News for Your Practice

The disturbing fact that epithelial ovarian cancer often recurs after clinical remission poses this challenge: How do we identify the women with subclinical disease who may benefit from additional consolidation therapy?

Given the inability of noninvasive studies such as computed tomography, magnetic resonance imaging, and positron emission tomography to reliably detect small-volume and microscopic disease, second-look laparotomy (SLL) is the only technique capable of confirming a complete pathologic response to therapy.

Ob/Gyns involved in care of women with advanced ovarian cancer face the challenge of weighing the benefits of SLL against the potential morbidities of invasive surgery. This article describes those benefits, surgical technique, the prognostic significance of findings, and the status of salvage and consolidation therapies.

What SLL conveys

“Second look laparotomy” has rather loosely described many secondary surgeries for ovarian cancer, but we adopt the more rigorous definition: “a systematic surgical reexploration in asymptomatic patients who have no clinical evidence of tumor following initial surgery and completion of a planned program of chemotherapy.”¹

Procedures to debulk recurrent or residual disease, relieve symptomatic tumor, or accomplish interval cytoreduction cannot be deemed second-look laparotomy.

Prognostic, therapeutic limitations complicate the decision

Although negative findings at SLL confer an improved prognosis, disease ultimately recurs in up to 60% of patients.^2,3 Moreover, despite intensive research, consistently effective consolidation and salvage regimens remain elusive.

SLL may provide some information about prognosis, but that information is far from certain. Because of the cost and morbidity inherent in SLL, routine use has largely been limited to patients in clinical trials, where findings may serve as a surrogate endpoint for investigational therapies.

For these reasons, we strongly recommend careful discussion of this complex decision with patients prior to surgery, in consultation with a gynecologic oncologist.

Which patients are and are not candidates?

Candidates should be in clinical remission as determined by physical examination, abdominopelvic imaging, and serum CA-125 determination. Although SLL will detect residual disease in up to 50% of patients undergoing the procedure after primary chemotherapy, SLL is an imperfect method of determining the true response to therapy. Thus, it should be offered only to patients for whom results will influence clinical decision-making.

Patients with stage I disease treated with appropriate chemotherapy should not undergo SLL because of the low incidence of positive findings.⁴

Residual disease: 30% to 50%

Second-look laparotomy requires thorough inspection of the peritoneal cavity and retroperitoneum, but when properly performed on appropriate candidates, SLL detects residual disease in 30% to 50% of patients.^2,5

Generally, stage and volume of residual disease at initial surgery are most closely correlated with findings. In a review of 31 series, patients with stage III and IV disease undergoing surgery had fewer negative SLLs (39% and 33%, respectively) than patients with stage I and II disease (81% and 69%, respectively).⁶ Similarly, in pooled data on 1,797 patients, 72% of those with no gross residual disease at the conclusion of primary surgery had negative findings at SLL, compared with 50% of those with optimal residual, and only 23% of those with suboptimal residual.⁶

Surgical technique

Surgery begins with a large vertical incision and involves the components listed in the TABLE.

If gross disease is apparent:

Consider surgical cytoreduction, which is typically performed at the surgeon’s discretion.

In the absence of gross tumor:

Use a 5-point strategy to search thoroughly for occult disease.

• Take washings for cytology from the abdomen and pelvis;
  
• lyse any adhesions to allow adequate examination of all peritoneal surfaces;
  
• obtain random biopsies from the pelvis, bladder serosa, vaginal cuff, culde-sac, paracolic gutters, and hemidiaphragms, as well as adhesions, sites of prior documented tumor, infundibulopelvic ligament pedicles, and areas suspicious for tumor recurrence;
  
• consider removing the uterus, adnexae, omentum, and appendix, if not done at the primary surgery; and
  
• sample any remaining pelvic and paraaortic lymph nodes.
  

Meticulous sampling is crucial

 

Although the number of biopsies performed at SLL varies widely by surgeon, meticulous sampling of peritoneal surfaces may be necessary to detect occult tumor. In cases of microscopic disease, fewer than 5% of biopsies may be positive for tumor.⁷ Not surprisingly, some studies have noted a significantly worse survival rate among patients deemed to be in complete pathologic remission who underwent fewer biopsies at the time of SLL.⁸

TABLE

Components of second-look laparotomy

Vertical incision
Thorough inspection of abdomen and pelvis
Abdominopelvic washings for cytologic analysis
Complete adhesiolysis
Systematic biopsy of:
Undersurfaces of bilateral hemidiaphragms Paracolic gutters Pelvic peritoneum Pedicles of ovarian vessels Any suspicious lesions Areas of known prior tumor Adhesions
If necessary: Complete hysterectomy, salpingo-oophorectomy, omentectomy, and appendectomy
Pelvic and paraaortic lymph node sampling

What do SLL findings predict?

Survival rates

Women who achieve a complete pathologic response after primary chemotherapy have the greatest survival. Rubin et al³ noted a 10-year survival rate of 51% for 91 patients after negative SLL. Median survivals for patients with negative findings have been reported in excess of 70 months.^7,9 Tuxen et al⁹ examined 242 patients after SLL and reported a median survival of 149 months for those with negative findings, versus 39 and 24 months for those with microscopic and gross disease, respectively (P<.0005>

Survival rates among women with negative findings were substantially higher than among patients with positive findings, even though the latter group received salvage chemotherapy.

Recurrence rates

In a review of 38 studies encompassing 1,511 patients, Barter and Barnes⁶ noted a 23% rate of recurrence among women with negative findings at SLL. Other studies from single institutions document recurrence rates approximating 50%.^3,10 Patients experiencing recurrence after negative SLL have median survivals of 11 to 45 months.^3,8,10-12

Gross versus microscopic disease

Studies comparing outcomes based on volume of disease detected at SLL have found statistically improved survival for patients without evidence of gross tumor.^9,13-15 Podratz et al¹⁴ reported 4-year survival of 55% for women with microscopic findings versus 19% for those with gross disease (P<.01>

The presence of gross tumor at SLL indicates a grave prognosis; median survival ranges between 13 and 24 months.^9,16,17 Nevertheless, several studies have shown that patients able to undergo debulking of all visible disease derive a survival benefit.^4,15,18,19

Given the potential complications of extensive debulking surgery and lack of a proven survival benefit for patients unable to achieve complete cytoreduction, debulking should only be attempted if persistent disease is judged to be completely resectable.

When SLL is positive: Salvage therapy regimens

Many different salvage regimens for epithelial ovarian cancer have been investigated for use after positive second-look laparotomy, including intraperitoneal radioactive phosphorus (³²P), systemic chemotherapy, whole abdominal radiation (WAR), hormonal therapy, and biologic response modifiers. Unfortunately, studies of salvage therapy tend to be retrospective, nonrandomized, and uncontrolled, and no proven regimen has yet been found.

Whole abdominal radiation

This modality appears to confer no definitive survival benefit and does produce toxicity. MacGibbon et al²⁰ treated 51 patients with WAR for both salvage and consolidation. Of these, 27% could not complete treatment because of progressive disease, bowel perforation, myelosuppression, and bowel toxicity. An additional 24% required treatment delays because of hematologic and gastrointestinal toxicity. Among those completing the prescribed course of radiation, 6 developed late bowel symptoms, and 2 of these required surgical intervention to relieve bowel obstruction.

Other salvage therapies

Recently, Dowdy et al¹⁸ reported long-term follow-up for 145 patients with positive findings at SLL. Neither intraperitoneal ³²P nor WAR provided a survival benefit. Multivariate analysis indicated that only grade and volume of residual disease following cytoreduction were associated with improved survival.

Other trials involving intraperitoneal interferon-alpha and carboplatin,²¹ and high-dose chemotherapy with autologous stem cell rescue²² have also failed to demonstrate any significant advantages in survival or rate of progression. An early phase II study of intraperitoneal paclitaxel showed promise: Markman et al²³ noted a complete pathologic response in 61% of patients with microscopic disease at SLL, but only 4% of those with gross disease achieved a complete response.

Need for effective consolidation therapy

A critical component of cancer care is targeting patients at highest risk of recurrence for effective consolidation therapy. The factors most strongly correlated with disease progression are stage at diagnosis, tumor grade, and volume of residual disease after initial cytoreduction.

Many consolidation therapies have been described, including systemic and intraperitoneal chemotherapy, WAR, intraperitoneal ³²P, and biologic response modifiers.

Significant risk of distant recurrences

Although most tumors recur in the abdomen and pelvis, approximately 30% recur at distant locations. For this reason, consider systemic treatment when planning the consolidation regimen. Bertucci et al²² studied systemic melphalan-based, high-dose chemotherapy with autologous stem cell rescue and noted a 5-year progression-free survival of 43% and overall survival of 75%.

 

Most therapies are localized. Most other studies have focused on therapies localized to the peritoneal cavity. Results for intraperitoneal ³²P and WAR are mixed. Several different regimens of intraperitoneal chemotherapy have produced median disease-free survival rates of 18 to 41 months.^24-27 In 1998, Barakat et al²⁷ examined the use of intraperitoneal cisplatin and etoposide, reporting a statistically improved median disease-free survival for patients receiving intraperitoneal consolidation (median disease-free survival not yet reached), compared with patients treated by observation (28.5 months).

Bottom line

Second-look laparotomy reveals that approximately 50% of patients with a complete clinical response still harbor residual disease after primary chemotherapy. Even women who achieve a complete pathologic response have recurrence rates as high as 60%. While SLL can be a useful tool, the information it yields must be weighed against the potential morbidities of invasive surgery. Given its limited prognostic value, SLL should be offered only when results will influence clinical decision-making, or as part of a clinical trial.

The authors report no financial relationships relevant to this article.

The disturbing fact that epithelial ovarian cancer often recurs after clinical remission poses this challenge: How do we identify the women with subclinical disease who may benefit from additional consolidation therapy?

Given the inability of noninvasive studies such as computed tomography, magnetic resonance imaging, and positron emission tomography to reliably detect small-volume and microscopic disease, second-look laparotomy (SLL) is the only technique capable of confirming a complete pathologic response to therapy.

Ob/Gyns involved in care of women with advanced ovarian cancer face the challenge of weighing the benefits of SLL against the potential morbidities of invasive surgery. This article describes those benefits, surgical technique, the prognostic significance of findings, and the status of salvage and consolidation therapies.

What SLL conveys

“Second look laparotomy” has rather loosely described many secondary surgeries for ovarian cancer, but we adopt the more rigorous definition: “a systematic surgical reexploration in asymptomatic patients who have no clinical evidence of tumor following initial surgery and completion of a planned program of chemotherapy.”¹

Procedures to debulk recurrent or residual disease, relieve symptomatic tumor, or accomplish interval cytoreduction cannot be deemed second-look laparotomy.

Prognostic, therapeutic limitations complicate the decision

Although negative findings at SLL confer an improved prognosis, disease ultimately recurs in up to 60% of patients.^2,3 Moreover, despite intensive research, consistently effective consolidation and salvage regimens remain elusive.

SLL may provide some information about prognosis, but that information is far from certain. Because of the cost and morbidity inherent in SLL, routine use has largely been limited to patients in clinical trials, where findings may serve as a surrogate endpoint for investigational therapies.

For these reasons, we strongly recommend careful discussion of this complex decision with patients prior to surgery, in consultation with a gynecologic oncologist.

Which patients are and are not candidates?

Candidates should be in clinical remission as determined by physical examination, abdominopelvic imaging, and serum CA-125 determination. Although SLL will detect residual disease in up to 50% of patients undergoing the procedure after primary chemotherapy, SLL is an imperfect method of determining the true response to therapy. Thus, it should be offered only to patients for whom results will influence clinical decision-making.

Patients with stage I disease treated with appropriate chemotherapy should not undergo SLL because of the low incidence of positive findings.⁴

Residual disease: 30% to 50%

Second-look laparotomy requires thorough inspection of the peritoneal cavity and retroperitoneum, but when properly performed on appropriate candidates, SLL detects residual disease in 30% to 50% of patients.^2,5

Generally, stage and volume of residual disease at initial surgery are most closely correlated with findings. In a review of 31 series, patients with stage III and IV disease undergoing surgery had fewer negative SLLs (39% and 33%, respectively) than patients with stage I and II disease (81% and 69%, respectively).⁶ Similarly, in pooled data on 1,797 patients, 72% of those with no gross residual disease at the conclusion of primary surgery had negative findings at SLL, compared with 50% of those with optimal residual, and only 23% of those with suboptimal residual.⁶

Surgical technique

Surgery begins with a large vertical incision and involves the components listed in the TABLE.

If gross disease is apparent:

Consider surgical cytoreduction, which is typically performed at the surgeon’s discretion.

In the absence of gross tumor:

Use a 5-point strategy to search thoroughly for occult disease.

• Take washings for cytology from the abdomen and pelvis;
  
• lyse any adhesions to allow adequate examination of all peritoneal surfaces;
  
• obtain random biopsies from the pelvis, bladder serosa, vaginal cuff, culde-sac, paracolic gutters, and hemidiaphragms, as well as adhesions, sites of prior documented tumor, infundibulopelvic ligament pedicles, and areas suspicious for tumor recurrence;
  
• consider removing the uterus, adnexae, omentum, and appendix, if not done at the primary surgery; and
  
• sample any remaining pelvic and paraaortic lymph nodes.
  

Meticulous sampling is crucial

 

Although the number of biopsies performed at SLL varies widely by surgeon, meticulous sampling of peritoneal surfaces may be necessary to detect occult tumor. In cases of microscopic disease, fewer than 5% of biopsies may be positive for tumor.⁷ Not surprisingly, some studies have noted a significantly worse survival rate among patients deemed to be in complete pathologic remission who underwent fewer biopsies at the time of SLL.⁸

TABLE

Components of second-look laparotomy

Vertical incision
Thorough inspection of abdomen and pelvis
Abdominopelvic washings for cytologic analysis
Complete adhesiolysis
Systematic biopsy of:
Undersurfaces of bilateral hemidiaphragms Paracolic gutters Pelvic peritoneum Pedicles of ovarian vessels Any suspicious lesions Areas of known prior tumor Adhesions
If necessary: Complete hysterectomy, salpingo-oophorectomy, omentectomy, and appendectomy
Pelvic and paraaortic lymph node sampling

What do SLL findings predict?

Survival rates

Women who achieve a complete pathologic response after primary chemotherapy have the greatest survival. Rubin et al³ noted a 10-year survival rate of 51% for 91 patients after negative SLL. Median survivals for patients with negative findings have been reported in excess of 70 months.^7,9 Tuxen et al⁹ examined 242 patients after SLL and reported a median survival of 149 months for those with negative findings, versus 39 and 24 months for those with microscopic and gross disease, respectively (P<.0005>

Survival rates among women with negative findings were substantially higher than among patients with positive findings, even though the latter group received salvage chemotherapy.

Recurrence rates

In a review of 38 studies encompassing 1,511 patients, Barter and Barnes⁶ noted a 23% rate of recurrence among women with negative findings at SLL. Other studies from single institutions document recurrence rates approximating 50%.^3,10 Patients experiencing recurrence after negative SLL have median survivals of 11 to 45 months.^3,8,10-12

Gross versus microscopic disease

Studies comparing outcomes based on volume of disease detected at SLL have found statistically improved survival for patients without evidence of gross tumor.^9,13-15 Podratz et al¹⁴ reported 4-year survival of 55% for women with microscopic findings versus 19% for those with gross disease (P<.01>

The presence of gross tumor at SLL indicates a grave prognosis; median survival ranges between 13 and 24 months.^9,16,17 Nevertheless, several studies have shown that patients able to undergo debulking of all visible disease derive a survival benefit.^4,15,18,19

Given the potential complications of extensive debulking surgery and lack of a proven survival benefit for patients unable to achieve complete cytoreduction, debulking should only be attempted if persistent disease is judged to be completely resectable.

When SLL is positive: Salvage therapy regimens

Many different salvage regimens for epithelial ovarian cancer have been investigated for use after positive second-look laparotomy, including intraperitoneal radioactive phosphorus (³²P), systemic chemotherapy, whole abdominal radiation (WAR), hormonal therapy, and biologic response modifiers. Unfortunately, studies of salvage therapy tend to be retrospective, nonrandomized, and uncontrolled, and no proven regimen has yet been found.

Whole abdominal radiation

This modality appears to confer no definitive survival benefit and does produce toxicity. MacGibbon et al²⁰ treated 51 patients with WAR for both salvage and consolidation. Of these, 27% could not complete treatment because of progressive disease, bowel perforation, myelosuppression, and bowel toxicity. An additional 24% required treatment delays because of hematologic and gastrointestinal toxicity. Among those completing the prescribed course of radiation, 6 developed late bowel symptoms, and 2 of these required surgical intervention to relieve bowel obstruction.

Other salvage therapies

Recently, Dowdy et al¹⁸ reported long-term follow-up for 145 patients with positive findings at SLL. Neither intraperitoneal ³²P nor WAR provided a survival benefit. Multivariate analysis indicated that only grade and volume of residual disease following cytoreduction were associated with improved survival.

Other trials involving intraperitoneal interferon-alpha and carboplatin,²¹ and high-dose chemotherapy with autologous stem cell rescue²² have also failed to demonstrate any significant advantages in survival or rate of progression. An early phase II study of intraperitoneal paclitaxel showed promise: Markman et al²³ noted a complete pathologic response in 61% of patients with microscopic disease at SLL, but only 4% of those with gross disease achieved a complete response.

Need for effective consolidation therapy

A critical component of cancer care is targeting patients at highest risk of recurrence for effective consolidation therapy. The factors most strongly correlated with disease progression are stage at diagnosis, tumor grade, and volume of residual disease after initial cytoreduction.

Many consolidation therapies have been described, including systemic and intraperitoneal chemotherapy, WAR, intraperitoneal ³²P, and biologic response modifiers.

Significant risk of distant recurrences

Although most tumors recur in the abdomen and pelvis, approximately 30% recur at distant locations. For this reason, consider systemic treatment when planning the consolidation regimen. Bertucci et al²² studied systemic melphalan-based, high-dose chemotherapy with autologous stem cell rescue and noted a 5-year progression-free survival of 43% and overall survival of 75%.

 

Most therapies are localized. Most other studies have focused on therapies localized to the peritoneal cavity. Results for intraperitoneal ³²P and WAR are mixed. Several different regimens of intraperitoneal chemotherapy have produced median disease-free survival rates of 18 to 41 months.^24-27 In 1998, Barakat et al²⁷ examined the use of intraperitoneal cisplatin and etoposide, reporting a statistically improved median disease-free survival for patients receiving intraperitoneal consolidation (median disease-free survival not yet reached), compared with patients treated by observation (28.5 months).

Bottom line

Second-look laparotomy reveals that approximately 50% of patients with a complete clinical response still harbor residual disease after primary chemotherapy. Even women who achieve a complete pathologic response have recurrence rates as high as 60%. While SLL can be a useful tool, the information it yields must be weighed against the potential morbidities of invasive surgery. Given its limited prognostic value, SLL should be offered only when results will influence clinical decision-making, or as part of a clinical trial.

The authors report no financial relationships relevant to this article.

The disturbing fact that epithelial ovarian cancer often recurs after clinical remission poses this challenge: How do we identify the women with subclinical disease who may benefit from additional consolidation therapy?

Given the inability of noninvasive studies such as computed tomography, magnetic resonance imaging, and positron emission tomography to reliably detect small-volume and microscopic disease, second-look laparotomy (SLL) is the only technique capable of confirming a complete pathologic response to therapy.

Ob/Gyns involved in care of women with advanced ovarian cancer face the challenge of weighing the benefits of SLL against the potential morbidities of invasive surgery. This article describes those benefits, surgical technique, the prognostic significance of findings, and the status of salvage and consolidation therapies.

What SLL conveys

“Second look laparotomy” has rather loosely described many secondary surgeries for ovarian cancer, but we adopt the more rigorous definition: “a systematic surgical reexploration in asymptomatic patients who have no clinical evidence of tumor following initial surgery and completion of a planned program of chemotherapy.”¹

Procedures to debulk recurrent or residual disease, relieve symptomatic tumor, or accomplish interval cytoreduction cannot be deemed second-look laparotomy.

Prognostic, therapeutic limitations complicate the decision

Although negative findings at SLL confer an improved prognosis, disease ultimately recurs in up to 60% of patients.^2,3 Moreover, despite intensive research, consistently effective consolidation and salvage regimens remain elusive.

SLL may provide some information about prognosis, but that information is far from certain. Because of the cost and morbidity inherent in SLL, routine use has largely been limited to patients in clinical trials, where findings may serve as a surrogate endpoint for investigational therapies.

For these reasons, we strongly recommend careful discussion of this complex decision with patients prior to surgery, in consultation with a gynecologic oncologist.

Which patients are and are not candidates?

Candidates should be in clinical remission as determined by physical examination, abdominopelvic imaging, and serum CA-125 determination. Although SLL will detect residual disease in up to 50% of patients undergoing the procedure after primary chemotherapy, SLL is an imperfect method of determining the true response to therapy. Thus, it should be offered only to patients for whom results will influence clinical decision-making.

Patients with stage I disease treated with appropriate chemotherapy should not undergo SLL because of the low incidence of positive findings.⁴

Residual disease: 30% to 50%

Second-look laparotomy requires thorough inspection of the peritoneal cavity and retroperitoneum, but when properly performed on appropriate candidates, SLL detects residual disease in 30% to 50% of patients.^2,5

Generally, stage and volume of residual disease at initial surgery are most closely correlated with findings. In a review of 31 series, patients with stage III and IV disease undergoing surgery had fewer negative SLLs (39% and 33%, respectively) than patients with stage I and II disease (81% and 69%, respectively).⁶ Similarly, in pooled data on 1,797 patients, 72% of those with no gross residual disease at the conclusion of primary surgery had negative findings at SLL, compared with 50% of those with optimal residual, and only 23% of those with suboptimal residual.⁶

Surgical technique

Surgery begins with a large vertical incision and involves the components listed in the TABLE.

If gross disease is apparent:

Consider surgical cytoreduction, which is typically performed at the surgeon’s discretion.

In the absence of gross tumor:

Use a 5-point strategy to search thoroughly for occult disease.

• Take washings for cytology from the abdomen and pelvis;
  
• lyse any adhesions to allow adequate examination of all peritoneal surfaces;
  
• obtain random biopsies from the pelvis, bladder serosa, vaginal cuff, culde-sac, paracolic gutters, and hemidiaphragms, as well as adhesions, sites of prior documented tumor, infundibulopelvic ligament pedicles, and areas suspicious for tumor recurrence;
  
• consider removing the uterus, adnexae, omentum, and appendix, if not done at the primary surgery; and
  
• sample any remaining pelvic and paraaortic lymph nodes.
  

Meticulous sampling is crucial

 

Although the number of biopsies performed at SLL varies widely by surgeon, meticulous sampling of peritoneal surfaces may be necessary to detect occult tumor. In cases of microscopic disease, fewer than 5% of biopsies may be positive for tumor.⁷ Not surprisingly, some studies have noted a significantly worse survival rate among patients deemed to be in complete pathologic remission who underwent fewer biopsies at the time of SLL.⁸

TABLE

Components of second-look laparotomy

Vertical incision
Thorough inspection of abdomen and pelvis
Abdominopelvic washings for cytologic analysis
Complete adhesiolysis
Systematic biopsy of:
Undersurfaces of bilateral hemidiaphragms Paracolic gutters Pelvic peritoneum Pedicles of ovarian vessels Any suspicious lesions Areas of known prior tumor Adhesions
If necessary: Complete hysterectomy, salpingo-oophorectomy, omentectomy, and appendectomy
Pelvic and paraaortic lymph node sampling

What do SLL findings predict?

Survival rates

Women who achieve a complete pathologic response after primary chemotherapy have the greatest survival. Rubin et al³ noted a 10-year survival rate of 51% for 91 patients after negative SLL. Median survivals for patients with negative findings have been reported in excess of 70 months.^7,9 Tuxen et al⁹ examined 242 patients after SLL and reported a median survival of 149 months for those with negative findings, versus 39 and 24 months for those with microscopic and gross disease, respectively (P<.0005>

Survival rates among women with negative findings were substantially higher than among patients with positive findings, even though the latter group received salvage chemotherapy.

Recurrence rates

In a review of 38 studies encompassing 1,511 patients, Barter and Barnes⁶ noted a 23% rate of recurrence among women with negative findings at SLL. Other studies from single institutions document recurrence rates approximating 50%.^3,10 Patients experiencing recurrence after negative SLL have median survivals of 11 to 45 months.^3,8,10-12

Gross versus microscopic disease

Studies comparing outcomes based on volume of disease detected at SLL have found statistically improved survival for patients without evidence of gross tumor.^9,13-15 Podratz et al¹⁴ reported 4-year survival of 55% for women with microscopic findings versus 19% for those with gross disease (P<.01>

The presence of gross tumor at SLL indicates a grave prognosis; median survival ranges between 13 and 24 months.^9,16,17 Nevertheless, several studies have shown that patients able to undergo debulking of all visible disease derive a survival benefit.^4,15,18,19

Given the potential complications of extensive debulking surgery and lack of a proven survival benefit for patients unable to achieve complete cytoreduction, debulking should only be attempted if persistent disease is judged to be completely resectable.

When SLL is positive: Salvage therapy regimens

Many different salvage regimens for epithelial ovarian cancer have been investigated for use after positive second-look laparotomy, including intraperitoneal radioactive phosphorus (³²P), systemic chemotherapy, whole abdominal radiation (WAR), hormonal therapy, and biologic response modifiers. Unfortunately, studies of salvage therapy tend to be retrospective, nonrandomized, and uncontrolled, and no proven regimen has yet been found.

Whole abdominal radiation

This modality appears to confer no definitive survival benefit and does produce toxicity. MacGibbon et al²⁰ treated 51 patients with WAR for both salvage and consolidation. Of these, 27% could not complete treatment because of progressive disease, bowel perforation, myelosuppression, and bowel toxicity. An additional 24% required treatment delays because of hematologic and gastrointestinal toxicity. Among those completing the prescribed course of radiation, 6 developed late bowel symptoms, and 2 of these required surgical intervention to relieve bowel obstruction.

Other salvage therapies

Recently, Dowdy et al¹⁸ reported long-term follow-up for 145 patients with positive findings at SLL. Neither intraperitoneal ³²P nor WAR provided a survival benefit. Multivariate analysis indicated that only grade and volume of residual disease following cytoreduction were associated with improved survival.

Other trials involving intraperitoneal interferon-alpha and carboplatin,²¹ and high-dose chemotherapy with autologous stem cell rescue²² have also failed to demonstrate any significant advantages in survival or rate of progression. An early phase II study of intraperitoneal paclitaxel showed promise: Markman et al²³ noted a complete pathologic response in 61% of patients with microscopic disease at SLL, but only 4% of those with gross disease achieved a complete response.

Need for effective consolidation therapy

A critical component of cancer care is targeting patients at highest risk of recurrence for effective consolidation therapy. The factors most strongly correlated with disease progression are stage at diagnosis, tumor grade, and volume of residual disease after initial cytoreduction.

Many consolidation therapies have been described, including systemic and intraperitoneal chemotherapy, WAR, intraperitoneal ³²P, and biologic response modifiers.

Significant risk of distant recurrences

Although most tumors recur in the abdomen and pelvis, approximately 30% recur at distant locations. For this reason, consider systemic treatment when planning the consolidation regimen. Bertucci et al²² studied systemic melphalan-based, high-dose chemotherapy with autologous stem cell rescue and noted a 5-year progression-free survival of 43% and overall survival of 75%.

 

Most therapies are localized. Most other studies have focused on therapies localized to the peritoneal cavity. Results for intraperitoneal ³²P and WAR are mixed. Several different regimens of intraperitoneal chemotherapy have produced median disease-free survival rates of 18 to 41 months.^24-27 In 1998, Barakat et al²⁷ examined the use of intraperitoneal cisplatin and etoposide, reporting a statistically improved median disease-free survival for patients receiving intraperitoneal consolidation (median disease-free survival not yet reached), compared with patients treated by observation (28.5 months).

Bottom line

Second-look laparotomy reveals that approximately 50% of patients with a complete clinical response still harbor residual disease after primary chemotherapy. Even women who achieve a complete pathologic response have recurrence rates as high as 60%. While SLL can be a useful tool, the information it yields must be weighed against the potential morbidities of invasive surgery. Given its limited prognostic value, SLL should be offered only when results will influence clinical decision-making, or as part of a clinical trial.

The authors report no financial relationships relevant to this article.

After several decades of slow progress, the field of urogynecology is experiencing dynamic change, including:

• new minimally invasive, tension-free, midurethral sling procedures, especially the transobturator approach,
• correction of size-specific defects to repair prolapse, and
• use of mesh/graft augmentation in pro lapse repair.

These developments are some of the most important since Kelly and Dunn first described suburethral fascial plication for stress incontinence and cystocele in 1914.¹ They have come about through increased understanding of the pathophysiology of incontinence and prolapse, innovative technology and techniques, and improved communication and coordination among physicians worldwide.

New sling procedures, promising outcomes

The minimally invasive midurethral sling procedure spawned notable new approaches and is a mainstay of surgical treatment for stress urinary incontinence.

First described in Sweden by Ulmsten in 1995,² the tension-free vaginal tape procedure is a revolutionary change in the suburethral sling procedure and is now the most widely performed surgery for stress incontinence worldwide.

In it, a tension-free vaginal tape (TVT) (Gynecare, Somerville, NJ) of synthetic polypropylene mesh is attached to 2 needles and passed through a vaginal incision and the retropubic space, exiting to small incisions in the suprapubic region to create a suburethral sling or hammock and provide urethral support during increased abdominal pressure. The sling remains fixed by friction and subsequent adhesions.

Although the traditional suburethral sling was less invasive than other abdominal incontinence procedures, it was associated with a steep learning curve and a high incidence of postoperative irritative bladder symptoms and voiding dysfunction.³

Tension-free vaginal tape: Excellent long-term cure

It can be performed routinely in under 30 minutes using local anesthesia, with minimal postoperative complications. Five-year cure rates approach 95%,⁴ and data presented at the 2003 International Urogynecology Association clinical meeting describe an objective 7-year cure rate of 82%.⁵

The incidence and severity of postoperative voiding dysfunction following the TVT procedure is significantly lower than that reported after traditional suburethral sling (2%–40%) or transvaginal needle suspension (2%–50%) procedures.^6-9 Although bladder perforation has occurred in up to 10% of patients, reports of complications, including major hemorrhage, tape erosion, and bowel and nerve injury, are rare.^10,11

Modifications

These products have a modified approach, materials, or refinements in technique to address various needs. For example, American Medical Systems (Minnetonka, Minn) introduced the SPARC procedure, which allows abdominal placement of the midurethral sling, similar to a needle suspension technique.

CR Bard (Murray Hill, NJ) introduced a midurethral sling of porcine dermis (Pelvicol) to address concerns physicians may have about using synthetic materials.

Minimally invasive midurethral slings include the Advantage (Boston Scientific, Natick, Mass), Centrasorb (Caldera Medical, Thousand Oaks, Calif), Stratasis TF (Cook, West Lafayette, Ind), and Uretex (CR Bard).

Newest approach: Transobturator sling

In this technique, the sling is placed in the midurethral position, but the insertion points are in the genital area lateral to the vagina, and the needle passes through the obturator membrane and paraurethral space. Because it avoids passage of the needles through the retropubic space, the transobturator approach theoretically should reduce the risk of bowel, bladder, and major blood vessel injury.

The procedure was initially described in Europe and introduced in the United States in 2003. Current product offerings include the outside-in approach of ObTape (Mentor, Santa Barbara, Calif), Monarc (American Medical Systems), and Uretex (CR Bard). Gynecare offers a variation of its TVT—the TVT-Obturator—which involves an inside-out approach to further minimize risk of vascular injury.

Shortage of long-term data, but good early results

In a 1-year follow-up of patients undergoing a sling procedure with the UraTape transobturator sling (Mentor), Delorme and colleagues¹² reported that 29 of 32 patients (90.6%) were cured and 3 (9.4%) improved. De Leval¹³ described his inside-out approach with equally good results: no bladder or urethral injuries and no vascular (hematoma or bleeding) or neurological complications. A transobturator technique using porcine dermis has also been described.

Tension-free vaginal tape versus transobturator sling

In 2004, a small randomized, prospective trial of TVT (n = 29) versus transobturator tape (n = 27) with 1-year follow-up found the transobturator approach to be safer and easier to place with equivalent short-term results.¹⁴ Mean operative time was significantly shorter in the transobturator group (15±4 minutes versus 27±8 minutes, P <.001).

No bladder injury occurred in the transobturator group versus 9.7% (n = 3) in the TVT group (P >.05). The rate of postoperative urinary retention was 25.8% (n = 8) in the TVT group versus 13.3% (n = 4) in the transobturator group (P >.05). Cure rates were similar for the TVT and transobturator groups: 83.9% versus 90%, respectively), improvement (9.7% versus 3.3%), and failure (6.5% versus 6.7%). No vaginal erosion occurred in either group.

 

Additional investigations of the transobturator tape procedure are underway.

Correcting site-specific defects in prolapse repair

This repair rationale should become the standard, although it has yet to be widely adopted and procedural refinement and research are continuing.

As early as 1908, site-specific defects in the endopelvic fascia were identified as the likely cause of anterior vaginal segment prolapse. Like hernia repair, which requires closure of the fascial defect, the “cystocele hernia” repair advocated by George White involved reattaching the endopelvic fascia to the arcus tendineus fascia pelvis using a series of interrupted sutures through an abdominal retropubic approach.

Although this view was later abandoned, it resurfaced in the 1980s, when Cullen Richardson described midline, lateral, and transverse defects (FIGURE 1) in the endopelvic fascia as the cause of cystocele and rectocele.¹⁵ Richardson advocated diagnosis that identified these fascial defects, along with treatment with site-specific repair.

(In the intervening decades, prolapse was thought to result from generalized weakening or attenuation of the endopelvic fascia that supports the bladder, rectum, or vagina, leading to cystocele, rectocele, or uterine prolapse, respectively. Traditional repairs, still widely performed by most gynecologists, consist of the anterior and posterior colporrhaphy, which involve midline plication of the endopelvic fascia to reduce the prolapse and recreate support by strengthening the weakened fascial layer.)

FIGURE 1 Identify the site of defect

Whether the defect that causes a rectocele or cystocele is transverse, central, or lateral determines the type of repair to be performed. Reprinted with permission from Richardson AC. The rectovaginal septum revisited: its relationship to rectocele and its importance in rectocele repair. Clin Obstet Gynecol.1993;36(4):976–983.

Excellent cure rates with fewer complications

Site-specific repair (FIGURE 2) has been adopted by many pelvic surgeons, who report excellent cure rates with fewer complications such as dyspareunia, vaginal narrowing, and increased blood loss—all of which are more common with traditional anterior and posterior colporrhaphy.

Traditional colporrhaphy does correct the underlying fascial defect when the “hernia” is in the midline. However, for lateral and transverse defects, traditional colporrhaphy leaves the defect uncorrected and may even create additional tension, resulting in recurrence.

Site-specific repair also is useful in the treatment of enterocele, which has been described as a herniation of the peritoneum through a defect of the anterior and posterior fascial planes at the vaginal apex.¹⁶

Widening but not broad acceptance

Although cure rates for site-specific prolapse repair range from 75% to 85%,^17,18 the concept has yet to be widely adopted and continues to undergo procedural refinement and research, as well as physician education. With increasing experience and clinical data, it may become the standard for pelvic prolapse repair.

FIGURE 2 Repair the defect to correct the rectocele

Surgical technique for a transverse tear in the rectovaginal fascia: After identifying the defect, place a series of interrupted sutures to reapproximate the fascial edges (copyright Miklos/Kohli).

Mesh augmentation: Useful in selected patients

Although augmentation with mesh or biomaterials is easy to perform, it remains unclear which technique and materials are optimal.

The use of mesh and biomaterials to augment repair of a cystocele, rectocele, or enterocele is slowly increasing, although general surgeons have been utilizing these materials for many years in hernia repair.

Augmentation has been advocated for “pelvic hernias” because of poor long-term cure rates for traditional prolapse surgeries (which range from 40% to 80%—well behind rates of 90% or more for incontinence procedures).

A recent informal survey of the members of the American Urogynecologic Society and International Urogynecologic Association revealed that most pelvic surgeons are using some type of graft or mesh to augment repairs in selected patients.

Synthetic mesh versus autologous and heterologous grafts

Synthetic materials have the advantage of being readily available, cost-effective, and consistent in quality, but they may cause significant complications, including infection, stricture, and erosion. This is especially important in the vagina, which needs to stretch during intercourse and which alters in thickness and other properties during a woman’s lifetime.

In contrast, autologous and heterologous donor grafts provide naturally occurring biomaterials capable of remodeling. Unfortunately, the in vivo tissue response is not yet fully understood. Other disadvantages: Biomaterials may lack consistent tissue properties and can be expensive.

For these reasons, graft materials remain in an early period of evaluation, although their use is expected to rise steadily with increasing experience and new product development.

Limited data on safety and efficacy

Although many pelvic surgeons use graft/mesh materials in prolapse repair, data on their safety and efficacy are limited, partly due to the variety of surgical techniques and materials available. Another factor is the difficulty of obtaining good long-term data with large patient numbers. Most of the literature is comprised of case reports, with few prospective, randomized trials.

 

That said, initial data suggest a significant improvement in cure rates, compared with traditional techniques, with minimal short-term complications. Long-term results and complication rates are not yet available.

What existing studies show

A variety of synthetic materials have been used in surgical correction of cystocele. In the largest series to date, Flood and colleagues¹⁹ reported their 12-year experience with 142 women undergoing a modified anterior colporrhaphy reinforced with Marlex (Davol, Cranston, RI) mesh: 100% success in correcting cystocele and a 74% success rate for urinary stress incontinence, with a mean follow-up of 3.2 years and no significant intraoperative complications.

In a prospective randomized trial of 125 patients utilizing absorbable polyglactin 910 mesh (Vicryl) (Ethicon, Somerville, NJ) to augment standard anterior colporrhaphy, Koduri et al²⁰ reported a failure rate of 13% in the colporrhaphy-alone group compared to 1% in the colporrhaphy-mesh group at the 1-year follow-up. Subjectively, both groups improved equally.

Clemons et al²¹ used a human dermis graft to treat advanced recurrent cystocele in 33 women, with a follow-up of 18 months. They noted 13 (41%) objective failures and 1 (3%) subjective failure. Complications included 1 case of febrile morbidity, 1 cystotomy, and 1 anterior wall breakdown secondary to hematoma formation caused by heparin therapy. No other erosions or rejections were seen.

Most effective applications

Graft/mesh augmentation may be most effective in posterior vaginal segment reconstruction and rectocele repair, as it obviates the need for levatorplasty in patients with poor rectovaginal fascia. A variety of synthetic materials have been used for posterior wall reconstruction in small series.

Mersilene mesh

Mersilene mesh (Ethicon) was used by Fox and Stanton²² to augment traditional rectocele repair in 29 women followed for 14 months. Most of the women had undergone previous rectocele repair with recurrence of their prolapse. All women with stage II and stage III vault prolapse were corrected, with an increase in stage I prolapse from 20% to 27%. All women with stage II and stage III rectocele were corrected, with a decrease in stage I prolapse from 36% to 7%. The only significant intraoperative complication was a cystotomy. One mesh became infected postoperatively, requiring removal.

Cadaveric dermal graft

Recently, Kohli and Miklos²³ reported their experience with 57 patients undergoing augmented rectocele repair using a cadaveric dermal graft (FIGURE 3) over a 2-year period. Average follow-up was 11 months. Average patient age in the follow-up group was 63.6±10.9 years (range: 33–79 years) and average parity was 2.8±1.5 (range: 0–7). No major intraoperative complications (hollow viscous injury, blood loss greater than 500 cc, or transfusion) or post-operative complications (infection, abscess, or hematoma) were noted. No graft-related complications such as rejection, erosion, infection, and fistula formation were noted during the follow-up period.

Using previously accepted Pelvic Organ Prolapse Quantification (POP-Q) parameters for success, Kohli and Miklos found 54 of 57 women (95%) to have surgical cure at follow-up. These authors have also described the use of a dermal graft in the repair of a complicated rectovaginal fistula.²⁴

FIGURE 3 Placement of mesh augmentation

Augment enterocele/rectocele repair by attaching the mesh apically, laterally, and distally (copyright Miklos/Kohli).

Future outlook

Further data on the efficacy and safety of graft/mesh augmentation—including identification of the optimal technique and ideal material—are necessary before this approach can be widely adopted. However, in selected patients, it represents a significant advance in the surgical treatment of pelvic prolapse.

The author is a preceptor for American Medical Systems, Gynecare, CR Bard, and Mentor and a consultant for Boston Scientific.

After several decades of slow progress, the field of urogynecology is experiencing dynamic change, including:

• new minimally invasive, tension-free, midurethral sling procedures, especially the transobturator approach,
• correction of size-specific defects to repair prolapse, and
• use of mesh/graft augmentation in pro lapse repair.

These developments are some of the most important since Kelly and Dunn first described suburethral fascial plication for stress incontinence and cystocele in 1914.¹ They have come about through increased understanding of the pathophysiology of incontinence and prolapse, innovative technology and techniques, and improved communication and coordination among physicians worldwide.

New sling procedures, promising outcomes

The minimally invasive midurethral sling procedure spawned notable new approaches and is a mainstay of surgical treatment for stress urinary incontinence.

First described in Sweden by Ulmsten in 1995,² the tension-free vaginal tape procedure is a revolutionary change in the suburethral sling procedure and is now the most widely performed surgery for stress incontinence worldwide.

In it, a tension-free vaginal tape (TVT) (Gynecare, Somerville, NJ) of synthetic polypropylene mesh is attached to 2 needles and passed through a vaginal incision and the retropubic space, exiting to small incisions in the suprapubic region to create a suburethral sling or hammock and provide urethral support during increased abdominal pressure. The sling remains fixed by friction and subsequent adhesions.

Although the traditional suburethral sling was less invasive than other abdominal incontinence procedures, it was associated with a steep learning curve and a high incidence of postoperative irritative bladder symptoms and voiding dysfunction.³

Tension-free vaginal tape: Excellent long-term cure

It can be performed routinely in under 30 minutes using local anesthesia, with minimal postoperative complications. Five-year cure rates approach 95%,⁴ and data presented at the 2003 International Urogynecology Association clinical meeting describe an objective 7-year cure rate of 82%.⁵

The incidence and severity of postoperative voiding dysfunction following the TVT procedure is significantly lower than that reported after traditional suburethral sling (2%–40%) or transvaginal needle suspension (2%–50%) procedures.^6-9 Although bladder perforation has occurred in up to 10% of patients, reports of complications, including major hemorrhage, tape erosion, and bowel and nerve injury, are rare.^10,11

Modifications

These products have a modified approach, materials, or refinements in technique to address various needs. For example, American Medical Systems (Minnetonka, Minn) introduced the SPARC procedure, which allows abdominal placement of the midurethral sling, similar to a needle suspension technique.

CR Bard (Murray Hill, NJ) introduced a midurethral sling of porcine dermis (Pelvicol) to address concerns physicians may have about using synthetic materials.

Minimally invasive midurethral slings include the Advantage (Boston Scientific, Natick, Mass), Centrasorb (Caldera Medical, Thousand Oaks, Calif), Stratasis TF (Cook, West Lafayette, Ind), and Uretex (CR Bard).

Newest approach: Transobturator sling

In this technique, the sling is placed in the midurethral position, but the insertion points are in the genital area lateral to the vagina, and the needle passes through the obturator membrane and paraurethral space. Because it avoids passage of the needles through the retropubic space, the transobturator approach theoretically should reduce the risk of bowel, bladder, and major blood vessel injury.

The procedure was initially described in Europe and introduced in the United States in 2003. Current product offerings include the outside-in approach of ObTape (Mentor, Santa Barbara, Calif), Monarc (American Medical Systems), and Uretex (CR Bard). Gynecare offers a variation of its TVT—the TVT-Obturator—which involves an inside-out approach to further minimize risk of vascular injury.

Shortage of long-term data, but good early results

In a 1-year follow-up of patients undergoing a sling procedure with the UraTape transobturator sling (Mentor), Delorme and colleagues¹² reported that 29 of 32 patients (90.6%) were cured and 3 (9.4%) improved. De Leval¹³ described his inside-out approach with equally good results: no bladder or urethral injuries and no vascular (hematoma or bleeding) or neurological complications. A transobturator technique using porcine dermis has also been described.

Tension-free vaginal tape versus transobturator sling

In 2004, a small randomized, prospective trial of TVT (n = 29) versus transobturator tape (n = 27) with 1-year follow-up found the transobturator approach to be safer and easier to place with equivalent short-term results.¹⁴ Mean operative time was significantly shorter in the transobturator group (15±4 minutes versus 27±8 minutes, P <.001).

No bladder injury occurred in the transobturator group versus 9.7% (n = 3) in the TVT group (P >.05). The rate of postoperative urinary retention was 25.8% (n = 8) in the TVT group versus 13.3% (n = 4) in the transobturator group (P >.05). Cure rates were similar for the TVT and transobturator groups: 83.9% versus 90%, respectively), improvement (9.7% versus 3.3%), and failure (6.5% versus 6.7%). No vaginal erosion occurred in either group.

 

Additional investigations of the transobturator tape procedure are underway.

Correcting site-specific defects in prolapse repair

This repair rationale should become the standard, although it has yet to be widely adopted and procedural refinement and research are continuing.

As early as 1908, site-specific defects in the endopelvic fascia were identified as the likely cause of anterior vaginal segment prolapse. Like hernia repair, which requires closure of the fascial defect, the “cystocele hernia” repair advocated by George White involved reattaching the endopelvic fascia to the arcus tendineus fascia pelvis using a series of interrupted sutures through an abdominal retropubic approach.

Although this view was later abandoned, it resurfaced in the 1980s, when Cullen Richardson described midline, lateral, and transverse defects (FIGURE 1) in the endopelvic fascia as the cause of cystocele and rectocele.¹⁵ Richardson advocated diagnosis that identified these fascial defects, along with treatment with site-specific repair.

(In the intervening decades, prolapse was thought to result from generalized weakening or attenuation of the endopelvic fascia that supports the bladder, rectum, or vagina, leading to cystocele, rectocele, or uterine prolapse, respectively. Traditional repairs, still widely performed by most gynecologists, consist of the anterior and posterior colporrhaphy, which involve midline plication of the endopelvic fascia to reduce the prolapse and recreate support by strengthening the weakened fascial layer.)

FIGURE 1 Identify the site of defect

Whether the defect that causes a rectocele or cystocele is transverse, central, or lateral determines the type of repair to be performed. Reprinted with permission from Richardson AC. The rectovaginal septum revisited: its relationship to rectocele and its importance in rectocele repair. Clin Obstet Gynecol.1993;36(4):976–983.

Excellent cure rates with fewer complications

Site-specific repair (FIGURE 2) has been adopted by many pelvic surgeons, who report excellent cure rates with fewer complications such as dyspareunia, vaginal narrowing, and increased blood loss—all of which are more common with traditional anterior and posterior colporrhaphy.

Traditional colporrhaphy does correct the underlying fascial defect when the “hernia” is in the midline. However, for lateral and transverse defects, traditional colporrhaphy leaves the defect uncorrected and may even create additional tension, resulting in recurrence.

Site-specific repair also is useful in the treatment of enterocele, which has been described as a herniation of the peritoneum through a defect of the anterior and posterior fascial planes at the vaginal apex.¹⁶

Widening but not broad acceptance

Although cure rates for site-specific prolapse repair range from 75% to 85%,^17,18 the concept has yet to be widely adopted and continues to undergo procedural refinement and research, as well as physician education. With increasing experience and clinical data, it may become the standard for pelvic prolapse repair.

FIGURE 2 Repair the defect to correct the rectocele

Surgical technique for a transverse tear in the rectovaginal fascia: After identifying the defect, place a series of interrupted sutures to reapproximate the fascial edges (copyright Miklos/Kohli).

Mesh augmentation: Useful in selected patients

Although augmentation with mesh or biomaterials is easy to perform, it remains unclear which technique and materials are optimal.

The use of mesh and biomaterials to augment repair of a cystocele, rectocele, or enterocele is slowly increasing, although general surgeons have been utilizing these materials for many years in hernia repair.

Augmentation has been advocated for “pelvic hernias” because of poor long-term cure rates for traditional prolapse surgeries (which range from 40% to 80%—well behind rates of 90% or more for incontinence procedures).

A recent informal survey of the members of the American Urogynecologic Society and International Urogynecologic Association revealed that most pelvic surgeons are using some type of graft or mesh to augment repairs in selected patients.

Synthetic mesh versus autologous and heterologous grafts

Synthetic materials have the advantage of being readily available, cost-effective, and consistent in quality, but they may cause significant complications, including infection, stricture, and erosion. This is especially important in the vagina, which needs to stretch during intercourse and which alters in thickness and other properties during a woman’s lifetime.

In contrast, autologous and heterologous donor grafts provide naturally occurring biomaterials capable of remodeling. Unfortunately, the in vivo tissue response is not yet fully understood. Other disadvantages: Biomaterials may lack consistent tissue properties and can be expensive.

For these reasons, graft materials remain in an early period of evaluation, although their use is expected to rise steadily with increasing experience and new product development.

Limited data on safety and efficacy

Although many pelvic surgeons use graft/mesh materials in prolapse repair, data on their safety and efficacy are limited, partly due to the variety of surgical techniques and materials available. Another factor is the difficulty of obtaining good long-term data with large patient numbers. Most of the literature is comprised of case reports, with few prospective, randomized trials.

 

That said, initial data suggest a significant improvement in cure rates, compared with traditional techniques, with minimal short-term complications. Long-term results and complication rates are not yet available.

What existing studies show

A variety of synthetic materials have been used in surgical correction of cystocele. In the largest series to date, Flood and colleagues¹⁹ reported their 12-year experience with 142 women undergoing a modified anterior colporrhaphy reinforced with Marlex (Davol, Cranston, RI) mesh: 100% success in correcting cystocele and a 74% success rate for urinary stress incontinence, with a mean follow-up of 3.2 years and no significant intraoperative complications.

In a prospective randomized trial of 125 patients utilizing absorbable polyglactin 910 mesh (Vicryl) (Ethicon, Somerville, NJ) to augment standard anterior colporrhaphy, Koduri et al²⁰ reported a failure rate of 13% in the colporrhaphy-alone group compared to 1% in the colporrhaphy-mesh group at the 1-year follow-up. Subjectively, both groups improved equally.

Clemons et al²¹ used a human dermis graft to treat advanced recurrent cystocele in 33 women, with a follow-up of 18 months. They noted 13 (41%) objective failures and 1 (3%) subjective failure. Complications included 1 case of febrile morbidity, 1 cystotomy, and 1 anterior wall breakdown secondary to hematoma formation caused by heparin therapy. No other erosions or rejections were seen.

Most effective applications

Graft/mesh augmentation may be most effective in posterior vaginal segment reconstruction and rectocele repair, as it obviates the need for levatorplasty in patients with poor rectovaginal fascia. A variety of synthetic materials have been used for posterior wall reconstruction in small series.

Mersilene mesh

Mersilene mesh (Ethicon) was used by Fox and Stanton²² to augment traditional rectocele repair in 29 women followed for 14 months. Most of the women had undergone previous rectocele repair with recurrence of their prolapse. All women with stage II and stage III vault prolapse were corrected, with an increase in stage I prolapse from 20% to 27%. All women with stage II and stage III rectocele were corrected, with a decrease in stage I prolapse from 36% to 7%. The only significant intraoperative complication was a cystotomy. One mesh became infected postoperatively, requiring removal.

Cadaveric dermal graft

Recently, Kohli and Miklos²³ reported their experience with 57 patients undergoing augmented rectocele repair using a cadaveric dermal graft (FIGURE 3) over a 2-year period. Average follow-up was 11 months. Average patient age in the follow-up group was 63.6±10.9 years (range: 33–79 years) and average parity was 2.8±1.5 (range: 0–7). No major intraoperative complications (hollow viscous injury, blood loss greater than 500 cc, or transfusion) or post-operative complications (infection, abscess, or hematoma) were noted. No graft-related complications such as rejection, erosion, infection, and fistula formation were noted during the follow-up period.

Using previously accepted Pelvic Organ Prolapse Quantification (POP-Q) parameters for success, Kohli and Miklos found 54 of 57 women (95%) to have surgical cure at follow-up. These authors have also described the use of a dermal graft in the repair of a complicated rectovaginal fistula.²⁴

FIGURE 3 Placement of mesh augmentation

Augment enterocele/rectocele repair by attaching the mesh apically, laterally, and distally (copyright Miklos/Kohli).

Future outlook

Further data on the efficacy and safety of graft/mesh augmentation—including identification of the optimal technique and ideal material—are necessary before this approach can be widely adopted. However, in selected patients, it represents a significant advance in the surgical treatment of pelvic prolapse.

The author is a preceptor for American Medical Systems, Gynecare, CR Bard, and Mentor and a consultant for Boston Scientific.

After several decades of slow progress, the field of urogynecology is experiencing dynamic change, including:

• new minimally invasive, tension-free, midurethral sling procedures, especially the transobturator approach,
• correction of size-specific defects to repair prolapse, and
• use of mesh/graft augmentation in pro lapse repair.

These developments are some of the most important since Kelly and Dunn first described suburethral fascial plication for stress incontinence and cystocele in 1914.¹ They have come about through increased understanding of the pathophysiology of incontinence and prolapse, innovative technology and techniques, and improved communication and coordination among physicians worldwide.

New sling procedures, promising outcomes

The minimally invasive midurethral sling procedure spawned notable new approaches and is a mainstay of surgical treatment for stress urinary incontinence.

First described in Sweden by Ulmsten in 1995,² the tension-free vaginal tape procedure is a revolutionary change in the suburethral sling procedure and is now the most widely performed surgery for stress incontinence worldwide.

In it, a tension-free vaginal tape (TVT) (Gynecare, Somerville, NJ) of synthetic polypropylene mesh is attached to 2 needles and passed through a vaginal incision and the retropubic space, exiting to small incisions in the suprapubic region to create a suburethral sling or hammock and provide urethral support during increased abdominal pressure. The sling remains fixed by friction and subsequent adhesions.

Although the traditional suburethral sling was less invasive than other abdominal incontinence procedures, it was associated with a steep learning curve and a high incidence of postoperative irritative bladder symptoms and voiding dysfunction.³

Tension-free vaginal tape: Excellent long-term cure

It can be performed routinely in under 30 minutes using local anesthesia, with minimal postoperative complications. Five-year cure rates approach 95%,⁴ and data presented at the 2003 International Urogynecology Association clinical meeting describe an objective 7-year cure rate of 82%.⁵

The incidence and severity of postoperative voiding dysfunction following the TVT procedure is significantly lower than that reported after traditional suburethral sling (2%–40%) or transvaginal needle suspension (2%–50%) procedures.^6-9 Although bladder perforation has occurred in up to 10% of patients, reports of complications, including major hemorrhage, tape erosion, and bowel and nerve injury, are rare.^10,11

Modifications

These products have a modified approach, materials, or refinements in technique to address various needs. For example, American Medical Systems (Minnetonka, Minn) introduced the SPARC procedure, which allows abdominal placement of the midurethral sling, similar to a needle suspension technique.

CR Bard (Murray Hill, NJ) introduced a midurethral sling of porcine dermis (Pelvicol) to address concerns physicians may have about using synthetic materials.

Minimally invasive midurethral slings include the Advantage (Boston Scientific, Natick, Mass), Centrasorb (Caldera Medical, Thousand Oaks, Calif), Stratasis TF (Cook, West Lafayette, Ind), and Uretex (CR Bard).

Newest approach: Transobturator sling

In this technique, the sling is placed in the midurethral position, but the insertion points are in the genital area lateral to the vagina, and the needle passes through the obturator membrane and paraurethral space. Because it avoids passage of the needles through the retropubic space, the transobturator approach theoretically should reduce the risk of bowel, bladder, and major blood vessel injury.

The procedure was initially described in Europe and introduced in the United States in 2003. Current product offerings include the outside-in approach of ObTape (Mentor, Santa Barbara, Calif), Monarc (American Medical Systems), and Uretex (CR Bard). Gynecare offers a variation of its TVT—the TVT-Obturator—which involves an inside-out approach to further minimize risk of vascular injury.

Shortage of long-term data, but good early results

In a 1-year follow-up of patients undergoing a sling procedure with the UraTape transobturator sling (Mentor), Delorme and colleagues¹² reported that 29 of 32 patients (90.6%) were cured and 3 (9.4%) improved. De Leval¹³ described his inside-out approach with equally good results: no bladder or urethral injuries and no vascular (hematoma or bleeding) or neurological complications. A transobturator technique using porcine dermis has also been described.

Tension-free vaginal tape versus transobturator sling

In 2004, a small randomized, prospective trial of TVT (n = 29) versus transobturator tape (n = 27) with 1-year follow-up found the transobturator approach to be safer and easier to place with equivalent short-term results.¹⁴ Mean operative time was significantly shorter in the transobturator group (15±4 minutes versus 27±8 minutes, P <.001).

No bladder injury occurred in the transobturator group versus 9.7% (n = 3) in the TVT group (P >.05). The rate of postoperative urinary retention was 25.8% (n = 8) in the TVT group versus 13.3% (n = 4) in the transobturator group (P >.05). Cure rates were similar for the TVT and transobturator groups: 83.9% versus 90%, respectively), improvement (9.7% versus 3.3%), and failure (6.5% versus 6.7%). No vaginal erosion occurred in either group.

 

Additional investigations of the transobturator tape procedure are underway.

Correcting site-specific defects in prolapse repair

This repair rationale should become the standard, although it has yet to be widely adopted and procedural refinement and research are continuing.

As early as 1908, site-specific defects in the endopelvic fascia were identified as the likely cause of anterior vaginal segment prolapse. Like hernia repair, which requires closure of the fascial defect, the “cystocele hernia” repair advocated by George White involved reattaching the endopelvic fascia to the arcus tendineus fascia pelvis using a series of interrupted sutures through an abdominal retropubic approach.

Although this view was later abandoned, it resurfaced in the 1980s, when Cullen Richardson described midline, lateral, and transverse defects (FIGURE 1) in the endopelvic fascia as the cause of cystocele and rectocele.¹⁵ Richardson advocated diagnosis that identified these fascial defects, along with treatment with site-specific repair.

(In the intervening decades, prolapse was thought to result from generalized weakening or attenuation of the endopelvic fascia that supports the bladder, rectum, or vagina, leading to cystocele, rectocele, or uterine prolapse, respectively. Traditional repairs, still widely performed by most gynecologists, consist of the anterior and posterior colporrhaphy, which involve midline plication of the endopelvic fascia to reduce the prolapse and recreate support by strengthening the weakened fascial layer.)

FIGURE 1 Identify the site of defect

Whether the defect that causes a rectocele or cystocele is transverse, central, or lateral determines the type of repair to be performed. Reprinted with permission from Richardson AC. The rectovaginal septum revisited: its relationship to rectocele and its importance in rectocele repair. Clin Obstet Gynecol.1993;36(4):976–983.

Excellent cure rates with fewer complications

Site-specific repair (FIGURE 2) has been adopted by many pelvic surgeons, who report excellent cure rates with fewer complications such as dyspareunia, vaginal narrowing, and increased blood loss—all of which are more common with traditional anterior and posterior colporrhaphy.

Traditional colporrhaphy does correct the underlying fascial defect when the “hernia” is in the midline. However, for lateral and transverse defects, traditional colporrhaphy leaves the defect uncorrected and may even create additional tension, resulting in recurrence.

Site-specific repair also is useful in the treatment of enterocele, which has been described as a herniation of the peritoneum through a defect of the anterior and posterior fascial planes at the vaginal apex.¹⁶

Widening but not broad acceptance

Although cure rates for site-specific prolapse repair range from 75% to 85%,^17,18 the concept has yet to be widely adopted and continues to undergo procedural refinement and research, as well as physician education. With increasing experience and clinical data, it may become the standard for pelvic prolapse repair.

FIGURE 2 Repair the defect to correct the rectocele

Surgical technique for a transverse tear in the rectovaginal fascia: After identifying the defect, place a series of interrupted sutures to reapproximate the fascial edges (copyright Miklos/Kohli).

Mesh augmentation: Useful in selected patients

Although augmentation with mesh or biomaterials is easy to perform, it remains unclear which technique and materials are optimal.

The use of mesh and biomaterials to augment repair of a cystocele, rectocele, or enterocele is slowly increasing, although general surgeons have been utilizing these materials for many years in hernia repair.

Augmentation has been advocated for “pelvic hernias” because of poor long-term cure rates for traditional prolapse surgeries (which range from 40% to 80%—well behind rates of 90% or more for incontinence procedures).

A recent informal survey of the members of the American Urogynecologic Society and International Urogynecologic Association revealed that most pelvic surgeons are using some type of graft or mesh to augment repairs in selected patients.

Synthetic mesh versus autologous and heterologous grafts

Synthetic materials have the advantage of being readily available, cost-effective, and consistent in quality, but they may cause significant complications, including infection, stricture, and erosion. This is especially important in the vagina, which needs to stretch during intercourse and which alters in thickness and other properties during a woman’s lifetime.

In contrast, autologous and heterologous donor grafts provide naturally occurring biomaterials capable of remodeling. Unfortunately, the in vivo tissue response is not yet fully understood. Other disadvantages: Biomaterials may lack consistent tissue properties and can be expensive.

For these reasons, graft materials remain in an early period of evaluation, although their use is expected to rise steadily with increasing experience and new product development.

Limited data on safety and efficacy

Although many pelvic surgeons use graft/mesh materials in prolapse repair, data on their safety and efficacy are limited, partly due to the variety of surgical techniques and materials available. Another factor is the difficulty of obtaining good long-term data with large patient numbers. Most of the literature is comprised of case reports, with few prospective, randomized trials.

 

That said, initial data suggest a significant improvement in cure rates, compared with traditional techniques, with minimal short-term complications. Long-term results and complication rates are not yet available.

What existing studies show

A variety of synthetic materials have been used in surgical correction of cystocele. In the largest series to date, Flood and colleagues¹⁹ reported their 12-year experience with 142 women undergoing a modified anterior colporrhaphy reinforced with Marlex (Davol, Cranston, RI) mesh: 100% success in correcting cystocele and a 74% success rate for urinary stress incontinence, with a mean follow-up of 3.2 years and no significant intraoperative complications.

In a prospective randomized trial of 125 patients utilizing absorbable polyglactin 910 mesh (Vicryl) (Ethicon, Somerville, NJ) to augment standard anterior colporrhaphy, Koduri et al²⁰ reported a failure rate of 13% in the colporrhaphy-alone group compared to 1% in the colporrhaphy-mesh group at the 1-year follow-up. Subjectively, both groups improved equally.

Clemons et al²¹ used a human dermis graft to treat advanced recurrent cystocele in 33 women, with a follow-up of 18 months. They noted 13 (41%) objective failures and 1 (3%) subjective failure. Complications included 1 case of febrile morbidity, 1 cystotomy, and 1 anterior wall breakdown secondary to hematoma formation caused by heparin therapy. No other erosions or rejections were seen.

Most effective applications

Graft/mesh augmentation may be most effective in posterior vaginal segment reconstruction and rectocele repair, as it obviates the need for levatorplasty in patients with poor rectovaginal fascia. A variety of synthetic materials have been used for posterior wall reconstruction in small series.

Mersilene mesh

Mersilene mesh (Ethicon) was used by Fox and Stanton²² to augment traditional rectocele repair in 29 women followed for 14 months. Most of the women had undergone previous rectocele repair with recurrence of their prolapse. All women with stage II and stage III vault prolapse were corrected, with an increase in stage I prolapse from 20% to 27%. All women with stage II and stage III rectocele were corrected, with a decrease in stage I prolapse from 36% to 7%. The only significant intraoperative complication was a cystotomy. One mesh became infected postoperatively, requiring removal.

Cadaveric dermal graft

Recently, Kohli and Miklos²³ reported their experience with 57 patients undergoing augmented rectocele repair using a cadaveric dermal graft (FIGURE 3) over a 2-year period. Average follow-up was 11 months. Average patient age in the follow-up group was 63.6±10.9 years (range: 33–79 years) and average parity was 2.8±1.5 (range: 0–7). No major intraoperative complications (hollow viscous injury, blood loss greater than 500 cc, or transfusion) or post-operative complications (infection, abscess, or hematoma) were noted. No graft-related complications such as rejection, erosion, infection, and fistula formation were noted during the follow-up period.

Using previously accepted Pelvic Organ Prolapse Quantification (POP-Q) parameters for success, Kohli and Miklos found 54 of 57 women (95%) to have surgical cure at follow-up. These authors have also described the use of a dermal graft in the repair of a complicated rectovaginal fistula.²⁴

FIGURE 3 Placement of mesh augmentation

Augment enterocele/rectocele repair by attaching the mesh apically, laterally, and distally (copyright Miklos/Kohli).

Future outlook

Further data on the efficacy and safety of graft/mesh augmentation—including identification of the optimal technique and ideal material—are necessary before this approach can be widely adopted. However, in selected patients, it represents a significant advance in the surgical treatment of pelvic prolapse.

The author is a preceptor for American Medical Systems, Gynecare, CR Bard, and Mentor and a consultant for Boston Scientific.

Major vessel injury is a two-sided coin: It can occur with alarming speed, but it is preventable.

Fortunately, the laparoscopic surgeon can avoid the problem by following simple precautions and steering clear of scenarios that increase the risk of injury. This article tells how to accomplish both objectives.

In the process, it reviews the evidence, details management for any injuries that occur, and includes a comprehensive table listing typical distances between the entry trocar and vascular structures, to help the surgeon adjust entry strategy.

Adequate prevention depends on:

• familiarity with the vascular anatomy, particularly in relation to the umbilicus, presacral space, infundibulopelvic ligament, and ovarian fossa.
• creating a proper pneumoperitoneum, especially when using disposable trocars.
• careful attention to primary trocar thrusting techniques to ensure midline insertion at the proper angle. Also exercise caution when placing secondary trocars. Specifically, during far lateral insertion, avoid cleaving the inferior epigastric artery from the external iliac or directly hitting the external artery or vein.
• avoiding long trocars, which are unnecessary to penetrate the peritoneal cavity.
• reliance on laparotomy if trocar insertion proves too difficult, vision is obscured, or appropriate anatomic dissection planes cannot be developed.
• when injury occurs, performing laparotomy using a vertical incision.

How big is the problem?

A French study¹ of 103,852 laparoscopic procedures—of which 15.7%, or 16,000 operations, were gynecologic—reported 47 cases of major vascular injury for an incidence of 0.5 per 1,000 cases and a mortality rate of 17%. Several additional articles^2-8 reported a range of vascular complications of between 0.1 and 6.4 per 1,000 laparoscopies.

 

In a study⁹ conducted in 7 gynecologic laparoscopy surgery centers in France over 9 years and involving 29,966 diagnostic and operative cases, the overall complication rate was 4.64 per 1,000 laparoscopies (n = 139). Of the 21 major vascular injuries associated with gynecologic surgery, the majority occurred during set-up, and 84.6% during insertion of the primary trocar. Two patients died from their injuries.

Bhoyrul and colleagues¹⁰ analyzed data reported to the US Food and Drug Administration and found that 408 of 629 trocar-related injuries involved major blood vessels, as did 26 of 32 deaths (81%). Most of the deaths (87%) were linked to the use of disposable trocars equipped with safety shields; 9% with direct-view trocars. Although surgeons asserted that the trocar malfunctioned in 41 cases, that claim was confirmed in only 1 case (2%).

Another study found that 37 of 79 (46.8%) serious complications involving optical-access trocars between 1994 and 2002 involved major vessels, injuring the aorta, iliac vessels, or vena cava.¹¹

A study¹² carried out in the Netherlands in 1994 evaluated the relative number of complications that occurred within a total of 25,764 laparoscopic procedures. The study divided complications into those occurring as the result of the laparoscopic approach (eg, trocar insertion) versus those happening during the performance of the operation. Fifty-seven percent of the 145 complications were caused by the laparoscopic approach; the 2 reported deaths also were secondary to that approach.

Snapshot of vascular injury: A series of 31 patients

In 2003, I published data¹³ on 31 cases of major vessel injury associated with gynecologic laparoscopy (see). These cases were collected from a variety of sources: medicolegal case files, hospital morbidity-mortality presentations, and quality-assurance departments. Eight cases involved diagnostic procedures, while 23 involved operative laparoscopy.

The medical records of these cases provided details on the nature of the injury. The cases were categorized by body mass index (BMI) and cause, ie, whether they occurred as the result of the laparoscopic approach (ie, entry-related) or arose during surgery.

Of the 31 cases, 22 (71%) involved women with BMIs from 25 to more than 30 (overweight or obese). A large majority—28 cases (90%)—were related to entry. Only 3 injuries occurred during surgery.

In several women, more than 1 vessel was damaged. Of the 49 total injuries, 38 (78%) involved the iliac vessels. Seven (23%) women died as a result of their injuries, all of which involved venous trauma.

Damage to structures in the vicinity of the injured vessels was substantial in 16 cases. Major morbidity included ureteral, nerve, and intestinal injury; arterial and venous thrombosis; compartment syndrome; and suturing of the wrong vessel.

Some patients also experienced edema or pain in an extremity (vascular insufficiency); infection; diffuse intravascular coagulation and/or adult respiratory distress; cardiac arrest; central nervous system injury (stroke); or hospitalization of more than 1 week. Cases also were categorized as early or late diagnosis, depending on whether shock had supervened. Diagnosis was early in 8 cases (26%) and late in 21 (68%). Two patients were diagnosed postoperatively; ie, they had gone to the recovery room prior to developing shock.

The volume of blood loss ranged from 1,000 mL to 7,000 mL, with a mean loss of 3,400 mL. All patients received packed red blood cells and/or a mixture of other blood products. The time required for cross-matching and receiving blood ranged from 10 to 120 minutes.

In all cases, a vascular or general surgeon was called to consult on the case.

Mapping vascular structures to ensure safe trocar entry

Knowing the distances between blood vessels and laparoscopic entry trocars is critical if injury is to be avoided. In pursuit of this goal, Hurd and colleagues¹⁴ performed a retrospective study involving women who had undergone magnetic resonance imaging or computed tomography scans of the abdomen. Investigators measured the distance between the lower abdominal wall and the aortic bifurcation in these women, who were all unanesthetized and in the supine position.

Distances increased with BMI

This occurred in the study by Hurd et al,¹⁴ as well as in a prospective study by Narendran and Baggish,¹⁵ who calculated body mass index in 101 consecutive women who were undergoing diagnostic or operative laparoscopy. These women were anesthetized, with pneumoperitoneum established and a laparoscope inserted; all were in the lithotomy position.

In this study, Narendran and Baggish measured the following distances from the entry trocar:

• perpendicular distance to aortic bifurcation,
• oblique distance to the right and left common iliac vessels,
• oblique distance to the superior margin of the bladder,
• perpendicular distance from the peritoneum to skin at the umbilicus (abdominal wall thickness), and
• oblique distance from the subumbilical peritoneal opening to the right and left common iliac vessels.

 

Wide range of BMIs

In the study by Narendran and Baggish, successful measurement panels were created for 99 of the 101 cases. Of these, 49 women had a BMI of less than 25 (normal), 29 had a BMI greater than 25 but less than 30 (overweight), and 21 had a BMI greater than 30 (obese).

A significant difference was observed in the perpendicular distance from the entry trocar to aortic bifurcation (TABLE 1). Specifically, as the BMI increased, so did the distance. The only other significant BMI-related increase was the abdominal wall thickness, which also varied directly with the BMI.

Other distances increase with height

The distance between the primary trocar and the iliac vessels and urinary bladder consistently increased with the patient’s height.

However, no significant change in distance between the great vessels and the primary trocar site occurred when the patient’s position changed from level to Trendelenburg.

Trocar insertion: Disposable devices require less force

Laparoscopic trocar thrusting is a dynamic process, and we observed that process in our study.¹⁵ When force is applied via trocar to the anterior abdominal wall, that structure is displaced toward the abdominal cavity in the direction of the posterior abdominal wall—even when countertraction is taken into consideration. The movement is more apparent in obese women because of greater elasticity created by the larger mass of properitoneal and subcutaneous fat. We measured the distortion and determined that the depression can be 5 cm or more.

In contrast, thin women have rigid, relatively unyielding anterior abdominal walls and therefore experience minimal displacement. In thin women, the greater risk is the shorter passive distance between the anterior abdominal wall and the great vessels.

Comparing force curves

We¹⁶ calculated the force required to thrust a disposable or reusable trocar through the anterior abdominal wall during actual laparoscopic surgery. We used a 25-lb compression load cell connected to the trocar by an Ultem handle, which could be sterilized between cases. A linear variable displacement transducer detected displacement, and the measuring apparata fed data into a computer. Ten women were randomized to a disposable trocar and 10 to a reusable device.

The mean thrusting force for disposable trocars was 10.2 lb versus 17.53 lb for the reusable device. The time to penetrate was likewise significantly shortened for disposable trocars: mean time of 3.54 seconds versus 11.64 seconds. Overall work tilted in favor of disposable trocars: 14.34 pound-seconds versus 103.88 pound-seconds.

The disposable trocar has the advantage for 2 reasons: its razor-sharp cutting edge and streamlined design.

FIGURE 1 shows typical force curves of disposable and reusable trocars.

FIGURE 1 Reusable trocar requires more force than disposable trocar

A considerable difference in force is required for insertion, depending on type of device, as this graph of typical force curves shows. The reusable trocar requires 18 to 20 lb of force over 12 seconds; the disposable, only 5 lb over 2 seconds.

Safe trocar insertion begins with pneumoperitoneum

McDougall et al¹⁷ demonstrated that adequate pneumoperitoneum lessens the force required to drive a trocar through the anterior abdominal wall. Although the differences were small, the forces required with an intraperitoneal gas pressure of 30 mm Hg were smaller than those required with a pressure of 15 mm Hg.¹⁷

Manufacturers of disposable trocars also recommend creating an adequate pneumoperitoneum prior to aiming and inserting the razor-sharp device. The goal is creating a carbon dioxide gas pocket large enough to permit rapid deployment of the “safety shield” after the trocar tip clears the properitoneal fat and peritoneal membrane.

Slow-motion video sequences of disposable trocar entry show the sharp trocar tip penetrating the parietal peritoneum of the anterior abdominal wall for 1 cm before the spring-loaded shield advances and locks over the blade. During this insertion, the anterior abdominal wall has an elastic reaction to the applied force; this reaction pushes it toward the posterior abdominal wall.

Direct insertions (ie, without adequate pneumoperitoneum) involve less space for the trocar’s safety shield to deploy. Thus, there is a greater risk of the armed trocar tip coming into direct contact with underlying viscera and blood vessels.

 

Use a shorter insufflation needle

Our data on women with a BMI greater than 30 (obese range) indicate that the mean thickness of the anterior abdominal wall is 5.05 cm and the distance to the aorta is 15.14 cm.¹⁵ A standard Verres needle measures 12.5 cm from the tip of the shaft to the point where the shaft joins the hub of the needle. This is clearly excessive length, since women with a BMI above 30 have an abdominal wall thickness of approximately 5.05 cm and women with BMIs between 25 and 30 have a thickness of only 3.85 cm.

I prefer a Touhy epidural needle for subumbilical insertion and creation of the pneumoperitoneum, since it is a relatively short 8.5 cm. Thus, it is less hazardous than the Verres needle. It also is less likely to clog with tissue fragments because of its curved tip, and more likely to create a successful pneumoperitoneum on the first try.

Fortunately, large-vessel injuries caused by the insufflation needle are rare.

Proper insertion technique

I have residents draw a straight line with a marking pen from the lower margin of the umbilicus to the superior margin of the pubic symphysis. This serves as a guide to keep the trocar pointing toward the middle of the abdomen, away from the iliac vessels. I also teach residents to thrust the trocar in the midline at a 45° to 60° angle in relation to the plane of the abdominal wall, with the trocar pointing toward the uterus (FIGURES 2 AND 3).

Many residents twist disposable trocars during insertion. This “door knob” movement works against the design of the trocar and traumatizes tissue. The correct approach is thrusting the device into the abdominal cavity, or holding the trocar (only for disposable trocar devices) like a dart and thrusting it into the abdomen as though throwing a dart. The only trocar designed for twisting is the conical reusable device; the sharp pyramidal reusable trocar should be thrust rather than twisted.

Avoid “long” trocars

These are a full 5 cm longer than the 20-cm standard device (hub of handle to tip of shaft). Abdominal wall measurements indicate that these devices are never required to simply penetrate the anterior abdominal wall; these trocars also carry the risk of hitting the iliac vessels.

Open laparoscopy is not foolproof

Although open laparoscopy would seem to guarantee safe entry of the primary trocar, reports of aortic injuries have recently been published. Similar data have been reported for optical access trocars.^11,18

FIGURE 2 Insert the trocar at 45° to 60° angle

At insertion, the trocar should be at a 45°to 60°angle relative to the abdominal wall, with the tip of the device tilted in the direction of the uterus and bladder. A 90°angle of insertion is dangerous.

FIGURE 3 Midline insertion is safest

Insert the primary trocar in the midline pointing toward the uterus; deviation to the right or left is dangerous. Also avoid injuring the inferior epigastric and external iliac vessels with far lateral trocar insertion.

Body habitus and vascular injury

The obese patient of short stature is at the greatest risk for vascular injury. Although the relative distances between the anterior abdominal wall and the aorta are greater at the highest BMI levels, short stature means that the iliac vessels are closer. Significantly, large vessel injuries in the series cited herein were associated with the use of disposable trocars 90% of the time.

I believe high-risk conditions are created when carbon dioxide gas is inadvertently infused into the properitoneal fat space (FIGURE 4). As the volume of gas grows, the anterior wall parietal peritoneum dissects free from the remainder of the anterior abdominal fat, creating a pseudo-pneumoperitoneum. The operator fails to realize that the true peritoneal cavity has not been entered and, in fact, has paradoxically constricted in size because of the enlarging pseudoperitoneal space. Careful attention to the pressure gauges would have aroused suspicion that gas was being infused into the wrong space, since pressures tend to be higher and flow erratic in such situations.

Nevertheless, the surgeon places a trocar into the space, looks through the laparoscope, sees red or yellow, and realizes that the peritoneal cavity has not been entered. More gas is insufflated and the trocar is tried again.

Typically, the duller, reusable trocar pushes the leading edge of the peritoneum rather than penetrating it, further enlarging the properitoneal space and bringing the anterior and posterior peritoneal walls very close together.

In another scenario, the same set of circumstances exists except, rather than employing a reusable trocar, the surgeon selects a disposable device or even, after 2 failures to enter the peritoneal cavity with the reusable device, an extra-long (11-inch) disposable trocar (FIGURE 4).

 

In this scenario, an armed trocar enters the pseudospace—without the safety shield deployed—because no resistance was encountered during penetration of the incision, owing to the fact that two 10–12-mm trocars have previously traversed the same skin incision.

As the tip of the trocar comes into contact with the leading edge of the peritoneum, it encounters resistance, and the razor-sharp blade cuts through the anterior peritoneum, traverses the narrow peritoneal space, and cuts through the posterior peritoneum and the underlying great vessel.

Often, the trocar’s knife edge injures an artery by glancing off the curved surface of the vessels and embedding itself in the neighboring or underlying vein.

The best technique to manage a pseudo-pneumoperitoneal pocket is to abandon the subumbilical site, insert a Touhy needle in the left upper quadrant, and enter and overinflate the peritoneal cavity, thereby obliterating the properitoneal gas space.

When injury occurs: 7 recommended management steps

In the event of a vascular injury, early diagnosis and treatment are vital. Do not observe retroperitoneal hematomas. The following steps are recommended:

1. Call for a vascular surgeon immediately and indicate that the situation is an emergency. Do not waste time trying to locate the injury before calling for help.
2. Get emergency type and cross-match for at least 6 U of whole blood.
3. Obtain baseline lab measurements, including hemoglobin, hematocrit, platelets, fibrinogen, and fibrin split products.
4. Open the abdomen using a vertical incision for maximum access and visibility.
5. Get accurate outputs and blood-loss estimates and have anesthesia keep careful records of fluids given.
6. Advise anesthesia staff to obtain additional help. This will facilitate starting additional IV sites, rapidly infusing blood products, obtaining key samples for laboratory data, and maintaining accurate and detailed records of blood gases, blood loss, replacement fluids, and blood products.
7. Use a circulator to manage urgent medications or laboratory tests.

The author reports no financial relationships relevant to this article.

Major vessel injury is a two-sided coin: It can occur with alarming speed, but it is preventable.

Fortunately, the laparoscopic surgeon can avoid the problem by following simple precautions and steering clear of scenarios that increase the risk of injury. This article tells how to accomplish both objectives.

In the process, it reviews the evidence, details management for any injuries that occur, and includes a comprehensive table listing typical distances between the entry trocar and vascular structures, to help the surgeon adjust entry strategy.

Adequate prevention depends on:

• familiarity with the vascular anatomy, particularly in relation to the umbilicus, presacral space, infundibulopelvic ligament, and ovarian fossa.
• creating a proper pneumoperitoneum, especially when using disposable trocars.
• careful attention to primary trocar thrusting techniques to ensure midline insertion at the proper angle. Also exercise caution when placing secondary trocars. Specifically, during far lateral insertion, avoid cleaving the inferior epigastric artery from the external iliac or directly hitting the external artery or vein.
• avoiding long trocars, which are unnecessary to penetrate the peritoneal cavity.
• reliance on laparotomy if trocar insertion proves too difficult, vision is obscured, or appropriate anatomic dissection planes cannot be developed.
• when injury occurs, performing laparotomy using a vertical incision.

How big is the problem?

A French study¹ of 103,852 laparoscopic procedures—of which 15.7%, or 16,000 operations, were gynecologic—reported 47 cases of major vascular injury for an incidence of 0.5 per 1,000 cases and a mortality rate of 17%. Several additional articles^2-8 reported a range of vascular complications of between 0.1 and 6.4 per 1,000 laparoscopies.

 

In a study⁹ conducted in 7 gynecologic laparoscopy surgery centers in France over 9 years and involving 29,966 diagnostic and operative cases, the overall complication rate was 4.64 per 1,000 laparoscopies (n = 139). Of the 21 major vascular injuries associated with gynecologic surgery, the majority occurred during set-up, and 84.6% during insertion of the primary trocar. Two patients died from their injuries.

Bhoyrul and colleagues¹⁰ analyzed data reported to the US Food and Drug Administration and found that 408 of 629 trocar-related injuries involved major blood vessels, as did 26 of 32 deaths (81%). Most of the deaths (87%) were linked to the use of disposable trocars equipped with safety shields; 9% with direct-view trocars. Although surgeons asserted that the trocar malfunctioned in 41 cases, that claim was confirmed in only 1 case (2%).

Another study found that 37 of 79 (46.8%) serious complications involving optical-access trocars between 1994 and 2002 involved major vessels, injuring the aorta, iliac vessels, or vena cava.¹¹

A study¹² carried out in the Netherlands in 1994 evaluated the relative number of complications that occurred within a total of 25,764 laparoscopic procedures. The study divided complications into those occurring as the result of the laparoscopic approach (eg, trocar insertion) versus those happening during the performance of the operation. Fifty-seven percent of the 145 complications were caused by the laparoscopic approach; the 2 reported deaths also were secondary to that approach.

Snapshot of vascular injury: A series of 31 patients

In 2003, I published data¹³ on 31 cases of major vessel injury associated with gynecologic laparoscopy (see). These cases were collected from a variety of sources: medicolegal case files, hospital morbidity-mortality presentations, and quality-assurance departments. Eight cases involved diagnostic procedures, while 23 involved operative laparoscopy.

The medical records of these cases provided details on the nature of the injury. The cases were categorized by body mass index (BMI) and cause, ie, whether they occurred as the result of the laparoscopic approach (ie, entry-related) or arose during surgery.

Of the 31 cases, 22 (71%) involved women with BMIs from 25 to more than 30 (overweight or obese). A large majority—28 cases (90%)—were related to entry. Only 3 injuries occurred during surgery.

In several women, more than 1 vessel was damaged. Of the 49 total injuries, 38 (78%) involved the iliac vessels. Seven (23%) women died as a result of their injuries, all of which involved venous trauma.

Damage to structures in the vicinity of the injured vessels was substantial in 16 cases. Major morbidity included ureteral, nerve, and intestinal injury; arterial and venous thrombosis; compartment syndrome; and suturing of the wrong vessel.

Some patients also experienced edema or pain in an extremity (vascular insufficiency); infection; diffuse intravascular coagulation and/or adult respiratory distress; cardiac arrest; central nervous system injury (stroke); or hospitalization of more than 1 week. Cases also were categorized as early or late diagnosis, depending on whether shock had supervened. Diagnosis was early in 8 cases (26%) and late in 21 (68%). Two patients were diagnosed postoperatively; ie, they had gone to the recovery room prior to developing shock.

The volume of blood loss ranged from 1,000 mL to 7,000 mL, with a mean loss of 3,400 mL. All patients received packed red blood cells and/or a mixture of other blood products. The time required for cross-matching and receiving blood ranged from 10 to 120 minutes.

In all cases, a vascular or general surgeon was called to consult on the case.

Mapping vascular structures to ensure safe trocar entry

Knowing the distances between blood vessels and laparoscopic entry trocars is critical if injury is to be avoided. In pursuit of this goal, Hurd and colleagues¹⁴ performed a retrospective study involving women who had undergone magnetic resonance imaging or computed tomography scans of the abdomen. Investigators measured the distance between the lower abdominal wall and the aortic bifurcation in these women, who were all unanesthetized and in the supine position.

Distances increased with BMI

This occurred in the study by Hurd et al,¹⁴ as well as in a prospective study by Narendran and Baggish,¹⁵ who calculated body mass index in 101 consecutive women who were undergoing diagnostic or operative laparoscopy. These women were anesthetized, with pneumoperitoneum established and a laparoscope inserted; all were in the lithotomy position.

In this study, Narendran and Baggish measured the following distances from the entry trocar:

• perpendicular distance to aortic bifurcation,
• oblique distance to the right and left common iliac vessels,
• oblique distance to the superior margin of the bladder,
• perpendicular distance from the peritoneum to skin at the umbilicus (abdominal wall thickness), and
• oblique distance from the subumbilical peritoneal opening to the right and left common iliac vessels.

 

Wide range of BMIs

In the study by Narendran and Baggish, successful measurement panels were created for 99 of the 101 cases. Of these, 49 women had a BMI of less than 25 (normal), 29 had a BMI greater than 25 but less than 30 (overweight), and 21 had a BMI greater than 30 (obese).

A significant difference was observed in the perpendicular distance from the entry trocar to aortic bifurcation (TABLE 1). Specifically, as the BMI increased, so did the distance. The only other significant BMI-related increase was the abdominal wall thickness, which also varied directly with the BMI.

Other distances increase with height

The distance between the primary trocar and the iliac vessels and urinary bladder consistently increased with the patient’s height.

However, no significant change in distance between the great vessels and the primary trocar site occurred when the patient’s position changed from level to Trendelenburg.

Trocar insertion: Disposable devices require less force

Laparoscopic trocar thrusting is a dynamic process, and we observed that process in our study.¹⁵ When force is applied via trocar to the anterior abdominal wall, that structure is displaced toward the abdominal cavity in the direction of the posterior abdominal wall—even when countertraction is taken into consideration. The movement is more apparent in obese women because of greater elasticity created by the larger mass of properitoneal and subcutaneous fat. We measured the distortion and determined that the depression can be 5 cm or more.

In contrast, thin women have rigid, relatively unyielding anterior abdominal walls and therefore experience minimal displacement. In thin women, the greater risk is the shorter passive distance between the anterior abdominal wall and the great vessels.

Comparing force curves

We¹⁶ calculated the force required to thrust a disposable or reusable trocar through the anterior abdominal wall during actual laparoscopic surgery. We used a 25-lb compression load cell connected to the trocar by an Ultem handle, which could be sterilized between cases. A linear variable displacement transducer detected displacement, and the measuring apparata fed data into a computer. Ten women were randomized to a disposable trocar and 10 to a reusable device.

The mean thrusting force for disposable trocars was 10.2 lb versus 17.53 lb for the reusable device. The time to penetrate was likewise significantly shortened for disposable trocars: mean time of 3.54 seconds versus 11.64 seconds. Overall work tilted in favor of disposable trocars: 14.34 pound-seconds versus 103.88 pound-seconds.

The disposable trocar has the advantage for 2 reasons: its razor-sharp cutting edge and streamlined design.

FIGURE 1 shows typical force curves of disposable and reusable trocars.

FIGURE 1 Reusable trocar requires more force than disposable trocar

A considerable difference in force is required for insertion, depending on type of device, as this graph of typical force curves shows. The reusable trocar requires 18 to 20 lb of force over 12 seconds; the disposable, only 5 lb over 2 seconds.

Safe trocar insertion begins with pneumoperitoneum

McDougall et al¹⁷ demonstrated that adequate pneumoperitoneum lessens the force required to drive a trocar through the anterior abdominal wall. Although the differences were small, the forces required with an intraperitoneal gas pressure of 30 mm Hg were smaller than those required with a pressure of 15 mm Hg.¹⁷

Manufacturers of disposable trocars also recommend creating an adequate pneumoperitoneum prior to aiming and inserting the razor-sharp device. The goal is creating a carbon dioxide gas pocket large enough to permit rapid deployment of the “safety shield” after the trocar tip clears the properitoneal fat and peritoneal membrane.

Slow-motion video sequences of disposable trocar entry show the sharp trocar tip penetrating the parietal peritoneum of the anterior abdominal wall for 1 cm before the spring-loaded shield advances and locks over the blade. During this insertion, the anterior abdominal wall has an elastic reaction to the applied force; this reaction pushes it toward the posterior abdominal wall.

Direct insertions (ie, without adequate pneumoperitoneum) involve less space for the trocar’s safety shield to deploy. Thus, there is a greater risk of the armed trocar tip coming into direct contact with underlying viscera and blood vessels.

 

Use a shorter insufflation needle

Our data on women with a BMI greater than 30 (obese range) indicate that the mean thickness of the anterior abdominal wall is 5.05 cm and the distance to the aorta is 15.14 cm.¹⁵ A standard Verres needle measures 12.5 cm from the tip of the shaft to the point where the shaft joins the hub of the needle. This is clearly excessive length, since women with a BMI above 30 have an abdominal wall thickness of approximately 5.05 cm and women with BMIs between 25 and 30 have a thickness of only 3.85 cm.

I prefer a Touhy epidural needle for subumbilical insertion and creation of the pneumoperitoneum, since it is a relatively short 8.5 cm. Thus, it is less hazardous than the Verres needle. It also is less likely to clog with tissue fragments because of its curved tip, and more likely to create a successful pneumoperitoneum on the first try.

Fortunately, large-vessel injuries caused by the insufflation needle are rare.

Proper insertion technique

I have residents draw a straight line with a marking pen from the lower margin of the umbilicus to the superior margin of the pubic symphysis. This serves as a guide to keep the trocar pointing toward the middle of the abdomen, away from the iliac vessels. I also teach residents to thrust the trocar in the midline at a 45° to 60° angle in relation to the plane of the abdominal wall, with the trocar pointing toward the uterus (FIGURES 2 AND 3).

Many residents twist disposable trocars during insertion. This “door knob” movement works against the design of the trocar and traumatizes tissue. The correct approach is thrusting the device into the abdominal cavity, or holding the trocar (only for disposable trocar devices) like a dart and thrusting it into the abdomen as though throwing a dart. The only trocar designed for twisting is the conical reusable device; the sharp pyramidal reusable trocar should be thrust rather than twisted.

Avoid “long” trocars

These are a full 5 cm longer than the 20-cm standard device (hub of handle to tip of shaft). Abdominal wall measurements indicate that these devices are never required to simply penetrate the anterior abdominal wall; these trocars also carry the risk of hitting the iliac vessels.

Open laparoscopy is not foolproof

Although open laparoscopy would seem to guarantee safe entry of the primary trocar, reports of aortic injuries have recently been published. Similar data have been reported for optical access trocars.^11,18

FIGURE 2 Insert the trocar at 45° to 60° angle

At insertion, the trocar should be at a 45°to 60°angle relative to the abdominal wall, with the tip of the device tilted in the direction of the uterus and bladder. A 90°angle of insertion is dangerous.

FIGURE 3 Midline insertion is safest

Insert the primary trocar in the midline pointing toward the uterus; deviation to the right or left is dangerous. Also avoid injuring the inferior epigastric and external iliac vessels with far lateral trocar insertion.

Body habitus and vascular injury

The obese patient of short stature is at the greatest risk for vascular injury. Although the relative distances between the anterior abdominal wall and the aorta are greater at the highest BMI levels, short stature means that the iliac vessels are closer. Significantly, large vessel injuries in the series cited herein were associated with the use of disposable trocars 90% of the time.

I believe high-risk conditions are created when carbon dioxide gas is inadvertently infused into the properitoneal fat space (FIGURE 4). As the volume of gas grows, the anterior wall parietal peritoneum dissects free from the remainder of the anterior abdominal fat, creating a pseudo-pneumoperitoneum. The operator fails to realize that the true peritoneal cavity has not been entered and, in fact, has paradoxically constricted in size because of the enlarging pseudoperitoneal space. Careful attention to the pressure gauges would have aroused suspicion that gas was being infused into the wrong space, since pressures tend to be higher and flow erratic in such situations.

Nevertheless, the surgeon places a trocar into the space, looks through the laparoscope, sees red or yellow, and realizes that the peritoneal cavity has not been entered. More gas is insufflated and the trocar is tried again.

Typically, the duller, reusable trocar pushes the leading edge of the peritoneum rather than penetrating it, further enlarging the properitoneal space and bringing the anterior and posterior peritoneal walls very close together.

In another scenario, the same set of circumstances exists except, rather than employing a reusable trocar, the surgeon selects a disposable device or even, after 2 failures to enter the peritoneal cavity with the reusable device, an extra-long (11-inch) disposable trocar (FIGURE 4).

 

In this scenario, an armed trocar enters the pseudospace—without the safety shield deployed—because no resistance was encountered during penetration of the incision, owing to the fact that two 10–12-mm trocars have previously traversed the same skin incision.

As the tip of the trocar comes into contact with the leading edge of the peritoneum, it encounters resistance, and the razor-sharp blade cuts through the anterior peritoneum, traverses the narrow peritoneal space, and cuts through the posterior peritoneum and the underlying great vessel.

Often, the trocar’s knife edge injures an artery by glancing off the curved surface of the vessels and embedding itself in the neighboring or underlying vein.

The best technique to manage a pseudo-pneumoperitoneal pocket is to abandon the subumbilical site, insert a Touhy needle in the left upper quadrant, and enter and overinflate the peritoneal cavity, thereby obliterating the properitoneal gas space.

When injury occurs: 7 recommended management steps

In the event of a vascular injury, early diagnosis and treatment are vital. Do not observe retroperitoneal hematomas. The following steps are recommended:

1. Call for a vascular surgeon immediately and indicate that the situation is an emergency. Do not waste time trying to locate the injury before calling for help.
2. Get emergency type and cross-match for at least 6 U of whole blood.
3. Obtain baseline lab measurements, including hemoglobin, hematocrit, platelets, fibrinogen, and fibrin split products.
4. Open the abdomen using a vertical incision for maximum access and visibility.
5. Get accurate outputs and blood-loss estimates and have anesthesia keep careful records of fluids given.
6. Advise anesthesia staff to obtain additional help. This will facilitate starting additional IV sites, rapidly infusing blood products, obtaining key samples for laboratory data, and maintaining accurate and detailed records of blood gases, blood loss, replacement fluids, and blood products.
7. Use a circulator to manage urgent medications or laboratory tests.

The author reports no financial relationships relevant to this article.

Major vessel injury is a two-sided coin: It can occur with alarming speed, but it is preventable.

Fortunately, the laparoscopic surgeon can avoid the problem by following simple precautions and steering clear of scenarios that increase the risk of injury. This article tells how to accomplish both objectives.

In the process, it reviews the evidence, details management for any injuries that occur, and includes a comprehensive table listing typical distances between the entry trocar and vascular structures, to help the surgeon adjust entry strategy.

Adequate prevention depends on:

• familiarity with the vascular anatomy, particularly in relation to the umbilicus, presacral space, infundibulopelvic ligament, and ovarian fossa.
• creating a proper pneumoperitoneum, especially when using disposable trocars.
• careful attention to primary trocar thrusting techniques to ensure midline insertion at the proper angle. Also exercise caution when placing secondary trocars. Specifically, during far lateral insertion, avoid cleaving the inferior epigastric artery from the external iliac or directly hitting the external artery or vein.
• avoiding long trocars, which are unnecessary to penetrate the peritoneal cavity.
• reliance on laparotomy if trocar insertion proves too difficult, vision is obscured, or appropriate anatomic dissection planes cannot be developed.
• when injury occurs, performing laparotomy using a vertical incision.

How big is the problem?

A French study¹ of 103,852 laparoscopic procedures—of which 15.7%, or 16,000 operations, were gynecologic—reported 47 cases of major vascular injury for an incidence of 0.5 per 1,000 cases and a mortality rate of 17%. Several additional articles^2-8 reported a range of vascular complications of between 0.1 and 6.4 per 1,000 laparoscopies.

 

In a study⁹ conducted in 7 gynecologic laparoscopy surgery centers in France over 9 years and involving 29,966 diagnostic and operative cases, the overall complication rate was 4.64 per 1,000 laparoscopies (n = 139). Of the 21 major vascular injuries associated with gynecologic surgery, the majority occurred during set-up, and 84.6% during insertion of the primary trocar. Two patients died from their injuries.

Bhoyrul and colleagues¹⁰ analyzed data reported to the US Food and Drug Administration and found that 408 of 629 trocar-related injuries involved major blood vessels, as did 26 of 32 deaths (81%). Most of the deaths (87%) were linked to the use of disposable trocars equipped with safety shields; 9% with direct-view trocars. Although surgeons asserted that the trocar malfunctioned in 41 cases, that claim was confirmed in only 1 case (2%).

Another study found that 37 of 79 (46.8%) serious complications involving optical-access trocars between 1994 and 2002 involved major vessels, injuring the aorta, iliac vessels, or vena cava.¹¹

A study¹² carried out in the Netherlands in 1994 evaluated the relative number of complications that occurred within a total of 25,764 laparoscopic procedures. The study divided complications into those occurring as the result of the laparoscopic approach (eg, trocar insertion) versus those happening during the performance of the operation. Fifty-seven percent of the 145 complications were caused by the laparoscopic approach; the 2 reported deaths also were secondary to that approach.

Snapshot of vascular injury: A series of 31 patients

In 2003, I published data¹³ on 31 cases of major vessel injury associated with gynecologic laparoscopy (see). These cases were collected from a variety of sources: medicolegal case files, hospital morbidity-mortality presentations, and quality-assurance departments. Eight cases involved diagnostic procedures, while 23 involved operative laparoscopy.

The medical records of these cases provided details on the nature of the injury. The cases were categorized by body mass index (BMI) and cause, ie, whether they occurred as the result of the laparoscopic approach (ie, entry-related) or arose during surgery.

Of the 31 cases, 22 (71%) involved women with BMIs from 25 to more than 30 (overweight or obese). A large majority—28 cases (90%)—were related to entry. Only 3 injuries occurred during surgery.

In several women, more than 1 vessel was damaged. Of the 49 total injuries, 38 (78%) involved the iliac vessels. Seven (23%) women died as a result of their injuries, all of which involved venous trauma.

Damage to structures in the vicinity of the injured vessels was substantial in 16 cases. Major morbidity included ureteral, nerve, and intestinal injury; arterial and venous thrombosis; compartment syndrome; and suturing of the wrong vessel.

Some patients also experienced edema or pain in an extremity (vascular insufficiency); infection; diffuse intravascular coagulation and/or adult respiratory distress; cardiac arrest; central nervous system injury (stroke); or hospitalization of more than 1 week. Cases also were categorized as early or late diagnosis, depending on whether shock had supervened. Diagnosis was early in 8 cases (26%) and late in 21 (68%). Two patients were diagnosed postoperatively; ie, they had gone to the recovery room prior to developing shock.

The volume of blood loss ranged from 1,000 mL to 7,000 mL, with a mean loss of 3,400 mL. All patients received packed red blood cells and/or a mixture of other blood products. The time required for cross-matching and receiving blood ranged from 10 to 120 minutes.

In all cases, a vascular or general surgeon was called to consult on the case.

Mapping vascular structures to ensure safe trocar entry

Knowing the distances between blood vessels and laparoscopic entry trocars is critical if injury is to be avoided. In pursuit of this goal, Hurd and colleagues¹⁴ performed a retrospective study involving women who had undergone magnetic resonance imaging or computed tomography scans of the abdomen. Investigators measured the distance between the lower abdominal wall and the aortic bifurcation in these women, who were all unanesthetized and in the supine position.

Distances increased with BMI

This occurred in the study by Hurd et al,¹⁴ as well as in a prospective study by Narendran and Baggish,¹⁵ who calculated body mass index in 101 consecutive women who were undergoing diagnostic or operative laparoscopy. These women were anesthetized, with pneumoperitoneum established and a laparoscope inserted; all were in the lithotomy position.

In this study, Narendran and Baggish measured the following distances from the entry trocar:

• perpendicular distance to aortic bifurcation,
• oblique distance to the right and left common iliac vessels,
• oblique distance to the superior margin of the bladder,
• perpendicular distance from the peritoneum to skin at the umbilicus (abdominal wall thickness), and
• oblique distance from the subumbilical peritoneal opening to the right and left common iliac vessels.

 

Wide range of BMIs

In the study by Narendran and Baggish, successful measurement panels were created for 99 of the 101 cases. Of these, 49 women had a BMI of less than 25 (normal), 29 had a BMI greater than 25 but less than 30 (overweight), and 21 had a BMI greater than 30 (obese).

A significant difference was observed in the perpendicular distance from the entry trocar to aortic bifurcation (TABLE 1). Specifically, as the BMI increased, so did the distance. The only other significant BMI-related increase was the abdominal wall thickness, which also varied directly with the BMI.

Other distances increase with height

The distance between the primary trocar and the iliac vessels and urinary bladder consistently increased with the patient’s height.

However, no significant change in distance between the great vessels and the primary trocar site occurred when the patient’s position changed from level to Trendelenburg.

Trocar insertion: Disposable devices require less force

Laparoscopic trocar thrusting is a dynamic process, and we observed that process in our study.¹⁵ When force is applied via trocar to the anterior abdominal wall, that structure is displaced toward the abdominal cavity in the direction of the posterior abdominal wall—even when countertraction is taken into consideration. The movement is more apparent in obese women because of greater elasticity created by the larger mass of properitoneal and subcutaneous fat. We measured the distortion and determined that the depression can be 5 cm or more.

In contrast, thin women have rigid, relatively unyielding anterior abdominal walls and therefore experience minimal displacement. In thin women, the greater risk is the shorter passive distance between the anterior abdominal wall and the great vessels.

Comparing force curves

We¹⁶ calculated the force required to thrust a disposable or reusable trocar through the anterior abdominal wall during actual laparoscopic surgery. We used a 25-lb compression load cell connected to the trocar by an Ultem handle, which could be sterilized between cases. A linear variable displacement transducer detected displacement, and the measuring apparata fed data into a computer. Ten women were randomized to a disposable trocar and 10 to a reusable device.

The mean thrusting force for disposable trocars was 10.2 lb versus 17.53 lb for the reusable device. The time to penetrate was likewise significantly shortened for disposable trocars: mean time of 3.54 seconds versus 11.64 seconds. Overall work tilted in favor of disposable trocars: 14.34 pound-seconds versus 103.88 pound-seconds.

The disposable trocar has the advantage for 2 reasons: its razor-sharp cutting edge and streamlined design.

FIGURE 1 shows typical force curves of disposable and reusable trocars.

FIGURE 1 Reusable trocar requires more force than disposable trocar

A considerable difference in force is required for insertion, depending on type of device, as this graph of typical force curves shows. The reusable trocar requires 18 to 20 lb of force over 12 seconds; the disposable, only 5 lb over 2 seconds.

Safe trocar insertion begins with pneumoperitoneum

McDougall et al¹⁷ demonstrated that adequate pneumoperitoneum lessens the force required to drive a trocar through the anterior abdominal wall. Although the differences were small, the forces required with an intraperitoneal gas pressure of 30 mm Hg were smaller than those required with a pressure of 15 mm Hg.¹⁷

Manufacturers of disposable trocars also recommend creating an adequate pneumoperitoneum prior to aiming and inserting the razor-sharp device. The goal is creating a carbon dioxide gas pocket large enough to permit rapid deployment of the “safety shield” after the trocar tip clears the properitoneal fat and peritoneal membrane.

Slow-motion video sequences of disposable trocar entry show the sharp trocar tip penetrating the parietal peritoneum of the anterior abdominal wall for 1 cm before the spring-loaded shield advances and locks over the blade. During this insertion, the anterior abdominal wall has an elastic reaction to the applied force; this reaction pushes it toward the posterior abdominal wall.

Direct insertions (ie, without adequate pneumoperitoneum) involve less space for the trocar’s safety shield to deploy. Thus, there is a greater risk of the armed trocar tip coming into direct contact with underlying viscera and blood vessels.

 

Use a shorter insufflation needle

Our data on women with a BMI greater than 30 (obese range) indicate that the mean thickness of the anterior abdominal wall is 5.05 cm and the distance to the aorta is 15.14 cm.¹⁵ A standard Verres needle measures 12.5 cm from the tip of the shaft to the point where the shaft joins the hub of the needle. This is clearly excessive length, since women with a BMI above 30 have an abdominal wall thickness of approximately 5.05 cm and women with BMIs between 25 and 30 have a thickness of only 3.85 cm.

I prefer a Touhy epidural needle for subumbilical insertion and creation of the pneumoperitoneum, since it is a relatively short 8.5 cm. Thus, it is less hazardous than the Verres needle. It also is less likely to clog with tissue fragments because of its curved tip, and more likely to create a successful pneumoperitoneum on the first try.

Fortunately, large-vessel injuries caused by the insufflation needle are rare.

Proper insertion technique

I have residents draw a straight line with a marking pen from the lower margin of the umbilicus to the superior margin of the pubic symphysis. This serves as a guide to keep the trocar pointing toward the middle of the abdomen, away from the iliac vessels. I also teach residents to thrust the trocar in the midline at a 45° to 60° angle in relation to the plane of the abdominal wall, with the trocar pointing toward the uterus (FIGURES 2 AND 3).

Many residents twist disposable trocars during insertion. This “door knob” movement works against the design of the trocar and traumatizes tissue. The correct approach is thrusting the device into the abdominal cavity, or holding the trocar (only for disposable trocar devices) like a dart and thrusting it into the abdomen as though throwing a dart. The only trocar designed for twisting is the conical reusable device; the sharp pyramidal reusable trocar should be thrust rather than twisted.

Avoid “long” trocars

These are a full 5 cm longer than the 20-cm standard device (hub of handle to tip of shaft). Abdominal wall measurements indicate that these devices are never required to simply penetrate the anterior abdominal wall; these trocars also carry the risk of hitting the iliac vessels.

Open laparoscopy is not foolproof

Although open laparoscopy would seem to guarantee safe entry of the primary trocar, reports of aortic injuries have recently been published. Similar data have been reported for optical access trocars.^11,18

FIGURE 2 Insert the trocar at 45° to 60° angle

At insertion, the trocar should be at a 45°to 60°angle relative to the abdominal wall, with the tip of the device tilted in the direction of the uterus and bladder. A 90°angle of insertion is dangerous.

FIGURE 3 Midline insertion is safest

Insert the primary trocar in the midline pointing toward the uterus; deviation to the right or left is dangerous. Also avoid injuring the inferior epigastric and external iliac vessels with far lateral trocar insertion.

Body habitus and vascular injury

The obese patient of short stature is at the greatest risk for vascular injury. Although the relative distances between the anterior abdominal wall and the aorta are greater at the highest BMI levels, short stature means that the iliac vessels are closer. Significantly, large vessel injuries in the series cited herein were associated with the use of disposable trocars 90% of the time.

I believe high-risk conditions are created when carbon dioxide gas is inadvertently infused into the properitoneal fat space (FIGURE 4). As the volume of gas grows, the anterior wall parietal peritoneum dissects free from the remainder of the anterior abdominal fat, creating a pseudo-pneumoperitoneum. The operator fails to realize that the true peritoneal cavity has not been entered and, in fact, has paradoxically constricted in size because of the enlarging pseudoperitoneal space. Careful attention to the pressure gauges would have aroused suspicion that gas was being infused into the wrong space, since pressures tend to be higher and flow erratic in such situations.

Nevertheless, the surgeon places a trocar into the space, looks through the laparoscope, sees red or yellow, and realizes that the peritoneal cavity has not been entered. More gas is insufflated and the trocar is tried again.

Typically, the duller, reusable trocar pushes the leading edge of the peritoneum rather than penetrating it, further enlarging the properitoneal space and bringing the anterior and posterior peritoneal walls very close together.

In another scenario, the same set of circumstances exists except, rather than employing a reusable trocar, the surgeon selects a disposable device or even, after 2 failures to enter the peritoneal cavity with the reusable device, an extra-long (11-inch) disposable trocar (FIGURE 4).

 

In this scenario, an armed trocar enters the pseudospace—without the safety shield deployed—because no resistance was encountered during penetration of the incision, owing to the fact that two 10–12-mm trocars have previously traversed the same skin incision.

As the tip of the trocar comes into contact with the leading edge of the peritoneum, it encounters resistance, and the razor-sharp blade cuts through the anterior peritoneum, traverses the narrow peritoneal space, and cuts through the posterior peritoneum and the underlying great vessel.

Often, the trocar’s knife edge injures an artery by glancing off the curved surface of the vessels and embedding itself in the neighboring or underlying vein.

The best technique to manage a pseudo-pneumoperitoneal pocket is to abandon the subumbilical site, insert a Touhy needle in the left upper quadrant, and enter and overinflate the peritoneal cavity, thereby obliterating the properitoneal gas space.

When injury occurs: 7 recommended management steps

In the event of a vascular injury, early diagnosis and treatment are vital. Do not observe retroperitoneal hematomas. The following steps are recommended:

1. Call for a vascular surgeon immediately and indicate that the situation is an emergency. Do not waste time trying to locate the injury before calling for help.
2. Get emergency type and cross-match for at least 6 U of whole blood.
3. Obtain baseline lab measurements, including hemoglobin, hematocrit, platelets, fibrinogen, and fibrin split products.
4. Open the abdomen using a vertical incision for maximum access and visibility.
5. Get accurate outputs and blood-loss estimates and have anesthesia keep careful records of fluids given.
6. Advise anesthesia staff to obtain additional help. This will facilitate starting additional IV sites, rapidly infusing blood products, obtaining key samples for laboratory data, and maintaining accurate and detailed records of blood gases, blood loss, replacement fluids, and blood products.
7. Use a circulator to manage urgent medications or laboratory tests.

The author reports no financial relationships relevant to this article.

Thanks to the advent of minimally invasive, organ-preserving treatments such as endometrial ablation, progesterone-containing intrauterine delivery systems, and uterine fibroid embolization, today’s patients suffer less morbidity and enjoy better outcomes for a number of procedures. To take advantage of the potential for improved patient care, we try to use every new technology for every suitable candidate.

Hysterectomy is an obvious target. The number of hysterectomies performed has not declined substantially since these technologies were introduced, and persists at more than 550,000 per year in the United States. It is still the most widely performed major gynecological procedure.

Technological advances have made possible the use of laparoscopy to facilitate removal of the uterus without a major abdominal incision, with its inherent hazards. Many surgeons, seeking to make the most of new technology, have revisited laparoscopic subtotal hysterectomy, advocating preservation of the cervix to reduce surgical complications, sexual dysfunction, and pelvic-floor defects after hysterectomy.

New data, however—much of it released only in the last 12 to 18 months—tell us there is no difference in sexual function, pelvic floor support, or return to normal activities when the cervix is retained. What’s more, leaving the cervix in place puts the patient at greater risk of reoperation related to hysterectomy.

THEORY

Improved sexual function

EVIDENCE

Recent prospective analyses using validated measures of female sexual function have failed to demonstrate any advantage for supracervical hysterectomy.

Scientific study of sexual function is difficult at best. Many factors influence sexual behavior, and all must be considered when analyzing the effects of hysterectomy. To clearly understand the impact of hysterectomy on female sexual function, prospective studies in which women serve as their own controls provide the best quality evidence. That said, the contention that supracervical hysterectomy results in better sexual function than total hysterectomy stems from the research of a single group, which in 1983 retrospectively compared coital frequency, dyspareunia, libido, and orgasm after “supravaginal uterine amputation” with total hysterectomy.^1,2

Simple hysterectomy causes minimal disruption of Frankenhauser’s plexus of autonomic nerves.

They theorized that supracervical operation preserves Frankenhauser’s plexus of autonomic nerves, resulting in better sexual function. However, careful anatomic assessment of the nerve content in the ligaments supporting the uterus has since demonstrated that the rich nerve supply to the uterosacral and cardinal ligaments occurs in the lateral two thirds of these structures. Simple hysterectomy causes minimal disruption of these autonomic nerves, ganglia, and extensions of the inferior hypogastric plexus.³

Thakar et al,⁴ in a pivotal multicenter, double-blind, randomized trial conducted in the United Kingdom, randomized 279 patients with benign disease to supracervical or total hysterectomy and followed them for 12 months. Surgical technique was standardized and the endocervix was coagulated in all patients.

The 2 groups were similar in measures of sexual function, including frequency of intercourse, orgasm, and rating of relationship with partner.

The Danish Hysterectomy Group⁵ randomized 319 patients with benign disease to total abdominal hysterectomy or subtotal abdominal hysterectomy, of whom 276 completed validated mailed questionnaires preoperatively, and at 2, 6, and 12 months postoperatively.

There was no change in sexual satisfaction in either group from their prehysterectomy levels. Overall quality of life improved significantly in both groups, in both mental and physical measures.

Roovers et al,⁶ in a multicenter, nonrandomized trial—powered well to detect 20% differences—compared vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy (technique chosen by the surgeon).

Of the 379 patients recruited (from 13 teaching and nonteaching hospitals in the Netherlands) who had a male partner, 93% completed a validated questionnaire before and 6 months after surgery.

The questionnaire—used to assess sexual pleasure, activity, and problems—specifically addressed lubrication, orgasm, pain, and arousal on a 5-point scale (“not bothered” to “severely bothered”). Their findings:

• Sexual pleasure increased significantly in all groups regardless of type of hysterectomy.
  
• There was no difference in the incidence of bothersome sexual problems, but a significant number were reported: 43% after vaginal, 41% after subtotal, and 39% after total abdominal hysterectomy (P =.88).
  
• New sexual problems were reported in 9 patients (23%) after vaginal hysterectomy, 8 patients (24%) after subtotal hysterectomy, and 12 patients (19%) after total abdominal hysterectomy.
  
• There was a nonsignificant trend toward higher prevalence of arousal and lubrication problems after subtotal hysterectomy and total abdominal hysterectomy, compared with vaginal hysterectomy.
  

 

Theory

Improved pelvic floor support, less incontinence

Evidence

Pelvic floor support and urinary incontinence do not seem to be improved with the supracervical approach.

Proponents of supracervical hysterectomy argue that preservation of the cardinal and uterosacral ligaments will reduce the incidence of apical prolapse. In addition, maintenance of the pubocervical ring should lead to less posthysterectomy urinary incontinence.

Our newfound understanding that the nerves are, for the most part, spared at simple hysterectomy should argue against allegations that bowel and urinary function are better preserved by retaining the cervix.

Clearly, long-term outcome studies are required to assess these issues. The randomized trials thus far comparing supracervical with total hysterectomy have not followed patients beyond 2 years.

Nevertheless, at 12 to 24 months, published trials^5,7 report an increased incidence of urinary incontinence in patients randomized to supracervical hysterectomy. Prolapse was also reported in a larger number of the patients undergoing subtotal as compared with total hysterectomy (1 to 2% versus 0% at 12 months).

The Total or Supracervical Hysterectomy (TOSH) Research Group⁷ conducted a multi-center randomized trial with a diverse patient population (78% of women were African American). From January 1998 through April 2000, 135 patients at 4 centers were randomized to supracervical hysterectomy or total abdominal hysterectomy. All patients had benign disease. Surgical technique varied by surgeon as in the general community. Patients and researchers were not blinded as to the technique performed. Subjects were followed for 2 years.

Women undergoing supracervical hysterectomy had a greater incidence of urinary incontinence after surgery.

Both techniques resulted in significant decreases in complaints of urinary incontinence and voiding dysfunction

The Danish Hysterectomy Group⁵ found that patients who had supracervical hysterectomies had a statistically greater incidence of urinary incontinence after surgery than those undergoing total abdominal hysterectomy (18% versus 9% P = .04). The incidence of new incontinence symptoms was 2.1% in the total abdominal hysterectomy group compared with 7.6% in the subtotal group. There was no change in bowel function in either group.

Thakar et al⁴ found urinary frequency declined significantly in both groups.

Theory

Fewer injuries and complications, less blood loss

Evidence

Randomized trials have offered no evidence to support a reduction in complication rates or bleeding requiring transfusion.

Since the creation of a bladder flap and division of the cardinal ligaments is not required in supracervical hysterectomy, we might theoretically expect to see reduced rates of injury to the ureters and bladder. Without the need for colpotomy, blood loss should also be reduced.

Cyclic bleeding may occur after supracervical hysterectomy even when residual endocervical tissue is cored or coagulated.

Given the low incidence of these complications at total hysterectomy, however, a meta-analysis of published randomized trials would be required to properly evaluate this issue. Thus far, randomized trials have offered no evidence to support a reduction in complication rates or bleeding requiring transfusion.

Thakar et al⁴ found a significant reduction in operating time as well as a reduction in blood loss (422 mL versus 320 mL) for the supracervical group compared with the total hysterectomy group; however there were no differences in the need for transfusion (5% in each group).

Women who underwent total abdominal hysterectomy had a higher incidence of fever while in the hospital (27% versus 10%), but there was no difference in the rate of infectious morbidity.

Within 1 year of discharge, more patients undergoing supracervical hysterectomy experienced complications: 7% had cyclic bleeding; 2% had cervical prolapse.

The TOSH Research Group⁷ found no difference in the rate of complications, activity limitations, or symptom improvement between groups. During the first 3 months, there was no difference in missed work, restricting activities, or bed rest. Both techniques resulted in significant decreases in complaints of pelvic pain, pressure, and back pain.

Of women undergoing supracervical hysterectomy, 5% had cyclic vaginal bleeding (only half of the patients in this series had the endocervix ablated).

Further, there were more readmissions related to the hysterectomy in the supracervical group, though this was not statistically significant (relative risk 1.99; 95% confidence interval, 0.58 to 6.8).

Twenty percent of women in the Danish Hysterectomy Group study ⁵ had persistent vaginal bleeding after subtotal hysterectomy; 2 went on to have trachelectomy for cyclic bleeding.

Prolapse of the cervical stump occurred in 3/136 patients after subtotal hysterectomy, versus no prolapse after total abdominal hysterectomy.

 

Long-term outcomes: the downside

For a mean of 66 months (range: 4 to 7 years), Okaro et al⁸ followed 70 patients undergoing laparoscopic supracervical hysterectomy by a single, highly skilled laparoscopic surgeon.

Their findings point out the downside of cervical preservation. Although all patients had the endocervical canal and transition zone cored out, over 24% reported symptoms related to the cervical stump—and all required further surgery. Further, cyclic vaginal bleeding occurred in 11% of women.

One patient developed cervical intraepithelial neoplasia. Dyspareunia and pelvic pain were significant complaints in 19% of the patients. (These women were more likely to have had hysterectomy for endometriosis.) Sixteen of the 17 patients with cervical complaints required trachelectomy within the follow-up time period.

“How empty is theory in the presence of fact!”
Mark Twain, A Connecticut Yankee in King Arthur’s Court

Practice recommendations

We, as clinicians, must accumulate evidence from basic science as well as clinical research, put it all together, and make recommendations based on these data. The data, tell us, in fact, that there is no difference in sexual dysfunction, pelvic floor support, or return to normal activity levels when the cervix is retained, and no evidence to support an advantage to supracervical hysterectomy.

My recommendation is for vaginal hysterectomy when possible. The theoretical advantages of retention of the cervix have driven many clinicians to abandon the vaginal approach in favor of laparoscopic supracervical hysterectomy; no data support this theory.

While not the focus of this article, ample data tell us that the vaginal approach, when technically feasible, is less invasive and carries fewer risks for our patients than laparoscopic or abdominal hysterectomy, and permits excellent access for support of the pelvic floor. I do think that patients who truly believe that their sex lives will be ruined after total hysterectomy or that they will do dramatically better if the cervix remains, may experience this self-fulfilling prophecy.

What I tell patients. I carefully review all the facts with patients in helping them select the appropriate surgical procedure.

I tell patients:

• That overwhelming evidence suggests that sexual function improves in the vast majority of women after hysterectomy, whether or not the cervix is left.
  
• That there is a real possibility that cyclic bleeding may occur after supracervical hysterectomy, even when the residual endocervical tissue is cored or coagulated. I stress this point to all women who elect hysterectomy.
  
• That randomized trials demonstrate a significant incidence of reoperation for persistent bleeding.
  

The author serves on the Speakers Bureaus for Barr, Berlex, and Wyeth-Ayerst.

Thanks to the advent of minimally invasive, organ-preserving treatments such as endometrial ablation, progesterone-containing intrauterine delivery systems, and uterine fibroid embolization, today’s patients suffer less morbidity and enjoy better outcomes for a number of procedures. To take advantage of the potential for improved patient care, we try to use every new technology for every suitable candidate.

Hysterectomy is an obvious target. The number of hysterectomies performed has not declined substantially since these technologies were introduced, and persists at more than 550,000 per year in the United States. It is still the most widely performed major gynecological procedure.

Technological advances have made possible the use of laparoscopy to facilitate removal of the uterus without a major abdominal incision, with its inherent hazards. Many surgeons, seeking to make the most of new technology, have revisited laparoscopic subtotal hysterectomy, advocating preservation of the cervix to reduce surgical complications, sexual dysfunction, and pelvic-floor defects after hysterectomy.

New data, however—much of it released only in the last 12 to 18 months—tell us there is no difference in sexual function, pelvic floor support, or return to normal activities when the cervix is retained. What’s more, leaving the cervix in place puts the patient at greater risk of reoperation related to hysterectomy.

THEORY

Improved sexual function

EVIDENCE

Recent prospective analyses using validated measures of female sexual function have failed to demonstrate any advantage for supracervical hysterectomy.

Scientific study of sexual function is difficult at best. Many factors influence sexual behavior, and all must be considered when analyzing the effects of hysterectomy. To clearly understand the impact of hysterectomy on female sexual function, prospective studies in which women serve as their own controls provide the best quality evidence. That said, the contention that supracervical hysterectomy results in better sexual function than total hysterectomy stems from the research of a single group, which in 1983 retrospectively compared coital frequency, dyspareunia, libido, and orgasm after “supravaginal uterine amputation” with total hysterectomy.^1,2

Simple hysterectomy causes minimal disruption of Frankenhauser’s plexus of autonomic nerves.

They theorized that supracervical operation preserves Frankenhauser’s plexus of autonomic nerves, resulting in better sexual function. However, careful anatomic assessment of the nerve content in the ligaments supporting the uterus has since demonstrated that the rich nerve supply to the uterosacral and cardinal ligaments occurs in the lateral two thirds of these structures. Simple hysterectomy causes minimal disruption of these autonomic nerves, ganglia, and extensions of the inferior hypogastric plexus.³

Thakar et al,⁴ in a pivotal multicenter, double-blind, randomized trial conducted in the United Kingdom, randomized 279 patients with benign disease to supracervical or total hysterectomy and followed them for 12 months. Surgical technique was standardized and the endocervix was coagulated in all patients.

The 2 groups were similar in measures of sexual function, including frequency of intercourse, orgasm, and rating of relationship with partner.

The Danish Hysterectomy Group⁵ randomized 319 patients with benign disease to total abdominal hysterectomy or subtotal abdominal hysterectomy, of whom 276 completed validated mailed questionnaires preoperatively, and at 2, 6, and 12 months postoperatively.

There was no change in sexual satisfaction in either group from their prehysterectomy levels. Overall quality of life improved significantly in both groups, in both mental and physical measures.

Roovers et al,⁶ in a multicenter, nonrandomized trial—powered well to detect 20% differences—compared vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy (technique chosen by the surgeon).

Of the 379 patients recruited (from 13 teaching and nonteaching hospitals in the Netherlands) who had a male partner, 93% completed a validated questionnaire before and 6 months after surgery.

The questionnaire—used to assess sexual pleasure, activity, and problems—specifically addressed lubrication, orgasm, pain, and arousal on a 5-point scale (“not bothered” to “severely bothered”). Their findings:

• Sexual pleasure increased significantly in all groups regardless of type of hysterectomy.
  
• There was no difference in the incidence of bothersome sexual problems, but a significant number were reported: 43% after vaginal, 41% after subtotal, and 39% after total abdominal hysterectomy (P =.88).
  
• New sexual problems were reported in 9 patients (23%) after vaginal hysterectomy, 8 patients (24%) after subtotal hysterectomy, and 12 patients (19%) after total abdominal hysterectomy.
  
• There was a nonsignificant trend toward higher prevalence of arousal and lubrication problems after subtotal hysterectomy and total abdominal hysterectomy, compared with vaginal hysterectomy.
  

 

Theory

Improved pelvic floor support, less incontinence

Evidence

Pelvic floor support and urinary incontinence do not seem to be improved with the supracervical approach.

Proponents of supracervical hysterectomy argue that preservation of the cardinal and uterosacral ligaments will reduce the incidence of apical prolapse. In addition, maintenance of the pubocervical ring should lead to less posthysterectomy urinary incontinence.

Our newfound understanding that the nerves are, for the most part, spared at simple hysterectomy should argue against allegations that bowel and urinary function are better preserved by retaining the cervix.

Clearly, long-term outcome studies are required to assess these issues. The randomized trials thus far comparing supracervical with total hysterectomy have not followed patients beyond 2 years.

Nevertheless, at 12 to 24 months, published trials^5,7 report an increased incidence of urinary incontinence in patients randomized to supracervical hysterectomy. Prolapse was also reported in a larger number of the patients undergoing subtotal as compared with total hysterectomy (1 to 2% versus 0% at 12 months).

The Total or Supracervical Hysterectomy (TOSH) Research Group⁷ conducted a multi-center randomized trial with a diverse patient population (78% of women were African American). From January 1998 through April 2000, 135 patients at 4 centers were randomized to supracervical hysterectomy or total abdominal hysterectomy. All patients had benign disease. Surgical technique varied by surgeon as in the general community. Patients and researchers were not blinded as to the technique performed. Subjects were followed for 2 years.

Women undergoing supracervical hysterectomy had a greater incidence of urinary incontinence after surgery.

Both techniques resulted in significant decreases in complaints of urinary incontinence and voiding dysfunction

The Danish Hysterectomy Group⁵ found that patients who had supracervical hysterectomies had a statistically greater incidence of urinary incontinence after surgery than those undergoing total abdominal hysterectomy (18% versus 9% P = .04). The incidence of new incontinence symptoms was 2.1% in the total abdominal hysterectomy group compared with 7.6% in the subtotal group. There was no change in bowel function in either group.

Thakar et al⁴ found urinary frequency declined significantly in both groups.

Theory

Fewer injuries and complications, less blood loss

Evidence

Randomized trials have offered no evidence to support a reduction in complication rates or bleeding requiring transfusion.

Since the creation of a bladder flap and division of the cardinal ligaments is not required in supracervical hysterectomy, we might theoretically expect to see reduced rates of injury to the ureters and bladder. Without the need for colpotomy, blood loss should also be reduced.

Cyclic bleeding may occur after supracervical hysterectomy even when residual endocervical tissue is cored or coagulated.

Given the low incidence of these complications at total hysterectomy, however, a meta-analysis of published randomized trials would be required to properly evaluate this issue. Thus far, randomized trials have offered no evidence to support a reduction in complication rates or bleeding requiring transfusion.

Thakar et al⁴ found a significant reduction in operating time as well as a reduction in blood loss (422 mL versus 320 mL) for the supracervical group compared with the total hysterectomy group; however there were no differences in the need for transfusion (5% in each group).

Women who underwent total abdominal hysterectomy had a higher incidence of fever while in the hospital (27% versus 10%), but there was no difference in the rate of infectious morbidity.

Within 1 year of discharge, more patients undergoing supracervical hysterectomy experienced complications: 7% had cyclic bleeding; 2% had cervical prolapse.

The TOSH Research Group⁷ found no difference in the rate of complications, activity limitations, or symptom improvement between groups. During the first 3 months, there was no difference in missed work, restricting activities, or bed rest. Both techniques resulted in significant decreases in complaints of pelvic pain, pressure, and back pain.

Of women undergoing supracervical hysterectomy, 5% had cyclic vaginal bleeding (only half of the patients in this series had the endocervix ablated).

Further, there were more readmissions related to the hysterectomy in the supracervical group, though this was not statistically significant (relative risk 1.99; 95% confidence interval, 0.58 to 6.8).

Twenty percent of women in the Danish Hysterectomy Group study ⁵ had persistent vaginal bleeding after subtotal hysterectomy; 2 went on to have trachelectomy for cyclic bleeding.

Prolapse of the cervical stump occurred in 3/136 patients after subtotal hysterectomy, versus no prolapse after total abdominal hysterectomy.

 

Long-term outcomes: the downside

For a mean of 66 months (range: 4 to 7 years), Okaro et al⁸ followed 70 patients undergoing laparoscopic supracervical hysterectomy by a single, highly skilled laparoscopic surgeon.

Their findings point out the downside of cervical preservation. Although all patients had the endocervical canal and transition zone cored out, over 24% reported symptoms related to the cervical stump—and all required further surgery. Further, cyclic vaginal bleeding occurred in 11% of women.

One patient developed cervical intraepithelial neoplasia. Dyspareunia and pelvic pain were significant complaints in 19% of the patients. (These women were more likely to have had hysterectomy for endometriosis.) Sixteen of the 17 patients with cervical complaints required trachelectomy within the follow-up time period.

“How empty is theory in the presence of fact!”
Mark Twain, A Connecticut Yankee in King Arthur’s Court

Practice recommendations

We, as clinicians, must accumulate evidence from basic science as well as clinical research, put it all together, and make recommendations based on these data. The data, tell us, in fact, that there is no difference in sexual dysfunction, pelvic floor support, or return to normal activity levels when the cervix is retained, and no evidence to support an advantage to supracervical hysterectomy.

My recommendation is for vaginal hysterectomy when possible. The theoretical advantages of retention of the cervix have driven many clinicians to abandon the vaginal approach in favor of laparoscopic supracervical hysterectomy; no data support this theory.

While not the focus of this article, ample data tell us that the vaginal approach, when technically feasible, is less invasive and carries fewer risks for our patients than laparoscopic or abdominal hysterectomy, and permits excellent access for support of the pelvic floor. I do think that patients who truly believe that their sex lives will be ruined after total hysterectomy or that they will do dramatically better if the cervix remains, may experience this self-fulfilling prophecy.

What I tell patients. I carefully review all the facts with patients in helping them select the appropriate surgical procedure.

I tell patients:

• That overwhelming evidence suggests that sexual function improves in the vast majority of women after hysterectomy, whether or not the cervix is left.
  
• That there is a real possibility that cyclic bleeding may occur after supracervical hysterectomy, even when the residual endocervical tissue is cored or coagulated. I stress this point to all women who elect hysterectomy.
  
• That randomized trials demonstrate a significant incidence of reoperation for persistent bleeding.
  

The author serves on the Speakers Bureaus for Barr, Berlex, and Wyeth-Ayerst.

Thanks to the advent of minimally invasive, organ-preserving treatments such as endometrial ablation, progesterone-containing intrauterine delivery systems, and uterine fibroid embolization, today’s patients suffer less morbidity and enjoy better outcomes for a number of procedures. To take advantage of the potential for improved patient care, we try to use every new technology for every suitable candidate.

Hysterectomy is an obvious target. The number of hysterectomies performed has not declined substantially since these technologies were introduced, and persists at more than 550,000 per year in the United States. It is still the most widely performed major gynecological procedure.

Technological advances have made possible the use of laparoscopy to facilitate removal of the uterus without a major abdominal incision, with its inherent hazards. Many surgeons, seeking to make the most of new technology, have revisited laparoscopic subtotal hysterectomy, advocating preservation of the cervix to reduce surgical complications, sexual dysfunction, and pelvic-floor defects after hysterectomy.

New data, however—much of it released only in the last 12 to 18 months—tell us there is no difference in sexual function, pelvic floor support, or return to normal activities when the cervix is retained. What’s more, leaving the cervix in place puts the patient at greater risk of reoperation related to hysterectomy.

THEORY

Improved sexual function

EVIDENCE

Recent prospective analyses using validated measures of female sexual function have failed to demonstrate any advantage for supracervical hysterectomy.

Scientific study of sexual function is difficult at best. Many factors influence sexual behavior, and all must be considered when analyzing the effects of hysterectomy. To clearly understand the impact of hysterectomy on female sexual function, prospective studies in which women serve as their own controls provide the best quality evidence. That said, the contention that supracervical hysterectomy results in better sexual function than total hysterectomy stems from the research of a single group, which in 1983 retrospectively compared coital frequency, dyspareunia, libido, and orgasm after “supravaginal uterine amputation” with total hysterectomy.^1,2

Simple hysterectomy causes minimal disruption of Frankenhauser’s plexus of autonomic nerves.

They theorized that supracervical operation preserves Frankenhauser’s plexus of autonomic nerves, resulting in better sexual function. However, careful anatomic assessment of the nerve content in the ligaments supporting the uterus has since demonstrated that the rich nerve supply to the uterosacral and cardinal ligaments occurs in the lateral two thirds of these structures. Simple hysterectomy causes minimal disruption of these autonomic nerves, ganglia, and extensions of the inferior hypogastric plexus.³

Thakar et al,⁴ in a pivotal multicenter, double-blind, randomized trial conducted in the United Kingdom, randomized 279 patients with benign disease to supracervical or total hysterectomy and followed them for 12 months. Surgical technique was standardized and the endocervix was coagulated in all patients.

The 2 groups were similar in measures of sexual function, including frequency of intercourse, orgasm, and rating of relationship with partner.

The Danish Hysterectomy Group⁵ randomized 319 patients with benign disease to total abdominal hysterectomy or subtotal abdominal hysterectomy, of whom 276 completed validated mailed questionnaires preoperatively, and at 2, 6, and 12 months postoperatively.

There was no change in sexual satisfaction in either group from their prehysterectomy levels. Overall quality of life improved significantly in both groups, in both mental and physical measures.

Roovers et al,⁶ in a multicenter, nonrandomized trial—powered well to detect 20% differences—compared vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy (technique chosen by the surgeon).

Of the 379 patients recruited (from 13 teaching and nonteaching hospitals in the Netherlands) who had a male partner, 93% completed a validated questionnaire before and 6 months after surgery.

The questionnaire—used to assess sexual pleasure, activity, and problems—specifically addressed lubrication, orgasm, pain, and arousal on a 5-point scale (“not bothered” to “severely bothered”). Their findings:

• Sexual pleasure increased significantly in all groups regardless of type of hysterectomy.
  
• There was no difference in the incidence of bothersome sexual problems, but a significant number were reported: 43% after vaginal, 41% after subtotal, and 39% after total abdominal hysterectomy (P =.88).
  
• New sexual problems were reported in 9 patients (23%) after vaginal hysterectomy, 8 patients (24%) after subtotal hysterectomy, and 12 patients (19%) after total abdominal hysterectomy.
  
• There was a nonsignificant trend toward higher prevalence of arousal and lubrication problems after subtotal hysterectomy and total abdominal hysterectomy, compared with vaginal hysterectomy.
  

 

Theory

Improved pelvic floor support, less incontinence

Evidence

Pelvic floor support and urinary incontinence do not seem to be improved with the supracervical approach.

Proponents of supracervical hysterectomy argue that preservation of the cardinal and uterosacral ligaments will reduce the incidence of apical prolapse. In addition, maintenance of the pubocervical ring should lead to less posthysterectomy urinary incontinence.

Our newfound understanding that the nerves are, for the most part, spared at simple hysterectomy should argue against allegations that bowel and urinary function are better preserved by retaining the cervix.

Clearly, long-term outcome studies are required to assess these issues. The randomized trials thus far comparing supracervical with total hysterectomy have not followed patients beyond 2 years.

Nevertheless, at 12 to 24 months, published trials^5,7 report an increased incidence of urinary incontinence in patients randomized to supracervical hysterectomy. Prolapse was also reported in a larger number of the patients undergoing subtotal as compared with total hysterectomy (1 to 2% versus 0% at 12 months).

The Total or Supracervical Hysterectomy (TOSH) Research Group⁷ conducted a multi-center randomized trial with a diverse patient population (78% of women were African American). From January 1998 through April 2000, 135 patients at 4 centers were randomized to supracervical hysterectomy or total abdominal hysterectomy. All patients had benign disease. Surgical technique varied by surgeon as in the general community. Patients and researchers were not blinded as to the technique performed. Subjects were followed for 2 years.

Women undergoing supracervical hysterectomy had a greater incidence of urinary incontinence after surgery.

Both techniques resulted in significant decreases in complaints of urinary incontinence and voiding dysfunction

The Danish Hysterectomy Group⁵ found that patients who had supracervical hysterectomies had a statistically greater incidence of urinary incontinence after surgery than those undergoing total abdominal hysterectomy (18% versus 9% P = .04). The incidence of new incontinence symptoms was 2.1% in the total abdominal hysterectomy group compared with 7.6% in the subtotal group. There was no change in bowel function in either group.

Thakar et al⁴ found urinary frequency declined significantly in both groups.

Theory

Fewer injuries and complications, less blood loss

Evidence

Randomized trials have offered no evidence to support a reduction in complication rates or bleeding requiring transfusion.

Since the creation of a bladder flap and division of the cardinal ligaments is not required in supracervical hysterectomy, we might theoretically expect to see reduced rates of injury to the ureters and bladder. Without the need for colpotomy, blood loss should also be reduced.

Cyclic bleeding may occur after supracervical hysterectomy even when residual endocervical tissue is cored or coagulated.

Given the low incidence of these complications at total hysterectomy, however, a meta-analysis of published randomized trials would be required to properly evaluate this issue. Thus far, randomized trials have offered no evidence to support a reduction in complication rates or bleeding requiring transfusion.

Thakar et al⁴ found a significant reduction in operating time as well as a reduction in blood loss (422 mL versus 320 mL) for the supracervical group compared with the total hysterectomy group; however there were no differences in the need for transfusion (5% in each group).

Women who underwent total abdominal hysterectomy had a higher incidence of fever while in the hospital (27% versus 10%), but there was no difference in the rate of infectious morbidity.

Within 1 year of discharge, more patients undergoing supracervical hysterectomy experienced complications: 7% had cyclic bleeding; 2% had cervical prolapse.

The TOSH Research Group⁷ found no difference in the rate of complications, activity limitations, or symptom improvement between groups. During the first 3 months, there was no difference in missed work, restricting activities, or bed rest. Both techniques resulted in significant decreases in complaints of pelvic pain, pressure, and back pain.

Of women undergoing supracervical hysterectomy, 5% had cyclic vaginal bleeding (only half of the patients in this series had the endocervix ablated).

Further, there were more readmissions related to the hysterectomy in the supracervical group, though this was not statistically significant (relative risk 1.99; 95% confidence interval, 0.58 to 6.8).

Twenty percent of women in the Danish Hysterectomy Group study ⁵ had persistent vaginal bleeding after subtotal hysterectomy; 2 went on to have trachelectomy for cyclic bleeding.

Prolapse of the cervical stump occurred in 3/136 patients after subtotal hysterectomy, versus no prolapse after total abdominal hysterectomy.

 

Long-term outcomes: the downside

For a mean of 66 months (range: 4 to 7 years), Okaro et al⁸ followed 70 patients undergoing laparoscopic supracervical hysterectomy by a single, highly skilled laparoscopic surgeon.

Their findings point out the downside of cervical preservation. Although all patients had the endocervical canal and transition zone cored out, over 24% reported symptoms related to the cervical stump—and all required further surgery. Further, cyclic vaginal bleeding occurred in 11% of women.

One patient developed cervical intraepithelial neoplasia. Dyspareunia and pelvic pain were significant complaints in 19% of the patients. (These women were more likely to have had hysterectomy for endometriosis.) Sixteen of the 17 patients with cervical complaints required trachelectomy within the follow-up time period.

“How empty is theory in the presence of fact!”
Mark Twain, A Connecticut Yankee in King Arthur’s Court

Practice recommendations

We, as clinicians, must accumulate evidence from basic science as well as clinical research, put it all together, and make recommendations based on these data. The data, tell us, in fact, that there is no difference in sexual dysfunction, pelvic floor support, or return to normal activity levels when the cervix is retained, and no evidence to support an advantage to supracervical hysterectomy.

My recommendation is for vaginal hysterectomy when possible. The theoretical advantages of retention of the cervix have driven many clinicians to abandon the vaginal approach in favor of laparoscopic supracervical hysterectomy; no data support this theory.

While not the focus of this article, ample data tell us that the vaginal approach, when technically feasible, is less invasive and carries fewer risks for our patients than laparoscopic or abdominal hysterectomy, and permits excellent access for support of the pelvic floor. I do think that patients who truly believe that their sex lives will be ruined after total hysterectomy or that they will do dramatically better if the cervix remains, may experience this self-fulfilling prophecy.

What I tell patients. I carefully review all the facts with patients in helping them select the appropriate surgical procedure.

I tell patients:

• That overwhelming evidence suggests that sexual function improves in the vast majority of women after hysterectomy, whether or not the cervix is left.
  
• That there is a real possibility that cyclic bleeding may occur after supracervical hysterectomy, even when the residual endocervical tissue is cored or coagulated. I stress this point to all women who elect hysterectomy.
  
• That randomized trials demonstrate a significant incidence of reoperation for persistent bleeding.
  

The author serves on the Speakers Bureaus for Barr, Berlex, and Wyeth-Ayerst.

This dreaded complication requires vigilance and skill to avoid, and adequate training and experience to manage and repair. In a perfect world, every gynecologist would be trained in techniques to prevent and repair inadvertent bowel injuries. Unfortunately, residency programs often do not provide such training.

Gynecologists routinely operate on patients with risk factors for bowel injury—obesity, endometriosis, multiple abdominal procedures, pelvic inflammatory disease, history of malignancy, and advanced age. A general surgeon is often called, however, for bowel repairs that can be performed by a gynecologist with sufficient training and experience. (There are instances, however, in which a general surgical consultation may not be readily available—another reason to master repair of bowel injuries encountered during gynecologic surgery.)

This article describes techniques to avert and manage intestinal injury. Topics include adhesiolysis, repair of bowel perforations, segmental bowel resection, and pre- and postoperative management. Vascular anatomy of the bowel is illustrated.

We emphasize the need for direct supervision by an experienced surgeon while mastering these techniques.

Bowel preparation: A useful tool to reduce infection, leakage

Isolated reports have questioned the need for mechanical bowel preparation,^1,2 and some experts point to the recent success of primary repairs of gunshot and stab wounds to the colon as evidence that bowel preparation and preoperative oral antibiotics are unnecessary.

Other studies indicate potential benefits, namely reducing infectious complications and anastomotic leakage following repair of inadvertent enterotomy. Indeed, the vast majority of North American surgeons continue to use some form of bowel preparation,^3,4 and it is the standard of care for elective intestinal surgery. For these reasons, bowel preparation is strongly encouraged for the gynecologic surgeon operating on a pelvic mass, endometriosis, or malignancy, or when difficult dissection is anticipated with the potential for inadvertent enterotomy and spillage of intestinal contents.

Bowel preparation consists of 2 phases: mechanical cleansing and antibiotic administration (TABLE). The postoperative infection rate can be reduced to well below 10% when these are properly performed.

Mechanical cleansing reduces the bulk of stool content within the lumen of the bowel, which also decreases the absolute amount of bacteria.⁵ Anaerobes are the predominant flora in the colon, with an estimated density of 10¹⁰ organisms per gram of stool. Perforation and spillage of colon contents contaminates the peritoneal cavity with more than 400 species of bacteria.

Perforation and spillage of colon contents contaminates the peritoneal cavity with more than 400 species of bacteria.

In the past, stool bulk was reduced via a low-residue or liquid diet combined with cathartics, enemas, or other agents given over 2 to 3 days. This regimen was time-consuming, patient compliance was poor, and nutritional intake was severely restricted prior to major surgery.

Today, polyethylene glycol and sodium phosphate are the 2 most popular methods of bowel preparation.

• Polyethylene glycol (Golytely, Braintree Labs, Braintree, Mass) is a balanced electrolyte solution dispensed in a 4-L quantity that must be taken over 4 hours. Some patients find this volume difficult to consume; one option is administering the solution via a small nasogastric tube. Complications may include nausea/vomiting, abdominal cramping, and, rarely, fluid overload and electrolyte disturbances.
  
• Sodium phosphate (Fleet Phosphosoda, C.B. Fleet Co, Lynchburg, Va) is administered in two 45-mL increments several hours apart. There is no consensus on which bowel-prep method is superior^3,4; most surgeons prefer one or the other. Due to potential electrolyte abnormalities with the use of sodium phosphate, polyethylene glycol is favored for patients with significant renal, cardiac, or hepatic disease.
  
• We recommend minimally absorbed oral antibiotics (1 g each of neomycin and erythromycin, given at 1 PM, 2 PM, and 11 PM the day before surgery) in combination with an intravenous second-generation cephalosporin (1 g if using cefotetan, 2 g if using cefoxitin; given immediately before surgery and continued postoperatively for 3 doses).
  
• Timing of antibiotic administration is important, since postoperative antibiotics alone do not appear to be effective. If significant spillage occurs intraoperatively, parenteral antibiotics should be continued for 5 days.
  

 

TABLE

Bowel prep regimen

DAY BEFORE SURGERY
Morning
Light breakfast
Noon
Clear liquids
Polyethylene glycol, 4L, to be consumed over 4 to 6 hours
1 PM
Neomycin, 1 g orally
Erythromycin, 1 g orally
2 PM
Neomycin, 1 g orally
Erythromycin, 1 g orally
Evening
Clear liquids
11 PM
Neomycin, 1 g orally
Erythromycin, 1 g orally
DAY OF SURGERY
Morning
Intravenous cephalosporin (1 g cefotetan or 2 g cefoxitin); 1 hour before incision, continued postoperatively for 3 doses

Thermal injury due to unipolar cautery is particularly ominous because the extent of injury exceeds what is grossly observed.

When injuries are most likely

Intestinal injuries during gynecologic surgery usually involve the small bowel and can be minor, such as a serosal tear or a small, full-thickness laceration—or major, involving a devitalized bowel loop or its mesentery.

Bowel injury may occur during a variety of surgical procedures. One study showed that most injuries occur during adhesiolysis or entry into the peritoneal cavity. A smaller but substantial number of cases occur during “less extensive” procedures such as uterine curettage and laparoscopy.⁶

Upon entering the peritoneal cavity, keep in mind the possibility of injuring an adherent loop of bowel. Because of its anatomical relationships to the pelvic viscera, portions of the bowel may become involved in adhesions, which can lead to extremely challenging pelvic dissections in conditions such as endometriosis or severe pelvic infection. Dissection of pelvic adhesions is a common cause of bowel injury, because bowel loops are retracted deeply downward by adhesive bands, and the limited pelvic space hampers visualization and gentle adhesiolysis.

At special risk for bowel injury are women who have undergone prior abdominal operations or who are obese. In a series of 270 general surgery patients undergoing reoperation,⁷ 52 (19%) sustained inadvertent enterotomy. These patients had undergone a mean of 3.3 previous laparotomies and had a higher body mass index (mean of 25.5 versus 21.9).

Age may be another risk factor, since patients with enterotomies were 60 years or older.⁷

Injury during laparoscopy. Inadvertent bowel injuries may occur during laparoscopic procedures, especially at the time of trocar insertion or manipulation of pelvic structures.⁵ One device that helps prevent these injuries is the optical trocar (Visiport, US Surgical, Norwalk, Conn), which allows physicians to visualize the layers of the abdominal wall as penetration occurs.

We also routinely direct anesthesia personnel to insert a nasogastric tube at the beginning of laparoscopic procedures to facilitate decompression of the stomach and small bowel.

The risks of electrosurgery. Electrocautery used for tubal ligation, pelvic dissection, or hemostasis may injure the bowel if the surgeon is not careful. Thermal injury due to unipolar cautery is particularly ominous because the extent of injury is greater than what can be grossly observed. The incidence of this type of injury can be reduced using bipolar cautery devices, as well as clips or bands for tubal ligation.

Injury as a result of uterine perforation is unlikely, but can occur. If perforation occurs during dilation and curettage, bowel laceration may result, particularly adhesions are present between the uterus and bowel loops. In extremely rare instances, a loop of bowel may be pulled through a perforation into the uterine cavity or vagina, requiring laparotomy for reduction and repair. Caution is advised during curettage, especially in a gravid uterus, to prevent this potentially catastrophic event.

Avoid the temptation to lyse opaque adhesions using blunt dissection, as serosal tears and enterotomies may occur.

Adhesiolysis: Plan on a lengthy, meticulous procedure

Adhesions are a common cause of pelvic pain, infertility, and bowel obstruction, and their presence may make it difficult to carry out the intended surgical procedure. Adhesiolysis may be necessary to mobilize loops of bowel tightly adherent to pelvic structures, to provide sufficient exposure of the surgical field and prevent subsequent bowel obstruction.

The extent of adhesions does not necessarily correlate with clinical symptoms.

Adhesions may be of the thin, filmy, “friendly” variety or dense, thick bands.

How adhesions occur. When tissue is injured, fibrin is deposited on the peritoneal and serosal surfaces. The extent to which this fibrin is infiltrated with fibroblasts and the degree of subsequent fibrosis determine adhesion density. Any process that impairs fibrinolysis tends to delay resolution of adhesions.

Contributing factors. Adhesions are commonly encountered in pelvic surgery and may be observed in 50% to 90% of patients who have undergone previous surgery.⁸

Obese patients also are more susceptible to adhesions. Other contributing factors include pelvic infection, bleeding, irradiation, chemical irritants, and conditions such as endometriosis.

Lysis technique. Apply gentle, controlled traction—as well as countertraction—on the bowel loops to facilitate isolation and dissection with sharp Metzenbaum scissors or a scalpel. (Forceful traction or rough handling of bowel loops may cause a breach in the bowel wall with subsequent spillage of intestinal contents.)

 

Avoid the temptation to lyse adhesions using blunt dissection (serosal tears and enterotomies may occur)—except in the case of translucent adhesions. These may be lysed via gentle, blunt dissection by rubbing the index finger and thumb back and forth over tissue. They also may be sharply cut using the tip of the scissors to form a “window” in a portion of the adhesion and cutting the adhesive segments in increments.

A characteristic line of demarcation often appears between adhesions and their peritoneal attachment, denoting a safe dissection plane.

Technique for special challenges: Chronic pelvic disease, prior laparotomies. When operating on these patients, be prepared for a long, meticulous procedure. A hasty approach in such cases is perilous and increases the likelihood of postoperative complications.

First, dissect the anterior abdominal wall from the adherent bowel on either side of the incision. Then extend the dissection laterally on both sides until the ascending and descending colon are identified. Next, dissect the small bowel free and mobilize it out of the pelvis.

It often is helpful to move to another area when dissection becomes too difficult; dissection through easier planes often will clarify the relationship of pelvic structures and adherent bowel loops.

Once the small bowel has been mobilized from the pelvis, lyse adhesions between loops of bowel that are causing kinking or narrowing of the lumen, to reduce the risk of postoperative bowel obstruction. Next, carefully dissect pelvic structures from the sigmoid colon and rectum.

How and when to repair serosal injury

Serosal injury is a breach of integrity of the visceral peritoneum, the outermost covering of the bowel wall. This may occur when the serosa is cut during entry into the abdomen or when it is torn during blunt dissection of dense adhesions.

If the underlying muscular and mucosal layers remain intact, these small areas of “denuded” serosa need not be repaired, since most experts believe that suture placement increases the likelihood of future adhesions. The serosal and muscular layers should be repaired if the mucosa is exposed, however. Otherwise the bowel wall will weaken at the site, making it vulnerable to perforation. The seromuscular layers can be approximated easily using interrupted 4-0 silk on a small tapered needle. Be careful to avoid placing the stitch through the mucosa, which would violate the bowel lumen.

When the defect of the seromuscular layer is large (when a more extensive area is denuded during dissection of densely adherent bowel away from a tumor or endometriotic lesion), repair becomes more involved. This may require resection of the injured area with primary anastomosis.

Intestinal perforations: Early recognition is essential

This critical serious complication can become disastrous if not immediately recognized and repaired. Perforation of the small intestine (enterotomy) or large bowel (colotomy) often occurs upon entry into the peritoneal cavity or during a difficult dissection, particularly when extensive adhesions are present.

Exercise special caution when operating on patients who have undergone prior surgery, who are advanced in age, or both.

Reoperation technique. When entering the abdomen through an old scar, reduce the likelihood of bowel injury by extending the new incision to either side of the old scar. Then enter the peritoneal cavity in a virgin area of the abdominal wall, where adherent loops of bowel are less likely.

Carefully open the fascia and dissect the preperitoneal fat down to the peritoneum. Before entering the abdominal cavity, retract the peritoneum upward with smooth forceps and palpate it between the thumb and index finger to ensure that a bowel loop is not in harm’s way.

If the underlying muscular and mucosal layers remain intact, small areas of “denuded” serosa need not be repaired.

Examine the entire small and large bowel carefully after surgery, to rule out injury. It is not uncommon for more than 1 perforation to occur in a bowel segment during a difficult dissection.

Begin at the ligament of Treitz and continue to the ileocecal junction. This is “running” the bowel—ie, inspecting in hand-over-hand fashion.

In the small bowel, the division between the jejunum and ileum is arbitrary, with no sharply defined line of demarcation. However, the diameter of the lumen decreases as one moves from jejunum to ileum, the number of vascular arcades increases, and the number of windows of Deaver diminishes. Also, the wall of the jejunum is generally thicker than that of the ileum.

In addition, inspect the colon in its entirety, with special emphasis on the sigmoid and rectum. Besides its larger lumen, the large bowel is distinguished by 3 longitudinal muscular bands called taenia coli, out-pouching of the wall (sacculations), and epiploic appendages.

 

Also examine the mesentery to exclude vascular compromise to the bowel wall.

Repair perforations immediately to limit contamination of the peritoneal cavity. Prior to closure, inspect wound edges for devitalized tissue and, if found, promptly debride it.

If colotomy occurs in the setting of an unprepared bowel with significant spillage, follow closure with copious irrigation.

Small perforations can usually be closed in 2 layers, with an inner layer of 3-0 delayed synthetic absorbable suture (Dexon, Vicryl) through the full thickness of the bowel wall, ensuring mucosal approximation. It is vital that this layer be “waterproof,” allowing no leakage of intestinal contents. Then place a second row of suture in the seromuscular layer using 4-0 silk to imbricate the first suture line.

General surgical consultation is needed whenever the gynecologist is inexperienced with bowel resection and anastomosis.

It also is essential that the suture line be perpendicular to the long axis of the bowel, rather than parallel; otherwise, the bowel lumen would narrow. Even perforations extending along the longitudinal axis for several centimeters should be repaired in transverse fashion to provide a lumen of adequate diameter.

Resecting the small bowel: If inexperienced, obtain general surgery consultation

Bowel resection and anastomosis require a greater degree of skill than is attained in a typical gynecologic training program. For that reason, resection is addressed here only superficially. Our primary caveat: A general surgical consultation should be obtained whenever the gynecologist is inexperienced with bowel resection and anastomosis.

Indications for resection. Strongly consider resection and anastomosis if the perforation involves more than 50% of the circumference of the bowel wall, if multiple perforations occur in a short segment of bowel, or if there is vascular compromise to a segment of bowel. Adequate perfusion to the bowel usually is indicated by a pink serosal surface. If the serosa remains dark or dusky and fails to become pink after several minutes of observation, vascular compromise is likely and resection is preferred.

If there is doubt about the blood supply to the bowel, give 1 g fluorescein intravenously and inspect the bowel under ultraviolet light (Wood’s lamp). Normal vascularized bowel will have a homogenous yellow-green appearance. Patchy fluorescence or areas without any fluorescence are evidence of ischemia.

To drain or not to drain

Because perforation and resection both involve entry into the bowel lumen, some degree of spillage is inevitable. This is of greater concern when the large bowel is involved, because of the increased likelihood of bacterial contamination. Immediate copious irrigation of the peritoneal cavity is indicated. Also consider a pelvic drain, especially when dissection has been extensive or raw surfaces are oozing.

The combination of bacterial contamination and free peritoneal blood in the pelvis increases the risk for infection. A strategically placed, half-inch Jackson Pratt drain (or a similar device) may help prevent abscess. In the event of anastomotic leakage, a drain often allows for a controlled enterocutaneous fistula to be managed without reoperation.

Some surgeons have satisfactory results without these drainage techniques.

When to begin postop feeding: Depends on type of repair

Opinion varies about the appropriate time to commence feeding after major abdominal surgery, particularly bowel surgery. Over the past decade, with the pressure to discharge patients earlier, many physicians have opted for earlier timing.

Traditionally, feeding was withheld until bowel sounds were auscultated; then it progressed slowly. Today many surgeons advance the diet much more quickly, with little or no delay in recovery. Fanning and Andrews⁹ demonstrated that early feeding does not increase the incidence of anastomotic leakage, dehiscence, or aspiration pneumonia—although it is associated with increased emesis.

Patients undergoing surgery for relatively minor injuries can have their diet advanced as if there were no intestinal involvement.

Feeding after minor repairs. When the surgery has involved relatively minor injuries, such as isolated serosal tears and adhesiolysis, nasogastric tube placement is not required. These patients can have their diet advanced as if there were no intestinal involvement. Give clear liquids when bowel sounds are heard and, if tolerated, advance to solids. It is probably not necessary to await a bowel movement before discharging the patient; she can be released once flatus is passed.

Substantial repairs. When major injuries have been repaired, such as with a large perforation repair or bowel resection, it is prudent to proceed more slowly.

Place a nasogastric tube to minimize bowel distention and subsequent leakage from the repair site. Give the patient nothing by mouth until bowel sounds are clearly present and flatus is passed. Then clamp the nasogastric tube for 24 hours, remove it, and institute clear liquids, provided there is no nausea, vomiting, or distension. Advance to full liquids and then solids, tailoring this process to the patient. When she can tolerate a regular diet, with substantial passage of flatus or bowel movement, recovery is signaled.

 

Need for additional training

The techniques necessary to manage simple bowel injury are not difficult to master. However, Ob/Gyn residency programs need to extend training in this area. Additional rotations on the general surgery or trauma services as second- or third-year residents would be ideal, but the use of animal laboratories is a good alternative.

The authors report no financial relationships relevant to this article.

This dreaded complication requires vigilance and skill to avoid, and adequate training and experience to manage and repair. In a perfect world, every gynecologist would be trained in techniques to prevent and repair inadvertent bowel injuries. Unfortunately, residency programs often do not provide such training.

Gynecologists routinely operate on patients with risk factors for bowel injury—obesity, endometriosis, multiple abdominal procedures, pelvic inflammatory disease, history of malignancy, and advanced age. A general surgeon is often called, however, for bowel repairs that can be performed by a gynecologist with sufficient training and experience. (There are instances, however, in which a general surgical consultation may not be readily available—another reason to master repair of bowel injuries encountered during gynecologic surgery.)

This article describes techniques to avert and manage intestinal injury. Topics include adhesiolysis, repair of bowel perforations, segmental bowel resection, and pre- and postoperative management. Vascular anatomy of the bowel is illustrated.

We emphasize the need for direct supervision by an experienced surgeon while mastering these techniques.

Bowel preparation: A useful tool to reduce infection, leakage

Isolated reports have questioned the need for mechanical bowel preparation,^1,2 and some experts point to the recent success of primary repairs of gunshot and stab wounds to the colon as evidence that bowel preparation and preoperative oral antibiotics are unnecessary.

Other studies indicate potential benefits, namely reducing infectious complications and anastomotic leakage following repair of inadvertent enterotomy. Indeed, the vast majority of North American surgeons continue to use some form of bowel preparation,^3,4 and it is the standard of care for elective intestinal surgery. For these reasons, bowel preparation is strongly encouraged for the gynecologic surgeon operating on a pelvic mass, endometriosis, or malignancy, or when difficult dissection is anticipated with the potential for inadvertent enterotomy and spillage of intestinal contents.

Bowel preparation consists of 2 phases: mechanical cleansing and antibiotic administration (TABLE). The postoperative infection rate can be reduced to well below 10% when these are properly performed.

Mechanical cleansing reduces the bulk of stool content within the lumen of the bowel, which also decreases the absolute amount of bacteria.⁵ Anaerobes are the predominant flora in the colon, with an estimated density of 10¹⁰ organisms per gram of stool. Perforation and spillage of colon contents contaminates the peritoneal cavity with more than 400 species of bacteria.

Perforation and spillage of colon contents contaminates the peritoneal cavity with more than 400 species of bacteria.

In the past, stool bulk was reduced via a low-residue or liquid diet combined with cathartics, enemas, or other agents given over 2 to 3 days. This regimen was time-consuming, patient compliance was poor, and nutritional intake was severely restricted prior to major surgery.

Today, polyethylene glycol and sodium phosphate are the 2 most popular methods of bowel preparation.

• Polyethylene glycol (Golytely, Braintree Labs, Braintree, Mass) is a balanced electrolyte solution dispensed in a 4-L quantity that must be taken over 4 hours. Some patients find this volume difficult to consume; one option is administering the solution via a small nasogastric tube. Complications may include nausea/vomiting, abdominal cramping, and, rarely, fluid overload and electrolyte disturbances.
  
• Sodium phosphate (Fleet Phosphosoda, C.B. Fleet Co, Lynchburg, Va) is administered in two 45-mL increments several hours apart. There is no consensus on which bowel-prep method is superior^3,4; most surgeons prefer one or the other. Due to potential electrolyte abnormalities with the use of sodium phosphate, polyethylene glycol is favored for patients with significant renal, cardiac, or hepatic disease.
  
• We recommend minimally absorbed oral antibiotics (1 g each of neomycin and erythromycin, given at 1 PM, 2 PM, and 11 PM the day before surgery) in combination with an intravenous second-generation cephalosporin (1 g if using cefotetan, 2 g if using cefoxitin; given immediately before surgery and continued postoperatively for 3 doses).
  
• Timing of antibiotic administration is important, since postoperative antibiotics alone do not appear to be effective. If significant spillage occurs intraoperatively, parenteral antibiotics should be continued for 5 days.
  

 

TABLE

Bowel prep regimen

DAY BEFORE SURGERY
Morning
Light breakfast
Noon
Clear liquids
Polyethylene glycol, 4L, to be consumed over 4 to 6 hours
1 PM
Neomycin, 1 g orally
Erythromycin, 1 g orally
2 PM
Neomycin, 1 g orally
Erythromycin, 1 g orally
Evening
Clear liquids
11 PM
Neomycin, 1 g orally
Erythromycin, 1 g orally
DAY OF SURGERY
Morning
Intravenous cephalosporin (1 g cefotetan or 2 g cefoxitin); 1 hour before incision, continued postoperatively for 3 doses

Thermal injury due to unipolar cautery is particularly ominous because the extent of injury exceeds what is grossly observed.

When injuries are most likely

Intestinal injuries during gynecologic surgery usually involve the small bowel and can be minor, such as a serosal tear or a small, full-thickness laceration—or major, involving a devitalized bowel loop or its mesentery.

Bowel injury may occur during a variety of surgical procedures. One study showed that most injuries occur during adhesiolysis or entry into the peritoneal cavity. A smaller but substantial number of cases occur during “less extensive” procedures such as uterine curettage and laparoscopy.⁶

Upon entering the peritoneal cavity, keep in mind the possibility of injuring an adherent loop of bowel. Because of its anatomical relationships to the pelvic viscera, portions of the bowel may become involved in adhesions, which can lead to extremely challenging pelvic dissections in conditions such as endometriosis or severe pelvic infection. Dissection of pelvic adhesions is a common cause of bowel injury, because bowel loops are retracted deeply downward by adhesive bands, and the limited pelvic space hampers visualization and gentle adhesiolysis.

At special risk for bowel injury are women who have undergone prior abdominal operations or who are obese. In a series of 270 general surgery patients undergoing reoperation,⁷ 52 (19%) sustained inadvertent enterotomy. These patients had undergone a mean of 3.3 previous laparotomies and had a higher body mass index (mean of 25.5 versus 21.9).

Age may be another risk factor, since patients with enterotomies were 60 years or older.⁷

Injury during laparoscopy. Inadvertent bowel injuries may occur during laparoscopic procedures, especially at the time of trocar insertion or manipulation of pelvic structures.⁵ One device that helps prevent these injuries is the optical trocar (Visiport, US Surgical, Norwalk, Conn), which allows physicians to visualize the layers of the abdominal wall as penetration occurs.

We also routinely direct anesthesia personnel to insert a nasogastric tube at the beginning of laparoscopic procedures to facilitate decompression of the stomach and small bowel.

The risks of electrosurgery. Electrocautery used for tubal ligation, pelvic dissection, or hemostasis may injure the bowel if the surgeon is not careful. Thermal injury due to unipolar cautery is particularly ominous because the extent of injury is greater than what can be grossly observed. The incidence of this type of injury can be reduced using bipolar cautery devices, as well as clips or bands for tubal ligation.

Injury as a result of uterine perforation is unlikely, but can occur. If perforation occurs during dilation and curettage, bowel laceration may result, particularly adhesions are present between the uterus and bowel loops. In extremely rare instances, a loop of bowel may be pulled through a perforation into the uterine cavity or vagina, requiring laparotomy for reduction and repair. Caution is advised during curettage, especially in a gravid uterus, to prevent this potentially catastrophic event.

Avoid the temptation to lyse opaque adhesions using blunt dissection, as serosal tears and enterotomies may occur.

Adhesiolysis: Plan on a lengthy, meticulous procedure

Adhesions are a common cause of pelvic pain, infertility, and bowel obstruction, and their presence may make it difficult to carry out the intended surgical procedure. Adhesiolysis may be necessary to mobilize loops of bowel tightly adherent to pelvic structures, to provide sufficient exposure of the surgical field and prevent subsequent bowel obstruction.

The extent of adhesions does not necessarily correlate with clinical symptoms.

Adhesions may be of the thin, filmy, “friendly” variety or dense, thick bands.

How adhesions occur. When tissue is injured, fibrin is deposited on the peritoneal and serosal surfaces. The extent to which this fibrin is infiltrated with fibroblasts and the degree of subsequent fibrosis determine adhesion density. Any process that impairs fibrinolysis tends to delay resolution of adhesions.

Contributing factors. Adhesions are commonly encountered in pelvic surgery and may be observed in 50% to 90% of patients who have undergone previous surgery.⁸

Obese patients also are more susceptible to adhesions. Other contributing factors include pelvic infection, bleeding, irradiation, chemical irritants, and conditions such as endometriosis.

Lysis technique. Apply gentle, controlled traction—as well as countertraction—on the bowel loops to facilitate isolation and dissection with sharp Metzenbaum scissors or a scalpel. (Forceful traction or rough handling of bowel loops may cause a breach in the bowel wall with subsequent spillage of intestinal contents.)

 

Avoid the temptation to lyse adhesions using blunt dissection (serosal tears and enterotomies may occur)—except in the case of translucent adhesions. These may be lysed via gentle, blunt dissection by rubbing the index finger and thumb back and forth over tissue. They also may be sharply cut using the tip of the scissors to form a “window” in a portion of the adhesion and cutting the adhesive segments in increments.

A characteristic line of demarcation often appears between adhesions and their peritoneal attachment, denoting a safe dissection plane.

Technique for special challenges: Chronic pelvic disease, prior laparotomies. When operating on these patients, be prepared for a long, meticulous procedure. A hasty approach in such cases is perilous and increases the likelihood of postoperative complications.

First, dissect the anterior abdominal wall from the adherent bowel on either side of the incision. Then extend the dissection laterally on both sides until the ascending and descending colon are identified. Next, dissect the small bowel free and mobilize it out of the pelvis.

It often is helpful to move to another area when dissection becomes too difficult; dissection through easier planes often will clarify the relationship of pelvic structures and adherent bowel loops.

Once the small bowel has been mobilized from the pelvis, lyse adhesions between loops of bowel that are causing kinking or narrowing of the lumen, to reduce the risk of postoperative bowel obstruction. Next, carefully dissect pelvic structures from the sigmoid colon and rectum.

How and when to repair serosal injury

Serosal injury is a breach of integrity of the visceral peritoneum, the outermost covering of the bowel wall. This may occur when the serosa is cut during entry into the abdomen or when it is torn during blunt dissection of dense adhesions.

If the underlying muscular and mucosal layers remain intact, these small areas of “denuded” serosa need not be repaired, since most experts believe that suture placement increases the likelihood of future adhesions. The serosal and muscular layers should be repaired if the mucosa is exposed, however. Otherwise the bowel wall will weaken at the site, making it vulnerable to perforation. The seromuscular layers can be approximated easily using interrupted 4-0 silk on a small tapered needle. Be careful to avoid placing the stitch through the mucosa, which would violate the bowel lumen.

When the defect of the seromuscular layer is large (when a more extensive area is denuded during dissection of densely adherent bowel away from a tumor or endometriotic lesion), repair becomes more involved. This may require resection of the injured area with primary anastomosis.

Intestinal perforations: Early recognition is essential

This critical serious complication can become disastrous if not immediately recognized and repaired. Perforation of the small intestine (enterotomy) or large bowel (colotomy) often occurs upon entry into the peritoneal cavity or during a difficult dissection, particularly when extensive adhesions are present.

Exercise special caution when operating on patients who have undergone prior surgery, who are advanced in age, or both.

Reoperation technique. When entering the abdomen through an old scar, reduce the likelihood of bowel injury by extending the new incision to either side of the old scar. Then enter the peritoneal cavity in a virgin area of the abdominal wall, where adherent loops of bowel are less likely.

Carefully open the fascia and dissect the preperitoneal fat down to the peritoneum. Before entering the abdominal cavity, retract the peritoneum upward with smooth forceps and palpate it between the thumb and index finger to ensure that a bowel loop is not in harm’s way.

If the underlying muscular and mucosal layers remain intact, small areas of “denuded” serosa need not be repaired.

Examine the entire small and large bowel carefully after surgery, to rule out injury. It is not uncommon for more than 1 perforation to occur in a bowel segment during a difficult dissection.

Begin at the ligament of Treitz and continue to the ileocecal junction. This is “running” the bowel—ie, inspecting in hand-over-hand fashion.

In the small bowel, the division between the jejunum and ileum is arbitrary, with no sharply defined line of demarcation. However, the diameter of the lumen decreases as one moves from jejunum to ileum, the number of vascular arcades increases, and the number of windows of Deaver diminishes. Also, the wall of the jejunum is generally thicker than that of the ileum.

In addition, inspect the colon in its entirety, with special emphasis on the sigmoid and rectum. Besides its larger lumen, the large bowel is distinguished by 3 longitudinal muscular bands called taenia coli, out-pouching of the wall (sacculations), and epiploic appendages.

 

Also examine the mesentery to exclude vascular compromise to the bowel wall.

Repair perforations immediately to limit contamination of the peritoneal cavity. Prior to closure, inspect wound edges for devitalized tissue and, if found, promptly debride it.

If colotomy occurs in the setting of an unprepared bowel with significant spillage, follow closure with copious irrigation.

Small perforations can usually be closed in 2 layers, with an inner layer of 3-0 delayed synthetic absorbable suture (Dexon, Vicryl) through the full thickness of the bowel wall, ensuring mucosal approximation. It is vital that this layer be “waterproof,” allowing no leakage of intestinal contents. Then place a second row of suture in the seromuscular layer using 4-0 silk to imbricate the first suture line.

General surgical consultation is needed whenever the gynecologist is inexperienced with bowel resection and anastomosis.

It also is essential that the suture line be perpendicular to the long axis of the bowel, rather than parallel; otherwise, the bowel lumen would narrow. Even perforations extending along the longitudinal axis for several centimeters should be repaired in transverse fashion to provide a lumen of adequate diameter.

Resecting the small bowel: If inexperienced, obtain general surgery consultation

Bowel resection and anastomosis require a greater degree of skill than is attained in a typical gynecologic training program. For that reason, resection is addressed here only superficially. Our primary caveat: A general surgical consultation should be obtained whenever the gynecologist is inexperienced with bowel resection and anastomosis.

Indications for resection. Strongly consider resection and anastomosis if the perforation involves more than 50% of the circumference of the bowel wall, if multiple perforations occur in a short segment of bowel, or if there is vascular compromise to a segment of bowel. Adequate perfusion to the bowel usually is indicated by a pink serosal surface. If the serosa remains dark or dusky and fails to become pink after several minutes of observation, vascular compromise is likely and resection is preferred.

If there is doubt about the blood supply to the bowel, give 1 g fluorescein intravenously and inspect the bowel under ultraviolet light (Wood’s lamp). Normal vascularized bowel will have a homogenous yellow-green appearance. Patchy fluorescence or areas without any fluorescence are evidence of ischemia.

To drain or not to drain

Because perforation and resection both involve entry into the bowel lumen, some degree of spillage is inevitable. This is of greater concern when the large bowel is involved, because of the increased likelihood of bacterial contamination. Immediate copious irrigation of the peritoneal cavity is indicated. Also consider a pelvic drain, especially when dissection has been extensive or raw surfaces are oozing.

The combination of bacterial contamination and free peritoneal blood in the pelvis increases the risk for infection. A strategically placed, half-inch Jackson Pratt drain (or a similar device) may help prevent abscess. In the event of anastomotic leakage, a drain often allows for a controlled enterocutaneous fistula to be managed without reoperation.

Some surgeons have satisfactory results without these drainage techniques.

When to begin postop feeding: Depends on type of repair

Opinion varies about the appropriate time to commence feeding after major abdominal surgery, particularly bowel surgery. Over the past decade, with the pressure to discharge patients earlier, many physicians have opted for earlier timing.

Traditionally, feeding was withheld until bowel sounds were auscultated; then it progressed slowly. Today many surgeons advance the diet much more quickly, with little or no delay in recovery. Fanning and Andrews⁹ demonstrated that early feeding does not increase the incidence of anastomotic leakage, dehiscence, or aspiration pneumonia—although it is associated with increased emesis.

Patients undergoing surgery for relatively minor injuries can have their diet advanced as if there were no intestinal involvement.

Feeding after minor repairs. When the surgery has involved relatively minor injuries, such as isolated serosal tears and adhesiolysis, nasogastric tube placement is not required. These patients can have their diet advanced as if there were no intestinal involvement. Give clear liquids when bowel sounds are heard and, if tolerated, advance to solids. It is probably not necessary to await a bowel movement before discharging the patient; she can be released once flatus is passed.

Substantial repairs. When major injuries have been repaired, such as with a large perforation repair or bowel resection, it is prudent to proceed more slowly.

Place a nasogastric tube to minimize bowel distention and subsequent leakage from the repair site. Give the patient nothing by mouth until bowel sounds are clearly present and flatus is passed. Then clamp the nasogastric tube for 24 hours, remove it, and institute clear liquids, provided there is no nausea, vomiting, or distension. Advance to full liquids and then solids, tailoring this process to the patient. When she can tolerate a regular diet, with substantial passage of flatus or bowel movement, recovery is signaled.

 

Need for additional training

The techniques necessary to manage simple bowel injury are not difficult to master. However, Ob/Gyn residency programs need to extend training in this area. Additional rotations on the general surgery or trauma services as second- or third-year residents would be ideal, but the use of animal laboratories is a good alternative.

The authors report no financial relationships relevant to this article.

This dreaded complication requires vigilance and skill to avoid, and adequate training and experience to manage and repair. In a perfect world, every gynecologist would be trained in techniques to prevent and repair inadvertent bowel injuries. Unfortunately, residency programs often do not provide such training.

Gynecologists routinely operate on patients with risk factors for bowel injury—obesity, endometriosis, multiple abdominal procedures, pelvic inflammatory disease, history of malignancy, and advanced age. A general surgeon is often called, however, for bowel repairs that can be performed by a gynecologist with sufficient training and experience. (There are instances, however, in which a general surgical consultation may not be readily available—another reason to master repair of bowel injuries encountered during gynecologic surgery.)

This article describes techniques to avert and manage intestinal injury. Topics include adhesiolysis, repair of bowel perforations, segmental bowel resection, and pre- and postoperative management. Vascular anatomy of the bowel is illustrated.

We emphasize the need for direct supervision by an experienced surgeon while mastering these techniques.

Bowel preparation: A useful tool to reduce infection, leakage

Isolated reports have questioned the need for mechanical bowel preparation,^1,2 and some experts point to the recent success of primary repairs of gunshot and stab wounds to the colon as evidence that bowel preparation and preoperative oral antibiotics are unnecessary.

Other studies indicate potential benefits, namely reducing infectious complications and anastomotic leakage following repair of inadvertent enterotomy. Indeed, the vast majority of North American surgeons continue to use some form of bowel preparation,^3,4 and it is the standard of care for elective intestinal surgery. For these reasons, bowel preparation is strongly encouraged for the gynecologic surgeon operating on a pelvic mass, endometriosis, or malignancy, or when difficult dissection is anticipated with the potential for inadvertent enterotomy and spillage of intestinal contents.

Bowel preparation consists of 2 phases: mechanical cleansing and antibiotic administration (TABLE). The postoperative infection rate can be reduced to well below 10% when these are properly performed.

Mechanical cleansing reduces the bulk of stool content within the lumen of the bowel, which also decreases the absolute amount of bacteria.⁵ Anaerobes are the predominant flora in the colon, with an estimated density of 10¹⁰ organisms per gram of stool. Perforation and spillage of colon contents contaminates the peritoneal cavity with more than 400 species of bacteria.

Perforation and spillage of colon contents contaminates the peritoneal cavity with more than 400 species of bacteria.

In the past, stool bulk was reduced via a low-residue or liquid diet combined with cathartics, enemas, or other agents given over 2 to 3 days. This regimen was time-consuming, patient compliance was poor, and nutritional intake was severely restricted prior to major surgery.

Today, polyethylene glycol and sodium phosphate are the 2 most popular methods of bowel preparation.

• Polyethylene glycol (Golytely, Braintree Labs, Braintree, Mass) is a balanced electrolyte solution dispensed in a 4-L quantity that must be taken over 4 hours. Some patients find this volume difficult to consume; one option is administering the solution via a small nasogastric tube. Complications may include nausea/vomiting, abdominal cramping, and, rarely, fluid overload and electrolyte disturbances.
  
• Sodium phosphate (Fleet Phosphosoda, C.B. Fleet Co, Lynchburg, Va) is administered in two 45-mL increments several hours apart. There is no consensus on which bowel-prep method is superior^3,4; most surgeons prefer one or the other. Due to potential electrolyte abnormalities with the use of sodium phosphate, polyethylene glycol is favored for patients with significant renal, cardiac, or hepatic disease.
  
• We recommend minimally absorbed oral antibiotics (1 g each of neomycin and erythromycin, given at 1 PM, 2 PM, and 11 PM the day before surgery) in combination with an intravenous second-generation cephalosporin (1 g if using cefotetan, 2 g if using cefoxitin; given immediately before surgery and continued postoperatively for 3 doses).
  
• Timing of antibiotic administration is important, since postoperative antibiotics alone do not appear to be effective. If significant spillage occurs intraoperatively, parenteral antibiotics should be continued for 5 days.
  

 

TABLE

Bowel prep regimen

DAY BEFORE SURGERY
Morning
Light breakfast
Noon
Clear liquids
Polyethylene glycol, 4L, to be consumed over 4 to 6 hours
1 PM
Neomycin, 1 g orally
Erythromycin, 1 g orally
2 PM
Neomycin, 1 g orally
Erythromycin, 1 g orally
Evening
Clear liquids
11 PM
Neomycin, 1 g orally
Erythromycin, 1 g orally
DAY OF SURGERY
Morning
Intravenous cephalosporin (1 g cefotetan or 2 g cefoxitin); 1 hour before incision, continued postoperatively for 3 doses

Thermal injury due to unipolar cautery is particularly ominous because the extent of injury exceeds what is grossly observed.

When injuries are most likely

Intestinal injuries during gynecologic surgery usually involve the small bowel and can be minor, such as a serosal tear or a small, full-thickness laceration—or major, involving a devitalized bowel loop or its mesentery.

Bowel injury may occur during a variety of surgical procedures. One study showed that most injuries occur during adhesiolysis or entry into the peritoneal cavity. A smaller but substantial number of cases occur during “less extensive” procedures such as uterine curettage and laparoscopy.⁶

Upon entering the peritoneal cavity, keep in mind the possibility of injuring an adherent loop of bowel. Because of its anatomical relationships to the pelvic viscera, portions of the bowel may become involved in adhesions, which can lead to extremely challenging pelvic dissections in conditions such as endometriosis or severe pelvic infection. Dissection of pelvic adhesions is a common cause of bowel injury, because bowel loops are retracted deeply downward by adhesive bands, and the limited pelvic space hampers visualization and gentle adhesiolysis.

At special risk for bowel injury are women who have undergone prior abdominal operations or who are obese. In a series of 270 general surgery patients undergoing reoperation,⁷ 52 (19%) sustained inadvertent enterotomy. These patients had undergone a mean of 3.3 previous laparotomies and had a higher body mass index (mean of 25.5 versus 21.9).

Age may be another risk factor, since patients with enterotomies were 60 years or older.⁷

Injury during laparoscopy. Inadvertent bowel injuries may occur during laparoscopic procedures, especially at the time of trocar insertion or manipulation of pelvic structures.⁵ One device that helps prevent these injuries is the optical trocar (Visiport, US Surgical, Norwalk, Conn), which allows physicians to visualize the layers of the abdominal wall as penetration occurs.

We also routinely direct anesthesia personnel to insert a nasogastric tube at the beginning of laparoscopic procedures to facilitate decompression of the stomach and small bowel.

The risks of electrosurgery. Electrocautery used for tubal ligation, pelvic dissection, or hemostasis may injure the bowel if the surgeon is not careful. Thermal injury due to unipolar cautery is particularly ominous because the extent of injury is greater than what can be grossly observed. The incidence of this type of injury can be reduced using bipolar cautery devices, as well as clips or bands for tubal ligation.

Injury as a result of uterine perforation is unlikely, but can occur. If perforation occurs during dilation and curettage, bowel laceration may result, particularly adhesions are present between the uterus and bowel loops. In extremely rare instances, a loop of bowel may be pulled through a perforation into the uterine cavity or vagina, requiring laparotomy for reduction and repair. Caution is advised during curettage, especially in a gravid uterus, to prevent this potentially catastrophic event.

Avoid the temptation to lyse opaque adhesions using blunt dissection, as serosal tears and enterotomies may occur.

Adhesiolysis: Plan on a lengthy, meticulous procedure

Adhesions are a common cause of pelvic pain, infertility, and bowel obstruction, and their presence may make it difficult to carry out the intended surgical procedure. Adhesiolysis may be necessary to mobilize loops of bowel tightly adherent to pelvic structures, to provide sufficient exposure of the surgical field and prevent subsequent bowel obstruction.

The extent of adhesions does not necessarily correlate with clinical symptoms.

Adhesions may be of the thin, filmy, “friendly” variety or dense, thick bands.

How adhesions occur. When tissue is injured, fibrin is deposited on the peritoneal and serosal surfaces. The extent to which this fibrin is infiltrated with fibroblasts and the degree of subsequent fibrosis determine adhesion density. Any process that impairs fibrinolysis tends to delay resolution of adhesions.

Contributing factors. Adhesions are commonly encountered in pelvic surgery and may be observed in 50% to 90% of patients who have undergone previous surgery.⁸

Obese patients also are more susceptible to adhesions. Other contributing factors include pelvic infection, bleeding, irradiation, chemical irritants, and conditions such as endometriosis.

Lysis technique. Apply gentle, controlled traction—as well as countertraction—on the bowel loops to facilitate isolation and dissection with sharp Metzenbaum scissors or a scalpel. (Forceful traction or rough handling of bowel loops may cause a breach in the bowel wall with subsequent spillage of intestinal contents.)

 

Avoid the temptation to lyse adhesions using blunt dissection (serosal tears and enterotomies may occur)—except in the case of translucent adhesions. These may be lysed via gentle, blunt dissection by rubbing the index finger and thumb back and forth over tissue. They also may be sharply cut using the tip of the scissors to form a “window” in a portion of the adhesion and cutting the adhesive segments in increments.

A characteristic line of demarcation often appears between adhesions and their peritoneal attachment, denoting a safe dissection plane.

Technique for special challenges: Chronic pelvic disease, prior laparotomies. When operating on these patients, be prepared for a long, meticulous procedure. A hasty approach in such cases is perilous and increases the likelihood of postoperative complications.

First, dissect the anterior abdominal wall from the adherent bowel on either side of the incision. Then extend the dissection laterally on both sides until the ascending and descending colon are identified. Next, dissect the small bowel free and mobilize it out of the pelvis.

It often is helpful to move to another area when dissection becomes too difficult; dissection through easier planes often will clarify the relationship of pelvic structures and adherent bowel loops.

Once the small bowel has been mobilized from the pelvis, lyse adhesions between loops of bowel that are causing kinking or narrowing of the lumen, to reduce the risk of postoperative bowel obstruction. Next, carefully dissect pelvic structures from the sigmoid colon and rectum.

How and when to repair serosal injury

Serosal injury is a breach of integrity of the visceral peritoneum, the outermost covering of the bowel wall. This may occur when the serosa is cut during entry into the abdomen or when it is torn during blunt dissection of dense adhesions.

If the underlying muscular and mucosal layers remain intact, these small areas of “denuded” serosa need not be repaired, since most experts believe that suture placement increases the likelihood of future adhesions. The serosal and muscular layers should be repaired if the mucosa is exposed, however. Otherwise the bowel wall will weaken at the site, making it vulnerable to perforation. The seromuscular layers can be approximated easily using interrupted 4-0 silk on a small tapered needle. Be careful to avoid placing the stitch through the mucosa, which would violate the bowel lumen.

When the defect of the seromuscular layer is large (when a more extensive area is denuded during dissection of densely adherent bowel away from a tumor or endometriotic lesion), repair becomes more involved. This may require resection of the injured area with primary anastomosis.

Intestinal perforations: Early recognition is essential

This critical serious complication can become disastrous if not immediately recognized and repaired. Perforation of the small intestine (enterotomy) or large bowel (colotomy) often occurs upon entry into the peritoneal cavity or during a difficult dissection, particularly when extensive adhesions are present.

Exercise special caution when operating on patients who have undergone prior surgery, who are advanced in age, or both.

Reoperation technique. When entering the abdomen through an old scar, reduce the likelihood of bowel injury by extending the new incision to either side of the old scar. Then enter the peritoneal cavity in a virgin area of the abdominal wall, where adherent loops of bowel are less likely.

Carefully open the fascia and dissect the preperitoneal fat down to the peritoneum. Before entering the abdominal cavity, retract the peritoneum upward with smooth forceps and palpate it between the thumb and index finger to ensure that a bowel loop is not in harm’s way.

If the underlying muscular and mucosal layers remain intact, small areas of “denuded” serosa need not be repaired.

Examine the entire small and large bowel carefully after surgery, to rule out injury. It is not uncommon for more than 1 perforation to occur in a bowel segment during a difficult dissection.

Begin at the ligament of Treitz and continue to the ileocecal junction. This is “running” the bowel—ie, inspecting in hand-over-hand fashion.

In the small bowel, the division between the jejunum and ileum is arbitrary, with no sharply defined line of demarcation. However, the diameter of the lumen decreases as one moves from jejunum to ileum, the number of vascular arcades increases, and the number of windows of Deaver diminishes. Also, the wall of the jejunum is generally thicker than that of the ileum.

In addition, inspect the colon in its entirety, with special emphasis on the sigmoid and rectum. Besides its larger lumen, the large bowel is distinguished by 3 longitudinal muscular bands called taenia coli, out-pouching of the wall (sacculations), and epiploic appendages.

 

Also examine the mesentery to exclude vascular compromise to the bowel wall.

Repair perforations immediately to limit contamination of the peritoneal cavity. Prior to closure, inspect wound edges for devitalized tissue and, if found, promptly debride it.

If colotomy occurs in the setting of an unprepared bowel with significant spillage, follow closure with copious irrigation.

Small perforations can usually be closed in 2 layers, with an inner layer of 3-0 delayed synthetic absorbable suture (Dexon, Vicryl) through the full thickness of the bowel wall, ensuring mucosal approximation. It is vital that this layer be “waterproof,” allowing no leakage of intestinal contents. Then place a second row of suture in the seromuscular layer using 4-0 silk to imbricate the first suture line.

General surgical consultation is needed whenever the gynecologist is inexperienced with bowel resection and anastomosis.

It also is essential that the suture line be perpendicular to the long axis of the bowel, rather than parallel; otherwise, the bowel lumen would narrow. Even perforations extending along the longitudinal axis for several centimeters should be repaired in transverse fashion to provide a lumen of adequate diameter.

Resecting the small bowel: If inexperienced, obtain general surgery consultation

Bowel resection and anastomosis require a greater degree of skill than is attained in a typical gynecologic training program. For that reason, resection is addressed here only superficially. Our primary caveat: A general surgical consultation should be obtained whenever the gynecologist is inexperienced with bowel resection and anastomosis.

Indications for resection. Strongly consider resection and anastomosis if the perforation involves more than 50% of the circumference of the bowel wall, if multiple perforations occur in a short segment of bowel, or if there is vascular compromise to a segment of bowel. Adequate perfusion to the bowel usually is indicated by a pink serosal surface. If the serosa remains dark or dusky and fails to become pink after several minutes of observation, vascular compromise is likely and resection is preferred.

If there is doubt about the blood supply to the bowel, give 1 g fluorescein intravenously and inspect the bowel under ultraviolet light (Wood’s lamp). Normal vascularized bowel will have a homogenous yellow-green appearance. Patchy fluorescence or areas without any fluorescence are evidence of ischemia.

To drain or not to drain

Because perforation and resection both involve entry into the bowel lumen, some degree of spillage is inevitable. This is of greater concern when the large bowel is involved, because of the increased likelihood of bacterial contamination. Immediate copious irrigation of the peritoneal cavity is indicated. Also consider a pelvic drain, especially when dissection has been extensive or raw surfaces are oozing.

The combination of bacterial contamination and free peritoneal blood in the pelvis increases the risk for infection. A strategically placed, half-inch Jackson Pratt drain (or a similar device) may help prevent abscess. In the event of anastomotic leakage, a drain often allows for a controlled enterocutaneous fistula to be managed without reoperation.

Some surgeons have satisfactory results without these drainage techniques.

When to begin postop feeding: Depends on type of repair

Opinion varies about the appropriate time to commence feeding after major abdominal surgery, particularly bowel surgery. Over the past decade, with the pressure to discharge patients earlier, many physicians have opted for earlier timing.

Traditionally, feeding was withheld until bowel sounds were auscultated; then it progressed slowly. Today many surgeons advance the diet much more quickly, with little or no delay in recovery. Fanning and Andrews⁹ demonstrated that early feeding does not increase the incidence of anastomotic leakage, dehiscence, or aspiration pneumonia—although it is associated with increased emesis.

Patients undergoing surgery for relatively minor injuries can have their diet advanced as if there were no intestinal involvement.

Feeding after minor repairs. When the surgery has involved relatively minor injuries, such as isolated serosal tears and adhesiolysis, nasogastric tube placement is not required. These patients can have their diet advanced as if there were no intestinal involvement. Give clear liquids when bowel sounds are heard and, if tolerated, advance to solids. It is probably not necessary to await a bowel movement before discharging the patient; she can be released once flatus is passed.

Substantial repairs. When major injuries have been repaired, such as with a large perforation repair or bowel resection, it is prudent to proceed more slowly.

Place a nasogastric tube to minimize bowel distention and subsequent leakage from the repair site. Give the patient nothing by mouth until bowel sounds are clearly present and flatus is passed. Then clamp the nasogastric tube for 24 hours, remove it, and institute clear liquids, provided there is no nausea, vomiting, or distension. Advance to full liquids and then solids, tailoring this process to the patient. When she can tolerate a regular diet, with substantial passage of flatus or bowel movement, recovery is signaled.

 

Need for additional training

The techniques necessary to manage simple bowel injury are not difficult to master. However, Ob/Gyn residency programs need to extend training in this area. Additional rotations on the general surgery or trauma services as second- or third-year residents would be ideal, but the use of animal laboratories is a good alternative.

The authors report no financial relationships relevant to this article.

Endometrial tissues have amazing regenerative properties, with a controlled growth rate exceeding that of all known tumors. Within days of onset of menses, under appropriate estrogen stimulation, the endometrial surface “repairs” and “rebuilds”—from the basalis layer on up—rapidly achieving a thickness of 8 to 10 mm.

Thus, attempts to destroy it and achieve amenorrhea have met with limited success.

Hysterectomy is still the definitive treatment for excessive uterine bleeding, but a more conservative treatment, ablation, uses surgical or chemical means to obliterate the endometrial surface. Newer devices (FDA approved since 1997) allow office-based or same-day surgery; recovery time is shorter, and complication rates are lower than for hysterectomy.

This approach has gained popularity as instrumentation has improved; yet, because the endometrial surface is so resilient, success rates fall well shy of 100%. This article summaries the data on efficacy, and describes the indications, preoperative evaluation, and technique for 4 ablation options:

• thermal balloon ablation
  
• thermal fluid ablation
  
• cryotherapy
  
• impedance-controlled ablation
  

Other modalities include microwave, laser, and a progestin-releasing intrauterine contraception system.

Each uses a different energy-transfer technique to destroy the endometrium ( TABLE).

TABLE

4 global ablation devices at a glance

	THERMAL BALLOON (THERMACHOICE)	THERMAL FLUID (HYDROTHERMABLATOR)	CRYOTHERAPY (HER OPTION)	IMPEDANCE-CONTROLLED (NOVASURE)
Pretreatment	Yes	Yes	Yes	No
Time of energy delivery	8 minutes	10 minutes	10–12 minutes	90–120 seconds
Cornual ablation	No	Yes	User-dependent	Yes
Principle	Balloon filled with fluid (5% dextrose in water) at 87°C	Hydrothermal circulation of saline at 90°C	Probe with transfer media creates ice ball at –100 to –120°C	Bipolar, radiofrequency ablation at 100°C
Direct visualization	None	Hysteroscopy	Ultrasound guidance	None
Safety features	Pressure and temperature-sensing cutoffs	Fluid loss detection system	Ultrasound guidance	Uterine cavity integrity assessment system

Indications

The typical candidate for endometrial ablation has heavy menses requiring excessive sanitary protection (eg, tampon and pad simultaneously); her daily activity frequently is limited. The patient may have tried such management as nonsteroidal anti-inflammatory agents, oral contraceptives, or surgical dilatation and curettage (D&C) without success.

Excessive or abnormal uterine bleeding is defined as blood loss exceeding 80 mL per menses or a menstrual flow longer than 7 days. Abnormal uterine bleeding affects 22% of women of reproductive age.¹ Each year in the United States, approximately 180,000 women undergo hysterectomy for this indication.²

The optimal patient for endometrial ablation has a history of regular menses without excessive dysmenorrhea, which could suggest an underlying diagnosis of adenomyosis. (Findings suggestive of this difficult-to-diagnose condition include a tender, soft, boggy uterus at the time of menses.) Many women with adenomyosis fail to achieve adequate pain relief with endometrial ablation alone and eventually require a hysterectomy.

The patient should have completed childbearing and have a permanent method of contraception in place—endometrial ablation only reduces fertility, it does not eliminate it.

Preoperative evaluation

Laboratory studies include a complete blood count and urine human chorionic gonadotropin level, as well as screening for bleeding disorders when indicated.

A bleeding diary helps quantify symptoms. Its use should be encouraged.

Other tests and examinations. Also recommended are endometrial biopsy, a Pap test, and assessment of the endometrial cavity via hysteroscopy or sonohysterography.

Biopsy should reflect histologically normal tissue. The patient should have:

• regular menstrual cycles lasting 25 to 34 days
  
• no uterine anomaly or potential myometrial wall defect from a previous classical cesarean or transmural myomectomy
  

Preparing the endometrium. After careful patient selection and appropriate counseling for the procedure, preoperative preparation of the endometrium may be required, depending on the technique chosen. For example, thermal fluid ablation requires pretreatment with a gonadotropin-releasing hormone (GnRH) agonist or suction curettage. The most widely used preparation methods are hormonal treatment with GnRH agonists over 2 menstrual cycles, and suction D&C.

Contraindications

Anovulatory patients may not be good candidates because islands of endometrial tissue can remain after ablation. These tissue “nests” may spontaneously change to hyperplasia or endometrial carcinoma (due to unopposed estrogen). Further, uterine bleeding may not always occur when hyperplasia is present after endometrial ablation, delaying this serious diagnosis.

Relative contraindications include intramural or submucosal uterine myomas.

Earlier techniques: Hysteroscopic ablation

Techniques developed earlier require expert operative hysteroscopic skills and should be performed by experienced gynecologic surgeons to minimize complications.

For example, the first treatment of menorrhagia using a hysteroscopic approach with a Nd:YAG laser power source, reported in 1981 by Goldrath et al,³ utilized 55 watts of power with a 600-micron fiber dragged across the endometrium. Later, other surgeons used a rollerball unipolar electrode that coagulated the surface with continuous contact.^4,5

 

Modifications of this technique included a loop electrode that used monopolar electrical energy to “shave” the thicker portions of endometrium. In some reports, the rollerball electrode was used to reach the uterine cornu and endocoagulate the lower uterine segments. The most successful reports of this approach used a loop electrode to shave the endometrium followed by rollerball coagulation of the shaved areas. Amenorrhea rates with these techniques approached 60%.

Thermal balloon ablation

ThermaChoice (Gynecare, Somerville, NJ), the first global-ablation device to be marketed, was FDA-approved in 1997.^6,7 It is a single-use balloon that is filled with fluid (5% dextrose and water) and inflated to a pressure of 180 mm Hg.

Technique. After general or regional anesthesia and prior to balloon insertion, remove the superficial endometrium by suction curettage.

The balloon contains a central heating element that warms the fluid to 87°C for 8 minutes via electronic control. Pressure within the balloon must be stabilized within the uterine cavity.

Safety features include a pressure shut-off device that activates at 210 mm Hg or higher and 45 mm Hg or below. The procedure is terminated if the temperature exceeds 95°C or falls below 75°C.

Caveats. The device may not function optimally if the cavity is irregular. In addition, it may not destroy residual and endometrial tissue in cornual regions of the uterus.

Postoperative response. Patients have reported increased uterine pain secondary to release of prostaglandins and other tissue factors that may increase uterine contractility.

What the data show. In a series of 296 patients followed for 1 year, 88% reported decreased flow and 14% achieved amenorrhea.⁶ Meyer et al⁷ compared thermal balloon ablation with the rollerball technique and found an amenorrhea rate of 27% with rollerball and 15% with the balloon. Patient satisfaction remained high in both groups: 87% for rollerball versus 86% with the balloon.

More recently, 5- and 7-year follow-up studies have been published. At 5-year follow-up, Loffer and Grainger⁸ concluded that thermal balloon ablation therapy was an effective treatment of menorrhagia in premenopausal women, with clinical outcomes similar to rollerball ablation. Patient satisfaction was noted in 93% of women treated with thermal balloon ablation and 100% of those treated with rollerball ablation. A 7-year multicenter follow-up study of thermal balloon therapy defined avoidance of hysterectomy as the primary outcome.⁹ Overall, the probability of avoiding any surgery was 75% at 6.5 or 7 years.

Thermal fluid ablation

The HydroThermAblator (Boston Scientific, Natick, Mass) is similar to the balloon. It delivers heated saline at 90°C directly to the uterine cavity under hysteroscopic guidance.¹⁰ This solution is circulated at gravity pressure so that it remains in the uterine cavity and does not flow out the fallopian tubes into the peritoneal cavity. Approximately 10 minutes is required for the procedure.

Preparation is via GnRH-agonist hormonal suppression or a suction D&C.

Technique. Following regional or general anesthesia, the uterus is sounded and the endocervical canal dilated sufficiently to insert the operative hysteroscope. After inspection of the uterine cavity by direct visualization via the hysteroscope/TV monitor, the tubing that delivers the heated saline is connected to the operative hysteroscope to perform the ablation. The procedure takes place under direct visualization.

Safety features include automatic shutdown if there is a 10-mL fluid loss or an increase in fluid accumulation in excess of 20 mL.

What the data show. At 12 months, 1 trial reported an amenorrhea rate of 50%, hypomenorrhea of 39%, and eumenorrhea of 5.5%.¹¹

Cryotherapy

The Her Option cryoablation system (American Medical Systems, Minnetonka, Minn) involves insertion of a cryoprobe into the uterine cavity, cooling it to –100 to –120°C to form an ice ball, and destroying adjacent endometrium.

Preparation is via preoperative hormonal suppression with a GnRH agonist.

Abdominal ultrasound monitoring is necessary for insertion of the cryoprobe and ice ball formation.

Technique. In some patients, multiple ice balls may be needed to thoroughly ablate the endometrial cavity, which can prolong the procedure.

What the data show. A multicenter randomized trial comparing durability of treatment effects after endometrial cryoablation versus rollerball electroablation for abnormal uterine bleeding found 94% of patients (n = 94) free of abnormal uterine bleeding at 24 months of follow-up, compared to 93% of rollerball electroablation patients (n = 43).¹²

Impedance-controlled endometrial ablation

The NovaSure device (Novacept, Palo Alto, Calif) consists of a hand-held, disposable, 3-dimensional ablation wand that functions as a bipolar electrode. It is constructed of gold-plated fabric mesh mounted on a metal wire frame.

Treatment time. The procedure can be completed in less than 120 seconds. Because it is so quick, this technique can be accomplished with paracervical blockade and conscious sedation in suitable patients.

 

Pretreatment is not necessary. The procedure can be performed any time during the menstrual cycle.

Technique. After measuring the uterine cavity with a sound, insert and deploy the wand. Because it is flexible, it will make contact with and conform to the shape of the uterine cavity. Ablation depth is controlled by tissue impedance (electrical resistance).

As the wand makes contact with the endometrial surface, tissue is vaporized, and vapors are evacuated from the uterine cavity by continuous suction—which also brings additional endometrial tissue layers into contact with the bipolar electrode. As the device reaches myometrial tissue, resistance increases to a preset threshold and the device automatically shuts down.

The ablation electrode is configured so that the ablation zone in the lower uterine segment and corneal region will not exceed 2 mm; in the miduterine cavity, meanwhile, it reaches a depth of 5 to 7 mm.

Safety features. If inadvertent perforation occurs before the treatment cycle begins, the device will not activate.

What the data show. In a large multicenter clinical trial of 265 patients followed for 12 months, 41% reported amenorrhea and 88% eumenorrhea or hypomenorrhea.¹³

Other techniques

Microwave. Novel endometrial ablation techniques include use of microwave energies delivered to the uterine cavity via an 8-mm probe (Microsoulis, Waterloo, UK).¹⁴

Laser. A procedure known as endometrial laser intrauterine thermal therapy, or ELITT,¹⁵ delivers laser energy via a tri-fibershaped intrauterine device.

Progestin-releasing intrauterine system. Recently, the medical treatment of excessive uterine bleeding has been advanced by the levonorgestrel-releasing intrauterine device, approved by the FDA in 2000 for intrauterine contraception. The Mirena device (Berlex, Montville, NJ) has a Pearl index of 0.11 and is more reliable than tubal ligation. It can induce endometrial thinning and reduce menstrual blood loss by as much as 90%. When Mirena was compared with rollerball endometrial ablation, it was more effective in reducing menstrual blood loss and had similar satisfaction rates.¹⁶ No doubt future trials will compare Mirena with the newer ablation devices.

Complications and long-term considerations

Short-term complications, which are rare, include uterine perforation, low-grade endometritis, cervical stenosis, hematometra, and pelvic infection. These problems can be minimized by giving preoperative antibiotics and reducing tissue destruction in the lower uterine segment and cervix.

Long-term complications. Development of occult endometrial carcinoma in islands of endometrial tissue is a remote possibility. The likelihood of this rare occurrence remains low if the patient is ovulatory. Once a woman transitions into menopause and desires hormone therapy, a progestin should be included in treatment to reduce the risk of endometrial hyperplasia.

Pregnancy after endometrial ablation has been reported even in the absence of significant amounts of normal endometrial tissue.¹⁷ Thus, it is vital that the patient have a reliable and permanent form of contraception, such as tubal ligation or vasectomy.

Failure rates. Long-term failure rates in women undergoing ablation are not known, but clinical trials exploring the issue are under way.¹⁸

Dr. Brzozowski is a speaker for Novasure. Dr. Liu reports no financial relationships relevant to this article.

Endometrial tissues have amazing regenerative properties, with a controlled growth rate exceeding that of all known tumors. Within days of onset of menses, under appropriate estrogen stimulation, the endometrial surface “repairs” and “rebuilds”—from the basalis layer on up—rapidly achieving a thickness of 8 to 10 mm.

Thus, attempts to destroy it and achieve amenorrhea have met with limited success.

Hysterectomy is still the definitive treatment for excessive uterine bleeding, but a more conservative treatment, ablation, uses surgical or chemical means to obliterate the endometrial surface. Newer devices (FDA approved since 1997) allow office-based or same-day surgery; recovery time is shorter, and complication rates are lower than for hysterectomy.

This approach has gained popularity as instrumentation has improved; yet, because the endometrial surface is so resilient, success rates fall well shy of 100%. This article summaries the data on efficacy, and describes the indications, preoperative evaluation, and technique for 4 ablation options:

• thermal balloon ablation
  
• thermal fluid ablation
  
• cryotherapy
  
• impedance-controlled ablation
  

Other modalities include microwave, laser, and a progestin-releasing intrauterine contraception system.

Each uses a different energy-transfer technique to destroy the endometrium ( TABLE).

TABLE

4 global ablation devices at a glance

	THERMAL BALLOON (THERMACHOICE)	THERMAL FLUID (HYDROTHERMABLATOR)	CRYOTHERAPY (HER OPTION)	IMPEDANCE-CONTROLLED (NOVASURE)
Pretreatment	Yes	Yes	Yes	No
Time of energy delivery	8 minutes	10 minutes	10–12 minutes	90–120 seconds
Cornual ablation	No	Yes	User-dependent	Yes
Principle	Balloon filled with fluid (5% dextrose in water) at 87°C	Hydrothermal circulation of saline at 90°C	Probe with transfer media creates ice ball at –100 to –120°C	Bipolar, radiofrequency ablation at 100°C
Direct visualization	None	Hysteroscopy	Ultrasound guidance	None
Safety features	Pressure and temperature-sensing cutoffs	Fluid loss detection system	Ultrasound guidance	Uterine cavity integrity assessment system

Indications

The typical candidate for endometrial ablation has heavy menses requiring excessive sanitary protection (eg, tampon and pad simultaneously); her daily activity frequently is limited. The patient may have tried such management as nonsteroidal anti-inflammatory agents, oral contraceptives, or surgical dilatation and curettage (D&C) without success.

Excessive or abnormal uterine bleeding is defined as blood loss exceeding 80 mL per menses or a menstrual flow longer than 7 days. Abnormal uterine bleeding affects 22% of women of reproductive age.¹ Each year in the United States, approximately 180,000 women undergo hysterectomy for this indication.²

The optimal patient for endometrial ablation has a history of regular menses without excessive dysmenorrhea, which could suggest an underlying diagnosis of adenomyosis. (Findings suggestive of this difficult-to-diagnose condition include a tender, soft, boggy uterus at the time of menses.) Many women with adenomyosis fail to achieve adequate pain relief with endometrial ablation alone and eventually require a hysterectomy.

The patient should have completed childbearing and have a permanent method of contraception in place—endometrial ablation only reduces fertility, it does not eliminate it.

Preoperative evaluation

Laboratory studies include a complete blood count and urine human chorionic gonadotropin level, as well as screening for bleeding disorders when indicated.

A bleeding diary helps quantify symptoms. Its use should be encouraged.

Other tests and examinations. Also recommended are endometrial biopsy, a Pap test, and assessment of the endometrial cavity via hysteroscopy or sonohysterography.

Biopsy should reflect histologically normal tissue. The patient should have:

• regular menstrual cycles lasting 25 to 34 days
  
• no uterine anomaly or potential myometrial wall defect from a previous classical cesarean or transmural myomectomy
  

Preparing the endometrium. After careful patient selection and appropriate counseling for the procedure, preoperative preparation of the endometrium may be required, depending on the technique chosen. For example, thermal fluid ablation requires pretreatment with a gonadotropin-releasing hormone (GnRH) agonist or suction curettage. The most widely used preparation methods are hormonal treatment with GnRH agonists over 2 menstrual cycles, and suction D&C.

Contraindications

Anovulatory patients may not be good candidates because islands of endometrial tissue can remain after ablation. These tissue “nests” may spontaneously change to hyperplasia or endometrial carcinoma (due to unopposed estrogen). Further, uterine bleeding may not always occur when hyperplasia is present after endometrial ablation, delaying this serious diagnosis.

Relative contraindications include intramural or submucosal uterine myomas.

Earlier techniques: Hysteroscopic ablation

Techniques developed earlier require expert operative hysteroscopic skills and should be performed by experienced gynecologic surgeons to minimize complications.

For example, the first treatment of menorrhagia using a hysteroscopic approach with a Nd:YAG laser power source, reported in 1981 by Goldrath et al,³ utilized 55 watts of power with a 600-micron fiber dragged across the endometrium. Later, other surgeons used a rollerball unipolar electrode that coagulated the surface with continuous contact.^4,5

 

Modifications of this technique included a loop electrode that used monopolar electrical energy to “shave” the thicker portions of endometrium. In some reports, the rollerball electrode was used to reach the uterine cornu and endocoagulate the lower uterine segments. The most successful reports of this approach used a loop electrode to shave the endometrium followed by rollerball coagulation of the shaved areas. Amenorrhea rates with these techniques approached 60%.

Thermal balloon ablation

ThermaChoice (Gynecare, Somerville, NJ), the first global-ablation device to be marketed, was FDA-approved in 1997.^6,7 It is a single-use balloon that is filled with fluid (5% dextrose and water) and inflated to a pressure of 180 mm Hg.

Technique. After general or regional anesthesia and prior to balloon insertion, remove the superficial endometrium by suction curettage.

The balloon contains a central heating element that warms the fluid to 87°C for 8 minutes via electronic control. Pressure within the balloon must be stabilized within the uterine cavity.

Safety features include a pressure shut-off device that activates at 210 mm Hg or higher and 45 mm Hg or below. The procedure is terminated if the temperature exceeds 95°C or falls below 75°C.

Caveats. The device may not function optimally if the cavity is irregular. In addition, it may not destroy residual and endometrial tissue in cornual regions of the uterus.

Postoperative response. Patients have reported increased uterine pain secondary to release of prostaglandins and other tissue factors that may increase uterine contractility.

What the data show. In a series of 296 patients followed for 1 year, 88% reported decreased flow and 14% achieved amenorrhea.⁶ Meyer et al⁷ compared thermal balloon ablation with the rollerball technique and found an amenorrhea rate of 27% with rollerball and 15% with the balloon. Patient satisfaction remained high in both groups: 87% for rollerball versus 86% with the balloon.

More recently, 5- and 7-year follow-up studies have been published. At 5-year follow-up, Loffer and Grainger⁸ concluded that thermal balloon ablation therapy was an effective treatment of menorrhagia in premenopausal women, with clinical outcomes similar to rollerball ablation. Patient satisfaction was noted in 93% of women treated with thermal balloon ablation and 100% of those treated with rollerball ablation. A 7-year multicenter follow-up study of thermal balloon therapy defined avoidance of hysterectomy as the primary outcome.⁹ Overall, the probability of avoiding any surgery was 75% at 6.5 or 7 years.

Thermal fluid ablation

The HydroThermAblator (Boston Scientific, Natick, Mass) is similar to the balloon. It delivers heated saline at 90°C directly to the uterine cavity under hysteroscopic guidance.¹⁰ This solution is circulated at gravity pressure so that it remains in the uterine cavity and does not flow out the fallopian tubes into the peritoneal cavity. Approximately 10 minutes is required for the procedure.

Preparation is via GnRH-agonist hormonal suppression or a suction D&C.

Technique. Following regional or general anesthesia, the uterus is sounded and the endocervical canal dilated sufficiently to insert the operative hysteroscope. After inspection of the uterine cavity by direct visualization via the hysteroscope/TV monitor, the tubing that delivers the heated saline is connected to the operative hysteroscope to perform the ablation. The procedure takes place under direct visualization.

Safety features include automatic shutdown if there is a 10-mL fluid loss or an increase in fluid accumulation in excess of 20 mL.

What the data show. At 12 months, 1 trial reported an amenorrhea rate of 50%, hypomenorrhea of 39%, and eumenorrhea of 5.5%.¹¹

Cryotherapy

The Her Option cryoablation system (American Medical Systems, Minnetonka, Minn) involves insertion of a cryoprobe into the uterine cavity, cooling it to –100 to –120°C to form an ice ball, and destroying adjacent endometrium.

Preparation is via preoperative hormonal suppression with a GnRH agonist.

Abdominal ultrasound monitoring is necessary for insertion of the cryoprobe and ice ball formation.

Technique. In some patients, multiple ice balls may be needed to thoroughly ablate the endometrial cavity, which can prolong the procedure.

What the data show. A multicenter randomized trial comparing durability of treatment effects after endometrial cryoablation versus rollerball electroablation for abnormal uterine bleeding found 94% of patients (n = 94) free of abnormal uterine bleeding at 24 months of follow-up, compared to 93% of rollerball electroablation patients (n = 43).¹²

Impedance-controlled endometrial ablation

The NovaSure device (Novacept, Palo Alto, Calif) consists of a hand-held, disposable, 3-dimensional ablation wand that functions as a bipolar electrode. It is constructed of gold-plated fabric mesh mounted on a metal wire frame.

Treatment time. The procedure can be completed in less than 120 seconds. Because it is so quick, this technique can be accomplished with paracervical blockade and conscious sedation in suitable patients.

 

Pretreatment is not necessary. The procedure can be performed any time during the menstrual cycle.

Technique. After measuring the uterine cavity with a sound, insert and deploy the wand. Because it is flexible, it will make contact with and conform to the shape of the uterine cavity. Ablation depth is controlled by tissue impedance (electrical resistance).

As the wand makes contact with the endometrial surface, tissue is vaporized, and vapors are evacuated from the uterine cavity by continuous suction—which also brings additional endometrial tissue layers into contact with the bipolar electrode. As the device reaches myometrial tissue, resistance increases to a preset threshold and the device automatically shuts down.

The ablation electrode is configured so that the ablation zone in the lower uterine segment and corneal region will not exceed 2 mm; in the miduterine cavity, meanwhile, it reaches a depth of 5 to 7 mm.

Safety features. If inadvertent perforation occurs before the treatment cycle begins, the device will not activate.

What the data show. In a large multicenter clinical trial of 265 patients followed for 12 months, 41% reported amenorrhea and 88% eumenorrhea or hypomenorrhea.¹³

Other techniques

Microwave. Novel endometrial ablation techniques include use of microwave energies delivered to the uterine cavity via an 8-mm probe (Microsoulis, Waterloo, UK).¹⁴

Laser. A procedure known as endometrial laser intrauterine thermal therapy, or ELITT,¹⁵ delivers laser energy via a tri-fibershaped intrauterine device.

Progestin-releasing intrauterine system. Recently, the medical treatment of excessive uterine bleeding has been advanced by the levonorgestrel-releasing intrauterine device, approved by the FDA in 2000 for intrauterine contraception. The Mirena device (Berlex, Montville, NJ) has a Pearl index of 0.11 and is more reliable than tubal ligation. It can induce endometrial thinning and reduce menstrual blood loss by as much as 90%. When Mirena was compared with rollerball endometrial ablation, it was more effective in reducing menstrual blood loss and had similar satisfaction rates.¹⁶ No doubt future trials will compare Mirena with the newer ablation devices.

Complications and long-term considerations

Short-term complications, which are rare, include uterine perforation, low-grade endometritis, cervical stenosis, hematometra, and pelvic infection. These problems can be minimized by giving preoperative antibiotics and reducing tissue destruction in the lower uterine segment and cervix.

Long-term complications. Development of occult endometrial carcinoma in islands of endometrial tissue is a remote possibility. The likelihood of this rare occurrence remains low if the patient is ovulatory. Once a woman transitions into menopause and desires hormone therapy, a progestin should be included in treatment to reduce the risk of endometrial hyperplasia.

Pregnancy after endometrial ablation has been reported even in the absence of significant amounts of normal endometrial tissue.¹⁷ Thus, it is vital that the patient have a reliable and permanent form of contraception, such as tubal ligation or vasectomy.

Failure rates. Long-term failure rates in women undergoing ablation are not known, but clinical trials exploring the issue are under way.¹⁸

Dr. Brzozowski is a speaker for Novasure. Dr. Liu reports no financial relationships relevant to this article.

Endometrial tissues have amazing regenerative properties, with a controlled growth rate exceeding that of all known tumors. Within days of onset of menses, under appropriate estrogen stimulation, the endometrial surface “repairs” and “rebuilds”—from the basalis layer on up—rapidly achieving a thickness of 8 to 10 mm.

Thus, attempts to destroy it and achieve amenorrhea have met with limited success.

Hysterectomy is still the definitive treatment for excessive uterine bleeding, but a more conservative treatment, ablation, uses surgical or chemical means to obliterate the endometrial surface. Newer devices (FDA approved since 1997) allow office-based or same-day surgery; recovery time is shorter, and complication rates are lower than for hysterectomy.

This approach has gained popularity as instrumentation has improved; yet, because the endometrial surface is so resilient, success rates fall well shy of 100%. This article summaries the data on efficacy, and describes the indications, preoperative evaluation, and technique for 4 ablation options:

• thermal balloon ablation
  
• thermal fluid ablation
  
• cryotherapy
  
• impedance-controlled ablation
  

Other modalities include microwave, laser, and a progestin-releasing intrauterine contraception system.

Each uses a different energy-transfer technique to destroy the endometrium ( TABLE).

TABLE

4 global ablation devices at a glance

	THERMAL BALLOON (THERMACHOICE)	THERMAL FLUID (HYDROTHERMABLATOR)	CRYOTHERAPY (HER OPTION)	IMPEDANCE-CONTROLLED (NOVASURE)
Pretreatment	Yes	Yes	Yes	No
Time of energy delivery	8 minutes	10 minutes	10–12 minutes	90–120 seconds
Cornual ablation	No	Yes	User-dependent	Yes
Principle	Balloon filled with fluid (5% dextrose in water) at 87°C	Hydrothermal circulation of saline at 90°C	Probe with transfer media creates ice ball at –100 to –120°C	Bipolar, radiofrequency ablation at 100°C
Direct visualization	None	Hysteroscopy	Ultrasound guidance	None
Safety features	Pressure and temperature-sensing cutoffs	Fluid loss detection system	Ultrasound guidance	Uterine cavity integrity assessment system

Indications

The typical candidate for endometrial ablation has heavy menses requiring excessive sanitary protection (eg, tampon and pad simultaneously); her daily activity frequently is limited. The patient may have tried such management as nonsteroidal anti-inflammatory agents, oral contraceptives, or surgical dilatation and curettage (D&C) without success.

Excessive or abnormal uterine bleeding is defined as blood loss exceeding 80 mL per menses or a menstrual flow longer than 7 days. Abnormal uterine bleeding affects 22% of women of reproductive age.¹ Each year in the United States, approximately 180,000 women undergo hysterectomy for this indication.²

The optimal patient for endometrial ablation has a history of regular menses without excessive dysmenorrhea, which could suggest an underlying diagnosis of adenomyosis. (Findings suggestive of this difficult-to-diagnose condition include a tender, soft, boggy uterus at the time of menses.) Many women with adenomyosis fail to achieve adequate pain relief with endometrial ablation alone and eventually require a hysterectomy.

The patient should have completed childbearing and have a permanent method of contraception in place—endometrial ablation only reduces fertility, it does not eliminate it.

Preoperative evaluation

Laboratory studies include a complete blood count and urine human chorionic gonadotropin level, as well as screening for bleeding disorders when indicated.

A bleeding diary helps quantify symptoms. Its use should be encouraged.

Other tests and examinations. Also recommended are endometrial biopsy, a Pap test, and assessment of the endometrial cavity via hysteroscopy or sonohysterography.

Biopsy should reflect histologically normal tissue. The patient should have:

• regular menstrual cycles lasting 25 to 34 days
  
• no uterine anomaly or potential myometrial wall defect from a previous classical cesarean or transmural myomectomy
  

Preparing the endometrium. After careful patient selection and appropriate counseling for the procedure, preoperative preparation of the endometrium may be required, depending on the technique chosen. For example, thermal fluid ablation requires pretreatment with a gonadotropin-releasing hormone (GnRH) agonist or suction curettage. The most widely used preparation methods are hormonal treatment with GnRH agonists over 2 menstrual cycles, and suction D&C.

Contraindications

Anovulatory patients may not be good candidates because islands of endometrial tissue can remain after ablation. These tissue “nests” may spontaneously change to hyperplasia or endometrial carcinoma (due to unopposed estrogen). Further, uterine bleeding may not always occur when hyperplasia is present after endometrial ablation, delaying this serious diagnosis.

Relative contraindications include intramural or submucosal uterine myomas.

Earlier techniques: Hysteroscopic ablation

Techniques developed earlier require expert operative hysteroscopic skills and should be performed by experienced gynecologic surgeons to minimize complications.

For example, the first treatment of menorrhagia using a hysteroscopic approach with a Nd:YAG laser power source, reported in 1981 by Goldrath et al,³ utilized 55 watts of power with a 600-micron fiber dragged across the endometrium. Later, other surgeons used a rollerball unipolar electrode that coagulated the surface with continuous contact.^4,5

 

Modifications of this technique included a loop electrode that used monopolar electrical energy to “shave” the thicker portions of endometrium. In some reports, the rollerball electrode was used to reach the uterine cornu and endocoagulate the lower uterine segments. The most successful reports of this approach used a loop electrode to shave the endometrium followed by rollerball coagulation of the shaved areas. Amenorrhea rates with these techniques approached 60%.

Thermal balloon ablation

ThermaChoice (Gynecare, Somerville, NJ), the first global-ablation device to be marketed, was FDA-approved in 1997.^6,7 It is a single-use balloon that is filled with fluid (5% dextrose and water) and inflated to a pressure of 180 mm Hg.

Technique. After general or regional anesthesia and prior to balloon insertion, remove the superficial endometrium by suction curettage.

The balloon contains a central heating element that warms the fluid to 87°C for 8 minutes via electronic control. Pressure within the balloon must be stabilized within the uterine cavity.

Safety features include a pressure shut-off device that activates at 210 mm Hg or higher and 45 mm Hg or below. The procedure is terminated if the temperature exceeds 95°C or falls below 75°C.

Caveats. The device may not function optimally if the cavity is irregular. In addition, it may not destroy residual and endometrial tissue in cornual regions of the uterus.

Postoperative response. Patients have reported increased uterine pain secondary to release of prostaglandins and other tissue factors that may increase uterine contractility.

What the data show. In a series of 296 patients followed for 1 year, 88% reported decreased flow and 14% achieved amenorrhea.⁶ Meyer et al⁷ compared thermal balloon ablation with the rollerball technique and found an amenorrhea rate of 27% with rollerball and 15% with the balloon. Patient satisfaction remained high in both groups: 87% for rollerball versus 86% with the balloon.

More recently, 5- and 7-year follow-up studies have been published. At 5-year follow-up, Loffer and Grainger⁸ concluded that thermal balloon ablation therapy was an effective treatment of menorrhagia in premenopausal women, with clinical outcomes similar to rollerball ablation. Patient satisfaction was noted in 93% of women treated with thermal balloon ablation and 100% of those treated with rollerball ablation. A 7-year multicenter follow-up study of thermal balloon therapy defined avoidance of hysterectomy as the primary outcome.⁹ Overall, the probability of avoiding any surgery was 75% at 6.5 or 7 years.

Thermal fluid ablation

The HydroThermAblator (Boston Scientific, Natick, Mass) is similar to the balloon. It delivers heated saline at 90°C directly to the uterine cavity under hysteroscopic guidance.¹⁰ This solution is circulated at gravity pressure so that it remains in the uterine cavity and does not flow out the fallopian tubes into the peritoneal cavity. Approximately 10 minutes is required for the procedure.

Preparation is via GnRH-agonist hormonal suppression or a suction D&C.

Technique. Following regional or general anesthesia, the uterus is sounded and the endocervical canal dilated sufficiently to insert the operative hysteroscope. After inspection of the uterine cavity by direct visualization via the hysteroscope/TV monitor, the tubing that delivers the heated saline is connected to the operative hysteroscope to perform the ablation. The procedure takes place under direct visualization.

Safety features include automatic shutdown if there is a 10-mL fluid loss or an increase in fluid accumulation in excess of 20 mL.

What the data show. At 12 months, 1 trial reported an amenorrhea rate of 50%, hypomenorrhea of 39%, and eumenorrhea of 5.5%.¹¹

Cryotherapy

The Her Option cryoablation system (American Medical Systems, Minnetonka, Minn) involves insertion of a cryoprobe into the uterine cavity, cooling it to –100 to –120°C to form an ice ball, and destroying adjacent endometrium.

Preparation is via preoperative hormonal suppression with a GnRH agonist.

Abdominal ultrasound monitoring is necessary for insertion of the cryoprobe and ice ball formation.

Technique. In some patients, multiple ice balls may be needed to thoroughly ablate the endometrial cavity, which can prolong the procedure.

What the data show. A multicenter randomized trial comparing durability of treatment effects after endometrial cryoablation versus rollerball electroablation for abnormal uterine bleeding found 94% of patients (n = 94) free of abnormal uterine bleeding at 24 months of follow-up, compared to 93% of rollerball electroablation patients (n = 43).¹²

Impedance-controlled endometrial ablation

The NovaSure device (Novacept, Palo Alto, Calif) consists of a hand-held, disposable, 3-dimensional ablation wand that functions as a bipolar electrode. It is constructed of gold-plated fabric mesh mounted on a metal wire frame.

Treatment time. The procedure can be completed in less than 120 seconds. Because it is so quick, this technique can be accomplished with paracervical blockade and conscious sedation in suitable patients.

 

Pretreatment is not necessary. The procedure can be performed any time during the menstrual cycle.

Technique. After measuring the uterine cavity with a sound, insert and deploy the wand. Because it is flexible, it will make contact with and conform to the shape of the uterine cavity. Ablation depth is controlled by tissue impedance (electrical resistance).

As the wand makes contact with the endometrial surface, tissue is vaporized, and vapors are evacuated from the uterine cavity by continuous suction—which also brings additional endometrial tissue layers into contact with the bipolar electrode. As the device reaches myometrial tissue, resistance increases to a preset threshold and the device automatically shuts down.

The ablation electrode is configured so that the ablation zone in the lower uterine segment and corneal region will not exceed 2 mm; in the miduterine cavity, meanwhile, it reaches a depth of 5 to 7 mm.

Safety features. If inadvertent perforation occurs before the treatment cycle begins, the device will not activate.

What the data show. In a large multicenter clinical trial of 265 patients followed for 12 months, 41% reported amenorrhea and 88% eumenorrhea or hypomenorrhea.¹³

Other techniques

Microwave. Novel endometrial ablation techniques include use of microwave energies delivered to the uterine cavity via an 8-mm probe (Microsoulis, Waterloo, UK).¹⁴

Laser. A procedure known as endometrial laser intrauterine thermal therapy, or ELITT,¹⁵ delivers laser energy via a tri-fibershaped intrauterine device.

Progestin-releasing intrauterine system. Recently, the medical treatment of excessive uterine bleeding has been advanced by the levonorgestrel-releasing intrauterine device, approved by the FDA in 2000 for intrauterine contraception. The Mirena device (Berlex, Montville, NJ) has a Pearl index of 0.11 and is more reliable than tubal ligation. It can induce endometrial thinning and reduce menstrual blood loss by as much as 90%. When Mirena was compared with rollerball endometrial ablation, it was more effective in reducing menstrual blood loss and had similar satisfaction rates.¹⁶ No doubt future trials will compare Mirena with the newer ablation devices.

Complications and long-term considerations

Short-term complications, which are rare, include uterine perforation, low-grade endometritis, cervical stenosis, hematometra, and pelvic infection. These problems can be minimized by giving preoperative antibiotics and reducing tissue destruction in the lower uterine segment and cervix.

Long-term complications. Development of occult endometrial carcinoma in islands of endometrial tissue is a remote possibility. The likelihood of this rare occurrence remains low if the patient is ovulatory. Once a woman transitions into menopause and desires hormone therapy, a progestin should be included in treatment to reduce the risk of endometrial hyperplasia.

Pregnancy after endometrial ablation has been reported even in the absence of significant amounts of normal endometrial tissue.¹⁷ Thus, it is vital that the patient have a reliable and permanent form of contraception, such as tubal ligation or vasectomy.

Failure rates. Long-term failure rates in women undergoing ablation are not known, but clinical trials exploring the issue are under way.¹⁸

Dr. Brzozowski is a speaker for Novasure. Dr. Liu reports no financial relationships relevant to this article.

Is the extensive dissection of the Pfannenstiel incision necessary in cesarean delivery? Is bladder dissection essential? Must the visceral and parietal peritoneum be closed?

The success of our minimally invasive cesarean technique suggests the answer is “no.”

The approach described here features a short operative time; minimal instrumentation; reduced surgical dissection; decreased postoperative pain; and reduced risk of blood loss, infection, and wound complications. It is easily learned and cost-effective, with a brief postoperative recovery period.

Among the updates made from the technique’s initial publication in the mid-1990s^1,2:

• addition of routine perioperative oxygen (80%), to reduce the risk of surgical wound infection (see “Perioperative considerations”)
• regular use of forced warm air covers applied to the anterior skin surface, to help patients maintain normothermia
• addition of a soft, self-retaining abdominal retractor—which creates an atraumatic circle of exposure up to a calculated 177 cm² for a 15-cm incision (versus 113 cm² calculated for traditional retraction)
• vertical, rather than lateral, digital extension of the initial transverse uterine incision
• identification of a subgroup in whom peritoneal closure is strongly recommended
• new data on the procedure’s effectiveness.³

Modified abdominal incision reduces dissection

Make a straight low transverse incision with a scalpel, at a point approximately 3 to 4 cm above the symphysis pubis (FIGURE 1A).

The length of the incision is individualized (13 to 15 cm), though difficult fetal extraction is more likely if the abdominal incision is less than 15 cm.^4,5

Divide the subcutaneous tissue transversely with an electrocautery knife. In a cutting and coagulation blend mode, the knife divides the fat while achieving hemostasis. To improve hemostasis, coagulate the blood vessels that cross the subcutaneous fat layer in a brushing manner before dividing them. To prevent unnecessary dead space, avoid filleting the fat and separating adherent subcutaneous fat from the anterior rectus fascia beyond what is needed to expose the fascia.

Open the fascia transversely with the electrocautery knife to the same length as the skin incision. Coagulate the blood vessels that cross the fascia before dividing them. Identify the median raphe by pulling up the superior edge of the abdominal incision.

Separate the rectus muscles in the midline by vertical blunt finger dissection (FIGURE 1B). If digital dissection is inefficient due to a dense, thick, or scarred median raphe, use an electrocautery knife, a scalpel, or scissors.

Open the peritoneum. This is facilitated by upward traction and elevation of the superior edge of the abdominal incision that lifts the peritoneum, allowing easy digital perforation using the index or middle finger (FIGURE 1C).

If this maneuver is not feasible, open the peritoneum in the traditional fashion.

Stretch the full thickness of the abdominal wall to full size of the skin incision, using 1 or 2 fingers of each hand (FIGURE 1D). Incorporate the skin, subcutaneous tissue, fascia layer, rectus muscles, and peritoneum. An assistant’s hands may be required. When needed, extend the peritoneal opening transversely on either side, to the midline and away from the bladder.

 

Digitally stretching the full-thickness abdominal incision is easily achieved due to the mechanical stretching of the anterior abdominal wall, edema, and increased vascularization that occur during pregnancy.

FIGURE 1A Create a modified abdominal incision

FIGURE 1B Create a modified abdominal incision

FIGURE 1C Create a modified abdominal incision

FIGURE 1D Create a modified abdominal incision

Retractor facilitates exposure

Our positive experience with the soft, self-retaining abdominal retractor for minilaparotomy and laparotomy^6-8 compelled us to incorporate its use for cesarean 3 years ago.

The device consists of a flexible plastic inner ring and a firmer outer ring connected by a soft plastic sleeve. We use the large size of either of the 2 models currently available: the Mobius (Apple Medical Corporation, Marlboro, Miss) and the Protractor (Weck Closure Systems, Research Triangle Park, NC).

Introduce a hand through the laparotomy incision and evaluate the pelvis to ensure that no significant adhesions are present that may interfere with swift placement of the inner ring. If significant adhesions are found, use traditional metal retractors instead.

Squeeze the inner ring and insert it into the abdominal cavity toward the patient’s head, allowing the device to spring open against the parietal peritoneum (FIGURE 2A). Apply upper traction and elevate the superior edge of the abdominal incision to facilitate placement. Perform a digital check to ensure no tissue is trapped between the inner ring and the abdominal wall.

Hold up the outer ring, then roll the plastic sleeve until the ring completely inverts (FIGURE 2B). Repeat the process until the top ring is snug against the patient’s skin.

Advantages of the soft, self-retaining abdominal retractor include atraumatic retraction; incision protection; and adjustable height, making it ideal for obese patients.

FIGURE 2A Place the abdominal retractor

FIGURE 2B Place the abdominal retractor

Transverse hysterotomy in lower uterine segment

Make a transverse 2-cm uterine incision with a scalpel, approximately 1 cm above the vesicouterine peritoneal fold (identify this using gentle digital pressure to elevate the uterus) (FIGURE 3A).

Traditional bladder dissection is eliminated. We have found that when an adequate transverse hysterotomy is performed, a bladder flap is not required.^1-3 In a recent randomized trial, Hohlagschwandtner et al⁹ confirmed our findings that bladder-flap omission was associated with reduced operative time and incision-delivery interval, decreased blood loss, and less need for postoperative analgesics.

An additional advantage of this omission: We can avoid making the uterine incision too low—especially when the cervix is fully dilated. Further, making the hysterotomy (uterine serosa and myometrium together) slightly above the vesicouterine peritoneal fold without bladder flap dissection frees the loose connective tissue between the uterus and the urinary bladder, allowing the spontaneous descent of the bladder.

Digitally extend the transverse uterine incision. We extend the initial incision not laterally but, instead, vertically (FIGURE 3B). The vertical digital traction on the initial transverse uterine incision creates a transverse dissociation of the horizontal myometrium fibers; this results in a transverse extension of the original incision.

This modification prevents unintended and uncontrolled lateral extensions of the incision that may lacerate the uterine vessels.¹⁰ It also prevents the uterine incision from becoming an inverted “U” and the undesirable accumulation of myometrium fibers at the ends of the incision. Such incisions usually do not reapproximate well during hysterotomy closure and may lead to sacculation-type defects.¹¹

FIGURE 3A Use a standard hysterotomy in the lower uterine segment

FIGURE 3B Use a standard hysterotomy in the lower uterine segment

Delivering the fetus

For vertex presentations, place your hand into the uterine cavity between the lower edge of the hysterotomy and fetal head. While applying transabdominal fundal pressure, lift the head with your fingers and deliver it through the incision (FIGURE 4A).

The self-retaining retractor facilitates delivery of the fetal head by creating a rigid border around the abdominal incision. The back of the surgeon’s hand that is in the uterine cavity achieves better leverage, as it now rests on a rigid plane on the inferior part of the incision rather than on the back hand and the softer and pliable wound edge of the standard abdominal incision.

Vacuum-assistance. When delivery of the fetal head proves difficult, we use the soft vacuum cup, which avoids unnecessary intrauterine manipulation that may result in fetal or maternal trauma (FIGURE 4B).¹²

Breech extraction or transverse lie delivery is performed using standard extraction maneuvers (FIGURE 4C).¹³ We have found no need to perform T or J vertical extensions of the low transverse uterine incision, even in cases of a poorly developed lower uterine segment, abnormal presentation, or prematurity.

 

FIGURE 4A Deliver the fetal head

FIGURE 4B Deliver the fetal head

FIGURE 4C Deliver the fetal head

Uterine incision: 1-layer, in situ close

Remove the placenta only after it separates spontaneously—this greatly reduces blood loss compared with immediate manual placental delivery or umbilical-cord traction. Manually deliver the placenta only if it has not separated spontaneously after 5 minutes. Avoid routine manual clean-out of the uterine cavity if the placenta is completely delivered.^1-3,14

Dilate the cervix to facilitate lochial discharge, when necessary.

Decrease uterine bleeding by massaging the uterus and administering diluted oxytocin.

Close the uterine incision in situ. Disadvantages of routine uterine exteriorization include discomfort and vomiting resulting from traction, exposure of the fallopian tubes to unnecessary trauma, increased risk of infection, possible rupture of the uteroovarian veins, and pulmonary embolism.

Exteriorization may also increase the risk of adhesion formation by exposing the uterine serosa to the abrasive effects of drying or microscopic abrasion if sponges are used to hold the uterus in place.^1,14-17

Use a single-layer closure with a running suture of polyglycolic acid to close the uterine incision (FIGURE 5A). If needed, use atraumatic clamps to grasp the edges of the hysterotomy to facilitate visualization and closure.

Begin suturing at a point just beyond one end of the incision, continuing to the opposite side. Be sure to penetrate the full thickness of the myometrium and avoid incorporating the decidua in the suture line. After the uterine closure, use individual figure-of-8 sutures to control areas of persistent bleeding.

Compared with 2-layer closures, single-layer closure of a low transverse incision is associated with reduced operating time, improved hemostasis, and less tissue disruption; introduces less foreign material into the surgical site; reduces the need for postoperative analgesia; and potentially reduces infectious morbidity. A trial of labor after a cesarean section with 1-layer closure appears safe.^18-22

We do not close the vesicouterine fold and parietal peritoneum (FIGURE 5B) or reapproximate the rectus muscles. It has been shown that a new peritoneal layer is formed within days of the original incision closure.

Leaving the peritoneum open leads to no increased postoperative complications, nor obvious differences in wound healing, wound dehiscence, or incidence of postoperative adhesions. Compared to women without peritoneal closure, those with peritoneal closure require a longer operative time, greater amounts of post-operative narcotics for postoperative pain, a greater need for bowel stimulants, and a longer postoperative hospitalization.²³

In 1995, we performed laparoscopy for gynecologic conditions in 23 patients and repeat cesarean in 10 patients who had undergone our technique (with visceral and parietal peritoneum left open).² We found no adhesions and a normal peritoneal lining in all cases.

In 1 subgroup, peritoneal closure is strongly recommended: cases in which 1 or both rectus muscles have been transected to increase surgical exposure. Extremely thick fibromuscular adhesions between the low anterior surface of the uterus and the under-surface of the rectus musculature may develop if the parietal peritoneum is not closed.

FIGURE 5A Close the incisions

FIGURE 5B Close the incisions

Abdominal closure

Close the rectus fascia with a continuous nonlocking 0 suture after the rectus muscles fall into place. Place entry and exit sites at 1-cm intervals, 1.5 cm beyond the wound edges—this minimizes the risk of sutures pulling through fascia. Interrupted sutures offer no greater tensile strength than continuous suturing.²⁴ Tight, continuous suturing can lead to tissue ischemia, which may weaken the sutured fascia, and thus should be avoided.

The subcutaneous layer is not closed separately. One exception is obese patients with at least 2 cm of thick subcutaneous tissue. Thickness of subcutaneous tissue appears to be a significant risk factor for wound infection after cesarean section.²⁵

In patients with thick subcutaneous tissue, you can reduce tension on the skin edges and the risk of subcutaneous infection, seroma formation, and wound disruption by placing interrupted 3-0 absorbable synthetic sutures to eliminate dead space.^26-28 We have found no need to place Penrose drains or closed drainage systems in the subcutaneous layer.^29-31

Close the skin using a subcuticular continuous absorbable 4-0 suture or, alternatively, metal staples, which are removed 4 days after surgery (FIGURE 5C).

FIGURE 5C Close the incisions

Prompt postoperative recovery

The patient may drink fluids in the recovery room, can resume a regular solid food diet within 4 hours after surgery, and may resume mobility as soon as anesthesia wears off.

Early breast-feeding is also allowed in the recovery room. In our experience, this has not been associated with complications, has been highly appreciated by the patients, and has led to earlier hospital discharge.

 

Control pain with meperidine (50–75 mg) or morphine (10 mg) parenterally every 3 to 4 hours. Other options include oxycodone and acetaminophen, oxycodone and aspirin, and ibuprofen.

Patients are usually discharged 48 to 72 hours following surgery.

Our experience: The numbers

Using this updated system, we have successfully completed 300 consecutive cesarean sections (210 primary, 90 repeat).

The average operating time was 19 minutes; average blood loss, 405 mL.

There was no postoperative febrile morbidity, wound infection, wound disruption, or wound hematoma.Only 3 patients developed superficial wound seromas, which were easily resolved. There were no intraoperative or postoperative complications.

We attribute the absence of wound infection to routine prophylactic antibiotics; supplemental perioperative oxygen; maintenance of normothermia; use of an electrocautery knife to create rapid hemostatic division of subcutaneous fat and anterior rectus fascia; a simplified abdominal wall opening; and placement of a self-retaining atraumatic retractor.^10,32-36

Additional surgical procedures (tubal sterilization, myomectomy, appendectomy, and adhesiolysis) did not alter the recovery period, and all patients were able to get out of bed, shower, breast-feed, and care for their infants within 8 hours of surgery.

No infant complications related to the cesarean procedure occurred.

Patients were discharged from the hospital within 72 hours.

A prospective comparison study demonstrated that the original Pelosi-type of cesarean delivery was faster to perform, more cost-effective, and resulted in less maternal morbidity than the traditional cesarean technique.³

Dr. Pelosi II is a consultant for Apple Medical Corporation. Dr. Pelosi III reports no financial relationships relevant to this article.