water has been dispersed within the abdominal cavity, switch to laparotomy and consult a general surgeon to inspect the entire intestine for injury. If perforation occurs during the use of electrosurgical energy, the same action is warranted. If uterine perforation occurs in isolation (ie, there is no thermal energy compounding the problem), admit the patient for careful observation, appropriate blood chemistries and hematologic studies, and radiologic examination.
• When hot liquids are spilled, switch to retrograde flow immediately and generously flush the vulva, vagina, and cervix with cold water. Cleanse the entire area with a soapless detergent, and apply clindamycin cream to the vagina and silver sulfadiazine cream to the vulva. Admit the patient for application of cold compresses, ice packs, and burn therapy, and obtain baseline cultures and hematologic studies and a plastic surgery consult. If third-degree (full thickness) burns are suspected, treat any suspected wound infection aggressively after obtaining cultures. Severe and inordinate pain should be investigated as a possible sign of necrotizing fasciitis. After discharge, follow the patient’s progress at weekly intervals.
• Talk to the patient and her family. It is a good idea to explain the complication in very clear terms. I believe it is reasonable to explain how the complication occurred, without speculation or theatrical explanations. Also be sure to document this conversation, including date and time. It may be useful to have a neutral witness present during the conversation. By and large, the patient and her family are likely to appreciate an honest account of how the complication occurred. Hiding data or attempting to cover up the injury may motivate the patient to seek legal representation.

 

What the future holds

The long-term success of endometrial ablation devices as a whole depends on several conditions. Foremost, the entire class of devices should demonstrate efficacy on par with hysteroscopic ablation. Currently, efficacy ranges from 80% to 95% (short-term follow-up).¹¹ The goal of minimally invasive procedures should be a sustainable 92% rate of amenorrhea, hypomenorrhea, or light, periodic menses. A long-term failure rate of 25% is unacceptable.^22-24 If the devices can, by their simplicity, be adapted to more or less universal office application and attain a 5-year success rate of 90% or higher, they will become the standard of care.

One size does not really fit all

Serious complications from endometrial ablation devices occur with regular frequency and must be eliminated or greatly reduced. Perforation is a significant problem and may be related to the “one-size-fits-all” design of the device. Perhaps a range of sizes needs to be produced and fitted to the individual uterine cavity.

If such complications as perforation and burns to the bowel, cervix, vagina, and vulva can be eliminated or relegated to rarity, then a happy future for these procedures lies beyond the horizon.

Price ceiling should be set at $1,000

If an operation can consistently be performed for less than $1,000 total cost—the cost of in-hospital endometrial ablation—it will gain mass appeal. In hospitals and so-called surgicenters, ablations are expensive and, therefore, less attractive to self- or third-party payers. If fees are based on the volume of cases, then a procedure may be price-efficient.

Outcome depends on patient selection

Poorly screened patients who have underlying hyperplasia may develop postablation carcinoma. Women who have dysmenorrhea before the procedure can be predicted to suffer from it afterward. Older women (ie, 40 years or older) will have better long-term success than younger women. And women with a large uterus or myomas will have a higher failure rate than women with smaller cavities (ie, less than 10 cm in length).

What this means for the individual surgeon

Although minimally invasive techniques are relatively easy to perform and simple to learn, each part of the procedure requires careful application and great attention to detail. Perforation of the uterus and leakage of scalding hot liquid must be avoided. If these complications occur, prompt diagnosis and appropriate treatment are critical. The removal of these procedures from the operating room to the office as well as competitive pricing of instrumentation will make nonhysteroscopic, minimally invasive endometrial ablation more cost-effective.

CASE: Leaking fluid causes intraoperative burns

G.S. is a 45-year-old mother of three who is admitted for surgery for persistent menorrhagia. She has experienced at least two menstrual periods every month for several months, each of them associated with heavy bleeding. She has a history of hypothyroidism and hypertension, but no serious disease or surgery, and considers herself to be in good physical and mental health.

G.S. undergoes endometrial hydrothermablation (HTA) under general inhalation anesthesia. After the HTA mechanism is primed, the heating cycle is started, with a good seal and no fluid leaking from the cervix.

Approximately 8 minutes into the procedure, a 5-mL fluid deficit is noted, and a small amount of hot fluid is observed to be leaking from the cervical os. Examination reveals a thermal injury to the cervix and anterior vaginal wall. The wound is irrigated with cool, sterile saline, and silver sulfadiazine cream is applied. The patient is discharged.

Could this injury have been avoided? Is further treatment warranted?

A minimally invasive operation does not necessarily translate to minimal risk of serious complications. Although few studies of nonhysteroscopic endometrial ablation techniques report any complications,^1,2 Baggish and Savells³ found a number of injuries when they searched hospital records and the Food and Drug Administration (FDA) database (TABLE). They identified serious complications associated with the following devices:

• HydroThermablator (Boston Scientific), which utilizes a modified operating hysteroscope to deliver 10 to 12 mL of preheated saline into the uterus under low pressure.⁴ Complications: 16 adverse events were reported to the FDA, 13 of which involved the retrograde leakage of hot water, causing burns to the cervix, vagina, and vulva. Six additional injuries not reported to the FDA were identified at a single institution.
• Novasure (Cytyc), which employs bipolar electrodes that cover a porous bag.^5,6 Complications: 32 injuries, 26 of them uterine perforations.
• Thermachoice (Gynecare), a fluid-distended balloon ablator.⁷ Complications: 22 injuries included retrograde leakage of hot water after balloon failure and transmural thermal injury, with spread to, and injury of, proximal structures. One death was reported.
• Microsulis (MEA), which uses microwave energy to ablate the endometrium.^8-10 Complications: 19 injuries, including 13 thermal injuries to the intestines.

Baggish and Savells³ initiated this study after discovering six adverse events within their own hospital system utilizing a single device (HTA). Because these injuries were not reported to the FDA, the overall number of complications is likely higher than the figures given here.

This article describes the proper use of nonhysteroscopic endometrial ablation devices, the best ways to avert serious injury, and optimal treatment when complication occurs.

TABLE

Complications associated with 4 endometrial ablation devices

COMPLICATION	HYDRO THERMABLATOR*	THERMACHOICE	NOVASURE	MICROSULIS
Uterine perforation	2	3	26	19
Intestinal injury	1†	1†	–	13†
Retrograde leakage burn	19	6	–	–
Infection/sepsis	–	1†	2	1
Fistula/sinus	–	1†	1	–
Transmural uterine burn	–	1	–	–
Cervical stenosis	–	8	1	–
Cardiac arrest	1	–	1	–
Death	–	1	–	–
Other major	–	3	1	4†
Total	22	22	32	20
* Includes author’s data; 6 retrograde leaks
† Collateral injury

CASE continued: Patient opts for hysterectomy

In the case just described, G.S. was examined 1 week after surgery and found to have an exophytic burn over the entire right half of the cervix, extending into the vagina. She was readmitted for 3 days of intravenous (IV) antibiotic treatment and wound care. Computed tomography imaging showed gas formation within the damaged cervix.

Six weeks after surgery, the patient was still menstruating heavily, but her cervix and vagina had healed. Six months later, she underwent total abdominal hysterectomy for continued menorrhagia.

When is endometrial ablation an option?

Indications for endometrial ablation using a nonhysteroscopic, minimally invasive technique are no different from those for hysteroscopic ablation.¹¹ Abnormal, or dysfunctional, uterine bleeding is the principal reason for this operation. Dysfunctional bleeding is heavy or prolonged menses over 6 months or longer that fail to respond to conservative measures and occur in the absence of tumor, pregnancy, or inflammation (ie, infection).

A woman who meets these criteria should have a desire to retain her uterus if she is to be a candidate for a nonhysteroscopic, minimally invasive technique. She also should understand that ablation can render pregnancy unlikely and even pathologic. Her understanding of this consequence should be documented in the chart! Last, she should be informed that ablation will not necessarily render her sterile, so contraception or sterilization will be required to avoid pregnancy. This should also be clearly documented in the medical record.

 

Endometrial ablation may also be an alternative to hysterectomy for a mentally retarded woman who is unable to manage menses. Abnormal uterine bleeding in conjunction with bleeding diathesis, significant obesity, or serious medical disorders can also be treated by endometrial ablation.

Avoid endometrial ablation in certain circumstances

These circumstances include the presence of endometrial hyperplasia, endometrial cancer, endocervical neoplasia, cervical stenosis, an undiagnosed adnexal mass, moderate to severe dysmenorrhea, adenomyosis, or a uterine cavity larger than 10 cm.^12-15

Valle and Baggish¹⁵ reported eight cases in which women developed endometrial carcinoma following ablation, and identified the following major risk factors for postablation cancer:

• endometrial hyperplasia unresponsive to progesterone or progestin therapy
• complex endometrial hyperplasia
• atypical hyperplasia.

These conditions are contraindications to endometrial ablation.

Avoid a rush to ablation

The growing popularity of office-based, minimally invasive, nonhysteroscopic techniques, coupled with an increasing desire for and acceptance of elective cessation of menses, may stretch the indications listed above and cut short the discovery of contraindications. Clearly, thorough endometrial sampling and precise histopathologic interpretation are required before embarking on any type of endometrial ablation, to minimize the risk of complications.

How to prevent injury

Reduce the risk of perforation

Uterine perforation occurs for a variety of reasons:

• position of the uterus is unknown
• uterus has not been gently and carefully sounded
• cervix is insufficiently dilated to permit passage of the probe
• device is too long (large) to be accommodated in an individual patient’s uterus
• uterine cavity is distorted by pathology, such as adhesions, myomas, etc.

Attention to these details before surgery can prevent perforation.

When uterine injury occurs, the bowel is also at risk

The intestines can be injured following perforation or transmural injury of the uterus. Bowel injury has been reported with hysteroscopic ablation and resection as well as with Nd-YAG laser ablation.^16-18

Do not activate hot water or electrosurgical energy unless you are 100% certain that the device is within the uterine cavity.

Ideally, manufacturers’ safety studies should guarantee no risk of transtubal spillage of hot liquid.

Hot fluid adds to risk of burns

Devices that permit retrograde leakage of hot fluid, such as the HTA, should be modified to ensure sealing at the level of the external and internal cervical os. The Enable device (Innerdyne), no longer marketed in the United States, had such a sealing mechanism, which minimized retrograde leakage of hot water.

Balloon failure may be an unavoidable injury, but pretesting of the device and careful attention to pressure readings—particularly in a small uterus—may mitigate the risk.

Be alert for electrical leakage

The microwave device operates at the megahertz range of frequency. At this high frequency, the risk of leakage is much greater than with devices that operate in the kilohertz range. Therefore, it is important to pay close attention to grounding sites, such as cardiovascular-monitoring electrodes.

High-power monopolar devices, prolonged application of energy to tissue, and high generator frequency are all associated with leakage and subsequent burns.

Early recognition and treatment are vital to ensure the patient’s safety and reduce the risk of medicolegal liability. I recommend the following steps:

• Stop the procedure immediately if perforation is suspected. If you suspect that hot water has been dispersed within the abdominal cavity, switch to laparotomy and consult a general surgeon to inspect the entire intestine for injury. If perforation occurs during the use of electrosurgical energy, the same action is warranted. If uterine perforation occurs in isolation (ie, there is no thermal energy compounding the problem), admit the patient for careful observation, appropriate blood chemistries and hematologic studies, and radiologic examination.
• When hot liquids are spilled, switch to retrograde flow immediately and generously flush the vulva, vagina, and cervix with cold water. Cleanse the entire area with a soapless detergent, and apply clindamycin cream to the vagina and silver sulfadiazine cream to the vulva. Admit the patient for application of cold compresses, ice packs, and burn therapy, and obtain baseline cultures and hematologic studies and a plastic surgery consult. If third-degree (full thickness) burns are suspected, treat any suspected wound infection aggressively after obtaining cultures. Severe and inordinate pain should be investigated as a possible sign of necrotizing fasciitis. After discharge, follow the patient’s progress at weekly intervals.
• Talk to the patient and her family. It is a good idea to explain the complication in very clear terms. I believe it is reasonable to explain how the complication occurred, without speculation or theatrical explanations. Also be sure to document this conversation, including date and time. It may be useful to have a neutral witness present during the conversation. By and large, the patient and her family are likely to appreciate an honest account of how the complication occurred. Hiding data or attempting to cover up the injury may motivate the patient to seek legal representation.

 

What the future holds

The long-term success of endometrial ablation devices as a whole depends on several conditions. Foremost, the entire class of devices should demonstrate efficacy on par with hysteroscopic ablation. Currently, efficacy ranges from 80% to 95% (short-term follow-up).¹¹ The goal of minimally invasive procedures should be a sustainable 92% rate of amenorrhea, hypomenorrhea, or light, periodic menses. A long-term failure rate of 25% is unacceptable.^22-24 If the devices can, by their simplicity, be adapted to more or less universal office application and attain a 5-year success rate of 90% or higher, they will become the standard of care.

One size does not really fit all

Serious complications from endometrial ablation devices occur with regular frequency and must be eliminated or greatly reduced. Perforation is a significant problem and may be related to the “one-size-fits-all” design of the device. Perhaps a range of sizes needs to be produced and fitted to the individual uterine cavity.

If such complications as perforation and burns to the bowel, cervix, vagina, and vulva can be eliminated or relegated to rarity, then a happy future for these procedures lies beyond the horizon.

Price ceiling should be set at $1,000

If an operation can consistently be performed for less than $1,000 total cost—the cost of in-hospital endometrial ablation—it will gain mass appeal. In hospitals and so-called surgicenters, ablations are expensive and, therefore, less attractive to self- or third-party payers. If fees are based on the volume of cases, then a procedure may be price-efficient.

Outcome depends on patient selection

Poorly screened patients who have underlying hyperplasia may develop postablation carcinoma. Women who have dysmenorrhea before the procedure can be predicted to suffer from it afterward. Older women (ie, 40 years or older) will have better long-term success than younger women. And women with a large uterus or myomas will have a higher failure rate than women with smaller cavities (ie, less than 10 cm in length).

What this means for the individual surgeon

Although minimally invasive techniques are relatively easy to perform and simple to learn, each part of the procedure requires careful application and great attention to detail. Perforation of the uterus and leakage of scalding hot liquid must be avoided. If these complications occur, prompt diagnosis and appropriate treatment are critical. The removal of these procedures from the operating room to the office as well as competitive pricing of instrumentation will make nonhysteroscopic, minimally invasive endometrial ablation more cost-effective.

CASE 1 What procedures should accompany hysterectomy?

A.E., 44, mother of one, complains of heavy irregular bleeding with no sensation of a vaginal bulge. She has tried oral contraceptives, but they did not improve her bleeding pattern. She also has undergone dilatation and curettage and hysteroscopy (benign findings), also with no improvement.

Examination reveals a 9- to 10-week-size fibroid uterus, which is confirmed by ultrasonography. Pelvic support appears to be excellent.

After a discussion of the options, the patient elects to undergo vaginal hysterectomy. Are other procedures warranted?

Ask a gynecologic surgeon to name the most significant challenges he or she faces, and the answer is likely to include preventing pelvic organ prolapse after surgical intervention. Approximately one third of operations for pelvic organ prolapse involve patients whose prolapse has recurred after previous surgery.¹ Although we have advanced our understanding of the anatomy of pelvic support and the pathophysiology of support defects, the various surgical strategies remain largely untested and unproven.

Even women with good pelvic support who are undergoing hysterectomy—like the patient described above—are vulnerable. One particular area of concern: the risk of enterocele or vaginal apical prolapse, or both, after hysterectomy. In this article, I describe a technique to reduce the risk of these defects after vaginal hysterectomy: high uterosacral suspension, or modified McCall culdoplasty.

Enterocele and apical prolapse do not always coexist

Enterocele and apical prolapse are distinct entities. The latter represents a deficiency in the level I supporting structures described by DeLancey²—primarily the uterosacral and cardinal ligaments (FIGURE 1). Enterocele, or peritoneocele, is a herniation of the cul-de-sac peritoneum, with or without intestinal contents. In women who have undergone hysterectomy, enterocele is usually caused by a lack of continuity of level II fibers, namely, the failure to approximate the pubocervical and rectovaginal connective tissues at the time of hysterectomy.³ Careful attention to the vaginal cuff and cul-de-sac at the time of hysterectomy is therefore imperative.

FIGURE 1 Three levels of support

The endopelvic fascia of a posthysterectomy patient divided into DeLancey’s biomechanical levels: level I—proximal suspension, level II—lateral attachment, and level III—distal fusion.

The McCall culdoplasty: 50 years “young”

In 1957, Milton McCall, MD, described a technique to manage the cul-de-sac at the time of vaginal hysterectomy.⁴ The McCall technique of posterior culdoplasty differs from other approaches by omitting dissection and excision of the hernia sac, or excess cul-de-sac peritoneum. The original McCall culdoplasty begins with the placement of several rows (average of 3) of nonabsorbable suture (“internal” McCall sutures), starting at the left uterosacral ligament about 2 cm above its cut edge, and proceeding across the redundant cul-de-sac to terminate in the right uterosacral ligament. Each subsequent row is placed superior to the first, by applying traction to the previously placed sutures.

Prior to the tying of these sutures, 3 “external” absorbable sutures are placed. These sutures incorporate posterior vaginal epithelium, each uterosacral ligament, and the contralateral vaginal epithelium in a mirror image of the first pass through the vagina. Again, several rows are placed, each more superior to the last, to move the newly created vaginal apex to the highest point on the uterosacral ligaments once all the sutures are tied.

Tying the internal sutures not only creates a firm, shelf-like midline structure, but obliterates the redundant cul-de-sac. The external sutures move the vaginal apex to the uterosacral bridge and are tied at the conclusion of the procedure (FIGURES 2 and 3).

FIGURE 2 Internal McCall sutures

Traction on the most dependent portion of the cul-de-sac and posterior vaginal epithelium allows placement of 3 rows of sutures across the cul-de-sac from one uterosacral ligament to the other.

FIGURE 3 External McCall sutures

Three additional rows of absorbable sutures incorporate vaginal epithelium and uterosacral ligaments to move the vaginal cuff superiorly.

Modifications enhance durability and support

When the surgical indication is significant apical vaginal prolapse, the efficacy of the McCall procedure as both treatment and prevention is uncertain, because we lack adequate studies in this population. However, assuming that identifiable defects or breaks in the uterosacral ligaments lead to apical prolapse,³ use of the portion of the uterosacral ligament nearest the vagina appears unlikely to create a durable repair.

 

Thus, the concept of a “high” uterosacral attachment came to be proposed to provide a strong midline site of support for the vaginal apex.^5,6 Further modifications include attachment of the uterosacral ligaments to pubocervical and rectovaginal connective tissues to create continuity of these level II fibers and prevent subsequent enterocele.⁷

With a high uterosacral attachment, the uterosacral ligaments need not be brought together in the midline.

Technique for modified approach

To locate each ligament, place traction on the vaginal apex toward the contralateral side. Palpate the pelvic structures posterior and medial to the ischial spines, at the 4 and 8 o’clock positions, to identify the strong tissue emanating from the sacrum.

Place several nonabsorbable sutures through the medial aspect of each uterosacral ligament, working from lateral to medial to minimize the risk of ureteral trauma. Then place 1 strand of each suture through the pubocervical and rectovaginal connective tissues. Tie the sutures to move the vaginal apex to the proximal segment of the uterosacral ligament (near the sacrum) and establish continuity of the pubocervical and rectovaginal connective tissues (FIGURES 4-6).

FIGURE 4 Suture placement is bilateral

Three sutures are placed in the uterosacral ligament pedicles on each side, with 1 arm of each suture placed in the transverse portion of the pubocervical and rectovaginal fascia.

FIGURE 5 Suspensory suture

Sagittal view of a suspensory suture in left uterosacral ligament with 1 arm through pubocervical fascia (PCF) and 1 arm through rectovaginal fascia (RVF).

FIGURE 6 The suspended vaginal vault

Sagittal view of pubocervical fascia (PCF) and rectovaginal fascia (RVF) suspended from uterosacral ligaments.

Main concern is ureteral injury

The ureter lies near the anterior margin of the uterosacral ligament, with a mean distance of 4.1±0.6 cm at the level of the sacrum and 2.3±0.9 cm at the level of the ischial spine.⁸ In 1 series of high uterosacral ligament suspension with site-specific endopelvic fascia defect repair, ureteral complications occurred in 11% of patients.⁵ Other series have reported rates of ureteral trauma in the range of 0.7%⁹ to 2.4%.⁶

Evaluate ureteral patency

After performing this procedure, the surgeon should ensure ureteral patency. For this reason, I believe that only surgeons skilled in cystoscopy and able to treat ureteral injury (or with ready access to those capable of treating this complication) should undertake high uterosacral suspension.

 

CASE 2 Is McCall procedure appropriate?

B.D., 57, complains of increasing pelvic pressure and a noticeable vaginal bulge. Her 2 children were delivered vaginally, the largest weighing 8 lb. B.D. reports that she remains sexually active.

Physical examination reveals the cervix to be at the level of the introitus, but it descends 2 cm beyond the introitus when the patient performs the valsalva maneuver. Although there is also some descent of the anterior and posterior vaginal walls (1 cm superior to the hymen with strain; Pelvic Organ Prolapse Quantification [POP-Q] value=-1), the predominant component of prolapse is an elongated cervix. The posterior vaginal fornix (POP-Q point D), representing apical support, descends to 7 cm superior to the hymen with strain, with a total vaginal length of 9 cm.

At surgery, the uterosacral ligaments do not appear to be attenuated. After vaginal hysterectomy, the apex of the vaginal vault is superior to the level of the ischial spines.

How do you proceed?

Given the relatively good support at the apex, this patient is a good candidate for a McCall-type culdoplasty. Whether or not this procedure will be truly prophylactic (because there is already some descent of the apex, albeit mild) is perhaps only a matter of semantics.

The author reports no financial relationships relevant to this article.

CASE 1 What procedures should accompany hysterectomy?

A.E., 44, mother of one, complains of heavy irregular bleeding with no sensation of a vaginal bulge. She has tried oral contraceptives, but they did not improve her bleeding pattern. She also has undergone dilatation and curettage and hysteroscopy (benign findings), also with no improvement.

Examination reveals a 9- to 10-week-size fibroid uterus, which is confirmed by ultrasonography. Pelvic support appears to be excellent.

After a discussion of the options, the patient elects to undergo vaginal hysterectomy. Are other procedures warranted?

Ask a gynecologic surgeon to name the most significant challenges he or she faces, and the answer is likely to include preventing pelvic organ prolapse after surgical intervention. Approximately one third of operations for pelvic organ prolapse involve patients whose prolapse has recurred after previous surgery.¹ Although we have advanced our understanding of the anatomy of pelvic support and the pathophysiology of support defects, the various surgical strategies remain largely untested and unproven.

Even women with good pelvic support who are undergoing hysterectomy—like the patient described above—are vulnerable. One particular area of concern: the risk of enterocele or vaginal apical prolapse, or both, after hysterectomy. In this article, I describe a technique to reduce the risk of these defects after vaginal hysterectomy: high uterosacral suspension, or modified McCall culdoplasty.

Enterocele and apical prolapse do not always coexist

Enterocele and apical prolapse are distinct entities. The latter represents a deficiency in the level I supporting structures described by DeLancey²—primarily the uterosacral and cardinal ligaments (FIGURE 1). Enterocele, or peritoneocele, is a herniation of the cul-de-sac peritoneum, with or without intestinal contents. In women who have undergone hysterectomy, enterocele is usually caused by a lack of continuity of level II fibers, namely, the failure to approximate the pubocervical and rectovaginal connective tissues at the time of hysterectomy.³ Careful attention to the vaginal cuff and cul-de-sac at the time of hysterectomy is therefore imperative.

FIGURE 1 Three levels of support

The endopelvic fascia of a posthysterectomy patient divided into DeLancey’s biomechanical levels: level I—proximal suspension, level II—lateral attachment, and level III—distal fusion.

The McCall culdoplasty: 50 years “young”

In 1957, Milton McCall, MD, described a technique to manage the cul-de-sac at the time of vaginal hysterectomy.⁴ The McCall technique of posterior culdoplasty differs from other approaches by omitting dissection and excision of the hernia sac, or excess cul-de-sac peritoneum. The original McCall culdoplasty begins with the placement of several rows (average of 3) of nonabsorbable suture (“internal” McCall sutures), starting at the left uterosacral ligament about 2 cm above its cut edge, and proceeding across the redundant cul-de-sac to terminate in the right uterosacral ligament. Each subsequent row is placed superior to the first, by applying traction to the previously placed sutures.

Prior to the tying of these sutures, 3 “external” absorbable sutures are placed. These sutures incorporate posterior vaginal epithelium, each uterosacral ligament, and the contralateral vaginal epithelium in a mirror image of the first pass through the vagina. Again, several rows are placed, each more superior to the last, to move the newly created vaginal apex to the highest point on the uterosacral ligaments once all the sutures are tied.

Tying the internal sutures not only creates a firm, shelf-like midline structure, but obliterates the redundant cul-de-sac. The external sutures move the vaginal apex to the uterosacral bridge and are tied at the conclusion of the procedure (FIGURES 2 and 3).

FIGURE 2 Internal McCall sutures

Traction on the most dependent portion of the cul-de-sac and posterior vaginal epithelium allows placement of 3 rows of sutures across the cul-de-sac from one uterosacral ligament to the other.

FIGURE 3 External McCall sutures

Three additional rows of absorbable sutures incorporate vaginal epithelium and uterosacral ligaments to move the vaginal cuff superiorly.

Modifications enhance durability and support

When the surgical indication is significant apical vaginal prolapse, the efficacy of the McCall procedure as both treatment and prevention is uncertain, because we lack adequate studies in this population. However, assuming that identifiable defects or breaks in the uterosacral ligaments lead to apical prolapse,³ use of the portion of the uterosacral ligament nearest the vagina appears unlikely to create a durable repair.

 

Thus, the concept of a “high” uterosacral attachment came to be proposed to provide a strong midline site of support for the vaginal apex.^5,6 Further modifications include attachment of the uterosacral ligaments to pubocervical and rectovaginal connective tissues to create continuity of these level II fibers and prevent subsequent enterocele.⁷

With a high uterosacral attachment, the uterosacral ligaments need not be brought together in the midline.

Technique for modified approach

To locate each ligament, place traction on the vaginal apex toward the contralateral side. Palpate the pelvic structures posterior and medial to the ischial spines, at the 4 and 8 o’clock positions, to identify the strong tissue emanating from the sacrum.

Place several nonabsorbable sutures through the medial aspect of each uterosacral ligament, working from lateral to medial to minimize the risk of ureteral trauma. Then place 1 strand of each suture through the pubocervical and rectovaginal connective tissues. Tie the sutures to move the vaginal apex to the proximal segment of the uterosacral ligament (near the sacrum) and establish continuity of the pubocervical and rectovaginal connective tissues (FIGURES 4-6).

FIGURE 4 Suture placement is bilateral

Three sutures are placed in the uterosacral ligament pedicles on each side, with 1 arm of each suture placed in the transverse portion of the pubocervical and rectovaginal fascia.

FIGURE 5 Suspensory suture

Sagittal view of a suspensory suture in left uterosacral ligament with 1 arm through pubocervical fascia (PCF) and 1 arm through rectovaginal fascia (RVF).

FIGURE 6 The suspended vaginal vault

Sagittal view of pubocervical fascia (PCF) and rectovaginal fascia (RVF) suspended from uterosacral ligaments.

Main concern is ureteral injury

The ureter lies near the anterior margin of the uterosacral ligament, with a mean distance of 4.1±0.6 cm at the level of the sacrum and 2.3±0.9 cm at the level of the ischial spine.⁸ In 1 series of high uterosacral ligament suspension with site-specific endopelvic fascia defect repair, ureteral complications occurred in 11% of patients.⁵ Other series have reported rates of ureteral trauma in the range of 0.7%⁹ to 2.4%.⁶

Evaluate ureteral patency

After performing this procedure, the surgeon should ensure ureteral patency. For this reason, I believe that only surgeons skilled in cystoscopy and able to treat ureteral injury (or with ready access to those capable of treating this complication) should undertake high uterosacral suspension.

 

CASE 2 Is McCall procedure appropriate?

B.D., 57, complains of increasing pelvic pressure and a noticeable vaginal bulge. Her 2 children were delivered vaginally, the largest weighing 8 lb. B.D. reports that she remains sexually active.

Physical examination reveals the cervix to be at the level of the introitus, but it descends 2 cm beyond the introitus when the patient performs the valsalva maneuver. Although there is also some descent of the anterior and posterior vaginal walls (1 cm superior to the hymen with strain; Pelvic Organ Prolapse Quantification [POP-Q] value=-1), the predominant component of prolapse is an elongated cervix. The posterior vaginal fornix (POP-Q point D), representing apical support, descends to 7 cm superior to the hymen with strain, with a total vaginal length of 9 cm.

At surgery, the uterosacral ligaments do not appear to be attenuated. After vaginal hysterectomy, the apex of the vaginal vault is superior to the level of the ischial spines.

How do you proceed?

Given the relatively good support at the apex, this patient is a good candidate for a McCall-type culdoplasty. Whether or not this procedure will be truly prophylactic (because there is already some descent of the apex, albeit mild) is perhaps only a matter of semantics.

The author reports no financial relationships relevant to this article.

CASE 1 What procedures should accompany hysterectomy?

A.E., 44, mother of one, complains of heavy irregular bleeding with no sensation of a vaginal bulge. She has tried oral contraceptives, but they did not improve her bleeding pattern. She also has undergone dilatation and curettage and hysteroscopy (benign findings), also with no improvement.

Examination reveals a 9- to 10-week-size fibroid uterus, which is confirmed by ultrasonography. Pelvic support appears to be excellent.

After a discussion of the options, the patient elects to undergo vaginal hysterectomy. Are other procedures warranted?

Ask a gynecologic surgeon to name the most significant challenges he or she faces, and the answer is likely to include preventing pelvic organ prolapse after surgical intervention. Approximately one third of operations for pelvic organ prolapse involve patients whose prolapse has recurred after previous surgery.¹ Although we have advanced our understanding of the anatomy of pelvic support and the pathophysiology of support defects, the various surgical strategies remain largely untested and unproven.

Even women with good pelvic support who are undergoing hysterectomy—like the patient described above—are vulnerable. One particular area of concern: the risk of enterocele or vaginal apical prolapse, or both, after hysterectomy. In this article, I describe a technique to reduce the risk of these defects after vaginal hysterectomy: high uterosacral suspension, or modified McCall culdoplasty.

Enterocele and apical prolapse do not always coexist

Enterocele and apical prolapse are distinct entities. The latter represents a deficiency in the level I supporting structures described by DeLancey²—primarily the uterosacral and cardinal ligaments (FIGURE 1). Enterocele, or peritoneocele, is a herniation of the cul-de-sac peritoneum, with or without intestinal contents. In women who have undergone hysterectomy, enterocele is usually caused by a lack of continuity of level II fibers, namely, the failure to approximate the pubocervical and rectovaginal connective tissues at the time of hysterectomy.³ Careful attention to the vaginal cuff and cul-de-sac at the time of hysterectomy is therefore imperative.

FIGURE 1 Three levels of support

The endopelvic fascia of a posthysterectomy patient divided into DeLancey’s biomechanical levels: level I—proximal suspension, level II—lateral attachment, and level III—distal fusion.

The McCall culdoplasty: 50 years “young”

In 1957, Milton McCall, MD, described a technique to manage the cul-de-sac at the time of vaginal hysterectomy.⁴ The McCall technique of posterior culdoplasty differs from other approaches by omitting dissection and excision of the hernia sac, or excess cul-de-sac peritoneum. The original McCall culdoplasty begins with the placement of several rows (average of 3) of nonabsorbable suture (“internal” McCall sutures), starting at the left uterosacral ligament about 2 cm above its cut edge, and proceeding across the redundant cul-de-sac to terminate in the right uterosacral ligament. Each subsequent row is placed superior to the first, by applying traction to the previously placed sutures.

Prior to the tying of these sutures, 3 “external” absorbable sutures are placed. These sutures incorporate posterior vaginal epithelium, each uterosacral ligament, and the contralateral vaginal epithelium in a mirror image of the first pass through the vagina. Again, several rows are placed, each more superior to the last, to move the newly created vaginal apex to the highest point on the uterosacral ligaments once all the sutures are tied.

Tying the internal sutures not only creates a firm, shelf-like midline structure, but obliterates the redundant cul-de-sac. The external sutures move the vaginal apex to the uterosacral bridge and are tied at the conclusion of the procedure (FIGURES 2 and 3).

FIGURE 2 Internal McCall sutures

Traction on the most dependent portion of the cul-de-sac and posterior vaginal epithelium allows placement of 3 rows of sutures across the cul-de-sac from one uterosacral ligament to the other.

FIGURE 3 External McCall sutures

Three additional rows of absorbable sutures incorporate vaginal epithelium and uterosacral ligaments to move the vaginal cuff superiorly.

Modifications enhance durability and support

When the surgical indication is significant apical vaginal prolapse, the efficacy of the McCall procedure as both treatment and prevention is uncertain, because we lack adequate studies in this population. However, assuming that identifiable defects or breaks in the uterosacral ligaments lead to apical prolapse,³ use of the portion of the uterosacral ligament nearest the vagina appears unlikely to create a durable repair.

 

Thus, the concept of a “high” uterosacral attachment came to be proposed to provide a strong midline site of support for the vaginal apex.^5,6 Further modifications include attachment of the uterosacral ligaments to pubocervical and rectovaginal connective tissues to create continuity of these level II fibers and prevent subsequent enterocele.⁷

With a high uterosacral attachment, the uterosacral ligaments need not be brought together in the midline.

Technique for modified approach

To locate each ligament, place traction on the vaginal apex toward the contralateral side. Palpate the pelvic structures posterior and medial to the ischial spines, at the 4 and 8 o’clock positions, to identify the strong tissue emanating from the sacrum.

Place several nonabsorbable sutures through the medial aspect of each uterosacral ligament, working from lateral to medial to minimize the risk of ureteral trauma. Then place 1 strand of each suture through the pubocervical and rectovaginal connective tissues. Tie the sutures to move the vaginal apex to the proximal segment of the uterosacral ligament (near the sacrum) and establish continuity of the pubocervical and rectovaginal connective tissues (FIGURES 4-6).

FIGURE 4 Suture placement is bilateral

Three sutures are placed in the uterosacral ligament pedicles on each side, with 1 arm of each suture placed in the transverse portion of the pubocervical and rectovaginal fascia.

FIGURE 5 Suspensory suture

Sagittal view of a suspensory suture in left uterosacral ligament with 1 arm through pubocervical fascia (PCF) and 1 arm through rectovaginal fascia (RVF).

FIGURE 6 The suspended vaginal vault

Sagittal view of pubocervical fascia (PCF) and rectovaginal fascia (RVF) suspended from uterosacral ligaments.

Main concern is ureteral injury

The ureter lies near the anterior margin of the uterosacral ligament, with a mean distance of 4.1±0.6 cm at the level of the sacrum and 2.3±0.9 cm at the level of the ischial spine.⁸ In 1 series of high uterosacral ligament suspension with site-specific endopelvic fascia defect repair, ureteral complications occurred in 11% of patients.⁵ Other series have reported rates of ureteral trauma in the range of 0.7%⁹ to 2.4%.⁶

Evaluate ureteral patency

After performing this procedure, the surgeon should ensure ureteral patency. For this reason, I believe that only surgeons skilled in cystoscopy and able to treat ureteral injury (or with ready access to those capable of treating this complication) should undertake high uterosacral suspension.

 

CASE 2 Is McCall procedure appropriate?

B.D., 57, complains of increasing pelvic pressure and a noticeable vaginal bulge. Her 2 children were delivered vaginally, the largest weighing 8 lb. B.D. reports that she remains sexually active.

Physical examination reveals the cervix to be at the level of the introitus, but it descends 2 cm beyond the introitus when the patient performs the valsalva maneuver. Although there is also some descent of the anterior and posterior vaginal walls (1 cm superior to the hymen with strain; Pelvic Organ Prolapse Quantification [POP-Q] value=-1), the predominant component of prolapse is an elongated cervix. The posterior vaginal fornix (POP-Q point D), representing apical support, descends to 7 cm superior to the hymen with strain, with a total vaginal length of 9 cm.

At surgery, the uterosacral ligaments do not appear to be attenuated. After vaginal hysterectomy, the apex of the vaginal vault is superior to the level of the ischial spines.

How do you proceed?

Given the relatively good support at the apex, this patient is a good candidate for a McCall-type culdoplasty. Whether or not this procedure will be truly prophylactic (because there is already some descent of the apex, albeit mild) is perhaps only a matter of semantics.

The author reports no financial relationships relevant to this article.

CASE 1 Problems entering the cul-de-sac

M.K. is a 43-year-old gravida 2 para 2 who is undergoing a vaginal hysterectomy for menorrhagia. A preoperative pelvic exam and ultrasound suggested a 12-week-size uterus with several small leiomyomata. Her gynecologist estimates the uterine weight at 240 g and notes that the uterus is mobile. M.K. asks that her ovaries be removed at the time of hysterectomy because of a family history of ovarian cancer.

During the initial dissection, the surgeon is unable to enter the anterior cul-de-sac due to distortion created by an anterior fibroid. The surgeon has entered the posterior cul-de-sac, but the uterus is too large to manipulate a finger around anteriorly to identify the peritoneal fold. Although he feels confident that the bladder has been adequately mobilized from the cervix, the surgeon is strongly considering abandoning the vaginal approach and completing the hysterectomy abdominally.

How should he proceed?

Entry into the peritoneal cavity through the anterior or posterior cul-de-sac can sometimes be challenging, as this case illustrates. However, there is no need for the surgeon to abandon the vaginal approach just yet. In my experience, the anterior peritoneal fold can be high or distorted by fibroids in some women. The key to successful surgery is a pause in activity to consider the case at hand and determine whether additional progress can be made safely without changing the approach.

Avoid blind entry at all costs

No less an authority than Heaney¹ advised against blind attempts to enter the anterior cul-de-sac. Such attempts are often frustrating, can involve bleeding, and raise the risk of injury to the bladder. However, once the surgeon is confident that the bladder is free and retracted out of the way, he or she can proceed without intraperitoneal entry. This is especially true if the posterior cul-de-sac has been entered safely.

The “climb up” technique

In some cases, the surgeon may safely proceed extraperitoneally even if neither cul-de-sac has been opened. Krige² coined the term “climb up” to describe the extraperitoneal approach to the inaccessible posterior cul-de-sac. He performed extensive extraperitoneal dissection that, if necessary, included both uterosacral and cardinal ligaments as well as uterine vessels. A surgeon may carry a total extraperitoneal dissection completely to the uterine fundus as long as the bladder and rectum are free.³

In M.K.’s case, the surgeon should proceed to take the uterosacral and cardinal ligaments posteriorly without swinging the clamps around to the anterior aspect of the cervix, if possible. Once these ligaments are taken, the uterus often descends enough that the anterior peritoneal fold becomes accessible. Once it is identified, the anterior cul-de-sac can be entered safely.

If safe entry still is not possible, the surgeon can take the uterine vessels if he or she is confident that the bladder is out of harm’s way. If the fold still cannot be identified after this bite, proceed with broad-ligament clamps, which usually lead to eventual opening of the peritoneal fold.

CASE 1 Some progress, then surgery stalls

The surgeon proceeds to operate extraperitoneally, as described above, and successfully enters the anterior cul-de-sac after the uterine vessels are ligated. However, after several additional bites of broad ligament on each side, progress stalls because of uterine size. The surgeon seems to be stuck and is growing increasingly frustrated.

What is the best way around this impasse?

Morcellation can involve a range of techniques

Whenever a large uterus prevents further progress, and the uterine vessels have been ligated, uterine morcellation can be performed. Morcellation techniques originated when vaginal hysterectomy was the archetypal gynecologic operation,^4-7 and include uterine bisection,^8-11 Lash intramyometrial coring,^6,8,9 myomectomy,^10,11 and wedge debulking.⁹ Although every surgeon has a favorite, some or all of these procedures may be necessary in the same patient.^12-15 In all cases it is mandatory that the uterine vessels be ligated before any morcellation procedure is initiated.

In my experience, a uterus in the range of 240 g usually lends itself very nicely to Lash intramyometrial coring. This technique is a nearly bloodless procedure that does not violate the endometrial cavity when it is performed properly. In addition, any intramyometrial fibroids can be easily removed.

If coring does not decompress the uterus enough for safe delivery, the core can be cut off and the remaining uterus can be further morcellated by removing wedges of myometrium or by bivalving the uterus. Since there is usually more room in the posterior vagina than in the anterior vagina, as much of the wedge morcellation as possible should be done posteriorly.

 

CASE 1 Ovaries appear out of reach

After Lash intramyometrial coring, the surgeon successfully removes the uterus. He then turns his attention to the bilateral adnexectomy. Unfortunately, the ovaries are higher than anticipated, and he once again considers switching to the abdominal route to remove them.

Is a change in route the best option?

Focus on the round ligaments

The key to safe removal of the adnexa, especially in difficult cases, is the separate transection and ligation of the round ligaments. Many authors have reported high success rates for vaginal oophorectomy using this technique, especially in premenopausal women.^16-19

Separate transection of the round ligament allows the surgeon to accomplish 2 very important tasks:

Once the round ligament is ligated and transected, I like to keep it on stretch so that the broad-ligament peritoneum can be opened parallel to the ovarian vessels, much as it is done in the abdominal approach. This allows the ovary to descend; it also isolates the infundibulopelvic ligament with the ovarian vessels, thus enabling more secure ligation of the vessels and reducing the risk of ureteral injury.

In many hysterectomy cases when oophorectomy is planned, this maneuver can be carried out prior to removal of the uterus. Once the round ligaments have been reached, the surgeon can deliver the uterine fundus anteriorly, allowing the round ligaments to be clamped and cut. It is not uncommon to be able to remove the uterus with both adnexa still attached.

With a large uterus, it may be necessary to clamp and transect the round ligament after the uterus is out. This does not preclude identification and transection of the round ligament to carry out the maneuvers described above.

Consider your tools

In very difficult cases, specialized clamps or sutures may be necessary. I find long, sturdy, right-angle clamps to be most useful. In addition, endoloop-type sutures often facilitate ligation of the vascular pedicle. The use of newer specialized bipolar electrosurgical instruments may be helpful, although I have no personal experience using them in vaginal surgery.

CASE 1 At closure, concerns about injury

After successful removal of both adnexa using the round-ligament technique, the surgeon is satisfied that he has achieved hemostasis and proceeds with his usual closure. However, he has nagging concerns about the possibility of undetected complications, because this case turned out to be more of a challenge than he had expected. He wonders if there is anything else he can do to ensure that everything is OK.

What would you do?

Besides ensuring satisfactory hemostasis, confirming the integrity of the urinary tract is the most important goal to achieve before leaving the operating room. Unrecognized injuries to the bladder or ureters are unacceptable and will lead to significant morbidity for the patient. I would certainly recommend that the surgeon in M.K.’s case perform cystoscopy after giving the patient intravenous indigo carmine to assure both ureteral patency and integrity of the bladder. I perform cystoscopy after all vaginal hysterectomies.

CASE 2 History of cesarean delivery

C.S. is a 38-year-old gravida 3 para 3 who presents with menometrorrhagia and dysmenorrhea unresponsive to medical therapy. Her first pregnancy resulted in vaginal delivery of a full-term infant without complications. Her second child was delivered via low-segment transverse cesarean section due to a persistent breech presentation at term. Her last child was delivered vaginally, also at term. Two years later C.S. underwent a laparoscopic tubal ligation without complications. That was 4 years ago. She began seeing her current gynecologist 2 years ago, when she moved to a new community.

Pelvic examination reveals a 6-week–size uterus and normal adnexa. Her uterus is mobile, and there does not appear to be any ventral fixation of the uterus to the abdominal wall from the cesarean section. Endometrial biopsy reveals proliferative endometrium only. Saline ultrasound demonstrates a 2-cm submucosal leiomyoma.

C.S. refuses hysteroscopic resection of the myoma and prefers hysterectomy as definitive therapy. She is the business manager for her family’s construction business, and she would like to be able to return to work as soon as possible after her surgery. She requests vaginal hysterectomy with conservation of her ovaries.

What is the best way to proceed at this point?

Many gynecologic surgeons regard previous pelvic surgery, including cesarean delivery, as a relative contraindication to vaginal hysterectomy. Although the major concern seems to be a potential for bladder injury during the bladder dissection, other problems such as ventral fixation of the uterus to the previous abdominal incision also are possible.

Vaginal hysterectomy requires a mobile uterus

 

All patients who will be undergoing vaginal hysterectomy must have demonstrated mobility of the uterus upon pelvic examination. This is particularly important in the case of prior pelvic surgery. In this case, the gynecologist also should make every attempt to obtain her surgical records—especially those from her laparoscopic tubal ligation—to exclude major adhesive disease in the pelvis.

Laparoscopic adhesiolysis may facilitate vaginal hysterectomy

If there is any concern that the uterus is fixed to the abdominal wall, abdominal hysterectomy should be considered. Even more preferable is laparoscopic adhesiolysis, which can make it possible to proceed with vaginal hysterectomy. I have used this approach in women with as many as 5 previous cesarean deliveries and severe ventral fixation of the uterus.²⁰ After adhesiolysis, the remainder of the hysterectomy can usually be performed solely through the vaginal route.

CASE 2 Medical records suggest the vaginal route is feasible

The gynecologist obtains C.S.’s previous medical records, which confirm that the cesarean delivery was uncomplicated. They also indicate that, at the time of the sterilization procedure, there was no evidence of ventral fixation of the uterus or other major adhesive disease.

The physician decides to proceed with vaginal hysterectomy, but remains very concerned about the possibility of bladder injury. How can she avoid inadvertent cystotomy?

Difficulty identifying and safely dissecting the bladder—because of distortion of the vesicouterine space from the previous cesarean delivery—is a legitimate concern. However, injury to a scarred and densely adherent bladder is a risk even with abdominal dissection.

The vaginal approach to the distal vesicouterine space has a clear advantage: The vesicouterine space closest to the initial vaginal dissection is unaffected by the previous operation on the lower uterine segment. In contrast, with the abdominal approach, dissection begins in the area of scar, and only after penetrating the scar does one find the unaffected space. With the vaginal approach, dissection begins in the correct surgical plane, which aids in identification of the location of the bladder and cesarean scar.

Sharp dissection is a must to protect the bladder

Once the correct surgical plane is encountered, sharp dissection is necessary to prevent tears of the adherent bladder, which can occur with blunt dissection.

Although sharp dissection is the key to success under these circumstances, other maneuvers may be helpful in some cases.

Nichols²¹ suggested performing dissection of the bladder after it has been filled with a dilute indigo carmine solution to stain the bladder tissues and help prevent bladder injury.

Hoffman and Jaeger²² describe the placement of a bent uterine sound in the posterior cul-de-sac. The sound is then brought around to the anterior cul-de-sac as an aid to dissection of the bladder and the vesicouterine peritoneal fold.

Sheth and Malpani²³ describe developing a lateral “window” through the broad ligament to the bladder dissection when there are dense midline adhesions.

Although these are all valuable suggestions, I have found that they are rarely needed with careful sharp dissection. Remember, it is essential to avoid the temptation of blunt dissection when performing vaginal hysterectomy in women with a prior cesarean delivery.

CASE 2 Procedure is a success

The vaginal hysterectomy is carried out without incident, and cystoscopy following the hysterectomy is negative for any bladder injury; both ureteral orifices promptly efflux indigo carmine.

The surgeon encountered little difficulty during the bladder dissection, which was performed sharply. In fact, she was surprised at how well she could actually identify the hysterotomy scar and bladder. The patient goes home after 24 hours and is back at work in 2 weeks.

As noted in both cases presented here, the gynecologic surgeon must be certain that the urinary tract is intact and uninjured prior to leaving the operating room. This includes careful inspection of the bladder grossly for any sign of injury, as well as cystoscopy.

Most bladder injuries that occur with hysterectomy—either vaginal or abdominal—are usually well above the trigone and can be carefully repaired by the gynecologic surgeon. Complex injuries to the bladder involving the trigone or ureters usually require urologic intraoperative consultation.

The author reports no financial relationships relevant to this article.

CASE 1 Problems entering the cul-de-sac

M.K. is a 43-year-old gravida 2 para 2 who is undergoing a vaginal hysterectomy for menorrhagia. A preoperative pelvic exam and ultrasound suggested a 12-week-size uterus with several small leiomyomata. Her gynecologist estimates the uterine weight at 240 g and notes that the uterus is mobile. M.K. asks that her ovaries be removed at the time of hysterectomy because of a family history of ovarian cancer.

During the initial dissection, the surgeon is unable to enter the anterior cul-de-sac due to distortion created by an anterior fibroid. The surgeon has entered the posterior cul-de-sac, but the uterus is too large to manipulate a finger around anteriorly to identify the peritoneal fold. Although he feels confident that the bladder has been adequately mobilized from the cervix, the surgeon is strongly considering abandoning the vaginal approach and completing the hysterectomy abdominally.

How should he proceed?

Entry into the peritoneal cavity through the anterior or posterior cul-de-sac can sometimes be challenging, as this case illustrates. However, there is no need for the surgeon to abandon the vaginal approach just yet. In my experience, the anterior peritoneal fold can be high or distorted by fibroids in some women. The key to successful surgery is a pause in activity to consider the case at hand and determine whether additional progress can be made safely without changing the approach.

Avoid blind entry at all costs

No less an authority than Heaney¹ advised against blind attempts to enter the anterior cul-de-sac. Such attempts are often frustrating, can involve bleeding, and raise the risk of injury to the bladder. However, once the surgeon is confident that the bladder is free and retracted out of the way, he or she can proceed without intraperitoneal entry. This is especially true if the posterior cul-de-sac has been entered safely.

The “climb up” technique

In some cases, the surgeon may safely proceed extraperitoneally even if neither cul-de-sac has been opened. Krige² coined the term “climb up” to describe the extraperitoneal approach to the inaccessible posterior cul-de-sac. He performed extensive extraperitoneal dissection that, if necessary, included both uterosacral and cardinal ligaments as well as uterine vessels. A surgeon may carry a total extraperitoneal dissection completely to the uterine fundus as long as the bladder and rectum are free.³

In M.K.’s case, the surgeon should proceed to take the uterosacral and cardinal ligaments posteriorly without swinging the clamps around to the anterior aspect of the cervix, if possible. Once these ligaments are taken, the uterus often descends enough that the anterior peritoneal fold becomes accessible. Once it is identified, the anterior cul-de-sac can be entered safely.

If safe entry still is not possible, the surgeon can take the uterine vessels if he or she is confident that the bladder is out of harm’s way. If the fold still cannot be identified after this bite, proceed with broad-ligament clamps, which usually lead to eventual opening of the peritoneal fold.

CASE 1 Some progress, then surgery stalls

The surgeon proceeds to operate extraperitoneally, as described above, and successfully enters the anterior cul-de-sac after the uterine vessels are ligated. However, after several additional bites of broad ligament on each side, progress stalls because of uterine size. The surgeon seems to be stuck and is growing increasingly frustrated.

What is the best way around this impasse?

Morcellation can involve a range of techniques

Whenever a large uterus prevents further progress, and the uterine vessels have been ligated, uterine morcellation can be performed. Morcellation techniques originated when vaginal hysterectomy was the archetypal gynecologic operation,^4-7 and include uterine bisection,^8-11 Lash intramyometrial coring,^6,8,9 myomectomy,^10,11 and wedge debulking.⁹ Although every surgeon has a favorite, some or all of these procedures may be necessary in the same patient.^12-15 In all cases it is mandatory that the uterine vessels be ligated before any morcellation procedure is initiated.

In my experience, a uterus in the range of 240 g usually lends itself very nicely to Lash intramyometrial coring. This technique is a nearly bloodless procedure that does not violate the endometrial cavity when it is performed properly. In addition, any intramyometrial fibroids can be easily removed.

If coring does not decompress the uterus enough for safe delivery, the core can be cut off and the remaining uterus can be further morcellated by removing wedges of myometrium or by bivalving the uterus. Since there is usually more room in the posterior vagina than in the anterior vagina, as much of the wedge morcellation as possible should be done posteriorly.

 

CASE 1 Ovaries appear out of reach

After Lash intramyometrial coring, the surgeon successfully removes the uterus. He then turns his attention to the bilateral adnexectomy. Unfortunately, the ovaries are higher than anticipated, and he once again considers switching to the abdominal route to remove them.

Is a change in route the best option?

Focus on the round ligaments

The key to safe removal of the adnexa, especially in difficult cases, is the separate transection and ligation of the round ligaments. Many authors have reported high success rates for vaginal oophorectomy using this technique, especially in premenopausal women.^16-19

Separate transection of the round ligament allows the surgeon to accomplish 2 very important tasks:

Once the round ligament is ligated and transected, I like to keep it on stretch so that the broad-ligament peritoneum can be opened parallel to the ovarian vessels, much as it is done in the abdominal approach. This allows the ovary to descend; it also isolates the infundibulopelvic ligament with the ovarian vessels, thus enabling more secure ligation of the vessels and reducing the risk of ureteral injury.

In many hysterectomy cases when oophorectomy is planned, this maneuver can be carried out prior to removal of the uterus. Once the round ligaments have been reached, the surgeon can deliver the uterine fundus anteriorly, allowing the round ligaments to be clamped and cut. It is not uncommon to be able to remove the uterus with both adnexa still attached.

With a large uterus, it may be necessary to clamp and transect the round ligament after the uterus is out. This does not preclude identification and transection of the round ligament to carry out the maneuvers described above.

Consider your tools

In very difficult cases, specialized clamps or sutures may be necessary. I find long, sturdy, right-angle clamps to be most useful. In addition, endoloop-type sutures often facilitate ligation of the vascular pedicle. The use of newer specialized bipolar electrosurgical instruments may be helpful, although I have no personal experience using them in vaginal surgery.

CASE 1 At closure, concerns about injury

After successful removal of both adnexa using the round-ligament technique, the surgeon is satisfied that he has achieved hemostasis and proceeds with his usual closure. However, he has nagging concerns about the possibility of undetected complications, because this case turned out to be more of a challenge than he had expected. He wonders if there is anything else he can do to ensure that everything is OK.

What would you do?

Besides ensuring satisfactory hemostasis, confirming the integrity of the urinary tract is the most important goal to achieve before leaving the operating room. Unrecognized injuries to the bladder or ureters are unacceptable and will lead to significant morbidity for the patient. I would certainly recommend that the surgeon in M.K.’s case perform cystoscopy after giving the patient intravenous indigo carmine to assure both ureteral patency and integrity of the bladder. I perform cystoscopy after all vaginal hysterectomies.

CASE 2 History of cesarean delivery

C.S. is a 38-year-old gravida 3 para 3 who presents with menometrorrhagia and dysmenorrhea unresponsive to medical therapy. Her first pregnancy resulted in vaginal delivery of a full-term infant without complications. Her second child was delivered via low-segment transverse cesarean section due to a persistent breech presentation at term. Her last child was delivered vaginally, also at term. Two years later C.S. underwent a laparoscopic tubal ligation without complications. That was 4 years ago. She began seeing her current gynecologist 2 years ago, when she moved to a new community.

Pelvic examination reveals a 6-week–size uterus and normal adnexa. Her uterus is mobile, and there does not appear to be any ventral fixation of the uterus to the abdominal wall from the cesarean section. Endometrial biopsy reveals proliferative endometrium only. Saline ultrasound demonstrates a 2-cm submucosal leiomyoma.

C.S. refuses hysteroscopic resection of the myoma and prefers hysterectomy as definitive therapy. She is the business manager for her family’s construction business, and she would like to be able to return to work as soon as possible after her surgery. She requests vaginal hysterectomy with conservation of her ovaries.

What is the best way to proceed at this point?

Many gynecologic surgeons regard previous pelvic surgery, including cesarean delivery, as a relative contraindication to vaginal hysterectomy. Although the major concern seems to be a potential for bladder injury during the bladder dissection, other problems such as ventral fixation of the uterus to the previous abdominal incision also are possible.

Vaginal hysterectomy requires a mobile uterus

 

All patients who will be undergoing vaginal hysterectomy must have demonstrated mobility of the uterus upon pelvic examination. This is particularly important in the case of prior pelvic surgery. In this case, the gynecologist also should make every attempt to obtain her surgical records—especially those from her laparoscopic tubal ligation—to exclude major adhesive disease in the pelvis.

Laparoscopic adhesiolysis may facilitate vaginal hysterectomy

If there is any concern that the uterus is fixed to the abdominal wall, abdominal hysterectomy should be considered. Even more preferable is laparoscopic adhesiolysis, which can make it possible to proceed with vaginal hysterectomy. I have used this approach in women with as many as 5 previous cesarean deliveries and severe ventral fixation of the uterus.²⁰ After adhesiolysis, the remainder of the hysterectomy can usually be performed solely through the vaginal route.

CASE 2 Medical records suggest the vaginal route is feasible

The gynecologist obtains C.S.’s previous medical records, which confirm that the cesarean delivery was uncomplicated. They also indicate that, at the time of the sterilization procedure, there was no evidence of ventral fixation of the uterus or other major adhesive disease.

The physician decides to proceed with vaginal hysterectomy, but remains very concerned about the possibility of bladder injury. How can she avoid inadvertent cystotomy?

Difficulty identifying and safely dissecting the bladder—because of distortion of the vesicouterine space from the previous cesarean delivery—is a legitimate concern. However, injury to a scarred and densely adherent bladder is a risk even with abdominal dissection.

The vaginal approach to the distal vesicouterine space has a clear advantage: The vesicouterine space closest to the initial vaginal dissection is unaffected by the previous operation on the lower uterine segment. In contrast, with the abdominal approach, dissection begins in the area of scar, and only after penetrating the scar does one find the unaffected space. With the vaginal approach, dissection begins in the correct surgical plane, which aids in identification of the location of the bladder and cesarean scar.

Sharp dissection is a must to protect the bladder

Once the correct surgical plane is encountered, sharp dissection is necessary to prevent tears of the adherent bladder, which can occur with blunt dissection.

Although sharp dissection is the key to success under these circumstances, other maneuvers may be helpful in some cases.

Nichols²¹ suggested performing dissection of the bladder after it has been filled with a dilute indigo carmine solution to stain the bladder tissues and help prevent bladder injury.

Hoffman and Jaeger²² describe the placement of a bent uterine sound in the posterior cul-de-sac. The sound is then brought around to the anterior cul-de-sac as an aid to dissection of the bladder and the vesicouterine peritoneal fold.

Sheth and Malpani²³ describe developing a lateral “window” through the broad ligament to the bladder dissection when there are dense midline adhesions.

Although these are all valuable suggestions, I have found that they are rarely needed with careful sharp dissection. Remember, it is essential to avoid the temptation of blunt dissection when performing vaginal hysterectomy in women with a prior cesarean delivery.

CASE 2 Procedure is a success

The vaginal hysterectomy is carried out without incident, and cystoscopy following the hysterectomy is negative for any bladder injury; both ureteral orifices promptly efflux indigo carmine.

The surgeon encountered little difficulty during the bladder dissection, which was performed sharply. In fact, she was surprised at how well she could actually identify the hysterotomy scar and bladder. The patient goes home after 24 hours and is back at work in 2 weeks.

As noted in both cases presented here, the gynecologic surgeon must be certain that the urinary tract is intact and uninjured prior to leaving the operating room. This includes careful inspection of the bladder grossly for any sign of injury, as well as cystoscopy.

Most bladder injuries that occur with hysterectomy—either vaginal or abdominal—are usually well above the trigone and can be carefully repaired by the gynecologic surgeon. Complex injuries to the bladder involving the trigone or ureters usually require urologic intraoperative consultation.

The author reports no financial relationships relevant to this article.

CASE 1 Problems entering the cul-de-sac

M.K. is a 43-year-old gravida 2 para 2 who is undergoing a vaginal hysterectomy for menorrhagia. A preoperative pelvic exam and ultrasound suggested a 12-week-size uterus with several small leiomyomata. Her gynecologist estimates the uterine weight at 240 g and notes that the uterus is mobile. M.K. asks that her ovaries be removed at the time of hysterectomy because of a family history of ovarian cancer.

During the initial dissection, the surgeon is unable to enter the anterior cul-de-sac due to distortion created by an anterior fibroid. The surgeon has entered the posterior cul-de-sac, but the uterus is too large to manipulate a finger around anteriorly to identify the peritoneal fold. Although he feels confident that the bladder has been adequately mobilized from the cervix, the surgeon is strongly considering abandoning the vaginal approach and completing the hysterectomy abdominally.

How should he proceed?

Entry into the peritoneal cavity through the anterior or posterior cul-de-sac can sometimes be challenging, as this case illustrates. However, there is no need for the surgeon to abandon the vaginal approach just yet. In my experience, the anterior peritoneal fold can be high or distorted by fibroids in some women. The key to successful surgery is a pause in activity to consider the case at hand and determine whether additional progress can be made safely without changing the approach.

Avoid blind entry at all costs

No less an authority than Heaney¹ advised against blind attempts to enter the anterior cul-de-sac. Such attempts are often frustrating, can involve bleeding, and raise the risk of injury to the bladder. However, once the surgeon is confident that the bladder is free and retracted out of the way, he or she can proceed without intraperitoneal entry. This is especially true if the posterior cul-de-sac has been entered safely.

The “climb up” technique

In some cases, the surgeon may safely proceed extraperitoneally even if neither cul-de-sac has been opened. Krige² coined the term “climb up” to describe the extraperitoneal approach to the inaccessible posterior cul-de-sac. He performed extensive extraperitoneal dissection that, if necessary, included both uterosacral and cardinal ligaments as well as uterine vessels. A surgeon may carry a total extraperitoneal dissection completely to the uterine fundus as long as the bladder and rectum are free.³

In M.K.’s case, the surgeon should proceed to take the uterosacral and cardinal ligaments posteriorly without swinging the clamps around to the anterior aspect of the cervix, if possible. Once these ligaments are taken, the uterus often descends enough that the anterior peritoneal fold becomes accessible. Once it is identified, the anterior cul-de-sac can be entered safely.

If safe entry still is not possible, the surgeon can take the uterine vessels if he or she is confident that the bladder is out of harm’s way. If the fold still cannot be identified after this bite, proceed with broad-ligament clamps, which usually lead to eventual opening of the peritoneal fold.

CASE 1 Some progress, then surgery stalls

The surgeon proceeds to operate extraperitoneally, as described above, and successfully enters the anterior cul-de-sac after the uterine vessels are ligated. However, after several additional bites of broad ligament on each side, progress stalls because of uterine size. The surgeon seems to be stuck and is growing increasingly frustrated.

What is the best way around this impasse?

Morcellation can involve a range of techniques

Whenever a large uterus prevents further progress, and the uterine vessels have been ligated, uterine morcellation can be performed. Morcellation techniques originated when vaginal hysterectomy was the archetypal gynecologic operation,^4-7 and include uterine bisection,^8-11 Lash intramyometrial coring,^6,8,9 myomectomy,^10,11 and wedge debulking.⁹ Although every surgeon has a favorite, some or all of these procedures may be necessary in the same patient.^12-15 In all cases it is mandatory that the uterine vessels be ligated before any morcellation procedure is initiated.

In my experience, a uterus in the range of 240 g usually lends itself very nicely to Lash intramyometrial coring. This technique is a nearly bloodless procedure that does not violate the endometrial cavity when it is performed properly. In addition, any intramyometrial fibroids can be easily removed.

If coring does not decompress the uterus enough for safe delivery, the core can be cut off and the remaining uterus can be further morcellated by removing wedges of myometrium or by bivalving the uterus. Since there is usually more room in the posterior vagina than in the anterior vagina, as much of the wedge morcellation as possible should be done posteriorly.

 

CASE 1 Ovaries appear out of reach

After Lash intramyometrial coring, the surgeon successfully removes the uterus. He then turns his attention to the bilateral adnexectomy. Unfortunately, the ovaries are higher than anticipated, and he once again considers switching to the abdominal route to remove them.

Is a change in route the best option?

Focus on the round ligaments

The key to safe removal of the adnexa, especially in difficult cases, is the separate transection and ligation of the round ligaments. Many authors have reported high success rates for vaginal oophorectomy using this technique, especially in premenopausal women.^16-19

Separate transection of the round ligament allows the surgeon to accomplish 2 very important tasks:

Once the round ligament is ligated and transected, I like to keep it on stretch so that the broad-ligament peritoneum can be opened parallel to the ovarian vessels, much as it is done in the abdominal approach. This allows the ovary to descend; it also isolates the infundibulopelvic ligament with the ovarian vessels, thus enabling more secure ligation of the vessels and reducing the risk of ureteral injury.

In many hysterectomy cases when oophorectomy is planned, this maneuver can be carried out prior to removal of the uterus. Once the round ligaments have been reached, the surgeon can deliver the uterine fundus anteriorly, allowing the round ligaments to be clamped and cut. It is not uncommon to be able to remove the uterus with both adnexa still attached.

With a large uterus, it may be necessary to clamp and transect the round ligament after the uterus is out. This does not preclude identification and transection of the round ligament to carry out the maneuvers described above.

Consider your tools

In very difficult cases, specialized clamps or sutures may be necessary. I find long, sturdy, right-angle clamps to be most useful. In addition, endoloop-type sutures often facilitate ligation of the vascular pedicle. The use of newer specialized bipolar electrosurgical instruments may be helpful, although I have no personal experience using them in vaginal surgery.

CASE 1 At closure, concerns about injury

After successful removal of both adnexa using the round-ligament technique, the surgeon is satisfied that he has achieved hemostasis and proceeds with his usual closure. However, he has nagging concerns about the possibility of undetected complications, because this case turned out to be more of a challenge than he had expected. He wonders if there is anything else he can do to ensure that everything is OK.

What would you do?

Besides ensuring satisfactory hemostasis, confirming the integrity of the urinary tract is the most important goal to achieve before leaving the operating room. Unrecognized injuries to the bladder or ureters are unacceptable and will lead to significant morbidity for the patient. I would certainly recommend that the surgeon in M.K.’s case perform cystoscopy after giving the patient intravenous indigo carmine to assure both ureteral patency and integrity of the bladder. I perform cystoscopy after all vaginal hysterectomies.

CASE 2 History of cesarean delivery

C.S. is a 38-year-old gravida 3 para 3 who presents with menometrorrhagia and dysmenorrhea unresponsive to medical therapy. Her first pregnancy resulted in vaginal delivery of a full-term infant without complications. Her second child was delivered via low-segment transverse cesarean section due to a persistent breech presentation at term. Her last child was delivered vaginally, also at term. Two years later C.S. underwent a laparoscopic tubal ligation without complications. That was 4 years ago. She began seeing her current gynecologist 2 years ago, when she moved to a new community.

Pelvic examination reveals a 6-week–size uterus and normal adnexa. Her uterus is mobile, and there does not appear to be any ventral fixation of the uterus to the abdominal wall from the cesarean section. Endometrial biopsy reveals proliferative endometrium only. Saline ultrasound demonstrates a 2-cm submucosal leiomyoma.

C.S. refuses hysteroscopic resection of the myoma and prefers hysterectomy as definitive therapy. She is the business manager for her family’s construction business, and she would like to be able to return to work as soon as possible after her surgery. She requests vaginal hysterectomy with conservation of her ovaries.

What is the best way to proceed at this point?

Many gynecologic surgeons regard previous pelvic surgery, including cesarean delivery, as a relative contraindication to vaginal hysterectomy. Although the major concern seems to be a potential for bladder injury during the bladder dissection, other problems such as ventral fixation of the uterus to the previous abdominal incision also are possible.

Vaginal hysterectomy requires a mobile uterus

 

All patients who will be undergoing vaginal hysterectomy must have demonstrated mobility of the uterus upon pelvic examination. This is particularly important in the case of prior pelvic surgery. In this case, the gynecologist also should make every attempt to obtain her surgical records—especially those from her laparoscopic tubal ligation—to exclude major adhesive disease in the pelvis.

Laparoscopic adhesiolysis may facilitate vaginal hysterectomy

If there is any concern that the uterus is fixed to the abdominal wall, abdominal hysterectomy should be considered. Even more preferable is laparoscopic adhesiolysis, which can make it possible to proceed with vaginal hysterectomy. I have used this approach in women with as many as 5 previous cesarean deliveries and severe ventral fixation of the uterus.²⁰ After adhesiolysis, the remainder of the hysterectomy can usually be performed solely through the vaginal route.

CASE 2 Medical records suggest the vaginal route is feasible

The gynecologist obtains C.S.’s previous medical records, which confirm that the cesarean delivery was uncomplicated. They also indicate that, at the time of the sterilization procedure, there was no evidence of ventral fixation of the uterus or other major adhesive disease.

The physician decides to proceed with vaginal hysterectomy, but remains very concerned about the possibility of bladder injury. How can she avoid inadvertent cystotomy?

Difficulty identifying and safely dissecting the bladder—because of distortion of the vesicouterine space from the previous cesarean delivery—is a legitimate concern. However, injury to a scarred and densely adherent bladder is a risk even with abdominal dissection.

The vaginal approach to the distal vesicouterine space has a clear advantage: The vesicouterine space closest to the initial vaginal dissection is unaffected by the previous operation on the lower uterine segment. In contrast, with the abdominal approach, dissection begins in the area of scar, and only after penetrating the scar does one find the unaffected space. With the vaginal approach, dissection begins in the correct surgical plane, which aids in identification of the location of the bladder and cesarean scar.

Sharp dissection is a must to protect the bladder

Once the correct surgical plane is encountered, sharp dissection is necessary to prevent tears of the adherent bladder, which can occur with blunt dissection.

Although sharp dissection is the key to success under these circumstances, other maneuvers may be helpful in some cases.

Nichols²¹ suggested performing dissection of the bladder after it has been filled with a dilute indigo carmine solution to stain the bladder tissues and help prevent bladder injury.

Hoffman and Jaeger²² describe the placement of a bent uterine sound in the posterior cul-de-sac. The sound is then brought around to the anterior cul-de-sac as an aid to dissection of the bladder and the vesicouterine peritoneal fold.

Sheth and Malpani²³ describe developing a lateral “window” through the broad ligament to the bladder dissection when there are dense midline adhesions.

Although these are all valuable suggestions, I have found that they are rarely needed with careful sharp dissection. Remember, it is essential to avoid the temptation of blunt dissection when performing vaginal hysterectomy in women with a prior cesarean delivery.

CASE 2 Procedure is a success

The vaginal hysterectomy is carried out without incident, and cystoscopy following the hysterectomy is negative for any bladder injury; both ureteral orifices promptly efflux indigo carmine.

The surgeon encountered little difficulty during the bladder dissection, which was performed sharply. In fact, she was surprised at how well she could actually identify the hysterotomy scar and bladder. The patient goes home after 24 hours and is back at work in 2 weeks.

As noted in both cases presented here, the gynecologic surgeon must be certain that the urinary tract is intact and uninjured prior to leaving the operating room. This includes careful inspection of the bladder grossly for any sign of injury, as well as cystoscopy.

Most bladder injuries that occur with hysterectomy—either vaginal or abdominal—are usually well above the trigone and can be carefully repaired by the gynecologic surgeon. Complex injuries to the bladder involving the trigone or ureters usually require urologic intraoperative consultation.

The author reports no financial relationships relevant to this article.

True or false: When it comes to hysterectomy, surgeons tend to use the route that is safest, least invasive, and most economical.

Sadly, the statement is false. Although vaginal hysterectomy tops all 3 categories, it is the least utilized of surgical routes. The number of vaginal hysterectomies may have increased slightly over the past decade, likely due to the incorporation of laparoscopically assisted vaginal hysterectomy into the mainstream and increased practice with the vaginal component, but fewer than 30% of hysterectomies are performed vaginally.

This article addresses 6 common challenges at vaginal hysterectomy and offers strategies to overcome them.

Laparoscopic strategies ease vaginal hysterectomy, too

Laparoscopic hysterectomy became widely accepted when surgical instruments were developed to overcome the technical challenges inherent in operating with limited access. By incorporating some of the techniques we routinely use for laparoscopic surgery, we can overcome many of the challenges faced during difficult vaginal surgery.

VAGINAL HYSTERECTOMY CHALLENGE 1: Obesity

Unfortunately, our population is increasingly rotund. This is not only a significant risk factor for the patient’s health in general, but it poses some unique challenges for surgeons. I must say that, as tough as it may be to complete a hysterectomy vaginally in a morbidly obese woman, I would much rather approach her pelvic organs through the cul-de-sac, which contains no fat cells, than through the abdominal wall—either laparoscopically or abdominally! The trick is gaining access to the posterior cul-de-sac.

How to enter the cul-de-sac

It seems to be a perverse rule of nature, but a tight upper vaginal ring seems almost universal in obese women. Added to the redundant sidewalls and the large buttocks, this tightness makes entry into the anterior or posterior cul-de-sac problematic. Several tricks make peritoneal access possible:

Position the patient to increase access, with the buttocks well over the edge of the operating table. This brings the operative field a bit closer to the surgeon, and permits the use of long-handled retractors posteriorly.

Use candy-cane stirrups to allow assistants better access to the operative field. Adequate assistance is essential in attempting vaginal surgery in the morbidly obese.

Avoid the Trendelenburg position. Although it might seem that this position would facilitate visualization and placement of a posterior weighted speculum, all it does is allow the patient to slide up on the table, making placement of alternate retractors difficult.

Use the right tools. If the posterior weighted speculum will not stay in place or does not afford access to the cul-de-sac due to an upper vaginal ring, use a narrow Deaver retractor posteriorly (without sidewall or anterior retraction). Use a Jacob’s tenaculum on the posterior lip of the cervix and have your assistant pull straight up on the tenaculum while using the Deaver retractor to see the area between the uterosacral ligaments.

Use the uterosacral ligaments as a guide. Another perversity in morbidly obese women: Despite multiparity, they seem to have little or no apical prolapse but lots of vaginal wall redundancy. The cervix is often elongated, but the uterosacral ligaments are sky high.

I palpate these ligaments, injecting them with a combination of vasopressin diluted 1:5 with bupivacaine and epinephrine (for enhanced hemostasis and preemptive analgesia), then use a pencil electrosurgical electrode to rapidly open the vaginal epithelium between the ligaments.

I then use a long, toothed tissue forceps to tent the peritoneum at 90 degrees to the plane of the posterior cul-de-sac and use Mayo scissors to enter the peritoneal cavity. Usually there is a spurt of fluid to mark appropriate entry into the peritoneum.

I then use the blades of my scissors to stretch the peritoneum between the ligaments and place a moistened 4×4 sponge into the incision.

At the onset of the procedure, inject indigo carmine dye intravenously so that any injury to the bladder will be immediately recognized. I have the circulating nurse empty the bladder while she is prepping the patient, but do not leave an indwelling catheter in place during the operation. I find it cumbersome to work around the catheter.

Problematic entries

When entry into the posterior cul-de-sac is difficult, I stop dissection, place a 4×4 sponge into the incision to reduce bleeding from the vagina, and proceed to attempt anterior entry.

 

I place the Deaver retractor into the anterior space and move the tenaculum to the anterior lip of the cervix. This gives maximal space for downward traction on the cervix while anterior entry is attempted.

Once again, I inject the tissue with the bupivacaine solution before incising the vaginal epithelium at the level of the internal os. I use sharp dissection only when creating a plane between the lower uterine segment and the bladder.

Ensuring room to move and good visualization

If neither the anterior nor the posterior cul-de-sac can be accessed, it may be time to rethink the vaginal approach—but there is no harm in taking the uterosacral and cardinal ligaments extraperitoneally in an effort to gain some mobility. Hugging the uterus and leaving the anterior retractor in place to lift the bladder superiorly are essential steps to protect the ureters. The cervix can then be split in the midline (12 to 6 o’clock) to easily identify the peritoneal reflections.

Other tips

Sidewall retractors are rarely needed. They significantly impair placement of clamps and sutures by creating a long, narrow, parallel passageway. An alternative trick is to use the suction tip to retract the vaginal sidewall as the surgeon is working.

A disposable, fiberoptic, lighted suction irrigator is another option. The light can be directed precisely where it is needed, and the irrigation helps keep the field clean and tidy, simplifying identification of anatomy.

Skip the sutures whenever possible. Because it is difficult to place sutures with precision in a tight, poorly illuminated space, I use a vessel sealer for all pedicles above the uterosacral ligaments. Some of these instruments were designed specifically for vaginal hysterectomy in the same shape and size as Heaney clamps. They are remarkably efficient and permit the completion of a vaginal procedure when suture placement is difficult.

Use a Heaney needleholder, with the suture loaded precisely in the center of the needle curve, along with the lighted suction irrigator to retract redundant tissue away from the track of the needle, to facilitate suturing high in the pelvis.

VAGINAL HYSTERECTOMY CHALLENGE 2: Nulliparity

Many of us are reluctant to attempt vaginal hysterectomy in a woman who has never had children. Although this situation can be challenging at times, in my experience, the access issues tend to be more difficult in obese, multiparous women.

The same tricks and techniques addressed above will permit the vaginal approach in almost all nulliparous women.

VAGINAL HYSTERECTOMY CHALLENGE 3: Previous cesarean section

A prior cesarean delivery is sometimes considered an indication for laparoscopic hysterectomy. There are 2 concerns here: The patient may have a small pelvis, and there may be significant scar tissue and difficulty gaining access to the anterior cul-de-sac, as a result of repeated dissection between the lower uterine segment and the bladder. Several tricks may be useful:

Examine the patient under anesthesia to ensure that the fundus is not stuck to the anterior abdominal wall. This can occur if the peritoneum was not closed during the last cesarean section.

Empty the bladder before beginning the hysterectomy, and inject indigo carmine dye intravenously with the induction of anesthesia.

Use careful sharp dissection between the bladder and lower uterine segment using fine Metzenbaum scissors, with the tips pointed toward the uterus. Dissect only as far as you can easily see.

Secure the uterosacral, cardinal, and broad ligaments, if necessary, before pursuing entry into the anterior cul-de-sac. It is not essential to gain anterior access before taking these pedicles. The additional mobility and descensus enable safe sharp dissection.

If pedicles have been secured up to the fundus, and the anterior cul-de-sac remains difficult to assess, flip the fundus through the posterior cul-de-sac and reach your finger or an instrument around the top of the fundus to identify the peritoneum anteriorly, then incise it under direct vision.

VAGINAL HYSTERECTOMY CHALLENGE 4: Previous abdominal/pelvic surgery

This history is another often-cited rationale for avoiding the vaginal approach. In reality, the adhesions created from prior surgery tend to arise between the anterior abdominal wall and the omentum or small bowel. This situation makes laparoscopic or open abdominal entry riskier than vaginal peritoneal access through the cul-de-sac.

Two possible exceptions: a patient who has had surgery for deeply infiltrating endometriosis in the cul-de-sac or a woman who has undergone myomectomies with posterior incisions. These patients may have dense scarring in the cul-de-sac, which would preclude a vaginal approach. Whatever the surgical route, appropriate bowel preparation is necessary to permit simple closure of any intestinal injury at the time of hysterectomy. Why not begin vaginally if the exam under anesthesia demonstrates an accessible and reasonably free cul-de-sac?

 

VAGINAL HYSTERECTOMY CHALLENGE 5: Large myomatous uterus

A uterus of any size can be removed vaginally as long as there is mobility with access to the uterine arteries. The one exception: a patient with a small, normal uterus and a massive pedunculated myoma arising from the top of the fundus. If the fibroid cannot be pulled into the true pelvis for morcellation, it cannot be removed transvaginally. Fortunately, this situation is quite rare.

Tips for safe morcellation

Keep the uterine serosa intact to maintain orientation.

Split the uterus from 12 to 6 o’clock (bivalving). Protect the bladder with a Deaver retractor anteriorly, and protect the posterior vaginal epithelium with the weighted speculum posteriorly.

Remove chunks of tissue from the inside of the specimen. Orient your scalpel blade so that you are always cutting toward the center of the specimen. That way, if the blade slips, you will not accidentally injure tissue on the pelvic sidewall.

Use Lahey thyroid clamps to place the tissue you plan to remove under tension. Finding the capsule of each myoma and gently separating it from the surrounding myometrium facilitates delivery of larger fibroids into the endometrial cavity. Some myomas require morcellation themselves for removal.

Replace the scalpel blade periodically to keep it sharp. Calcified fibroids can dull the blade rapidly.

Work systematically to remove as much central tissue as possible. Try to keep a clean, sharp margin of tissue around the edges for easy grasping. Torn, irregular tissue is very difficult to grab and may cause significant frustration.

If access becomes limited, try clamping additional pedicles on each side of the specimen. A tiny amount of additional descensus can make a huge difference.

Do not administer GnRH agonists prior to surgery. The uterus may shrink, but the myomas tend to become quite soft and difficult to remove. If the patient is seriously anemic, give norethindrone acetate, 5 to 20 mg daily, to stop bleeding and allow the patient’s red blood cell volume to improve before elective surgery.

Use a vessel-sealing instrument to control the pedicles. This strategy produces optimal hemostasis to permit a dry field during morcellation. Moreover, the seals do not get disrupted when the large uterus is pulled past them. Placing suture around pedicles when there is a large, bulky uterus in the pelvis is challenging at best, and it is frustrating to see significant bleeding after removal of the specimen. This problem does not seem to occur with the sealing devices.

Know when to quit! We should not promise any patient a minimally invasive operation. If there is uncontrolled bleeding or no progress after 5 to 10 minutes, convert to a laparoscopic or abdominal approach.

I schedule cases I know will be challenging as “possible” laparoscopic or open hysterectomy. This alerts the OR staff to have additional equipment ready and nearby should we need it. It is not a surgical failure or complication to convert a minimally invasive hysterectomy to a more invasive technique when appropriate. Better to have tried and failed than never to have tried at all!

VAGINAL HYSTERECTOMY CHALLENGE 6: Avoiding complications

The most common complications of vaginal hysterectomy are bleeding, infection, and injury to the bladder. Ureteral injury is less common at vaginal hysterectomy than with the abdominal or laparoscopic approaches. Thus, I do not think routine cystoscopy is essential after uncomplicated vaginal hysterectomy, although I recommend intravenous administration of indigo carmine dye at the beginning of the procedure to enable rapid recognition of even a small bladder laceration. Sharp, careful dissection of the bladder off the lower uterine segment and the avoidance of finger dissection (especially with a gauze sponge) keep these injuries to a minimum.

Minimize bleeding by using newer vessel-sealing technologies rather than suture for most of the pedicles. I attach the uterosacral–cardinal ligament pedicles to the vaginal cuff at closure with suture. I suture the first pedicle once I have entered the posterior cul-de-sac and hold that suture to stay oriented.

Pay attention to patient positioning. Careful positioning will help you avoid neurological injuries. Avoid hyperflexion at the hips, which stretches the femoral nerve. Large nerves have comparatively little blood supply, so stretching them for prolonged periods can cause hypoxic injury. Although such injuries are almost always rapidly reversible, they are disconcerting for both the patient and her surgeon.

When operating on a very thin woman with a bony sacrum, I like to place egg-crate foam beneath the buttocks to provide some cushioning. I am also very careful with these women to keep their legs in a neutral position, and I watch my surgical assistants to be sure they are not leaning on the patient during the procedure.

 

Prophylactic antibiotics are a must to avoid postoperative vaginal cuff infections and pelvic abscess. Smokers and women with preexisting bacterial vaginosis are at highest risk for infection. I ask women to discontinue smoking at least 2 weeks prior to surgery and inform all smokers that their risk of infection is heightened. I treat anaerobic overgrowth in the vagina prior to surgery to help prevent infections in women with bacterial vaginosis.

The timing of prophylactic antibiotics is important. Intravenous first-generation cephalosporins must be administered within 60 minutes of the initial incision, but it is important to give them early enough for them to adequately disseminate to tissue before the colpotomy incision.

DVT prophylaxis is especially important for women with large uteri. Routine use of sequential compression stockings is both cost-effective and equivalent to the prophylactic use of subcutaneous heparin, so I use them for all patients undergoing vaginal hysterectomy. Early ambulation (usually within 2 hours of surgery) is also helpful in avoiding thromboses.

90% of hysterectomies can be performed vaginally

Using the techniques described in this article, I have been able to perform over 90% of the hysterectomies in my practice vaginally. More than 50% of my patients are either morbidly obese, nulliparous, or have had previous abdominal surgery of some type.

The instruments I find most useful are the lighted suction irrigator and the vessel-sealing Heaney-type clamp.

Establishing a routine and approaching technically challenging cases with a systematic and standardized set of techniques make the vaginal route possible for the vast majority of patients with benign disease.

Dr. Levy has served as a consultant to ValleyLab.

True or false: When it comes to hysterectomy, surgeons tend to use the route that is safest, least invasive, and most economical.

Sadly, the statement is false. Although vaginal hysterectomy tops all 3 categories, it is the least utilized of surgical routes. The number of vaginal hysterectomies may have increased slightly over the past decade, likely due to the incorporation of laparoscopically assisted vaginal hysterectomy into the mainstream and increased practice with the vaginal component, but fewer than 30% of hysterectomies are performed vaginally.

This article addresses 6 common challenges at vaginal hysterectomy and offers strategies to overcome them.

Laparoscopic strategies ease vaginal hysterectomy, too

Laparoscopic hysterectomy became widely accepted when surgical instruments were developed to overcome the technical challenges inherent in operating with limited access. By incorporating some of the techniques we routinely use for laparoscopic surgery, we can overcome many of the challenges faced during difficult vaginal surgery.

VAGINAL HYSTERECTOMY CHALLENGE 1: Obesity

Unfortunately, our population is increasingly rotund. This is not only a significant risk factor for the patient’s health in general, but it poses some unique challenges for surgeons. I must say that, as tough as it may be to complete a hysterectomy vaginally in a morbidly obese woman, I would much rather approach her pelvic organs through the cul-de-sac, which contains no fat cells, than through the abdominal wall—either laparoscopically or abdominally! The trick is gaining access to the posterior cul-de-sac.

How to enter the cul-de-sac

It seems to be a perverse rule of nature, but a tight upper vaginal ring seems almost universal in obese women. Added to the redundant sidewalls and the large buttocks, this tightness makes entry into the anterior or posterior cul-de-sac problematic. Several tricks make peritoneal access possible:

Position the patient to increase access, with the buttocks well over the edge of the operating table. This brings the operative field a bit closer to the surgeon, and permits the use of long-handled retractors posteriorly.

Use candy-cane stirrups to allow assistants better access to the operative field. Adequate assistance is essential in attempting vaginal surgery in the morbidly obese.

Avoid the Trendelenburg position. Although it might seem that this position would facilitate visualization and placement of a posterior weighted speculum, all it does is allow the patient to slide up on the table, making placement of alternate retractors difficult.

Use the right tools. If the posterior weighted speculum will not stay in place or does not afford access to the cul-de-sac due to an upper vaginal ring, use a narrow Deaver retractor posteriorly (without sidewall or anterior retraction). Use a Jacob’s tenaculum on the posterior lip of the cervix and have your assistant pull straight up on the tenaculum while using the Deaver retractor to see the area between the uterosacral ligaments.

Use the uterosacral ligaments as a guide. Another perversity in morbidly obese women: Despite multiparity, they seem to have little or no apical prolapse but lots of vaginal wall redundancy. The cervix is often elongated, but the uterosacral ligaments are sky high.

I palpate these ligaments, injecting them with a combination of vasopressin diluted 1:5 with bupivacaine and epinephrine (for enhanced hemostasis and preemptive analgesia), then use a pencil electrosurgical electrode to rapidly open the vaginal epithelium between the ligaments.

I then use a long, toothed tissue forceps to tent the peritoneum at 90 degrees to the plane of the posterior cul-de-sac and use Mayo scissors to enter the peritoneal cavity. Usually there is a spurt of fluid to mark appropriate entry into the peritoneum.

I then use the blades of my scissors to stretch the peritoneum between the ligaments and place a moistened 4×4 sponge into the incision.

At the onset of the procedure, inject indigo carmine dye intravenously so that any injury to the bladder will be immediately recognized. I have the circulating nurse empty the bladder while she is prepping the patient, but do not leave an indwelling catheter in place during the operation. I find it cumbersome to work around the catheter.

Problematic entries

When entry into the posterior cul-de-sac is difficult, I stop dissection, place a 4×4 sponge into the incision to reduce bleeding from the vagina, and proceed to attempt anterior entry.

 

I place the Deaver retractor into the anterior space and move the tenaculum to the anterior lip of the cervix. This gives maximal space for downward traction on the cervix while anterior entry is attempted.

Once again, I inject the tissue with the bupivacaine solution before incising the vaginal epithelium at the level of the internal os. I use sharp dissection only when creating a plane between the lower uterine segment and the bladder.

Ensuring room to move and good visualization

If neither the anterior nor the posterior cul-de-sac can be accessed, it may be time to rethink the vaginal approach—but there is no harm in taking the uterosacral and cardinal ligaments extraperitoneally in an effort to gain some mobility. Hugging the uterus and leaving the anterior retractor in place to lift the bladder superiorly are essential steps to protect the ureters. The cervix can then be split in the midline (12 to 6 o’clock) to easily identify the peritoneal reflections.

Other tips

Sidewall retractors are rarely needed. They significantly impair placement of clamps and sutures by creating a long, narrow, parallel passageway. An alternative trick is to use the suction tip to retract the vaginal sidewall as the surgeon is working.

A disposable, fiberoptic, lighted suction irrigator is another option. The light can be directed precisely where it is needed, and the irrigation helps keep the field clean and tidy, simplifying identification of anatomy.

Skip the sutures whenever possible. Because it is difficult to place sutures with precision in a tight, poorly illuminated space, I use a vessel sealer for all pedicles above the uterosacral ligaments. Some of these instruments were designed specifically for vaginal hysterectomy in the same shape and size as Heaney clamps. They are remarkably efficient and permit the completion of a vaginal procedure when suture placement is difficult.

Use a Heaney needleholder, with the suture loaded precisely in the center of the needle curve, along with the lighted suction irrigator to retract redundant tissue away from the track of the needle, to facilitate suturing high in the pelvis.

VAGINAL HYSTERECTOMY CHALLENGE 2: Nulliparity

Many of us are reluctant to attempt vaginal hysterectomy in a woman who has never had children. Although this situation can be challenging at times, in my experience, the access issues tend to be more difficult in obese, multiparous women.

The same tricks and techniques addressed above will permit the vaginal approach in almost all nulliparous women.

VAGINAL HYSTERECTOMY CHALLENGE 3: Previous cesarean section

A prior cesarean delivery is sometimes considered an indication for laparoscopic hysterectomy. There are 2 concerns here: The patient may have a small pelvis, and there may be significant scar tissue and difficulty gaining access to the anterior cul-de-sac, as a result of repeated dissection between the lower uterine segment and the bladder. Several tricks may be useful:

Examine the patient under anesthesia to ensure that the fundus is not stuck to the anterior abdominal wall. This can occur if the peritoneum was not closed during the last cesarean section.

Empty the bladder before beginning the hysterectomy, and inject indigo carmine dye intravenously with the induction of anesthesia.

Use careful sharp dissection between the bladder and lower uterine segment using fine Metzenbaum scissors, with the tips pointed toward the uterus. Dissect only as far as you can easily see.

Secure the uterosacral, cardinal, and broad ligaments, if necessary, before pursuing entry into the anterior cul-de-sac. It is not essential to gain anterior access before taking these pedicles. The additional mobility and descensus enable safe sharp dissection.

If pedicles have been secured up to the fundus, and the anterior cul-de-sac remains difficult to assess, flip the fundus through the posterior cul-de-sac and reach your finger or an instrument around the top of the fundus to identify the peritoneum anteriorly, then incise it under direct vision.

VAGINAL HYSTERECTOMY CHALLENGE 4: Previous abdominal/pelvic surgery

This history is another often-cited rationale for avoiding the vaginal approach. In reality, the adhesions created from prior surgery tend to arise between the anterior abdominal wall and the omentum or small bowel. This situation makes laparoscopic or open abdominal entry riskier than vaginal peritoneal access through the cul-de-sac.

Two possible exceptions: a patient who has had surgery for deeply infiltrating endometriosis in the cul-de-sac or a woman who has undergone myomectomies with posterior incisions. These patients may have dense scarring in the cul-de-sac, which would preclude a vaginal approach. Whatever the surgical route, appropriate bowel preparation is necessary to permit simple closure of any intestinal injury at the time of hysterectomy. Why not begin vaginally if the exam under anesthesia demonstrates an accessible and reasonably free cul-de-sac?

 

VAGINAL HYSTERECTOMY CHALLENGE 5: Large myomatous uterus

A uterus of any size can be removed vaginally as long as there is mobility with access to the uterine arteries. The one exception: a patient with a small, normal uterus and a massive pedunculated myoma arising from the top of the fundus. If the fibroid cannot be pulled into the true pelvis for morcellation, it cannot be removed transvaginally. Fortunately, this situation is quite rare.

Tips for safe morcellation

Keep the uterine serosa intact to maintain orientation.

Split the uterus from 12 to 6 o’clock (bivalving). Protect the bladder with a Deaver retractor anteriorly, and protect the posterior vaginal epithelium with the weighted speculum posteriorly.

Remove chunks of tissue from the inside of the specimen. Orient your scalpel blade so that you are always cutting toward the center of the specimen. That way, if the blade slips, you will not accidentally injure tissue on the pelvic sidewall.

Use Lahey thyroid clamps to place the tissue you plan to remove under tension. Finding the capsule of each myoma and gently separating it from the surrounding myometrium facilitates delivery of larger fibroids into the endometrial cavity. Some myomas require morcellation themselves for removal.

Replace the scalpel blade periodically to keep it sharp. Calcified fibroids can dull the blade rapidly.

Work systematically to remove as much central tissue as possible. Try to keep a clean, sharp margin of tissue around the edges for easy grasping. Torn, irregular tissue is very difficult to grab and may cause significant frustration.

If access becomes limited, try clamping additional pedicles on each side of the specimen. A tiny amount of additional descensus can make a huge difference.

Do not administer GnRH agonists prior to surgery. The uterus may shrink, but the myomas tend to become quite soft and difficult to remove. If the patient is seriously anemic, give norethindrone acetate, 5 to 20 mg daily, to stop bleeding and allow the patient’s red blood cell volume to improve before elective surgery.

Use a vessel-sealing instrument to control the pedicles. This strategy produces optimal hemostasis to permit a dry field during morcellation. Moreover, the seals do not get disrupted when the large uterus is pulled past them. Placing suture around pedicles when there is a large, bulky uterus in the pelvis is challenging at best, and it is frustrating to see significant bleeding after removal of the specimen. This problem does not seem to occur with the sealing devices.

Know when to quit! We should not promise any patient a minimally invasive operation. If there is uncontrolled bleeding or no progress after 5 to 10 minutes, convert to a laparoscopic or abdominal approach.

I schedule cases I know will be challenging as “possible” laparoscopic or open hysterectomy. This alerts the OR staff to have additional equipment ready and nearby should we need it. It is not a surgical failure or complication to convert a minimally invasive hysterectomy to a more invasive technique when appropriate. Better to have tried and failed than never to have tried at all!

VAGINAL HYSTERECTOMY CHALLENGE 6: Avoiding complications

The most common complications of vaginal hysterectomy are bleeding, infection, and injury to the bladder. Ureteral injury is less common at vaginal hysterectomy than with the abdominal or laparoscopic approaches. Thus, I do not think routine cystoscopy is essential after uncomplicated vaginal hysterectomy, although I recommend intravenous administration of indigo carmine dye at the beginning of the procedure to enable rapid recognition of even a small bladder laceration. Sharp, careful dissection of the bladder off the lower uterine segment and the avoidance of finger dissection (especially with a gauze sponge) keep these injuries to a minimum.

Minimize bleeding by using newer vessel-sealing technologies rather than suture for most of the pedicles. I attach the uterosacral–cardinal ligament pedicles to the vaginal cuff at closure with suture. I suture the first pedicle once I have entered the posterior cul-de-sac and hold that suture to stay oriented.

Pay attention to patient positioning. Careful positioning will help you avoid neurological injuries. Avoid hyperflexion at the hips, which stretches the femoral nerve. Large nerves have comparatively little blood supply, so stretching them for prolonged periods can cause hypoxic injury. Although such injuries are almost always rapidly reversible, they are disconcerting for both the patient and her surgeon.

When operating on a very thin woman with a bony sacrum, I like to place egg-crate foam beneath the buttocks to provide some cushioning. I am also very careful with these women to keep their legs in a neutral position, and I watch my surgical assistants to be sure they are not leaning on the patient during the procedure.

 

Prophylactic antibiotics are a must to avoid postoperative vaginal cuff infections and pelvic abscess. Smokers and women with preexisting bacterial vaginosis are at highest risk for infection. I ask women to discontinue smoking at least 2 weeks prior to surgery and inform all smokers that their risk of infection is heightened. I treat anaerobic overgrowth in the vagina prior to surgery to help prevent infections in women with bacterial vaginosis.

The timing of prophylactic antibiotics is important. Intravenous first-generation cephalosporins must be administered within 60 minutes of the initial incision, but it is important to give them early enough for them to adequately disseminate to tissue before the colpotomy incision.

DVT prophylaxis is especially important for women with large uteri. Routine use of sequential compression stockings is both cost-effective and equivalent to the prophylactic use of subcutaneous heparin, so I use them for all patients undergoing vaginal hysterectomy. Early ambulation (usually within 2 hours of surgery) is also helpful in avoiding thromboses.

90% of hysterectomies can be performed vaginally

Using the techniques described in this article, I have been able to perform over 90% of the hysterectomies in my practice vaginally. More than 50% of my patients are either morbidly obese, nulliparous, or have had previous abdominal surgery of some type.

The instruments I find most useful are the lighted suction irrigator and the vessel-sealing Heaney-type clamp.

Establishing a routine and approaching technically challenging cases with a systematic and standardized set of techniques make the vaginal route possible for the vast majority of patients with benign disease.

Dr. Levy has served as a consultant to ValleyLab.

True or false: When it comes to hysterectomy, surgeons tend to use the route that is safest, least invasive, and most economical.

Sadly, the statement is false. Although vaginal hysterectomy tops all 3 categories, it is the least utilized of surgical routes. The number of vaginal hysterectomies may have increased slightly over the past decade, likely due to the incorporation of laparoscopically assisted vaginal hysterectomy into the mainstream and increased practice with the vaginal component, but fewer than 30% of hysterectomies are performed vaginally.

This article addresses 6 common challenges at vaginal hysterectomy and offers strategies to overcome them.

Laparoscopic strategies ease vaginal hysterectomy, too

Laparoscopic hysterectomy became widely accepted when surgical instruments were developed to overcome the technical challenges inherent in operating with limited access. By incorporating some of the techniques we routinely use for laparoscopic surgery, we can overcome many of the challenges faced during difficult vaginal surgery.

VAGINAL HYSTERECTOMY CHALLENGE 1: Obesity

Unfortunately, our population is increasingly rotund. This is not only a significant risk factor for the patient’s health in general, but it poses some unique challenges for surgeons. I must say that, as tough as it may be to complete a hysterectomy vaginally in a morbidly obese woman, I would much rather approach her pelvic organs through the cul-de-sac, which contains no fat cells, than through the abdominal wall—either laparoscopically or abdominally! The trick is gaining access to the posterior cul-de-sac.

How to enter the cul-de-sac

It seems to be a perverse rule of nature, but a tight upper vaginal ring seems almost universal in obese women. Added to the redundant sidewalls and the large buttocks, this tightness makes entry into the anterior or posterior cul-de-sac problematic. Several tricks make peritoneal access possible:

Position the patient to increase access, with the buttocks well over the edge of the operating table. This brings the operative field a bit closer to the surgeon, and permits the use of long-handled retractors posteriorly.

Use candy-cane stirrups to allow assistants better access to the operative field. Adequate assistance is essential in attempting vaginal surgery in the morbidly obese.

Avoid the Trendelenburg position. Although it might seem that this position would facilitate visualization and placement of a posterior weighted speculum, all it does is allow the patient to slide up on the table, making placement of alternate retractors difficult.

Use the right tools. If the posterior weighted speculum will not stay in place or does not afford access to the cul-de-sac due to an upper vaginal ring, use a narrow Deaver retractor posteriorly (without sidewall or anterior retraction). Use a Jacob’s tenaculum on the posterior lip of the cervix and have your assistant pull straight up on the tenaculum while using the Deaver retractor to see the area between the uterosacral ligaments.

Use the uterosacral ligaments as a guide. Another perversity in morbidly obese women: Despite multiparity, they seem to have little or no apical prolapse but lots of vaginal wall redundancy. The cervix is often elongated, but the uterosacral ligaments are sky high.

I palpate these ligaments, injecting them with a combination of vasopressin diluted 1:5 with bupivacaine and epinephrine (for enhanced hemostasis and preemptive analgesia), then use a pencil electrosurgical electrode to rapidly open the vaginal epithelium between the ligaments.

I then use a long, toothed tissue forceps to tent the peritoneum at 90 degrees to the plane of the posterior cul-de-sac and use Mayo scissors to enter the peritoneal cavity. Usually there is a spurt of fluid to mark appropriate entry into the peritoneum.

I then use the blades of my scissors to stretch the peritoneum between the ligaments and place a moistened 4×4 sponge into the incision.

At the onset of the procedure, inject indigo carmine dye intravenously so that any injury to the bladder will be immediately recognized. I have the circulating nurse empty the bladder while she is prepping the patient, but do not leave an indwelling catheter in place during the operation. I find it cumbersome to work around the catheter.

Problematic entries

When entry into the posterior cul-de-sac is difficult, I stop dissection, place a 4×4 sponge into the incision to reduce bleeding from the vagina, and proceed to attempt anterior entry.

 

I place the Deaver retractor into the anterior space and move the tenaculum to the anterior lip of the cervix. This gives maximal space for downward traction on the cervix while anterior entry is attempted.

Once again, I inject the tissue with the bupivacaine solution before incising the vaginal epithelium at the level of the internal os. I use sharp dissection only when creating a plane between the lower uterine segment and the bladder.

Ensuring room to move and good visualization

If neither the anterior nor the posterior cul-de-sac can be accessed, it may be time to rethink the vaginal approach—but there is no harm in taking the uterosacral and cardinal ligaments extraperitoneally in an effort to gain some mobility. Hugging the uterus and leaving the anterior retractor in place to lift the bladder superiorly are essential steps to protect the ureters. The cervix can then be split in the midline (12 to 6 o’clock) to easily identify the peritoneal reflections.

Other tips

Sidewall retractors are rarely needed. They significantly impair placement of clamps and sutures by creating a long, narrow, parallel passageway. An alternative trick is to use the suction tip to retract the vaginal sidewall as the surgeon is working.

A disposable, fiberoptic, lighted suction irrigator is another option. The light can be directed precisely where it is needed, and the irrigation helps keep the field clean and tidy, simplifying identification of anatomy.

Skip the sutures whenever possible. Because it is difficult to place sutures with precision in a tight, poorly illuminated space, I use a vessel sealer for all pedicles above the uterosacral ligaments. Some of these instruments were designed specifically for vaginal hysterectomy in the same shape and size as Heaney clamps. They are remarkably efficient and permit the completion of a vaginal procedure when suture placement is difficult.

Use a Heaney needleholder, with the suture loaded precisely in the center of the needle curve, along with the lighted suction irrigator to retract redundant tissue away from the track of the needle, to facilitate suturing high in the pelvis.

VAGINAL HYSTERECTOMY CHALLENGE 2: Nulliparity

Many of us are reluctant to attempt vaginal hysterectomy in a woman who has never had children. Although this situation can be challenging at times, in my experience, the access issues tend to be more difficult in obese, multiparous women.

The same tricks and techniques addressed above will permit the vaginal approach in almost all nulliparous women.

VAGINAL HYSTERECTOMY CHALLENGE 3: Previous cesarean section

A prior cesarean delivery is sometimes considered an indication for laparoscopic hysterectomy. There are 2 concerns here: The patient may have a small pelvis, and there may be significant scar tissue and difficulty gaining access to the anterior cul-de-sac, as a result of repeated dissection between the lower uterine segment and the bladder. Several tricks may be useful:

Examine the patient under anesthesia to ensure that the fundus is not stuck to the anterior abdominal wall. This can occur if the peritoneum was not closed during the last cesarean section.

Empty the bladder before beginning the hysterectomy, and inject indigo carmine dye intravenously with the induction of anesthesia.

Use careful sharp dissection between the bladder and lower uterine segment using fine Metzenbaum scissors, with the tips pointed toward the uterus. Dissect only as far as you can easily see.

Secure the uterosacral, cardinal, and broad ligaments, if necessary, before pursuing entry into the anterior cul-de-sac. It is not essential to gain anterior access before taking these pedicles. The additional mobility and descensus enable safe sharp dissection.

If pedicles have been secured up to the fundus, and the anterior cul-de-sac remains difficult to assess, flip the fundus through the posterior cul-de-sac and reach your finger or an instrument around the top of the fundus to identify the peritoneum anteriorly, then incise it under direct vision.

VAGINAL HYSTERECTOMY CHALLENGE 4: Previous abdominal/pelvic surgery

This history is another often-cited rationale for avoiding the vaginal approach. In reality, the adhesions created from prior surgery tend to arise between the anterior abdominal wall and the omentum or small bowel. This situation makes laparoscopic or open abdominal entry riskier than vaginal peritoneal access through the cul-de-sac.

Two possible exceptions: a patient who has had surgery for deeply infiltrating endometriosis in the cul-de-sac or a woman who has undergone myomectomies with posterior incisions. These patients may have dense scarring in the cul-de-sac, which would preclude a vaginal approach. Whatever the surgical route, appropriate bowel preparation is necessary to permit simple closure of any intestinal injury at the time of hysterectomy. Why not begin vaginally if the exam under anesthesia demonstrates an accessible and reasonably free cul-de-sac?

 

VAGINAL HYSTERECTOMY CHALLENGE 5: Large myomatous uterus

A uterus of any size can be removed vaginally as long as there is mobility with access to the uterine arteries. The one exception: a patient with a small, normal uterus and a massive pedunculated myoma arising from the top of the fundus. If the fibroid cannot be pulled into the true pelvis for morcellation, it cannot be removed transvaginally. Fortunately, this situation is quite rare.

Tips for safe morcellation

Keep the uterine serosa intact to maintain orientation.

Split the uterus from 12 to 6 o’clock (bivalving). Protect the bladder with a Deaver retractor anteriorly, and protect the posterior vaginal epithelium with the weighted speculum posteriorly.

Remove chunks of tissue from the inside of the specimen. Orient your scalpel blade so that you are always cutting toward the center of the specimen. That way, if the blade slips, you will not accidentally injure tissue on the pelvic sidewall.

Use Lahey thyroid clamps to place the tissue you plan to remove under tension. Finding the capsule of each myoma and gently separating it from the surrounding myometrium facilitates delivery of larger fibroids into the endometrial cavity. Some myomas require morcellation themselves for removal.

Replace the scalpel blade periodically to keep it sharp. Calcified fibroids can dull the blade rapidly.

Work systematically to remove as much central tissue as possible. Try to keep a clean, sharp margin of tissue around the edges for easy grasping. Torn, irregular tissue is very difficult to grab and may cause significant frustration.

If access becomes limited, try clamping additional pedicles on each side of the specimen. A tiny amount of additional descensus can make a huge difference.

Do not administer GnRH agonists prior to surgery. The uterus may shrink, but the myomas tend to become quite soft and difficult to remove. If the patient is seriously anemic, give norethindrone acetate, 5 to 20 mg daily, to stop bleeding and allow the patient’s red blood cell volume to improve before elective surgery.

Use a vessel-sealing instrument to control the pedicles. This strategy produces optimal hemostasis to permit a dry field during morcellation. Moreover, the seals do not get disrupted when the large uterus is pulled past them. Placing suture around pedicles when there is a large, bulky uterus in the pelvis is challenging at best, and it is frustrating to see significant bleeding after removal of the specimen. This problem does not seem to occur with the sealing devices.

Know when to quit! We should not promise any patient a minimally invasive operation. If there is uncontrolled bleeding or no progress after 5 to 10 minutes, convert to a laparoscopic or abdominal approach.

I schedule cases I know will be challenging as “possible” laparoscopic or open hysterectomy. This alerts the OR staff to have additional equipment ready and nearby should we need it. It is not a surgical failure or complication to convert a minimally invasive hysterectomy to a more invasive technique when appropriate. Better to have tried and failed than never to have tried at all!

VAGINAL HYSTERECTOMY CHALLENGE 6: Avoiding complications

The most common complications of vaginal hysterectomy are bleeding, infection, and injury to the bladder. Ureteral injury is less common at vaginal hysterectomy than with the abdominal or laparoscopic approaches. Thus, I do not think routine cystoscopy is essential after uncomplicated vaginal hysterectomy, although I recommend intravenous administration of indigo carmine dye at the beginning of the procedure to enable rapid recognition of even a small bladder laceration. Sharp, careful dissection of the bladder off the lower uterine segment and the avoidance of finger dissection (especially with a gauze sponge) keep these injuries to a minimum.

Minimize bleeding by using newer vessel-sealing technologies rather than suture for most of the pedicles. I attach the uterosacral–cardinal ligament pedicles to the vaginal cuff at closure with suture. I suture the first pedicle once I have entered the posterior cul-de-sac and hold that suture to stay oriented.

Pay attention to patient positioning. Careful positioning will help you avoid neurological injuries. Avoid hyperflexion at the hips, which stretches the femoral nerve. Large nerves have comparatively little blood supply, so stretching them for prolonged periods can cause hypoxic injury. Although such injuries are almost always rapidly reversible, they are disconcerting for both the patient and her surgeon.

When operating on a very thin woman with a bony sacrum, I like to place egg-crate foam beneath the buttocks to provide some cushioning. I am also very careful with these women to keep their legs in a neutral position, and I watch my surgical assistants to be sure they are not leaning on the patient during the procedure.

 

Prophylactic antibiotics are a must to avoid postoperative vaginal cuff infections and pelvic abscess. Smokers and women with preexisting bacterial vaginosis are at highest risk for infection. I ask women to discontinue smoking at least 2 weeks prior to surgery and inform all smokers that their risk of infection is heightened. I treat anaerobic overgrowth in the vagina prior to surgery to help prevent infections in women with bacterial vaginosis.

The timing of prophylactic antibiotics is important. Intravenous first-generation cephalosporins must be administered within 60 minutes of the initial incision, but it is important to give them early enough for them to adequately disseminate to tissue before the colpotomy incision.

DVT prophylaxis is especially important for women with large uteri. Routine use of sequential compression stockings is both cost-effective and equivalent to the prophylactic use of subcutaneous heparin, so I use them for all patients undergoing vaginal hysterectomy. Early ambulation (usually within 2 hours of surgery) is also helpful in avoiding thromboses.

90% of hysterectomies can be performed vaginally

Using the techniques described in this article, I have been able to perform over 90% of the hysterectomies in my practice vaginally. More than 50% of my patients are either morbidly obese, nulliparous, or have had previous abdominal surgery of some type.

The instruments I find most useful are the lighted suction irrigator and the vessel-sealing Heaney-type clamp.

Establishing a routine and approaching technically challenging cases with a systematic and standardized set of techniques make the vaginal route possible for the vast majority of patients with benign disease.

Dr. Levy has served as a consultant to ValleyLab.

The accomplished gynecologic surgeon must know the anatomy of the retroperitoneal space in order to avoid damage to normal structures, as well as remove pathology. Many disease processes involve the pelvic peritoneum, uterosacral ligaments, rectosigmoid or ovarian pedicles, and require the surgeon to enter the retroperitoneal space to identify the ureters and blood vessels and keep them out of harm’s way. The challenges are complex:

• Badly distorted anatomy and the anterior and posterior cul-de-sac necessitate mobilization of the rectosigmoid and bladder.
• Intraligamentous fibroids require knowledge of the blood supply in the retroperitoneal space. Malignant disorders mandate that the lymph nodes be dissected to determine extent of disease and as part of treatment.

Is training adequate?

Every training program should teach the surgical anatomy of the retroperitoneal space, since every surgeon needs to be comfortable exposing the anatomy, both to prevent injury and to accomplish the needed surgery. Videotapes and cadaver courses can prepare the resident for the operating room.

The “landmark” umbilical ligament

The umbilical ligament was the umbilical artery in fetal life and courses along the edge of the bladder to the anterior abdominal wall up to the umbilicus. It is a useful guide into the perivesicle space. Lateral to it are the iliac vessels, and medial is the bladder. It is also a good marker for finding the right spot to open the round ligament.

FIGURE 1 Opening the round ligament over the umbilical ligament

The round ligament is the key to exposing the retroperitoneal space. It should be open at the pelvic sidewall, just medial to the external iliac vessels. The umbilical ligament can be used as a landmark.

FIGURE 2 Opening lateral to the ovarian vessels

The divided round ligament is retracted ventrally and medially to place the ovarian vessels under traction. The peritoneum lateral to the ovarian vessels is divided up to the pelvic brim.

FIGURE 3 Right pelvic sidewall anatomy

Medial traction of the peritoneum around the ovarian vessels at the pelvic brim will expose the ureter coming over the iliac vessels at their bifurcation into external and internal branches.

FIGURE 4 Relationship of ureter to the umbilical ligament

The ureter comes off medial with the fold of peritoneum. Once the space is developed, the operator’s finger or the laparoscopic probe can be introduced along the medial side of the internal iliac artery and ventral to the curve of the sacrum. This will open the pararectal space. The ureter and the anterior branch of the internal iliac artery are nearly parallel as they course through the pelvis.

FIGURE 5 Hypogastric nerve

The anterior branch of the internal iliac artery gives off the uterine artery and the middle and superior vesicle arteries before continuing on as the umbilical ligament.

Endometriosis may imperil the ureter

Endometriomas and peritoneal implants are among the most common reasons for accessing the retroperitoneal space. Frequently the peritoneum between the ovarian vessels and the uterosacral ligaments (ovarian fossa) is thickened and retracted within the endometriosis implants. This alters the pelvic anatomy and puts the ureter at risk for injury.

Definitive surgical treatment for endometriosis includes removal of this diseased peritoneum. The ureter is best identified using the technique described, and then dissected off the peritoneum down to the uterine artery.

FIGURE 6 Finding the ureter lateral to an endometrioma

FIGURE 7 Relationship of ureter to the umbilical ligament

FIGURE 8 Dissecting the ureter out of the uterosacral ligament

The ureter may be placed on a Penrose drain to better isolate it and keep it under direct visualization. The cul-de-sac of Douglas is another site of endometrial implants. The fundus of the uterus is often adhesed to the rectosigmoid reflection and even the sigmoid colon. Nodules of endometriosis may infiltrate the uterosacral ligaments and extend into the rectovaginal space. To manage these implants, isolate the ureter to the point where it passes under the uterine artery.

FIGURE 9 Divide uterine artery lateral to endometrioma

Here, the uterine artery is taken lateral to the mass, enabling the surgeon to remove all of the uterosacral implants. The bladder flap will be developed and the bladder advanced caudad. By dissecting medial to the ureter as it courses under the uterine artery, it will be retracted laterally and provide the space necessary to resect the uterosacral implants.

FIGURE 10 Rectosigmoid reflection with endometrioma nodule

 

FIGURE 11 Postoperative appearance of endometriosis resection

As dissection proceeds medially, use the perirectal fatty plane to remove implants between the uterosacral area and rectum. In the midline, remove implants below the rectosigmoid peritoneal reflexion, taking care not to injure the rectum.

Implants above the peritoneal reflexion are often attached to the sigmoid tinea coli and cannot be removed without taking a portion of the bowel. Thus, patients with extensive endometriosis should have a bowel prep with two 10-ounce bottles of magnesium citrate the day before surgery.

If bowel resection is necessary, consult a general surgeon or gynecologic oncologist. A history of painful defecation or a finding of nodules in the cul-de-sac with rectal dimpling warrants preoperative consultation with a specialist skilled at bowel resection.

Preventing ureteral injury

Ureteral injuries occur in 0.5% to 2.5% of women undergoing gynecologic surgery.¹ The most common predisposing condition is previous pelvic surgery.^2,3 The usual sites of injury are at the pelvic rim close to the ovarian vessels, at the level of the uterine artery, and lateral to the vaginal cuff. Neither preoperative excretory urograms nor placement of ureteral catheters preoperatively have been found to be effective prevention measures.^2,4-6 Using the steps described above, the ureter can be identified and mobilized.

Blood supply to the ureter comes from the plexus of vessels that form a network along the length of the ureter. This plexus is fed by arteries from the renal pelvis, common iliac, internal iliac, uterine artery, and the base of the bladder. Complete mobilization of the ureter away from its peritoneal attachments and these lateral blood supply sources can be accomplished as long as the vascular plexus is not disrupted by cautery, crushing, or tearing. A clean transection can be re-anastomosed or reimplanted with the expectation of normal healing. Innervation of the ureter is from the inferior mesenteric plexus superiorly and the inferior hypogastric plexus in the pelvis. Ureteral peristalsis will continue, even if the ureter is completely divided or ligated.

Protecting pelvic blood vessels

The majority of gynecologic operations involve the ovarian vessels and the uterine vessels. The operator rarely needs to explore the lateral pelvis to identify the rest of the vessels. When faced with a large endometrioma or cancer, knowledge of the anatomy of the lateral blood vessels is vital.

Since the pathology is usually deeper in the pelvis, it is wise to identify the anatomy of the pelvis starting at the pelvic brim, where the common iliac bifurcates into the external and internal iliacs. There is a safe dissection plane medial to the internal iliac artery all the way to the uterine artery. This exposes the pararectal space, which can be opened without risk of major bleeding (FIGURE 5).

The obliterated umbilical vessel is the other friendly marker just distal to the uterine artery. It can be placed on traction and the uterine artery isolated. The inferior and superior vesical arteries are generally not dissected, as they are adjacent to the bladder and the surgery takes place medial to them in the prevesical fascial space.

Hypogastric artery ligations are rarely performed today, as interventional radiology is the standard of care for patients with postoperative and postpartum bleeding. When it becomes necessary, the hypogastric artery can be isolated and tied using the right-angle clamp to pass the tie. The superior gluteal artery branches so close to the bifurcation of the common iliac artery that it is not visualized. The inferior gluteal artery is the largest distal branch, which might be visualized during the ligation. It is not necessary to identify it.

Protecting pelvic nerves

FIGURE 12 Right genitofemoral nerve

The genitofemoral nerve runs along the medial aspect of the body of the psoas muscle. It is sometimes injured by the self-retaining retractors placed at the time of laparotomy. This leads to some numbness and burning of the skin of the anterior thigh.

FIGURE 13 Right pelvic sidewall anatomy

The obturator nerve is in the obturator space and typically far lateral to the usual dissection. Metastatic cancer to the obturator lymph nodes may entrap it, or it may be injured during a node dissection, causing loss of internal rotation of the anterior thigh.

The sciatic nerve is seen only during exenterative surgery. Pressure on the lateral pelvis by advanced pelvic tumors can lead to sciatic pain and motor weakness—even loss of motor function to the lower leg, which commonly leads to foot drop.

FIGURE 14 Superior hypogastric nerve bundle

The hypogastric plexus of nerves is sometimes damaged during surgery for endometriosis or for malignancy. The superior hypergastric plexus can be identified between the 2 common iliac arteries at the sacral promontory. The left common iliac vein runs underneath it.

 

FIGURE 15 Hypogastric nerve descending into the right pelvis

The right and left hypogastric nerves leave the hypogastric plexus and descend into the pelvis parallel to the ureter and 2 cm medial. It passes dorsal to the ureter as it goes through the cardinal ligament (FIGURE 5).

This plexus then supplies autonomic innervation of the bladder, rectum, uterus, and ureter. Complete disruption of the hypogastric nerve will lead to a hypertonic, noncontractile bladder and the necessity for self-catheterization to eliminate urine. Preservation of this nerve during radical hysterectomy or endometriosis resection is a high priority.

Laparoscopic uterosacral nerve ablation procedures divide the uterosacral ligament medial and caudad to the ureter and do not disrupt the main hypogastric nerve. Only the medial branches to the uterus are affected. Successful uterosacral nerve ablation has been reported in approximately 44% of women who have dysmenorrhea without visible endometriosis and approximately 62% of women who have visible endometriosis.^7,8 The efficacy of this procedure is controversial, however. Removal of the superior hypogastric plexus (presacral neurectomy) has not proved to be more effective in controlling pelvic pain than conservative surgery that only destroys endometrial implants. Presacral neurectomy is no longer advised.⁹

The accomplished gynecologic surgeon must know the anatomy of the retroperitoneal space in order to avoid damage to normal structures, as well as remove pathology. Many disease processes involve the pelvic peritoneum, uterosacral ligaments, rectosigmoid or ovarian pedicles, and require the surgeon to enter the retroperitoneal space to identify the ureters and blood vessels and keep them out of harm’s way. The challenges are complex:

• Badly distorted anatomy and the anterior and posterior cul-de-sac necessitate mobilization of the rectosigmoid and bladder.
• Intraligamentous fibroids require knowledge of the blood supply in the retroperitoneal space. Malignant disorders mandate that the lymph nodes be dissected to determine extent of disease and as part of treatment.

Is training adequate?

Every training program should teach the surgical anatomy of the retroperitoneal space, since every surgeon needs to be comfortable exposing the anatomy, both to prevent injury and to accomplish the needed surgery. Videotapes and cadaver courses can prepare the resident for the operating room.

The “landmark” umbilical ligament

The umbilical ligament was the umbilical artery in fetal life and courses along the edge of the bladder to the anterior abdominal wall up to the umbilicus. It is a useful guide into the perivesicle space. Lateral to it are the iliac vessels, and medial is the bladder. It is also a good marker for finding the right spot to open the round ligament.

FIGURE 1 Opening the round ligament over the umbilical ligament

The round ligament is the key to exposing the retroperitoneal space. It should be open at the pelvic sidewall, just medial to the external iliac vessels. The umbilical ligament can be used as a landmark.

FIGURE 2 Opening lateral to the ovarian vessels

The divided round ligament is retracted ventrally and medially to place the ovarian vessels under traction. The peritoneum lateral to the ovarian vessels is divided up to the pelvic brim.

FIGURE 3 Right pelvic sidewall anatomy

Medial traction of the peritoneum around the ovarian vessels at the pelvic brim will expose the ureter coming over the iliac vessels at their bifurcation into external and internal branches.

FIGURE 4 Relationship of ureter to the umbilical ligament

The ureter comes off medial with the fold of peritoneum. Once the space is developed, the operator’s finger or the laparoscopic probe can be introduced along the medial side of the internal iliac artery and ventral to the curve of the sacrum. This will open the pararectal space. The ureter and the anterior branch of the internal iliac artery are nearly parallel as they course through the pelvis.

FIGURE 5 Hypogastric nerve

The anterior branch of the internal iliac artery gives off the uterine artery and the middle and superior vesicle arteries before continuing on as the umbilical ligament.

Endometriosis may imperil the ureter

Endometriomas and peritoneal implants are among the most common reasons for accessing the retroperitoneal space. Frequently the peritoneum between the ovarian vessels and the uterosacral ligaments (ovarian fossa) is thickened and retracted within the endometriosis implants. This alters the pelvic anatomy and puts the ureter at risk for injury.

Definitive surgical treatment for endometriosis includes removal of this diseased peritoneum. The ureter is best identified using the technique described, and then dissected off the peritoneum down to the uterine artery.

FIGURE 6 Finding the ureter lateral to an endometrioma

FIGURE 7 Relationship of ureter to the umbilical ligament

FIGURE 8 Dissecting the ureter out of the uterosacral ligament

The ureter may be placed on a Penrose drain to better isolate it and keep it under direct visualization. The cul-de-sac of Douglas is another site of endometrial implants. The fundus of the uterus is often adhesed to the rectosigmoid reflection and even the sigmoid colon. Nodules of endometriosis may infiltrate the uterosacral ligaments and extend into the rectovaginal space. To manage these implants, isolate the ureter to the point where it passes under the uterine artery.

FIGURE 9 Divide uterine artery lateral to endometrioma

Here, the uterine artery is taken lateral to the mass, enabling the surgeon to remove all of the uterosacral implants. The bladder flap will be developed and the bladder advanced caudad. By dissecting medial to the ureter as it courses under the uterine artery, it will be retracted laterally and provide the space necessary to resect the uterosacral implants.

FIGURE 10 Rectosigmoid reflection with endometrioma nodule

 

FIGURE 11 Postoperative appearance of endometriosis resection

As dissection proceeds medially, use the perirectal fatty plane to remove implants between the uterosacral area and rectum. In the midline, remove implants below the rectosigmoid peritoneal reflexion, taking care not to injure the rectum.

Implants above the peritoneal reflexion are often attached to the sigmoid tinea coli and cannot be removed without taking a portion of the bowel. Thus, patients with extensive endometriosis should have a bowel prep with two 10-ounce bottles of magnesium citrate the day before surgery.

If bowel resection is necessary, consult a general surgeon or gynecologic oncologist. A history of painful defecation or a finding of nodules in the cul-de-sac with rectal dimpling warrants preoperative consultation with a specialist skilled at bowel resection.

Preventing ureteral injury

Ureteral injuries occur in 0.5% to 2.5% of women undergoing gynecologic surgery.¹ The most common predisposing condition is previous pelvic surgery.^2,3 The usual sites of injury are at the pelvic rim close to the ovarian vessels, at the level of the uterine artery, and lateral to the vaginal cuff. Neither preoperative excretory urograms nor placement of ureteral catheters preoperatively have been found to be effective prevention measures.^2,4-6 Using the steps described above, the ureter can be identified and mobilized.

Blood supply to the ureter comes from the plexus of vessels that form a network along the length of the ureter. This plexus is fed by arteries from the renal pelvis, common iliac, internal iliac, uterine artery, and the base of the bladder. Complete mobilization of the ureter away from its peritoneal attachments and these lateral blood supply sources can be accomplished as long as the vascular plexus is not disrupted by cautery, crushing, or tearing. A clean transection can be re-anastomosed or reimplanted with the expectation of normal healing. Innervation of the ureter is from the inferior mesenteric plexus superiorly and the inferior hypogastric plexus in the pelvis. Ureteral peristalsis will continue, even if the ureter is completely divided or ligated.

Protecting pelvic blood vessels

The majority of gynecologic operations involve the ovarian vessels and the uterine vessels. The operator rarely needs to explore the lateral pelvis to identify the rest of the vessels. When faced with a large endometrioma or cancer, knowledge of the anatomy of the lateral blood vessels is vital.

Since the pathology is usually deeper in the pelvis, it is wise to identify the anatomy of the pelvis starting at the pelvic brim, where the common iliac bifurcates into the external and internal iliacs. There is a safe dissection plane medial to the internal iliac artery all the way to the uterine artery. This exposes the pararectal space, which can be opened without risk of major bleeding (FIGURE 5).

The obliterated umbilical vessel is the other friendly marker just distal to the uterine artery. It can be placed on traction and the uterine artery isolated. The inferior and superior vesical arteries are generally not dissected, as they are adjacent to the bladder and the surgery takes place medial to them in the prevesical fascial space.

Hypogastric artery ligations are rarely performed today, as interventional radiology is the standard of care for patients with postoperative and postpartum bleeding. When it becomes necessary, the hypogastric artery can be isolated and tied using the right-angle clamp to pass the tie. The superior gluteal artery branches so close to the bifurcation of the common iliac artery that it is not visualized. The inferior gluteal artery is the largest distal branch, which might be visualized during the ligation. It is not necessary to identify it.

Protecting pelvic nerves

FIGURE 12 Right genitofemoral nerve

The genitofemoral nerve runs along the medial aspect of the body of the psoas muscle. It is sometimes injured by the self-retaining retractors placed at the time of laparotomy. This leads to some numbness and burning of the skin of the anterior thigh.

FIGURE 13 Right pelvic sidewall anatomy

The obturator nerve is in the obturator space and typically far lateral to the usual dissection. Metastatic cancer to the obturator lymph nodes may entrap it, or it may be injured during a node dissection, causing loss of internal rotation of the anterior thigh.

The sciatic nerve is seen only during exenterative surgery. Pressure on the lateral pelvis by advanced pelvic tumors can lead to sciatic pain and motor weakness—even loss of motor function to the lower leg, which commonly leads to foot drop.

FIGURE 14 Superior hypogastric nerve bundle

The hypogastric plexus of nerves is sometimes damaged during surgery for endometriosis or for malignancy. The superior hypergastric plexus can be identified between the 2 common iliac arteries at the sacral promontory. The left common iliac vein runs underneath it.

 

FIGURE 15 Hypogastric nerve descending into the right pelvis

The right and left hypogastric nerves leave the hypogastric plexus and descend into the pelvis parallel to the ureter and 2 cm medial. It passes dorsal to the ureter as it goes through the cardinal ligament (FIGURE 5).

This plexus then supplies autonomic innervation of the bladder, rectum, uterus, and ureter. Complete disruption of the hypogastric nerve will lead to a hypertonic, noncontractile bladder and the necessity for self-catheterization to eliminate urine. Preservation of this nerve during radical hysterectomy or endometriosis resection is a high priority.

Laparoscopic uterosacral nerve ablation procedures divide the uterosacral ligament medial and caudad to the ureter and do not disrupt the main hypogastric nerve. Only the medial branches to the uterus are affected. Successful uterosacral nerve ablation has been reported in approximately 44% of women who have dysmenorrhea without visible endometriosis and approximately 62% of women who have visible endometriosis.^7,8 The efficacy of this procedure is controversial, however. Removal of the superior hypogastric plexus (presacral neurectomy) has not proved to be more effective in controlling pelvic pain than conservative surgery that only destroys endometrial implants. Presacral neurectomy is no longer advised.⁹

The accomplished gynecologic surgeon must know the anatomy of the retroperitoneal space in order to avoid damage to normal structures, as well as remove pathology. Many disease processes involve the pelvic peritoneum, uterosacral ligaments, rectosigmoid or ovarian pedicles, and require the surgeon to enter the retroperitoneal space to identify the ureters and blood vessels and keep them out of harm’s way. The challenges are complex:

• Badly distorted anatomy and the anterior and posterior cul-de-sac necessitate mobilization of the rectosigmoid and bladder.
• Intraligamentous fibroids require knowledge of the blood supply in the retroperitoneal space. Malignant disorders mandate that the lymph nodes be dissected to determine extent of disease and as part of treatment.

Is training adequate?

Every training program should teach the surgical anatomy of the retroperitoneal space, since every surgeon needs to be comfortable exposing the anatomy, both to prevent injury and to accomplish the needed surgery. Videotapes and cadaver courses can prepare the resident for the operating room.

The “landmark” umbilical ligament

The umbilical ligament was the umbilical artery in fetal life and courses along the edge of the bladder to the anterior abdominal wall up to the umbilicus. It is a useful guide into the perivesicle space. Lateral to it are the iliac vessels, and medial is the bladder. It is also a good marker for finding the right spot to open the round ligament.

FIGURE 1 Opening the round ligament over the umbilical ligament

The round ligament is the key to exposing the retroperitoneal space. It should be open at the pelvic sidewall, just medial to the external iliac vessels. The umbilical ligament can be used as a landmark.

FIGURE 2 Opening lateral to the ovarian vessels

The divided round ligament is retracted ventrally and medially to place the ovarian vessels under traction. The peritoneum lateral to the ovarian vessels is divided up to the pelvic brim.

FIGURE 3 Right pelvic sidewall anatomy

Medial traction of the peritoneum around the ovarian vessels at the pelvic brim will expose the ureter coming over the iliac vessels at their bifurcation into external and internal branches.

FIGURE 4 Relationship of ureter to the umbilical ligament

The ureter comes off medial with the fold of peritoneum. Once the space is developed, the operator’s finger or the laparoscopic probe can be introduced along the medial side of the internal iliac artery and ventral to the curve of the sacrum. This will open the pararectal space. The ureter and the anterior branch of the internal iliac artery are nearly parallel as they course through the pelvis.

FIGURE 5 Hypogastric nerve

The anterior branch of the internal iliac artery gives off the uterine artery and the middle and superior vesicle arteries before continuing on as the umbilical ligament.

Endometriosis may imperil the ureter

Endometriomas and peritoneal implants are among the most common reasons for accessing the retroperitoneal space. Frequently the peritoneum between the ovarian vessels and the uterosacral ligaments (ovarian fossa) is thickened and retracted within the endometriosis implants. This alters the pelvic anatomy and puts the ureter at risk for injury.

Definitive surgical treatment for endometriosis includes removal of this diseased peritoneum. The ureter is best identified using the technique described, and then dissected off the peritoneum down to the uterine artery.

FIGURE 6 Finding the ureter lateral to an endometrioma

FIGURE 7 Relationship of ureter to the umbilical ligament

FIGURE 8 Dissecting the ureter out of the uterosacral ligament

The ureter may be placed on a Penrose drain to better isolate it and keep it under direct visualization. The cul-de-sac of Douglas is another site of endometrial implants. The fundus of the uterus is often adhesed to the rectosigmoid reflection and even the sigmoid colon. Nodules of endometriosis may infiltrate the uterosacral ligaments and extend into the rectovaginal space. To manage these implants, isolate the ureter to the point where it passes under the uterine artery.

FIGURE 9 Divide uterine artery lateral to endometrioma

Here, the uterine artery is taken lateral to the mass, enabling the surgeon to remove all of the uterosacral implants. The bladder flap will be developed and the bladder advanced caudad. By dissecting medial to the ureter as it courses under the uterine artery, it will be retracted laterally and provide the space necessary to resect the uterosacral implants.

FIGURE 10 Rectosigmoid reflection with endometrioma nodule

 

FIGURE 11 Postoperative appearance of endometriosis resection

As dissection proceeds medially, use the perirectal fatty plane to remove implants between the uterosacral area and rectum. In the midline, remove implants below the rectosigmoid peritoneal reflexion, taking care not to injure the rectum.

Implants above the peritoneal reflexion are often attached to the sigmoid tinea coli and cannot be removed without taking a portion of the bowel. Thus, patients with extensive endometriosis should have a bowel prep with two 10-ounce bottles of magnesium citrate the day before surgery.

If bowel resection is necessary, consult a general surgeon or gynecologic oncologist. A history of painful defecation or a finding of nodules in the cul-de-sac with rectal dimpling warrants preoperative consultation with a specialist skilled at bowel resection.

Preventing ureteral injury

Ureteral injuries occur in 0.5% to 2.5% of women undergoing gynecologic surgery.¹ The most common predisposing condition is previous pelvic surgery.^2,3 The usual sites of injury are at the pelvic rim close to the ovarian vessels, at the level of the uterine artery, and lateral to the vaginal cuff. Neither preoperative excretory urograms nor placement of ureteral catheters preoperatively have been found to be effective prevention measures.^2,4-6 Using the steps described above, the ureter can be identified and mobilized.

Blood supply to the ureter comes from the plexus of vessels that form a network along the length of the ureter. This plexus is fed by arteries from the renal pelvis, common iliac, internal iliac, uterine artery, and the base of the bladder. Complete mobilization of the ureter away from its peritoneal attachments and these lateral blood supply sources can be accomplished as long as the vascular plexus is not disrupted by cautery, crushing, or tearing. A clean transection can be re-anastomosed or reimplanted with the expectation of normal healing. Innervation of the ureter is from the inferior mesenteric plexus superiorly and the inferior hypogastric plexus in the pelvis. Ureteral peristalsis will continue, even if the ureter is completely divided or ligated.

Protecting pelvic blood vessels

The majority of gynecologic operations involve the ovarian vessels and the uterine vessels. The operator rarely needs to explore the lateral pelvis to identify the rest of the vessels. When faced with a large endometrioma or cancer, knowledge of the anatomy of the lateral blood vessels is vital.

Since the pathology is usually deeper in the pelvis, it is wise to identify the anatomy of the pelvis starting at the pelvic brim, where the common iliac bifurcates into the external and internal iliacs. There is a safe dissection plane medial to the internal iliac artery all the way to the uterine artery. This exposes the pararectal space, which can be opened without risk of major bleeding (FIGURE 5).

The obliterated umbilical vessel is the other friendly marker just distal to the uterine artery. It can be placed on traction and the uterine artery isolated. The inferior and superior vesical arteries are generally not dissected, as they are adjacent to the bladder and the surgery takes place medial to them in the prevesical fascial space.

Hypogastric artery ligations are rarely performed today, as interventional radiology is the standard of care for patients with postoperative and postpartum bleeding. When it becomes necessary, the hypogastric artery can be isolated and tied using the right-angle clamp to pass the tie. The superior gluteal artery branches so close to the bifurcation of the common iliac artery that it is not visualized. The inferior gluteal artery is the largest distal branch, which might be visualized during the ligation. It is not necessary to identify it.

Protecting pelvic nerves

FIGURE 12 Right genitofemoral nerve

The genitofemoral nerve runs along the medial aspect of the body of the psoas muscle. It is sometimes injured by the self-retaining retractors placed at the time of laparotomy. This leads to some numbness and burning of the skin of the anterior thigh.

FIGURE 13 Right pelvic sidewall anatomy

The obturator nerve is in the obturator space and typically far lateral to the usual dissection. Metastatic cancer to the obturator lymph nodes may entrap it, or it may be injured during a node dissection, causing loss of internal rotation of the anterior thigh.

The sciatic nerve is seen only during exenterative surgery. Pressure on the lateral pelvis by advanced pelvic tumors can lead to sciatic pain and motor weakness—even loss of motor function to the lower leg, which commonly leads to foot drop.

FIGURE 14 Superior hypogastric nerve bundle

The hypogastric plexus of nerves is sometimes damaged during surgery for endometriosis or for malignancy. The superior hypergastric plexus can be identified between the 2 common iliac arteries at the sacral promontory. The left common iliac vein runs underneath it.

 

FIGURE 15 Hypogastric nerve descending into the right pelvis

The right and left hypogastric nerves leave the hypogastric plexus and descend into the pelvis parallel to the ureter and 2 cm medial. It passes dorsal to the ureter as it goes through the cardinal ligament (FIGURE 5).

This plexus then supplies autonomic innervation of the bladder, rectum, uterus, and ureter. Complete disruption of the hypogastric nerve will lead to a hypertonic, noncontractile bladder and the necessity for self-catheterization to eliminate urine. Preservation of this nerve during radical hysterectomy or endometriosis resection is a high priority.

Laparoscopic uterosacral nerve ablation procedures divide the uterosacral ligament medial and caudad to the ureter and do not disrupt the main hypogastric nerve. Only the medial branches to the uterus are affected. Successful uterosacral nerve ablation has been reported in approximately 44% of women who have dysmenorrhea without visible endometriosis and approximately 62% of women who have visible endometriosis.^7,8 The efficacy of this procedure is controversial, however. Removal of the superior hypogastric plexus (presacral neurectomy) has not proved to be more effective in controlling pelvic pain than conservative surgery that only destroys endometrial implants. Presacral neurectomy is no longer advised.⁹

Why should we care about the CARE (Colpopexy and Urinary Reduction Efforts) trial?

Because pelvic organ prolapse and urinary incontinence are already major problems facing women as they age, and will become even more pervasive as the baby boomer generation moves through menopause and beyond.

Because the risk that a woman will experience stress incontinence after prolapse surgery ranges from 8% to 60%.^1-6

Because roughly one third of women who undergo prolapse or incontinence surgery require a second operation.

These are just a few of the factors that spurred the Pelvic Floor Disorders Network to undertake the CARE trial, published April 13 in the New England Journal of Medicine. OBG Management convened a panel of experts in female pelvic medicine, including 2 CARE trial investigators, to discuss the findings of this landmark study, its long-term implications, and the future of research into pelvic floor disorders.

How the trial was conducted

The CARE trial involved 322 women who required surgery to correct pelvic organ prolapse (POP) but lacked symptoms of stress urinary incontinence. All these women underwent sacrocolpopexy, an abdominal procedure in which graft material is attached between the vagina and sacrum to support the vagina and correct the prolapse. These women were randomized to undergo Burch colposuspension at the time of the sacrocolpopexy, or to undergo sacrocolpopexy only. The Burch procedure is performed through the same incision as the sacrocolpopexy and involves suturing the periurethral vaginal tissue to the iliopectineal ligaments on each side, providing urethral support.

Enrollment in the trial was halted after the first of 2 planned interim analyses because the frequency of postoperative stress incontinence was significantly lower in the group undergoing Burch colposuspension: 23.8% and 44.1% of women in the Burch and no-Burch groups, respectively, experienced stress symptoms by 3 months after the surgery.

Why the CARE trial is an epochal event

• First randomized trial of preventive incontinence surgery in women with prolapse
  
• Randomized design establishes cause and effect
  
• Subjects will be followed for 2 years
  

KOHLI: Dr. Brubaker, as lead investigator of the CARE trial, how would you characterize the study’s major strengths?

BRUBAKER: First, it is a well-designed, randomized, controlled trial and thus provides the highest level of evidence for clinical practice. Although there is no perfect study, this one minimized the risk of bias by involving multiple centers (7) and using multiple surgeons, making the findings more generalizable than would be the case in a single-surgeon case series.

In addition, the use of blinded urodynamic testing lent strength, because the ability of urodynamic testing to predict the need for a concomitant continence procedure was not known before the trial. Our follow-up manuscript, containing data presented at the recent Society of Gynecologic Surgeons meeting, will provide more details on this aspect of the trial.

WEBER: Randomized trials are held in such high esteem—provided all other aspects of study design and implementation are performed properly—because they support conclusions of cause and effect. The conclusion that Burch colposuspension prevents stress incontinence when performed at the time of abdominal sacrocolpopexy could only be drawn from a randomized trial.

 

Trial design standardized key elements

Many types of bias confound the results of nonrandomized studies, particularly selection bias (eg, when surgeons select which procedure to perform on the basis of patient characteristics), and valid conclusions of cause and effect cannot be drawn. However, with a randomized trial, subjects are separated into groups by chance and no other factor. Thus, the groups are equivalent at baseline—provided the sample size is large enough (and allowing for random differences)—and therefore any changes measured after the experimental intervention can be confidently attributed to the intervention itself.

Another strength of the trial is standardization. The subjects were “standardized” by rather broad inclusion and exclusion criteria to constitute an important clinical population and to ensure they were sufficiently similar so that the treatment (abdominal sacrocolpopexy) was appropriate for all. In addition, surgeons at the multiple participating sites agreed to standardization of the technical details of the Burch colposuspension so that the subjects received the same intervention regardless of site. And data collection in follow-up was performed in a standard way by research staff who were blinded to the subjects’ group assignment (intervention versus control), so the data were as free of bias as possible.

Homogeneous study population may be a weakness

KOHLI: I agree that the methodology of this well-designed study is its major strength. What are its weaknesses?

WEBER: No doubt there are several, only some of which may be apparent at this time. For example, most women in the study were Caucasian, and very few were Hispanic, Asian, or black. Although we have no scientific reason to believe that Burch colposuspension has different responses in women of different racial and ethnic backgrounds, the trial’s subjects are not diverse enough to analyze the data by subgroups to confirm or refute the hypothesis that response to the Burch procedure is independent of race or ethnicity.

BRUBAKER: Another weakness: Because this study was closed after the first interim analysis, some of our secondary analyses will be underpowered, although we clearly demonstrated a difference in our primary endpoint.

It is important to remember that this study is not “finished.” Our participants are still in active follow-up for 2 years following surgery. It will be interesting to see what happens during the longer follow-up, especially with regard to prolapse and incontinence. We are also doing additional in-depth analyses of urodynamic and other parameters.

KOHLI: Again, I think the study design and analysis were well thought out. It would have been interesting to see how the results broke down according to site, to see if there was variation—which could indicate variation in surgical technique.

BRUBAKER: We have not done this analysis and do not plan to at this time.

Why paravaginal repairs were allowed

KOHLI: What about the decision to include surgeries that involved paravaginal repair?

WEBER: That generated a fair amount of discussion during trial design, as there was no clear “right” answer. Perhaps it would have been “cleaner” to eliminate the option of performing paravaginal repair, but when the trial was designed, we lacked unequivocal evidence that paravaginal repair at the time of abdominal sacrocolpopexy provides additional support for the anterior vagina. Therefore, we decided to allow the decision to be based on surgeon judgment.

Some surgeons perform paravaginal repair with abdominal sacrocolpopexy in almost all women because they believe quite strongly that this reduces the risk of recurrent anterior vaginal prolapse. Others never perform paravaginal repair with abdominal sacrocolpopexy and feel just as strongly that their patients are adequately treated and protected from subsequent anterior vaginal prolapse.

Investigators feared paravaginal repairs could dilute Burch effects

Study surgeons did agree that paravaginal repair reduces the likelihood of postoperative stress incontinence, although not as effectively as Burch colposuspension. Thus, our dilemma: If paravaginal repairs were performed in a large number of subjects, thereby improving their postoperative continence status regardless of whether Burch was performed, the effect of Burch could be so diluted as to be lost. On the other hand, if paravaginal repairs were completely excluded, that would restrict some surgeons’ practices and potentially reduce the number of women who would be offered participation in the study if their surgeons felt their anterior vaginal prolapse would be potentially undertreated.

We resolved the dilemma as follows:

1. A relatively low proportion—about one quarter—of surgeons performed paravaginal repairs regularly with abdominal sacrocolpopexy, so the potential impact in the trial would not be great.
   
2. Paravaginal repairs were allowed, but only when declared necessary by the surgeon before randomization; this step prevented surgeons from changing their minds about the necessity of paravaginal repair if the subject was assigned to the Burch group (ie, the woman would be receiving additional anterior vaginal support by way of the Burch).
   
3. We stratified for paravaginal repair in the randomization, so women with paravaginal repair were equally distributed between the intervention and control groups.
   

 

Are subjective or objective measures better?

• Subjective measures convey a patient’s foremost concerns and how she is doing clinically
  
• Correlating symptoms with objective measures yields valuable insights into treatment
  

KOHLI: The CARE trial uses both objective and subjective measures of incontinence. Which do you think are most important?

BRUBAKER: I prefer subjective measures because I think they reflect what is most important to patients in quality-of-life disorders. However, I believe we need to understand the relationship between subjective outcomes and traditional “objective” outcomes.

WEBER: I think the research community is reaching a consensus that “subjective” measures—better described as patient-oriented outcomes—are more important than objective measures, particularly for conditions that affect patients in “subjective” ways, ie, ways that affect their health-related quality of life, rather than quantity of life. This does not mean that objective measures are useless—although we should first evaluate each measure critically to make that determination on the basis of evidence.

Nevertheless, when a patient seeks and receives treatment based on symptoms and how those symptoms impact her daily life, I think it is incumbent upon researchers and clinicians to ensure that the treatment that is considered most effective actually results in a change that the patient finds worthwhile.

What is “success”?

WALTERS: When it comes to incontinence, for which there is an imperfect correlation between various objective and subjective measures, I think both types of measures are valuable and important. Gathering several different types of outcomes for each patient helps us better understand the nuances of how well an intervention works.

I can understand why some clinicians and researchers place greater reliance on subjective measures of incontinence, such as a diary of incontinence episodes and quality-of-life measures, because these measures tell us exactly how the patient is doing clinically and how she feels about the intervention. If she reports that she is completely cured and “perfect,” then objective measures are irrelevant. However, for any subjective outcome short of perfect, correlation with the objective measures such as cough stress test, physical examination, and urodynamic tests can help investigators understand the reason for the imperfect outcome and point to areas of possible improvement.

KOHLI: In my practice, some women who continue to leak slightly after an incontinence procedure consider their surgery a complete success, whereas, as a surgeon, I consider it a suboptimal result. Both objective and subjective results are important.

Putting the CARE trial into practice

• Data relate directly only to women undergoing abdominal sacrocolpopexy
  
• Patient education, medicolegal, and reimbursement may also relate
  
• Results reflect the high prevalence of pelvic floor disorders and the need to routinely ask about them
  

KOHLI: How will the CARE trial findings affect your clinical practice?

BRUBAKER: I routinely counsel patients who are planning sacrocolpopexy but who do not have stress incontinence to consider a concomitant Burch procedure. I do not have them undergo urodynamic testing because, at this time, the results of that testing would not change my clinical practice.

WALTERS: I have always been liberal when it comes to adding retropubic colposuspension to abdominal sacrocolpopexy, even in women who do not have preoperative stress incontinence. The reason? Patients who are continent preoperatively, but become stress-incontinent postoperatively, are particularly unhappy with their outcome, especially if they need another surgery within a year to treat the stress incontinence. So this study verified what I was already doing.

What I didn’t learn is whether a paravaginal defect repair helps or hurts the Burch procedure from an anatomic and functional perspective.

It also appears that preoperative urodynamic testing has little value, although that was not the point of this study. I am glad it will be addressed in future studies.

KOHLI: I think the findings apply to those select patients undergoing abdominal sacrocolpopexy for prolapse. It would be dangerous to extrapolate these results to other abdominal vault suspension procedures or vaginal prolapse procedures. Based on the CARE trial, I plan to counsel patients about the risks and benefits of “optional” Burch colposuspension at the time of planned sacrocolpopexy. In reality, however, I have almost completely switched to minimally invasive midurethral slings, even in the case of abdominal prolapse procedures, because of their high cure rates, low complication rates, and ease of postoperative adjustment.

Clinical implications depend on surgeon’s routine

KOHLI: What are the implications for the majority of ObGyns?

WEBER: It depends on what ObGyns are doing for women with prolapse.

For ObGyns who are confident and competent, through training and experience, to perform abdominal sacrocolpopexy for women with advanced prolapse, the CARE trial results have a direct effect. Women with prolapse who are stress continent with no contraindications, can be reassured that they will benefit from a 50% reduction of postoperative stress incontinence with the Burch procedure.

 

For ObGyns who do not perform sacrocolpopexy, the CARE trial will have no direct clinical effects. Nevertheless, these clinicians need to be aware of the findings so they can discuss the options with patients before decisions on route or type of prolapse surgery are made.

The CARE trial and its results remind us of the high prevalence of pelvic floor disorders in women, potentially even after corrective surgery—and the need to actively screen all women for pelvic dysfunction.

Warn of potential incontinence even with the Burch

KOHLI: How does this study affect counseling of candidates for prolapse surgery?

BRUBAKER: I would offer stress-continent women a Burch procedure at the time of sacrocolpopexy. That much is clear. The interesting discussions come from “similar” clinical scenarios, where data are not yet available. For example, should a stress-continent woman facing a suspension via the vaginal route undergo a concomitant continence procedure?

WEBER: It is important to keep in mind that even when Burch colposuspension was performed, a number of women still experienced urinary incontinence (some stress, some urge, some mixed) after surgery; and the vast majority of women have urinary symptoms of some kind both before and after surgery. So preoperative counseling should include the information that urinary symptoms are very common after abdominal sacrocolpopexy—some as persistent or recurrent, and some as new symptoms.

As longer follow-up data from the CARE trial become available, we will learn how many women have urinary symptoms that are temporary versus long-lasting.

Is routine Burch best?

• When not all women benefit, should a procedure be offered prophylactically? In this case, experts say, “Yes”
  
• Some physicians favor other incontinence procedures
  
• Final decision rests with the patient
  

KOHLI: Based on study numbers, 100 Burch procedures at the time of abdominal sacrocolpopexy would be necessary to prevent 20 women from developing incontinence. Is that a fair equation?

WALTERS: It is an easy decision for me. As I said earlier, women are particularly unhappy if they go from continent to incontinent after a surgery. In fact, some women are more displeased with that outcome than with a failure of the prolapse surgery. Because most women with prolapse have substantial anterior vaginal wall prolapse, the Burch procedure—with or without a paravaginal defect repair—also serves as part of the prolapse repair of the anterior wall. And now we know it also improves postoperative urinary function.

BRUBAKER: Doing a Burch procedure at the time of sacrocolpopexy is a time-efficient and low-morbidity addition, so it is worthwhile for me and my patients. It is clearly not the same as doing a secondary, standalone procedure for new symptoms.

Over the next 2 years, we will see how many women who were moderately or greatly bothered by stress incontinence went on to a surgical treatment.

WEBER: Please note a careful distinction: I would be willing to recommend Burch colposuspension to 100 stress-continent women who are planning to undergo abdominal sacrocolpopexy for prolapse, with the expectation that this will prevent postoperative stress incontinence in roughly half the women who would have developed it otherwise. It is up to the patient to accept this recommendation or not.

Based on the CARE trial results, 44 of 100 previously continent women after only abdominal sacrocolpopexy develop postoperative stress incontinence, compared with about 24 of 100 women after Burch and abdominal sacrocolpopexy. Even more striking is the difference in women affected by bothersome stress incontinence: almost 25% in the control group versus 6% in the Burch group. Women in the Burch group did not experience an excess of adverse events, or a clinically significant difference in operative time or estimated blood loss, compared with women in the control group.

Is “wait and see” better?

KOHLI: Because I favor minimally invasive midurethral sling procedures, which can often be performed on an outpatient basis under local anesthesia, I counsel women undergoing prolapse surgery via an abdominal or vaginal route that it is best to treat the incontinence postoperatively if it occurs. Obviously, this applies to women who have no incontinence and do not demonstrate potential stress incontinence on urodynamic testing preoperatively.

Anecdotally, I have not found a high rate of new-onset urinary incontinence following prolapse procedures. We may retrospectively look at these patients more critically in light of this new data.

WALTERS: I think most women would be dissatisfied with a 44% risk of postoperative stress incontinence requiring a second surgery. Even if you counseled them appropriately, many women would ask that you try to manage everything at the first surgery.

What are nonclinical effects of the trial?

 

• Need for patient and physician education is great, and the CARE trial offers a valuable opportunity
  
• Potential for medicolegal risk if complications develop
  
• Payers may not be willing to reimburse for a prophylactic procedure
  

KOHLI: Are there any nonclinical issues that arise from application of the study’s conclusions—such as medicolegal, financial, or educational issues?

WEBER: Given how extensively the trial’s results were disseminated by the lay press, I think we have an important opportunity to educate both patients and health-care providers.

First, patients: For women who may be directly affected by the trial, knowledgeable clinicians should explain its results and limitations to help them reach a decision about their treatment.

For women who hear the trial’s results described incompletely or incorrectly (eg, “…2 stitches prevent incontinence…”), clinicians should take this opportunity to correct misunderstandings and educate women about incontinence, prolapse, and pelvic health in general.

For health-care providers, this trial reminds us of the extraordinarily high prevalence of pelvic floor disorders. Although current treatments are not perfect, virtually all women with pelvic floor disorders can be treated to substantially alleviate, if not eliminate, bothersome symptoms.

All clinicians should routinely inquire about pelvic symptoms and be prepared to initiate an evaluation or provide a referral.

Medicolegal fallout?

KOHLI: There is the question of medicolegal risk if complications occur after colposuspension when the patient had no complaints or evidence of stress incontinence at the time of preoperative urodynamic testing. I am not aware of any legal precedent in which a clinical study or data provided solid protection from a jury verdict. The study did not show increased risk or complication with the addition of the Burch procedure, but that may not be true for some surgeons and some patients.

Billing and coding

In terms of billing, how should we code for the Burch colposuspension when the patient had no demonstrable stress incontinence? Payment denials in this scenario seem likely. This may create a line of separation between what may be clinically indicated for the patient and what insurance companies are willing to pay for.

There may be the option to use the urethral hypermobility code (ICD 599.81) for the Burch colposuspension, but only time will tell if this will be reimbursed. I would be curious to hear the panel’s experience with reimbursement for a prophylactic procedure based on scientific data. Obviously, what is best for the patient is most important.

BRUBAKER: All these patients had urethral hypermobility, which is also an indication for a Burch colposuspension.

Is preoperative urodynamic testing useful?

• CARE trial data still to come
  
• Basic testing is probably helpful
  

KOHLI: Is urodynamic testing necessary for women undergoing prolapse surgery?

WEBER: In the CARE trial, the relative level of protection from postoperative stress incontinence provided by the Burch procedure did not depend on the stress-test component (with prolapse reduced) of preoperative urodynamic testing. About 50% fewer women had postoperative stress incontinence after Burch, whether preoperative urodynamic testing showed positive or negative stress tests with prolapse reduction.

Although subsequent analyses (presented at the Society of Gynecologic Surgeons 2006 meeting; manuscript under review) focused on urodynamic testing and postoperative outcomes, the CARE trial was not designed primarily to determine whether women planning prolapse surgery benefit from preoperative urodynamic testing. Therefore, conclusions about the “need” for urodynamic testing should not be based only on the CARE trial.

Should urodynamic testing determine treatment?

Randomized trials that directly address the cost-benefit of urodynamic testing are urgently needed. For now, as is standard in good clinical practice, a test should be performed only if results will change recommendations or provide reliable and clinically important prognostic information about a patient’s outcome after intervention. Clinicians should determine whether urodynamic testing meets even 1 of these 2 minimum criteria.

I want to point out that the CARE trial did not address the utility of urodynamic testing.

BRUBAKER: It is clear that some women have stress incontinence despite the concomitant Burch colposuspension. If we learn that an alternative operation can perform better and that any urodynamic (or other clinical measure) can predict improved outcomes, I would consider resuming urodynamic testing.

WALTERS: At first glance, it appears that complex urodynamic testing is definitely not necessary if the goal is to improve outcomes of surgery. However, I believe the patient should undergo some components of urodynamic testing such as a void with a post-void residual urine volume and a basic bladder-filling study noting sensation and capacity. I also do a cough stress test with the prolapse reduced, although we may find that this does not predict postoperative function.

 

KOHLI: The results of this study are very procedure-specific. If similar results are borne out when other approaches to prolapse and incontinence are analyzed, the value and utility of preoperative uro-dynamic testing in all patients may be questionable.

However, in my practice, I use the results of preoperative urodynamic testing not only for diagnosis, but also to make subtle adjustments when performing incontinence procedures—especially in regard to suburethral slings.

What if you prefer midurethral slings?

• Surgeons should be comfortable with more than 1 incontinence procedure
  
• We should not jump to untested conclusions
  

KOHLI: How does application of the CARE trial’s conclusions change if the physician is currently performing midurethral sling procedures for incontinence?

WEBER: Ideally, well trained and experienced gynecologic, urologic, or urogynecologic surgeons perform more than 1 type of incontinence procedure, to meet the needs of different patients.

As yet, we have no direct, evidence-based answers to issues such as these:

Can a midurethral sling be substituted for a Burch colposuspension and have the same average results in preventing post-operative stress incontinence without increasing urgency symptoms…

• …when abdominal sacrocolpopexy is performed for prolapse in a preoperatively stress-continent patient?
  

At present, all a clinician can do is reflect on data from case series of midurethral sling procedures for incontinence, and guess at the outcome when used as prophylaxis and combined with abdominal sacrocolpopexy.

• …when vaginal apical suspension is performed for prolapse in a preoperatively stress-continent patient?
  

I think the critical issue remains how the midurethral sling will perform when it is used for prophylaxis instead of treatment. As with the Burch, the most important clinical concern is the creation or worsening of urgency or other irritative bladder symptoms. When this occurs in the treatment setting, it may be acceptable to the patient and clinician. In the setting of prophylaxis, however, I doubt it would be acceptable.

Although it is tempting to jump 1 or 2 steps ahead and apply CARE trial data to situations that have not been tested directly, I would be cautious. We want to avoid creating long-lasting or refractory urgency symptoms—especially in a woman who had no such symptoms before surgery—because of a prophylactic procedure.

I think this is especially true because it is relatively easy to salvage patients who do develop bothersome stress incontinence after prolapse surgery.

Bonus: Burch helps anterior vaginal prolapse

WALTERS: I wonder whether prophylactic placement of a midurethral sling would yield the same results as a prophylactic Burch procedure. If your midurethral sling of choice is a tension-free vaginal tape (TVT), I would be cautious about placing it prophylactically, because the TVT has a 2% to 3% risk of prolonged voiding dysfunction requiring transection of the tape.

However, it is possible that prophylactic placement of a transobturator sling, which is associated with much less voiding dysfunction and fewer major surgical complications, might have a different outcome—though this requires further study.

In addition, midurethral slings would not be as effective as Burch colposuspension in treating anterior vaginal prolapse, so I would expect to see more anterior wall prolapse failures if slings replaced colposuspension.

What if you prefer the vaginal approach?

• Further study is needed
  

KOHLI: Since many, if not most, gynecologists surgically treat prolapse and incontinence using a vaginal approach, how does the CARE trial affect their practice?

WALTERS: I wonder whether a prophylactic transobturator midurethral sling at the time of transvaginal prolapse repair would yield similar results. I do cystocele repair with suburethral (“Kelly”) plication, which seems to work well at stabilizing the urethra in women without stress incontinence. But this approach is not as popular these days, and future studies may demonstrate that a prophylactic midurethral sling will result in better long-term function without significantly increasing the long-term risk.

WEBER: The CARE trial results are relevant to all pelvic surgeons because they demonstrate the need for and benefit from well-designed randomized surgical trials. Another benefit will be extended follow-up in what will become a prospective cohort study of women with advanced prolapse treated by abdominal sacrocolpopexy—providing higher-quality evidence than retrospective case series. Although not as valuable as randomized trials, these data can help guide clinical recommendations.

If long-term results support the effectiveness and durability of abdominal prolapse repair, then gynecologists can reflect on the evidence and choose the approach that best fits the patient’s needs.

Need for other studies?

• Randomized, multicenter trials addressing almost any surgical treatment of prolapse and incontinence are sorely needed
  

KOHLI: What other possible multicenter clinical studies involving prolapse/incontinence would you suggest?

 

BRUBAKER: Any and all high-quality, well-designed trial can improve our care of women with incontinence and/or prolapse.

WALTERS: I look forward to the follow-up studies from the CARE trial on the value of paravaginal defect repair, preoperative urodynamic testing, and the efficacy of various prolapse-reduction maneuvers in predicting surgical outcomes.

It would also seem logical to repeat this type of study using transvaginal prolapse repair with or without a prophylactic midurethral sling. Another option: anterior colporrhaphy with suburethral plication versus a prophylactic midurethral sling.

KOHLI: I look forward to data on surgical procedures currently being performed with greater frequency despite a lack of good-quality data. These include the transobturator suburethral midurethral sling procedures, laparoscopic sacrocolpopexy, and vaginal mesh augmentation for prolapse.

The Pelvic Floor Disorders Network affords a unique opportunity to perform well-designed multicenter trials to address the rapidly changing landscape of surgical treatment for prolapse and incontinence.

Why should we care about the CARE (Colpopexy and Urinary Reduction Efforts) trial?

Because pelvic organ prolapse and urinary incontinence are already major problems facing women as they age, and will become even more pervasive as the baby boomer generation moves through menopause and beyond.

Because the risk that a woman will experience stress incontinence after prolapse surgery ranges from 8% to 60%.^1-6

Because roughly one third of women who undergo prolapse or incontinence surgery require a second operation.

These are just a few of the factors that spurred the Pelvic Floor Disorders Network to undertake the CARE trial, published April 13 in the New England Journal of Medicine. OBG Management convened a panel of experts in female pelvic medicine, including 2 CARE trial investigators, to discuss the findings of this landmark study, its long-term implications, and the future of research into pelvic floor disorders.

How the trial was conducted

The CARE trial involved 322 women who required surgery to correct pelvic organ prolapse (POP) but lacked symptoms of stress urinary incontinence. All these women underwent sacrocolpopexy, an abdominal procedure in which graft material is attached between the vagina and sacrum to support the vagina and correct the prolapse. These women were randomized to undergo Burch colposuspension at the time of the sacrocolpopexy, or to undergo sacrocolpopexy only. The Burch procedure is performed through the same incision as the sacrocolpopexy and involves suturing the periurethral vaginal tissue to the iliopectineal ligaments on each side, providing urethral support.

Enrollment in the trial was halted after the first of 2 planned interim analyses because the frequency of postoperative stress incontinence was significantly lower in the group undergoing Burch colposuspension: 23.8% and 44.1% of women in the Burch and no-Burch groups, respectively, experienced stress symptoms by 3 months after the surgery.

Why the CARE trial is an epochal event

• First randomized trial of preventive incontinence surgery in women with prolapse
  
• Randomized design establishes cause and effect
  
• Subjects will be followed for 2 years
  

KOHLI: Dr. Brubaker, as lead investigator of the CARE trial, how would you characterize the study’s major strengths?

BRUBAKER: First, it is a well-designed, randomized, controlled trial and thus provides the highest level of evidence for clinical practice. Although there is no perfect study, this one minimized the risk of bias by involving multiple centers (7) and using multiple surgeons, making the findings more generalizable than would be the case in a single-surgeon case series.

In addition, the use of blinded urodynamic testing lent strength, because the ability of urodynamic testing to predict the need for a concomitant continence procedure was not known before the trial. Our follow-up manuscript, containing data presented at the recent Society of Gynecologic Surgeons meeting, will provide more details on this aspect of the trial.

WEBER: Randomized trials are held in such high esteem—provided all other aspects of study design and implementation are performed properly—because they support conclusions of cause and effect. The conclusion that Burch colposuspension prevents stress incontinence when performed at the time of abdominal sacrocolpopexy could only be drawn from a randomized trial.

 

Trial design standardized key elements

Many types of bias confound the results of nonrandomized studies, particularly selection bias (eg, when surgeons select which procedure to perform on the basis of patient characteristics), and valid conclusions of cause and effect cannot be drawn. However, with a randomized trial, subjects are separated into groups by chance and no other factor. Thus, the groups are equivalent at baseline—provided the sample size is large enough (and allowing for random differences)—and therefore any changes measured after the experimental intervention can be confidently attributed to the intervention itself.

Another strength of the trial is standardization. The subjects were “standardized” by rather broad inclusion and exclusion criteria to constitute an important clinical population and to ensure they were sufficiently similar so that the treatment (abdominal sacrocolpopexy) was appropriate for all. In addition, surgeons at the multiple participating sites agreed to standardization of the technical details of the Burch colposuspension so that the subjects received the same intervention regardless of site. And data collection in follow-up was performed in a standard way by research staff who were blinded to the subjects’ group assignment (intervention versus control), so the data were as free of bias as possible.

Homogeneous study population may be a weakness

KOHLI: I agree that the methodology of this well-designed study is its major strength. What are its weaknesses?

WEBER: No doubt there are several, only some of which may be apparent at this time. For example, most women in the study were Caucasian, and very few were Hispanic, Asian, or black. Although we have no scientific reason to believe that Burch colposuspension has different responses in women of different racial and ethnic backgrounds, the trial’s subjects are not diverse enough to analyze the data by subgroups to confirm or refute the hypothesis that response to the Burch procedure is independent of race or ethnicity.

BRUBAKER: Another weakness: Because this study was closed after the first interim analysis, some of our secondary analyses will be underpowered, although we clearly demonstrated a difference in our primary endpoint.

It is important to remember that this study is not “finished.” Our participants are still in active follow-up for 2 years following surgery. It will be interesting to see what happens during the longer follow-up, especially with regard to prolapse and incontinence. We are also doing additional in-depth analyses of urodynamic and other parameters.

KOHLI: Again, I think the study design and analysis were well thought out. It would have been interesting to see how the results broke down according to site, to see if there was variation—which could indicate variation in surgical technique.

BRUBAKER: We have not done this analysis and do not plan to at this time.

Why paravaginal repairs were allowed

KOHLI: What about the decision to include surgeries that involved paravaginal repair?

WEBER: That generated a fair amount of discussion during trial design, as there was no clear “right” answer. Perhaps it would have been “cleaner” to eliminate the option of performing paravaginal repair, but when the trial was designed, we lacked unequivocal evidence that paravaginal repair at the time of abdominal sacrocolpopexy provides additional support for the anterior vagina. Therefore, we decided to allow the decision to be based on surgeon judgment.

Some surgeons perform paravaginal repair with abdominal sacrocolpopexy in almost all women because they believe quite strongly that this reduces the risk of recurrent anterior vaginal prolapse. Others never perform paravaginal repair with abdominal sacrocolpopexy and feel just as strongly that their patients are adequately treated and protected from subsequent anterior vaginal prolapse.

Investigators feared paravaginal repairs could dilute Burch effects

Study surgeons did agree that paravaginal repair reduces the likelihood of postoperative stress incontinence, although not as effectively as Burch colposuspension. Thus, our dilemma: If paravaginal repairs were performed in a large number of subjects, thereby improving their postoperative continence status regardless of whether Burch was performed, the effect of Burch could be so diluted as to be lost. On the other hand, if paravaginal repairs were completely excluded, that would restrict some surgeons’ practices and potentially reduce the number of women who would be offered participation in the study if their surgeons felt their anterior vaginal prolapse would be potentially undertreated.

We resolved the dilemma as follows:

1. A relatively low proportion—about one quarter—of surgeons performed paravaginal repairs regularly with abdominal sacrocolpopexy, so the potential impact in the trial would not be great.
   
2. Paravaginal repairs were allowed, but only when declared necessary by the surgeon before randomization; this step prevented surgeons from changing their minds about the necessity of paravaginal repair if the subject was assigned to the Burch group (ie, the woman would be receiving additional anterior vaginal support by way of the Burch).
   
3. We stratified for paravaginal repair in the randomization, so women with paravaginal repair were equally distributed between the intervention and control groups.
   

 

Are subjective or objective measures better?

• Subjective measures convey a patient’s foremost concerns and how she is doing clinically
  
• Correlating symptoms with objective measures yields valuable insights into treatment
  

KOHLI: The CARE trial uses both objective and subjective measures of incontinence. Which do you think are most important?

BRUBAKER: I prefer subjective measures because I think they reflect what is most important to patients in quality-of-life disorders. However, I believe we need to understand the relationship between subjective outcomes and traditional “objective” outcomes.

WEBER: I think the research community is reaching a consensus that “subjective” measures—better described as patient-oriented outcomes—are more important than objective measures, particularly for conditions that affect patients in “subjective” ways, ie, ways that affect their health-related quality of life, rather than quantity of life. This does not mean that objective measures are useless—although we should first evaluate each measure critically to make that determination on the basis of evidence.

Nevertheless, when a patient seeks and receives treatment based on symptoms and how those symptoms impact her daily life, I think it is incumbent upon researchers and clinicians to ensure that the treatment that is considered most effective actually results in a change that the patient finds worthwhile.

What is “success”?

WALTERS: When it comes to incontinence, for which there is an imperfect correlation between various objective and subjective measures, I think both types of measures are valuable and important. Gathering several different types of outcomes for each patient helps us better understand the nuances of how well an intervention works.

I can understand why some clinicians and researchers place greater reliance on subjective measures of incontinence, such as a diary of incontinence episodes and quality-of-life measures, because these measures tell us exactly how the patient is doing clinically and how she feels about the intervention. If she reports that she is completely cured and “perfect,” then objective measures are irrelevant. However, for any subjective outcome short of perfect, correlation with the objective measures such as cough stress test, physical examination, and urodynamic tests can help investigators understand the reason for the imperfect outcome and point to areas of possible improvement.

KOHLI: In my practice, some women who continue to leak slightly after an incontinence procedure consider their surgery a complete success, whereas, as a surgeon, I consider it a suboptimal result. Both objective and subjective results are important.

Putting the CARE trial into practice

• Data relate directly only to women undergoing abdominal sacrocolpopexy
  
• Patient education, medicolegal, and reimbursement may also relate
  
• Results reflect the high prevalence of pelvic floor disorders and the need to routinely ask about them
  

KOHLI: How will the CARE trial findings affect your clinical practice?

BRUBAKER: I routinely counsel patients who are planning sacrocolpopexy but who do not have stress incontinence to consider a concomitant Burch procedure. I do not have them undergo urodynamic testing because, at this time, the results of that testing would not change my clinical practice.

WALTERS: I have always been liberal when it comes to adding retropubic colposuspension to abdominal sacrocolpopexy, even in women who do not have preoperative stress incontinence. The reason? Patients who are continent preoperatively, but become stress-incontinent postoperatively, are particularly unhappy with their outcome, especially if they need another surgery within a year to treat the stress incontinence. So this study verified what I was already doing.

What I didn’t learn is whether a paravaginal defect repair helps or hurts the Burch procedure from an anatomic and functional perspective.

It also appears that preoperative urodynamic testing has little value, although that was not the point of this study. I am glad it will be addressed in future studies.

KOHLI: I think the findings apply to those select patients undergoing abdominal sacrocolpopexy for prolapse. It would be dangerous to extrapolate these results to other abdominal vault suspension procedures or vaginal prolapse procedures. Based on the CARE trial, I plan to counsel patients about the risks and benefits of “optional” Burch colposuspension at the time of planned sacrocolpopexy. In reality, however, I have almost completely switched to minimally invasive midurethral slings, even in the case of abdominal prolapse procedures, because of their high cure rates, low complication rates, and ease of postoperative adjustment.

Clinical implications depend on surgeon’s routine

KOHLI: What are the implications for the majority of ObGyns?

WEBER: It depends on what ObGyns are doing for women with prolapse.

For ObGyns who are confident and competent, through training and experience, to perform abdominal sacrocolpopexy for women with advanced prolapse, the CARE trial results have a direct effect. Women with prolapse who are stress continent with no contraindications, can be reassured that they will benefit from a 50% reduction of postoperative stress incontinence with the Burch procedure.

 

For ObGyns who do not perform sacrocolpopexy, the CARE trial will have no direct clinical effects. Nevertheless, these clinicians need to be aware of the findings so they can discuss the options with patients before decisions on route or type of prolapse surgery are made.

The CARE trial and its results remind us of the high prevalence of pelvic floor disorders in women, potentially even after corrective surgery—and the need to actively screen all women for pelvic dysfunction.

Warn of potential incontinence even with the Burch

KOHLI: How does this study affect counseling of candidates for prolapse surgery?

BRUBAKER: I would offer stress-continent women a Burch procedure at the time of sacrocolpopexy. That much is clear. The interesting discussions come from “similar” clinical scenarios, where data are not yet available. For example, should a stress-continent woman facing a suspension via the vaginal route undergo a concomitant continence procedure?

WEBER: It is important to keep in mind that even when Burch colposuspension was performed, a number of women still experienced urinary incontinence (some stress, some urge, some mixed) after surgery; and the vast majority of women have urinary symptoms of some kind both before and after surgery. So preoperative counseling should include the information that urinary symptoms are very common after abdominal sacrocolpopexy—some as persistent or recurrent, and some as new symptoms.

As longer follow-up data from the CARE trial become available, we will learn how many women have urinary symptoms that are temporary versus long-lasting.

Is routine Burch best?

• When not all women benefit, should a procedure be offered prophylactically? In this case, experts say, “Yes”
  
• Some physicians favor other incontinence procedures
  
• Final decision rests with the patient
  

KOHLI: Based on study numbers, 100 Burch procedures at the time of abdominal sacrocolpopexy would be necessary to prevent 20 women from developing incontinence. Is that a fair equation?

WALTERS: It is an easy decision for me. As I said earlier, women are particularly unhappy if they go from continent to incontinent after a surgery. In fact, some women are more displeased with that outcome than with a failure of the prolapse surgery. Because most women with prolapse have substantial anterior vaginal wall prolapse, the Burch procedure—with or without a paravaginal defect repair—also serves as part of the prolapse repair of the anterior wall. And now we know it also improves postoperative urinary function.

BRUBAKER: Doing a Burch procedure at the time of sacrocolpopexy is a time-efficient and low-morbidity addition, so it is worthwhile for me and my patients. It is clearly not the same as doing a secondary, standalone procedure for new symptoms.

Over the next 2 years, we will see how many women who were moderately or greatly bothered by stress incontinence went on to a surgical treatment.

WEBER: Please note a careful distinction: I would be willing to recommend Burch colposuspension to 100 stress-continent women who are planning to undergo abdominal sacrocolpopexy for prolapse, with the expectation that this will prevent postoperative stress incontinence in roughly half the women who would have developed it otherwise. It is up to the patient to accept this recommendation or not.

Based on the CARE trial results, 44 of 100 previously continent women after only abdominal sacrocolpopexy develop postoperative stress incontinence, compared with about 24 of 100 women after Burch and abdominal sacrocolpopexy. Even more striking is the difference in women affected by bothersome stress incontinence: almost 25% in the control group versus 6% in the Burch group. Women in the Burch group did not experience an excess of adverse events, or a clinically significant difference in operative time or estimated blood loss, compared with women in the control group.

Is “wait and see” better?

KOHLI: Because I favor minimally invasive midurethral sling procedures, which can often be performed on an outpatient basis under local anesthesia, I counsel women undergoing prolapse surgery via an abdominal or vaginal route that it is best to treat the incontinence postoperatively if it occurs. Obviously, this applies to women who have no incontinence and do not demonstrate potential stress incontinence on urodynamic testing preoperatively.

Anecdotally, I have not found a high rate of new-onset urinary incontinence following prolapse procedures. We may retrospectively look at these patients more critically in light of this new data.

WALTERS: I think most women would be dissatisfied with a 44% risk of postoperative stress incontinence requiring a second surgery. Even if you counseled them appropriately, many women would ask that you try to manage everything at the first surgery.

What are nonclinical effects of the trial?

 

• Need for patient and physician education is great, and the CARE trial offers a valuable opportunity
  
• Potential for medicolegal risk if complications develop
  
• Payers may not be willing to reimburse for a prophylactic procedure
  

KOHLI: Are there any nonclinical issues that arise from application of the study’s conclusions—such as medicolegal, financial, or educational issues?

WEBER: Given how extensively the trial’s results were disseminated by the lay press, I think we have an important opportunity to educate both patients and health-care providers.

First, patients: For women who may be directly affected by the trial, knowledgeable clinicians should explain its results and limitations to help them reach a decision about their treatment.

For women who hear the trial’s results described incompletely or incorrectly (eg, “…2 stitches prevent incontinence…”), clinicians should take this opportunity to correct misunderstandings and educate women about incontinence, prolapse, and pelvic health in general.

For health-care providers, this trial reminds us of the extraordinarily high prevalence of pelvic floor disorders. Although current treatments are not perfect, virtually all women with pelvic floor disorders can be treated to substantially alleviate, if not eliminate, bothersome symptoms.

All clinicians should routinely inquire about pelvic symptoms and be prepared to initiate an evaluation or provide a referral.

Medicolegal fallout?

KOHLI: There is the question of medicolegal risk if complications occur after colposuspension when the patient had no complaints or evidence of stress incontinence at the time of preoperative urodynamic testing. I am not aware of any legal precedent in which a clinical study or data provided solid protection from a jury verdict. The study did not show increased risk or complication with the addition of the Burch procedure, but that may not be true for some surgeons and some patients.

Billing and coding

In terms of billing, how should we code for the Burch colposuspension when the patient had no demonstrable stress incontinence? Payment denials in this scenario seem likely. This may create a line of separation between what may be clinically indicated for the patient and what insurance companies are willing to pay for.

There may be the option to use the urethral hypermobility code (ICD 599.81) for the Burch colposuspension, but only time will tell if this will be reimbursed. I would be curious to hear the panel’s experience with reimbursement for a prophylactic procedure based on scientific data. Obviously, what is best for the patient is most important.

BRUBAKER: All these patients had urethral hypermobility, which is also an indication for a Burch colposuspension.

Is preoperative urodynamic testing useful?

• CARE trial data still to come
  
• Basic testing is probably helpful
  

KOHLI: Is urodynamic testing necessary for women undergoing prolapse surgery?

WEBER: In the CARE trial, the relative level of protection from postoperative stress incontinence provided by the Burch procedure did not depend on the stress-test component (with prolapse reduced) of preoperative urodynamic testing. About 50% fewer women had postoperative stress incontinence after Burch, whether preoperative urodynamic testing showed positive or negative stress tests with prolapse reduction.

Although subsequent analyses (presented at the Society of Gynecologic Surgeons 2006 meeting; manuscript under review) focused on urodynamic testing and postoperative outcomes, the CARE trial was not designed primarily to determine whether women planning prolapse surgery benefit from preoperative urodynamic testing. Therefore, conclusions about the “need” for urodynamic testing should not be based only on the CARE trial.

Should urodynamic testing determine treatment?

Randomized trials that directly address the cost-benefit of urodynamic testing are urgently needed. For now, as is standard in good clinical practice, a test should be performed only if results will change recommendations or provide reliable and clinically important prognostic information about a patient’s outcome after intervention. Clinicians should determine whether urodynamic testing meets even 1 of these 2 minimum criteria.

I want to point out that the CARE trial did not address the utility of urodynamic testing.

BRUBAKER: It is clear that some women have stress incontinence despite the concomitant Burch colposuspension. If we learn that an alternative operation can perform better and that any urodynamic (or other clinical measure) can predict improved outcomes, I would consider resuming urodynamic testing.

WALTERS: At first glance, it appears that complex urodynamic testing is definitely not necessary if the goal is to improve outcomes of surgery. However, I believe the patient should undergo some components of urodynamic testing such as a void with a post-void residual urine volume and a basic bladder-filling study noting sensation and capacity. I also do a cough stress test with the prolapse reduced, although we may find that this does not predict postoperative function.

 

KOHLI: The results of this study are very procedure-specific. If similar results are borne out when other approaches to prolapse and incontinence are analyzed, the value and utility of preoperative uro-dynamic testing in all patients may be questionable.

However, in my practice, I use the results of preoperative urodynamic testing not only for diagnosis, but also to make subtle adjustments when performing incontinence procedures—especially in regard to suburethral slings.

What if you prefer midurethral slings?

• Surgeons should be comfortable with more than 1 incontinence procedure
  
• We should not jump to untested conclusions
  

KOHLI: How does application of the CARE trial’s conclusions change if the physician is currently performing midurethral sling procedures for incontinence?

WEBER: Ideally, well trained and experienced gynecologic, urologic, or urogynecologic surgeons perform more than 1 type of incontinence procedure, to meet the needs of different patients.

As yet, we have no direct, evidence-based answers to issues such as these:

Can a midurethral sling be substituted for a Burch colposuspension and have the same average results in preventing post-operative stress incontinence without increasing urgency symptoms…

• …when abdominal sacrocolpopexy is performed for prolapse in a preoperatively stress-continent patient?
  

At present, all a clinician can do is reflect on data from case series of midurethral sling procedures for incontinence, and guess at the outcome when used as prophylaxis and combined with abdominal sacrocolpopexy.

• …when vaginal apical suspension is performed for prolapse in a preoperatively stress-continent patient?
  

I think the critical issue remains how the midurethral sling will perform when it is used for prophylaxis instead of treatment. As with the Burch, the most important clinical concern is the creation or worsening of urgency or other irritative bladder symptoms. When this occurs in the treatment setting, it may be acceptable to the patient and clinician. In the setting of prophylaxis, however, I doubt it would be acceptable.

Although it is tempting to jump 1 or 2 steps ahead and apply CARE trial data to situations that have not been tested directly, I would be cautious. We want to avoid creating long-lasting or refractory urgency symptoms—especially in a woman who had no such symptoms before surgery—because of a prophylactic procedure.

I think this is especially true because it is relatively easy to salvage patients who do develop bothersome stress incontinence after prolapse surgery.

Bonus: Burch helps anterior vaginal prolapse

WALTERS: I wonder whether prophylactic placement of a midurethral sling would yield the same results as a prophylactic Burch procedure. If your midurethral sling of choice is a tension-free vaginal tape (TVT), I would be cautious about placing it prophylactically, because the TVT has a 2% to 3% risk of prolonged voiding dysfunction requiring transection of the tape.

However, it is possible that prophylactic placement of a transobturator sling, which is associated with much less voiding dysfunction and fewer major surgical complications, might have a different outcome—though this requires further study.

In addition, midurethral slings would not be as effective as Burch colposuspension in treating anterior vaginal prolapse, so I would expect to see more anterior wall prolapse failures if slings replaced colposuspension.

What if you prefer the vaginal approach?

• Further study is needed
  

KOHLI: Since many, if not most, gynecologists surgically treat prolapse and incontinence using a vaginal approach, how does the CARE trial affect their practice?

WALTERS: I wonder whether a prophylactic transobturator midurethral sling at the time of transvaginal prolapse repair would yield similar results. I do cystocele repair with suburethral (“Kelly”) plication, which seems to work well at stabilizing the urethra in women without stress incontinence. But this approach is not as popular these days, and future studies may demonstrate that a prophylactic midurethral sling will result in better long-term function without significantly increasing the long-term risk.

WEBER: The CARE trial results are relevant to all pelvic surgeons because they demonstrate the need for and benefit from well-designed randomized surgical trials. Another benefit will be extended follow-up in what will become a prospective cohort study of women with advanced prolapse treated by abdominal sacrocolpopexy—providing higher-quality evidence than retrospective case series. Although not as valuable as randomized trials, these data can help guide clinical recommendations.

If long-term results support the effectiveness and durability of abdominal prolapse repair, then gynecologists can reflect on the evidence and choose the approach that best fits the patient’s needs.

Need for other studies?

• Randomized, multicenter trials addressing almost any surgical treatment of prolapse and incontinence are sorely needed
  

KOHLI: What other possible multicenter clinical studies involving prolapse/incontinence would you suggest?

 

BRUBAKER: Any and all high-quality, well-designed trial can improve our care of women with incontinence and/or prolapse.

WALTERS: I look forward to the follow-up studies from the CARE trial on the value of paravaginal defect repair, preoperative urodynamic testing, and the efficacy of various prolapse-reduction maneuvers in predicting surgical outcomes.

It would also seem logical to repeat this type of study using transvaginal prolapse repair with or without a prophylactic midurethral sling. Another option: anterior colporrhaphy with suburethral plication versus a prophylactic midurethral sling.

KOHLI: I look forward to data on surgical procedures currently being performed with greater frequency despite a lack of good-quality data. These include the transobturator suburethral midurethral sling procedures, laparoscopic sacrocolpopexy, and vaginal mesh augmentation for prolapse.

The Pelvic Floor Disorders Network affords a unique opportunity to perform well-designed multicenter trials to address the rapidly changing landscape of surgical treatment for prolapse and incontinence.

Why should we care about the CARE (Colpopexy and Urinary Reduction Efforts) trial?

Because pelvic organ prolapse and urinary incontinence are already major problems facing women as they age, and will become even more pervasive as the baby boomer generation moves through menopause and beyond.

Because the risk that a woman will experience stress incontinence after prolapse surgery ranges from 8% to 60%.^1-6

Because roughly one third of women who undergo prolapse or incontinence surgery require a second operation.

These are just a few of the factors that spurred the Pelvic Floor Disorders Network to undertake the CARE trial, published April 13 in the New England Journal of Medicine. OBG Management convened a panel of experts in female pelvic medicine, including 2 CARE trial investigators, to discuss the findings of this landmark study, its long-term implications, and the future of research into pelvic floor disorders.

How the trial was conducted

The CARE trial involved 322 women who required surgery to correct pelvic organ prolapse (POP) but lacked symptoms of stress urinary incontinence. All these women underwent sacrocolpopexy, an abdominal procedure in which graft material is attached between the vagina and sacrum to support the vagina and correct the prolapse. These women were randomized to undergo Burch colposuspension at the time of the sacrocolpopexy, or to undergo sacrocolpopexy only. The Burch procedure is performed through the same incision as the sacrocolpopexy and involves suturing the periurethral vaginal tissue to the iliopectineal ligaments on each side, providing urethral support.

Enrollment in the trial was halted after the first of 2 planned interim analyses because the frequency of postoperative stress incontinence was significantly lower in the group undergoing Burch colposuspension: 23.8% and 44.1% of women in the Burch and no-Burch groups, respectively, experienced stress symptoms by 3 months after the surgery.

Why the CARE trial is an epochal event

• First randomized trial of preventive incontinence surgery in women with prolapse
  
• Randomized design establishes cause and effect
  
• Subjects will be followed for 2 years
  

KOHLI: Dr. Brubaker, as lead investigator of the CARE trial, how would you characterize the study’s major strengths?

BRUBAKER: First, it is a well-designed, randomized, controlled trial and thus provides the highest level of evidence for clinical practice. Although there is no perfect study, this one minimized the risk of bias by involving multiple centers (7) and using multiple surgeons, making the findings more generalizable than would be the case in a single-surgeon case series.

In addition, the use of blinded urodynamic testing lent strength, because the ability of urodynamic testing to predict the need for a concomitant continence procedure was not known before the trial. Our follow-up manuscript, containing data presented at the recent Society of Gynecologic Surgeons meeting, will provide more details on this aspect of the trial.

WEBER: Randomized trials are held in such high esteem—provided all other aspects of study design and implementation are performed properly—because they support conclusions of cause and effect. The conclusion that Burch colposuspension prevents stress incontinence when performed at the time of abdominal sacrocolpopexy could only be drawn from a randomized trial.

 

Trial design standardized key elements

Many types of bias confound the results of nonrandomized studies, particularly selection bias (eg, when surgeons select which procedure to perform on the basis of patient characteristics), and valid conclusions of cause and effect cannot be drawn. However, with a randomized trial, subjects are separated into groups by chance and no other factor. Thus, the groups are equivalent at baseline—provided the sample size is large enough (and allowing for random differences)—and therefore any changes measured after the experimental intervention can be confidently attributed to the intervention itself.

Another strength of the trial is standardization. The subjects were “standardized” by rather broad inclusion and exclusion criteria to constitute an important clinical population and to ensure they were sufficiently similar so that the treatment (abdominal sacrocolpopexy) was appropriate for all. In addition, surgeons at the multiple participating sites agreed to standardization of the technical details of the Burch colposuspension so that the subjects received the same intervention regardless of site. And data collection in follow-up was performed in a standard way by research staff who were blinded to the subjects’ group assignment (intervention versus control), so the data were as free of bias as possible.

Homogeneous study population may be a weakness

KOHLI: I agree that the methodology of this well-designed study is its major strength. What are its weaknesses?

WEBER: No doubt there are several, only some of which may be apparent at this time. For example, most women in the study were Caucasian, and very few were Hispanic, Asian, or black. Although we have no scientific reason to believe that Burch colposuspension has different responses in women of different racial and ethnic backgrounds, the trial’s subjects are not diverse enough to analyze the data by subgroups to confirm or refute the hypothesis that response to the Burch procedure is independent of race or ethnicity.

BRUBAKER: Another weakness: Because this study was closed after the first interim analysis, some of our secondary analyses will be underpowered, although we clearly demonstrated a difference in our primary endpoint.

It is important to remember that this study is not “finished.” Our participants are still in active follow-up for 2 years following surgery. It will be interesting to see what happens during the longer follow-up, especially with regard to prolapse and incontinence. We are also doing additional in-depth analyses of urodynamic and other parameters.

KOHLI: Again, I think the study design and analysis were well thought out. It would have been interesting to see how the results broke down according to site, to see if there was variation—which could indicate variation in surgical technique.

BRUBAKER: We have not done this analysis and do not plan to at this time.

Why paravaginal repairs were allowed

KOHLI: What about the decision to include surgeries that involved paravaginal repair?

WEBER: That generated a fair amount of discussion during trial design, as there was no clear “right” answer. Perhaps it would have been “cleaner” to eliminate the option of performing paravaginal repair, but when the trial was designed, we lacked unequivocal evidence that paravaginal repair at the time of abdominal sacrocolpopexy provides additional support for the anterior vagina. Therefore, we decided to allow the decision to be based on surgeon judgment.

Some surgeons perform paravaginal repair with abdominal sacrocolpopexy in almost all women because they believe quite strongly that this reduces the risk of recurrent anterior vaginal prolapse. Others never perform paravaginal repair with abdominal sacrocolpopexy and feel just as strongly that their patients are adequately treated and protected from subsequent anterior vaginal prolapse.

Investigators feared paravaginal repairs could dilute Burch effects

Study surgeons did agree that paravaginal repair reduces the likelihood of postoperative stress incontinence, although not as effectively as Burch colposuspension. Thus, our dilemma: If paravaginal repairs were performed in a large number of subjects, thereby improving their postoperative continence status regardless of whether Burch was performed, the effect of Burch could be so diluted as to be lost. On the other hand, if paravaginal repairs were completely excluded, that would restrict some surgeons’ practices and potentially reduce the number of women who would be offered participation in the study if their surgeons felt their anterior vaginal prolapse would be potentially undertreated.

We resolved the dilemma as follows:

1. A relatively low proportion—about one quarter—of surgeons performed paravaginal repairs regularly with abdominal sacrocolpopexy, so the potential impact in the trial would not be great.
   
2. Paravaginal repairs were allowed, but only when declared necessary by the surgeon before randomization; this step prevented surgeons from changing their minds about the necessity of paravaginal repair if the subject was assigned to the Burch group (ie, the woman would be receiving additional anterior vaginal support by way of the Burch).
   
3. We stratified for paravaginal repair in the randomization, so women with paravaginal repair were equally distributed between the intervention and control groups.
   

 

Are subjective or objective measures better?

• Subjective measures convey a patient’s foremost concerns and how she is doing clinically
  
• Correlating symptoms with objective measures yields valuable insights into treatment
  

KOHLI: The CARE trial uses both objective and subjective measures of incontinence. Which do you think are most important?

BRUBAKER: I prefer subjective measures because I think they reflect what is most important to patients in quality-of-life disorders. However, I believe we need to understand the relationship between subjective outcomes and traditional “objective” outcomes.

WEBER: I think the research community is reaching a consensus that “subjective” measures—better described as patient-oriented outcomes—are more important than objective measures, particularly for conditions that affect patients in “subjective” ways, ie, ways that affect their health-related quality of life, rather than quantity of life. This does not mean that objective measures are useless—although we should first evaluate each measure critically to make that determination on the basis of evidence.

Nevertheless, when a patient seeks and receives treatment based on symptoms and how those symptoms impact her daily life, I think it is incumbent upon researchers and clinicians to ensure that the treatment that is considered most effective actually results in a change that the patient finds worthwhile.

What is “success”?

WALTERS: When it comes to incontinence, for which there is an imperfect correlation between various objective and subjective measures, I think both types of measures are valuable and important. Gathering several different types of outcomes for each patient helps us better understand the nuances of how well an intervention works.

I can understand why some clinicians and researchers place greater reliance on subjective measures of incontinence, such as a diary of incontinence episodes and quality-of-life measures, because these measures tell us exactly how the patient is doing clinically and how she feels about the intervention. If she reports that she is completely cured and “perfect,” then objective measures are irrelevant. However, for any subjective outcome short of perfect, correlation with the objective measures such as cough stress test, physical examination, and urodynamic tests can help investigators understand the reason for the imperfect outcome and point to areas of possible improvement.

KOHLI: In my practice, some women who continue to leak slightly after an incontinence procedure consider their surgery a complete success, whereas, as a surgeon, I consider it a suboptimal result. Both objective and subjective results are important.

Putting the CARE trial into practice

• Data relate directly only to women undergoing abdominal sacrocolpopexy
  
• Patient education, medicolegal, and reimbursement may also relate
  
• Results reflect the high prevalence of pelvic floor disorders and the need to routinely ask about them
  

KOHLI: How will the CARE trial findings affect your clinical practice?

BRUBAKER: I routinely counsel patients who are planning sacrocolpopexy but who do not have stress incontinence to consider a concomitant Burch procedure. I do not have them undergo urodynamic testing because, at this time, the results of that testing would not change my clinical practice.

WALTERS: I have always been liberal when it comes to adding retropubic colposuspension to abdominal sacrocolpopexy, even in women who do not have preoperative stress incontinence. The reason? Patients who are continent preoperatively, but become stress-incontinent postoperatively, are particularly unhappy with their outcome, especially if they need another surgery within a year to treat the stress incontinence. So this study verified what I was already doing.

What I didn’t learn is whether a paravaginal defect repair helps or hurts the Burch procedure from an anatomic and functional perspective.

It also appears that preoperative urodynamic testing has little value, although that was not the point of this study. I am glad it will be addressed in future studies.

KOHLI: I think the findings apply to those select patients undergoing abdominal sacrocolpopexy for prolapse. It would be dangerous to extrapolate these results to other abdominal vault suspension procedures or vaginal prolapse procedures. Based on the CARE trial, I plan to counsel patients about the risks and benefits of “optional” Burch colposuspension at the time of planned sacrocolpopexy. In reality, however, I have almost completely switched to minimally invasive midurethral slings, even in the case of abdominal prolapse procedures, because of their high cure rates, low complication rates, and ease of postoperative adjustment.

Clinical implications depend on surgeon’s routine

KOHLI: What are the implications for the majority of ObGyns?

WEBER: It depends on what ObGyns are doing for women with prolapse.

For ObGyns who are confident and competent, through training and experience, to perform abdominal sacrocolpopexy for women with advanced prolapse, the CARE trial results have a direct effect. Women with prolapse who are stress continent with no contraindications, can be reassured that they will benefit from a 50% reduction of postoperative stress incontinence with the Burch procedure.

 

For ObGyns who do not perform sacrocolpopexy, the CARE trial will have no direct clinical effects. Nevertheless, these clinicians need to be aware of the findings so they can discuss the options with patients before decisions on route or type of prolapse surgery are made.

The CARE trial and its results remind us of the high prevalence of pelvic floor disorders in women, potentially even after corrective surgery—and the need to actively screen all women for pelvic dysfunction.

Warn of potential incontinence even with the Burch

KOHLI: How does this study affect counseling of candidates for prolapse surgery?

BRUBAKER: I would offer stress-continent women a Burch procedure at the time of sacrocolpopexy. That much is clear. The interesting discussions come from “similar” clinical scenarios, where data are not yet available. For example, should a stress-continent woman facing a suspension via the vaginal route undergo a concomitant continence procedure?

WEBER: It is important to keep in mind that even when Burch colposuspension was performed, a number of women still experienced urinary incontinence (some stress, some urge, some mixed) after surgery; and the vast majority of women have urinary symptoms of some kind both before and after surgery. So preoperative counseling should include the information that urinary symptoms are very common after abdominal sacrocolpopexy—some as persistent or recurrent, and some as new symptoms.

As longer follow-up data from the CARE trial become available, we will learn how many women have urinary symptoms that are temporary versus long-lasting.

Is routine Burch best?

• When not all women benefit, should a procedure be offered prophylactically? In this case, experts say, “Yes”
  
• Some physicians favor other incontinence procedures
  
• Final decision rests with the patient
  

KOHLI: Based on study numbers, 100 Burch procedures at the time of abdominal sacrocolpopexy would be necessary to prevent 20 women from developing incontinence. Is that a fair equation?

WALTERS: It is an easy decision for me. As I said earlier, women are particularly unhappy if they go from continent to incontinent after a surgery. In fact, some women are more displeased with that outcome than with a failure of the prolapse surgery. Because most women with prolapse have substantial anterior vaginal wall prolapse, the Burch procedure—with or without a paravaginal defect repair—also serves as part of the prolapse repair of the anterior wall. And now we know it also improves postoperative urinary function.

BRUBAKER: Doing a Burch procedure at the time of sacrocolpopexy is a time-efficient and low-morbidity addition, so it is worthwhile for me and my patients. It is clearly not the same as doing a secondary, standalone procedure for new symptoms.

Over the next 2 years, we will see how many women who were moderately or greatly bothered by stress incontinence went on to a surgical treatment.

WEBER: Please note a careful distinction: I would be willing to recommend Burch colposuspension to 100 stress-continent women who are planning to undergo abdominal sacrocolpopexy for prolapse, with the expectation that this will prevent postoperative stress incontinence in roughly half the women who would have developed it otherwise. It is up to the patient to accept this recommendation or not.

Based on the CARE trial results, 44 of 100 previously continent women after only abdominal sacrocolpopexy develop postoperative stress incontinence, compared with about 24 of 100 women after Burch and abdominal sacrocolpopexy. Even more striking is the difference in women affected by bothersome stress incontinence: almost 25% in the control group versus 6% in the Burch group. Women in the Burch group did not experience an excess of adverse events, or a clinically significant difference in operative time or estimated blood loss, compared with women in the control group.

Is “wait and see” better?

KOHLI: Because I favor minimally invasive midurethral sling procedures, which can often be performed on an outpatient basis under local anesthesia, I counsel women undergoing prolapse surgery via an abdominal or vaginal route that it is best to treat the incontinence postoperatively if it occurs. Obviously, this applies to women who have no incontinence and do not demonstrate potential stress incontinence on urodynamic testing preoperatively.

Anecdotally, I have not found a high rate of new-onset urinary incontinence following prolapse procedures. We may retrospectively look at these patients more critically in light of this new data.

WALTERS: I think most women would be dissatisfied with a 44% risk of postoperative stress incontinence requiring a second surgery. Even if you counseled them appropriately, many women would ask that you try to manage everything at the first surgery.

What are nonclinical effects of the trial?

 

• Need for patient and physician education is great, and the CARE trial offers a valuable opportunity
  
• Potential for medicolegal risk if complications develop
  
• Payers may not be willing to reimburse for a prophylactic procedure
  

KOHLI: Are there any nonclinical issues that arise from application of the study’s conclusions—such as medicolegal, financial, or educational issues?

WEBER: Given how extensively the trial’s results were disseminated by the lay press, I think we have an important opportunity to educate both patients and health-care providers.

First, patients: For women who may be directly affected by the trial, knowledgeable clinicians should explain its results and limitations to help them reach a decision about their treatment.

For women who hear the trial’s results described incompletely or incorrectly (eg, “…2 stitches prevent incontinence…”), clinicians should take this opportunity to correct misunderstandings and educate women about incontinence, prolapse, and pelvic health in general.

For health-care providers, this trial reminds us of the extraordinarily high prevalence of pelvic floor disorders. Although current treatments are not perfect, virtually all women with pelvic floor disorders can be treated to substantially alleviate, if not eliminate, bothersome symptoms.

All clinicians should routinely inquire about pelvic symptoms and be prepared to initiate an evaluation or provide a referral.

Medicolegal fallout?

KOHLI: There is the question of medicolegal risk if complications occur after colposuspension when the patient had no complaints or evidence of stress incontinence at the time of preoperative urodynamic testing. I am not aware of any legal precedent in which a clinical study or data provided solid protection from a jury verdict. The study did not show increased risk or complication with the addition of the Burch procedure, but that may not be true for some surgeons and some patients.

Billing and coding

In terms of billing, how should we code for the Burch colposuspension when the patient had no demonstrable stress incontinence? Payment denials in this scenario seem likely. This may create a line of separation between what may be clinically indicated for the patient and what insurance companies are willing to pay for.

There may be the option to use the urethral hypermobility code (ICD 599.81) for the Burch colposuspension, but only time will tell if this will be reimbursed. I would be curious to hear the panel’s experience with reimbursement for a prophylactic procedure based on scientific data. Obviously, what is best for the patient is most important.

BRUBAKER: All these patients had urethral hypermobility, which is also an indication for a Burch colposuspension.

Is preoperative urodynamic testing useful?

• CARE trial data still to come
  
• Basic testing is probably helpful
  

KOHLI: Is urodynamic testing necessary for women undergoing prolapse surgery?

WEBER: In the CARE trial, the relative level of protection from postoperative stress incontinence provided by the Burch procedure did not depend on the stress-test component (with prolapse reduced) of preoperative urodynamic testing. About 50% fewer women had postoperative stress incontinence after Burch, whether preoperative urodynamic testing showed positive or negative stress tests with prolapse reduction.

Although subsequent analyses (presented at the Society of Gynecologic Surgeons 2006 meeting; manuscript under review) focused on urodynamic testing and postoperative outcomes, the CARE trial was not designed primarily to determine whether women planning prolapse surgery benefit from preoperative urodynamic testing. Therefore, conclusions about the “need” for urodynamic testing should not be based only on the CARE trial.

Should urodynamic testing determine treatment?

Randomized trials that directly address the cost-benefit of urodynamic testing are urgently needed. For now, as is standard in good clinical practice, a test should be performed only if results will change recommendations or provide reliable and clinically important prognostic information about a patient’s outcome after intervention. Clinicians should determine whether urodynamic testing meets even 1 of these 2 minimum criteria.

I want to point out that the CARE trial did not address the utility of urodynamic testing.

BRUBAKER: It is clear that some women have stress incontinence despite the concomitant Burch colposuspension. If we learn that an alternative operation can perform better and that any urodynamic (or other clinical measure) can predict improved outcomes, I would consider resuming urodynamic testing.

WALTERS: At first glance, it appears that complex urodynamic testing is definitely not necessary if the goal is to improve outcomes of surgery. However, I believe the patient should undergo some components of urodynamic testing such as a void with a post-void residual urine volume and a basic bladder-filling study noting sensation and capacity. I also do a cough stress test with the prolapse reduced, although we may find that this does not predict postoperative function.

 

KOHLI: The results of this study are very procedure-specific. If similar results are borne out when other approaches to prolapse and incontinence are analyzed, the value and utility of preoperative uro-dynamic testing in all patients may be questionable.

However, in my practice, I use the results of preoperative urodynamic testing not only for diagnosis, but also to make subtle adjustments when performing incontinence procedures—especially in regard to suburethral slings.

What if you prefer midurethral slings?

• Surgeons should be comfortable with more than 1 incontinence procedure
  
• We should not jump to untested conclusions
  

KOHLI: How does application of the CARE trial’s conclusions change if the physician is currently performing midurethral sling procedures for incontinence?

WEBER: Ideally, well trained and experienced gynecologic, urologic, or urogynecologic surgeons perform more than 1 type of incontinence procedure, to meet the needs of different patients.

As yet, we have no direct, evidence-based answers to issues such as these:

Can a midurethral sling be substituted for a Burch colposuspension and have the same average results in preventing post-operative stress incontinence without increasing urgency symptoms…

• …when abdominal sacrocolpopexy is performed for prolapse in a preoperatively stress-continent patient?
  

At present, all a clinician can do is reflect on data from case series of midurethral sling procedures for incontinence, and guess at the outcome when used as prophylaxis and combined with abdominal sacrocolpopexy.

• …when vaginal apical suspension is performed for prolapse in a preoperatively stress-continent patient?
  

I think the critical issue remains how the midurethral sling will perform when it is used for prophylaxis instead of treatment. As with the Burch, the most important clinical concern is the creation or worsening of urgency or other irritative bladder symptoms. When this occurs in the treatment setting, it may be acceptable to the patient and clinician. In the setting of prophylaxis, however, I doubt it would be acceptable.

Although it is tempting to jump 1 or 2 steps ahead and apply CARE trial data to situations that have not been tested directly, I would be cautious. We want to avoid creating long-lasting or refractory urgency symptoms—especially in a woman who had no such symptoms before surgery—because of a prophylactic procedure.

I think this is especially true because it is relatively easy to salvage patients who do develop bothersome stress incontinence after prolapse surgery.

Bonus: Burch helps anterior vaginal prolapse

WALTERS: I wonder whether prophylactic placement of a midurethral sling would yield the same results as a prophylactic Burch procedure. If your midurethral sling of choice is a tension-free vaginal tape (TVT), I would be cautious about placing it prophylactically, because the TVT has a 2% to 3% risk of prolonged voiding dysfunction requiring transection of the tape.

However, it is possible that prophylactic placement of a transobturator sling, which is associated with much less voiding dysfunction and fewer major surgical complications, might have a different outcome—though this requires further study.

In addition, midurethral slings would not be as effective as Burch colposuspension in treating anterior vaginal prolapse, so I would expect to see more anterior wall prolapse failures if slings replaced colposuspension.

What if you prefer the vaginal approach?

• Further study is needed
  

KOHLI: Since many, if not most, gynecologists surgically treat prolapse and incontinence using a vaginal approach, how does the CARE trial affect their practice?

WALTERS: I wonder whether a prophylactic transobturator midurethral sling at the time of transvaginal prolapse repair would yield similar results. I do cystocele repair with suburethral (“Kelly”) plication, which seems to work well at stabilizing the urethra in women without stress incontinence. But this approach is not as popular these days, and future studies may demonstrate that a prophylactic midurethral sling will result in better long-term function without significantly increasing the long-term risk.

WEBER: The CARE trial results are relevant to all pelvic surgeons because they demonstrate the need for and benefit from well-designed randomized surgical trials. Another benefit will be extended follow-up in what will become a prospective cohort study of women with advanced prolapse treated by abdominal sacrocolpopexy—providing higher-quality evidence than retrospective case series. Although not as valuable as randomized trials, these data can help guide clinical recommendations.

If long-term results support the effectiveness and durability of abdominal prolapse repair, then gynecologists can reflect on the evidence and choose the approach that best fits the patient’s needs.

Need for other studies?

• Randomized, multicenter trials addressing almost any surgical treatment of prolapse and incontinence are sorely needed
  

KOHLI: What other possible multicenter clinical studies involving prolapse/incontinence would you suggest?

 

BRUBAKER: Any and all high-quality, well-designed trial can improve our care of women with incontinence and/or prolapse.

WALTERS: I look forward to the follow-up studies from the CARE trial on the value of paravaginal defect repair, preoperative urodynamic testing, and the efficacy of various prolapse-reduction maneuvers in predicting surgical outcomes.

It would also seem logical to repeat this type of study using transvaginal prolapse repair with or without a prophylactic midurethral sling. Another option: anterior colporrhaphy with suburethral plication versus a prophylactic midurethral sling.

KOHLI: I look forward to data on surgical procedures currently being performed with greater frequency despite a lack of good-quality data. These include the transobturator suburethral midurethral sling procedures, laparoscopic sacrocolpopexy, and vaginal mesh augmentation for prolapse.

The Pelvic Floor Disorders Network affords a unique opportunity to perform well-designed multicenter trials to address the rapidly changing landscape of surgical treatment for prolapse and incontinence.

CASE Symptoms point to yet another prolapse recurrence

A 52-year-old woman presents with a bulge and pressure in her vagina. She has undergone 2 prior reconstructive surgeries. The first was a vaginal hysterectomy, anterior and posterior repair, and sling; the second was an abdominal procedure that included a sacrocolpopexy and paravaginal repair.

A physical examination reveals a recurrent 4th-degree cystocele that protrudes 2 cm beyond the hymenal ring. The vault and posterior compartment are well supported, and the patient reports no incontinence, a fact confirmed by urodynamics testing. She asks that you do everything in your power to prevent further recurrence.

How do you proceed?

This patient ultimately underwent anterior colporrhaphy and vaginal paravaginal repair using a decellularized dermal cadaveric implant. She was still doing well 1 year later, with no recurrence.

Despite success stories like this one, the use of graft materials to repair cystoceles and rectoceles is controversial. One reason is the difficulty of interpreting published data, since studies lack uniformity in technique, patient characteristics, graft shape, type of material, attachment sites, and duration of follow-up. Level I evidence that augmented repairs have a clear benefit over traditional repairs is sparse.

Advocates of graft materials argue that native tissue is already compromised—hence, the prolapse—making surgical failure likely.¹ They claim graft materials help strengthen repairs, especially in the case of cystoceles. They also point out that adjuvant materials have been used in burns, plastic surgery, and orthopedics for more than 10 years and are generally well tolerated. Their success in hernia repairs prompted their consideration for the pelvic floor.

A pervasive problem, but only 10% to 20% seek help

Roughly 1 of 2 parous women lose pelvic support as they age, but only 10% to 20% seek medical care, with a lifetime risk of surgery for pelvic organ prolapse (POP) of 11% by age 80.²

With women living longer than ever and remaining active later in life, this percentage is likely to rise. Unfortunately, few alternatives to surgical treatment exist, and the reoperation rate for recurrence is 29%, according to a 1995 review.² If surgical management is the only hope of cure, how can we lower the 29% recurrence rate?

Graft materials may provide part or all of the solution.

Elements of prolapse

Anterior compartment

Central and/or lateral defects can occur in the anterior compartment.

Lateral (paravaginal) defects indicate that the endopelvic connective tissue has separated from the arcus tendineus fascia pelvis. Lateral defects can be repaired vaginally or abdominally.

One study³ found that 67% of women with anterior wall prolapse had paravaginal defects, but no randomized trials have evaluated the clinical benefit of repairing these defects, compared with traditional colporrhaphies.

Central defects involve site-specific defects and/or general attenuation of the endopelvic connective tissue. These are usually repaired vaginally.

Recurrence rates for lateral and central defects range from 3% to 70%.^4-8

Two large series of vaginal paravaginal repairs noted the following recurrence rates:

• Shull et al⁶ found a recurrence rate of 7% to the hymenal ring or beyond.
• Young et al⁷ observed a recurrence rate for lateral defects of 2%, with recurrence rates as high as 22% for central defects.

In a comparison of 3 techniques for vaginal repair of central defects, using strict criteria to assess anatomic outcomes, Weber et al⁴ found recurrence rates of 54% to 70%. Other studies show symptomatic recurrence rates of 3% to 22% for cystoceles.^5,8

With grafts, both paravaginal and central defects can be repaired. Vaginal paravaginal repairs are not popular due to the technical difficulty involved. With the use of grafts, however, both paravaginal and central defects can be addressed simultaneously with relative ease.

Posterior compartment

Defects in the posterior compartment are less likely to recur. Reported success rates range from 80% to 90%.^9,10

Posterior compartment defects include general attenuation of Denonvillier’s fascia or a tear anywhere along the fascia or any of its attachments.

Recurrence rates. Site-specific repairs are thought to minimize complications such as dyspareunia. However, few studies have compared the efficacy of site-specific repairs with that of traditional colporrhaphies. At our institution, women who underwent traditional colporrhaphy had fewer recurrences than controls (33% vs 14%), with no differences in postoperative symptoms such as dyspareunia, constipation, and fecal incontinence.¹¹

Graft materials of questionable benefit. In the posterior compartment, these materials have not been shown to be beneficial, compared with traditional or site-specific repairs. Sand et al¹² found no benefit for repairs in which absorbable Vicryl mesh was imbricated, but this randomized trial may have lacked sufficient power to show statistical significance. Large cohorts would be needed to show significant benefit of meshes in the posterior compartment.

 

A complex web of support

In the normal pelvis, support of reproductive organs depends on a complex web of muscles, fascia, and connective tissue. To ensure success, prolapse repairs should correct any separation or attenuation of tissue and preserve or enhance tissue resilience.

Risk factors for recurrent prolapse

• Poor tissue (assess tissue quality before and during surgery)
• Impaired healing
• Chronic increases in intraabdominal pressure due to obstructive pulmonary disease, asthma, or constipation
• High-grade cystocele
• Age 60 or above¹³

Patients with these conditions may benefit from the use of adjuvant materials in the anterior compartment.

Note that women who have had recurrences after earlier repairs may experience repeat recurrence.

Advantages of grafts

Using graft materials, the surgeon can repair all vaginal defects faster and with less effort. In the anterior compartment, a graft can be placed and anchored bilaterally from arcus to arcus tendineus, and posteriorly to the level of the spine, recreating level I support. Graft materials also offer the potential to treat stress urinary incontinence concomitantly using different shaped materials. Two authors have already described their success performing this type of repair.¹⁴

Nevertheless, great care and consideration should be devoted to actual and theoretical short- and long-term risks, many of which have not been fully elucidated.

Once a successful material is identified or developed, it may decrease operating time and morbidity in vaginal surgeries. It may also reduce the higher hospital costs normally associated with abdominal procedures.

Types of graft materials

There are 2 types of materials: synthetic or biologic. Synthetic materials can be further classified into permanent or absorbable.

The most widely used biologic materials include allografts such as human freeze-dried or solvent-dehydrated fascia lata (Tutoplast), decellularized human cadaveric dermis (Alloderm, Repliform), porcine dermal xenografts such as Pelvicol or Intexene, and bovine pericardial implants (Veritas).

Soft polypropylene meshes such as Gynemesh and Atrium are commonly used permanent materials, and polyglactin 910 is an absorbable material (TABLE).

TABLE

How successful are adjuvant materials in cystocele and rectocele repairs?

MATERIAL (SIZE IN CM)	AUTHOR	NO. IN STUDY	RECURRENCE RATE (%)	SITE OF ATTACHMENT	FOLLOW-UP (MONTHS)	COMPLICATIONS
BIOLOGIC MATERIALS
Alloderm 3×7 patch with concomitant sling	Chung29	19	16	Pubocervical fascia	28	None
Intexene 6×8 with sling	Gomelsky et al 200420	70	9 stage II 4 stage III	Arcus tendineus fascia pelvis	24	1 wound separation
Solvent-dehydrated cadaveric fascia lata patch with sling	Gandhi et al 200521	76 patch vs 72 no patch	21 vs 29, respectively (P=.23)	Overlay	13	None
Alloderm 3×7 trapezoid	Clemons et al 200322	33	41 stage II 3 symptomatic	Arcus tendineus fascia pelvis	18	None
SYNTHETIC MATERIALS WITH CONCOMITANT SLINGS*
Marlex 10×3×5	Nicita 199823	44	0	Arcus tendineus fascia pelvis	13	1 vaginal erosion
Polyglactin 910 absorbable mesh	Sand et al12	80 mesh vs 80 no mesh	25 vs 43 stage II cystoceles, respectively(P=.02)	Insert in the anterior and posterior colporrhaphy suture line	12	None
Polyglactin 910 absorbable mesh	Weber et al4	26 with mesh + standard repair; 24 with ultra-lateral repair; 33 with standard repair	58 vs 54 vs 70 stage II, respectively (P=.58)	Overlay	23	None
SYNTHETIC PERMANENT GRAFTS WITHOUT CONCOMITANT SLINGS
Marlex trapezoid	Julian 199619	12 with 12 without	0 vs 33, respectively	Arcus tendineus fascia pelvis	24	3 vaginal erosions
Mixed-fiber mesh (polyglactin 910 and polyester 5×5)	Migliari and Usai 199924	12	25	Pubourethral and cardinal ligaments	20	None
Prolene (Atrium)	Dwyer and O’Reilly25	64 anterior 50 posterior	6 grade II	Tension-free	29	8% vaginal erosion 1 rectovaginal fistula
Gynemesh 6×15	de Tayrac et al 200526	87	7 stage II 2 stage III	Tension-free	24	8% vaginal erosion
Prolene mesh patch	Milani et al 200527	32 anterior 31 posterior	6 stage II	Fixed to endopelvic connective tissue	17	20% anterior, 63% posterior dyspareunia; 13% vaginal erosion (anterior); 1 pelvic abscess (posterior)
Prolene mesh (double-wing shape)	Natale et al 2000 28	138	3	Tension-free	18	9% vaginal erosion 7% dyspareunia 1 hematoma
*Absorbable and permanent.

Classification of synthetic materials

• Type 1 grafts are totally macroporous (>75 μm), which allows fibroblast, macrophage, and collagen penetration with angiogenesis. Examples include Prolene and Marlex meshes.
• Type 2 mesh is microporous (<10 μm in 1 dimension). This prevents penetration of fibroblasts, macrophages, or collagen. Gore-Tex is an example of a Type 2 mesh.
• Type 3 mesh is macroporous (>75 μm) with multifilamentous or microporous components. Examples include Mersilene (braided Dacron mesh), Teflon (polytetrafluoroethylene [PTFE]), Surgipro (braided polypropylene mesh), and MycroMesh (perforated PTFE patch).
• Type 4 mesh has a submicron pore size that prevents penetration. Examples include Silastic, Cellgard (polypropylene sheeting), and Preclude pericardial membrane/Preclude dura-substitute.¹

2 other important properties are composition of fibers (multifilamentous materials commonly have interstices less than 10 microns) and flexibility (which has a bearing on erosion of the material).¹

Bacteria can penetrate pores smaller than 1 μm, whereas polymorphonuclear white blood cells and macrophages need a pore size larger than 10 μm, and capillary ingrowth requires a size larger than 75 microns. Thus, Type 1 offers the advantages of larger pore size and monofilamentous interstices to allow for capillary ingrowth.

Which material is best?

Although the literature is difficult to interpret because of the diversity of studies and other factors, some findings are worth noting:

 

• Tutoplast and Alloderm appear to have the best tensile strength, maximum load to capacity, and microscopic architecture similar to the original tissue.^15-17 However, these qualities were documented prior to implantation in vivo.
• Slings appear to help prevent cystocele recurrences, according to a study by Goldberg et al.¹⁸
• A fascial patch had no benefit when placed as an overlay in the anterior compartment in a randomized, controlled trial (involving 162 women) by Sand et al.¹²
• Marlex. One group of women with recurrent prolapse underwent synthetic graft (Marlex) augmentation with bilateral ATFP attachment, while the other group had anterior colporrhaphy only.¹⁹ None of the women who received grafts had further recurrence, while 33% of the control group did. However, 25% of the women with the graft had vaginal erosions.
• Polyglactin 910 had a protective effect when embedded in the plication, according to Sand et al.¹² However, it had no benefit when used as an overlay to a traditional repair in a study by Weber et al.⁴ The discrepancy may be related to small sample size; the study by Weber et al was powered to detect only a 30% difference. However, these studies suggest that it is not only the type of graft that is important, but how it is used or attached.

In general, synthetic grafts may have slightly higher success rates, whereas biologic materials appear to be better tolerated.

Prospective, comparative trials of these materials are desperately needed.

CASE Symptoms point to yet another prolapse recurrence

A 52-year-old woman presents with a bulge and pressure in her vagina. She has undergone 2 prior reconstructive surgeries. The first was a vaginal hysterectomy, anterior and posterior repair, and sling; the second was an abdominal procedure that included a sacrocolpopexy and paravaginal repair.

A physical examination reveals a recurrent 4th-degree cystocele that protrudes 2 cm beyond the hymenal ring. The vault and posterior compartment are well supported, and the patient reports no incontinence, a fact confirmed by urodynamics testing. She asks that you do everything in your power to prevent further recurrence.

How do you proceed?

This patient ultimately underwent anterior colporrhaphy and vaginal paravaginal repair using a decellularized dermal cadaveric implant. She was still doing well 1 year later, with no recurrence.

Despite success stories like this one, the use of graft materials to repair cystoceles and rectoceles is controversial. One reason is the difficulty of interpreting published data, since studies lack uniformity in technique, patient characteristics, graft shape, type of material, attachment sites, and duration of follow-up. Level I evidence that augmented repairs have a clear benefit over traditional repairs is sparse.

Advocates of graft materials argue that native tissue is already compromised—hence, the prolapse—making surgical failure likely.¹ They claim graft materials help strengthen repairs, especially in the case of cystoceles. They also point out that adjuvant materials have been used in burns, plastic surgery, and orthopedics for more than 10 years and are generally well tolerated. Their success in hernia repairs prompted their consideration for the pelvic floor.

A pervasive problem, but only 10% to 20% seek help

Roughly 1 of 2 parous women lose pelvic support as they age, but only 10% to 20% seek medical care, with a lifetime risk of surgery for pelvic organ prolapse (POP) of 11% by age 80.²

With women living longer than ever and remaining active later in life, this percentage is likely to rise. Unfortunately, few alternatives to surgical treatment exist, and the reoperation rate for recurrence is 29%, according to a 1995 review.² If surgical management is the only hope of cure, how can we lower the 29% recurrence rate?

Graft materials may provide part or all of the solution.

Elements of prolapse

Anterior compartment

Central and/or lateral defects can occur in the anterior compartment.

Lateral (paravaginal) defects indicate that the endopelvic connective tissue has separated from the arcus tendineus fascia pelvis. Lateral defects can be repaired vaginally or abdominally.

One study³ found that 67% of women with anterior wall prolapse had paravaginal defects, but no randomized trials have evaluated the clinical benefit of repairing these defects, compared with traditional colporrhaphies.

Central defects involve site-specific defects and/or general attenuation of the endopelvic connective tissue. These are usually repaired vaginally.

Recurrence rates for lateral and central defects range from 3% to 70%.^4-8

Two large series of vaginal paravaginal repairs noted the following recurrence rates:

• Shull et al⁶ found a recurrence rate of 7% to the hymenal ring or beyond.
• Young et al⁷ observed a recurrence rate for lateral defects of 2%, with recurrence rates as high as 22% for central defects.

In a comparison of 3 techniques for vaginal repair of central defects, using strict criteria to assess anatomic outcomes, Weber et al⁴ found recurrence rates of 54% to 70%. Other studies show symptomatic recurrence rates of 3% to 22% for cystoceles.^5,8

With grafts, both paravaginal and central defects can be repaired. Vaginal paravaginal repairs are not popular due to the technical difficulty involved. With the use of grafts, however, both paravaginal and central defects can be addressed simultaneously with relative ease.

Posterior compartment

Defects in the posterior compartment are less likely to recur. Reported success rates range from 80% to 90%.^9,10

Posterior compartment defects include general attenuation of Denonvillier’s fascia or a tear anywhere along the fascia or any of its attachments.

Recurrence rates. Site-specific repairs are thought to minimize complications such as dyspareunia. However, few studies have compared the efficacy of site-specific repairs with that of traditional colporrhaphies. At our institution, women who underwent traditional colporrhaphy had fewer recurrences than controls (33% vs 14%), with no differences in postoperative symptoms such as dyspareunia, constipation, and fecal incontinence.¹¹

Graft materials of questionable benefit. In the posterior compartment, these materials have not been shown to be beneficial, compared with traditional or site-specific repairs. Sand et al¹² found no benefit for repairs in which absorbable Vicryl mesh was imbricated, but this randomized trial may have lacked sufficient power to show statistical significance. Large cohorts would be needed to show significant benefit of meshes in the posterior compartment.

 

A complex web of support

In the normal pelvis, support of reproductive organs depends on a complex web of muscles, fascia, and connective tissue. To ensure success, prolapse repairs should correct any separation or attenuation of tissue and preserve or enhance tissue resilience.

Risk factors for recurrent prolapse

• Poor tissue (assess tissue quality before and during surgery)
• Impaired healing
• Chronic increases in intraabdominal pressure due to obstructive pulmonary disease, asthma, or constipation
• High-grade cystocele
• Age 60 or above¹³

Patients with these conditions may benefit from the use of adjuvant materials in the anterior compartment.

Note that women who have had recurrences after earlier repairs may experience repeat recurrence.

Advantages of grafts

Using graft materials, the surgeon can repair all vaginal defects faster and with less effort. In the anterior compartment, a graft can be placed and anchored bilaterally from arcus to arcus tendineus, and posteriorly to the level of the spine, recreating level I support. Graft materials also offer the potential to treat stress urinary incontinence concomitantly using different shaped materials. Two authors have already described their success performing this type of repair.¹⁴

Nevertheless, great care and consideration should be devoted to actual and theoretical short- and long-term risks, many of which have not been fully elucidated.

Once a successful material is identified or developed, it may decrease operating time and morbidity in vaginal surgeries. It may also reduce the higher hospital costs normally associated with abdominal procedures.

Types of graft materials

There are 2 types of materials: synthetic or biologic. Synthetic materials can be further classified into permanent or absorbable.

The most widely used biologic materials include allografts such as human freeze-dried or solvent-dehydrated fascia lata (Tutoplast), decellularized human cadaveric dermis (Alloderm, Repliform), porcine dermal xenografts such as Pelvicol or Intexene, and bovine pericardial implants (Veritas).

Soft polypropylene meshes such as Gynemesh and Atrium are commonly used permanent materials, and polyglactin 910 is an absorbable material (TABLE).

TABLE

How successful are adjuvant materials in cystocele and rectocele repairs?

MATERIAL (SIZE IN CM)	AUTHOR	NO. IN STUDY	RECURRENCE RATE (%)	SITE OF ATTACHMENT	FOLLOW-UP (MONTHS)	COMPLICATIONS
BIOLOGIC MATERIALS
Alloderm 3×7 patch with concomitant sling	Chung29	19	16	Pubocervical fascia	28	None
Intexene 6×8 with sling	Gomelsky et al 200420	70	9 stage II 4 stage III	Arcus tendineus fascia pelvis	24	1 wound separation
Solvent-dehydrated cadaveric fascia lata patch with sling	Gandhi et al 200521	76 patch vs 72 no patch	21 vs 29, respectively (P=.23)	Overlay	13	None
Alloderm 3×7 trapezoid	Clemons et al 200322	33	41 stage II 3 symptomatic	Arcus tendineus fascia pelvis	18	None
SYNTHETIC MATERIALS WITH CONCOMITANT SLINGS*
Marlex 10×3×5	Nicita 199823	44	0	Arcus tendineus fascia pelvis	13	1 vaginal erosion
Polyglactin 910 absorbable mesh	Sand et al12	80 mesh vs 80 no mesh	25 vs 43 stage II cystoceles, respectively(P=.02)	Insert in the anterior and posterior colporrhaphy suture line	12	None
Polyglactin 910 absorbable mesh	Weber et al4	26 with mesh + standard repair; 24 with ultra-lateral repair; 33 with standard repair	58 vs 54 vs 70 stage II, respectively (P=.58)	Overlay	23	None
SYNTHETIC PERMANENT GRAFTS WITHOUT CONCOMITANT SLINGS
Marlex trapezoid	Julian 199619	12 with 12 without	0 vs 33, respectively	Arcus tendineus fascia pelvis	24	3 vaginal erosions
Mixed-fiber mesh (polyglactin 910 and polyester 5×5)	Migliari and Usai 199924	12	25	Pubourethral and cardinal ligaments	20	None
Prolene (Atrium)	Dwyer and O’Reilly25	64 anterior 50 posterior	6 grade II	Tension-free	29	8% vaginal erosion 1 rectovaginal fistula
Gynemesh 6×15	de Tayrac et al 200526	87	7 stage II 2 stage III	Tension-free	24	8% vaginal erosion
Prolene mesh patch	Milani et al 200527	32 anterior 31 posterior	6 stage II	Fixed to endopelvic connective tissue	17	20% anterior, 63% posterior dyspareunia; 13% vaginal erosion (anterior); 1 pelvic abscess (posterior)
Prolene mesh (double-wing shape)	Natale et al 2000 28	138	3	Tension-free	18	9% vaginal erosion 7% dyspareunia 1 hematoma
*Absorbable and permanent.

Classification of synthetic materials

• Type 1 grafts are totally macroporous (>75 μm), which allows fibroblast, macrophage, and collagen penetration with angiogenesis. Examples include Prolene and Marlex meshes.
• Type 2 mesh is microporous (<10 μm in 1 dimension). This prevents penetration of fibroblasts, macrophages, or collagen. Gore-Tex is an example of a Type 2 mesh.
• Type 3 mesh is macroporous (>75 μm) with multifilamentous or microporous components. Examples include Mersilene (braided Dacron mesh), Teflon (polytetrafluoroethylene [PTFE]), Surgipro (braided polypropylene mesh), and MycroMesh (perforated PTFE patch).
• Type 4 mesh has a submicron pore size that prevents penetration. Examples include Silastic, Cellgard (polypropylene sheeting), and Preclude pericardial membrane/Preclude dura-substitute.¹

2 other important properties are composition of fibers (multifilamentous materials commonly have interstices less than 10 microns) and flexibility (which has a bearing on erosion of the material).¹

Bacteria can penetrate pores smaller than 1 μm, whereas polymorphonuclear white blood cells and macrophages need a pore size larger than 10 μm, and capillary ingrowth requires a size larger than 75 microns. Thus, Type 1 offers the advantages of larger pore size and monofilamentous interstices to allow for capillary ingrowth.

Which material is best?

Although the literature is difficult to interpret because of the diversity of studies and other factors, some findings are worth noting:

 

• Tutoplast and Alloderm appear to have the best tensile strength, maximum load to capacity, and microscopic architecture similar to the original tissue.^15-17 However, these qualities were documented prior to implantation in vivo.
• Slings appear to help prevent cystocele recurrences, according to a study by Goldberg et al.¹⁸
• A fascial patch had no benefit when placed as an overlay in the anterior compartment in a randomized, controlled trial (involving 162 women) by Sand et al.¹²
• Marlex. One group of women with recurrent prolapse underwent synthetic graft (Marlex) augmentation with bilateral ATFP attachment, while the other group had anterior colporrhaphy only.¹⁹ None of the women who received grafts had further recurrence, while 33% of the control group did. However, 25% of the women with the graft had vaginal erosions.
• Polyglactin 910 had a protective effect when embedded in the plication, according to Sand et al.¹² However, it had no benefit when used as an overlay to a traditional repair in a study by Weber et al.⁴ The discrepancy may be related to small sample size; the study by Weber et al was powered to detect only a 30% difference. However, these studies suggest that it is not only the type of graft that is important, but how it is used or attached.

In general, synthetic grafts may have slightly higher success rates, whereas biologic materials appear to be better tolerated.

Prospective, comparative trials of these materials are desperately needed.