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Minimally invasive surgery series

The Evolving Role of Laparoscopic Surgery for Treatment of Gynecologic Masses and Cancers

R. Kevin Reynolds, MD; William M. Burke, MD

Endometrial, ovarian, and cervical cancers are the three most common gynecologic malignancies in the United States, cumulatively accounting for 77,700 new cases per year.¹ Historically, gynecologic cancers have been treated with multimodal therapy, including radical surgery combined with radiation and chemotherapy based on the stage and type of disease. While this approach has led to substantial improvement in outcomes, it has come at the cost of significant patient morbidity. However, laparoscopic approaches have been developed to many gynecologic surgical procedures for cancer in the last 15 years, reducing postoperative morbidity while producing outcomes that appear to match those of laparotomy. This paper presents an overview of the laparoscopic approach to the management of gynecologic cancer. It is not intended to be an exhaustive review, but focuses on benefits, controversies, outcomes, and credentials for surgeons.

ENDOMETRIAL CANCER

Endometrial cancer is the most common gynecologic cancer in the United States. Current staging and surgical treatment of early-stage endometrial cancer includes cytologic washings of the peritoneum, hysterectomy, and bilateral salpingo-oophorectomy. Selective pelvic and para-aortic lymphadenectomy is usually performed based on risk factors such as tumor grade and depth of myometrial invasion.

Feasibility

The goal of studies on laparoscopic cancer staging is to demonstrate equivalence with laparotomy in completeness of surgical staging and survival rates. One study looked at laparoscopic lymphadenectomy combined with laparoscopically assisted vaginal hysterectomy to treat endometrial cancer in 59 women.² The decision to proceed with pelvic and para-aortic lymphadenectomy was based on tumor grade and depth of myometrial invasion. One patient required laparotomy, while laparoscopic lymphadenectomy was not possible in 6% because of limited exposure secondary to patient obesity. Complications occurred in 5%, including ureteral transection, cystotomy, and development of a pneumothorax in a woman with congenital diaphragm defects.

In a report on 90 women with clinical stage I disease, 90% underwent complete laparoscopic staging.³ Among the women who underwent laparoscopy, 5.8% required conversion to laparotomy. The authors compared these cases with 57 women who underwent abdominal staging during the same time period, and found that laparoscopic patients had significantly smaller body mass indices, longer surgical times, more pelvic lymph nodes retrieved, smaller changes in postoperative hematocrit, lower pain medication requirements, and shorter hospital stays. The patients who underwent laparoscopic staging also had an earlier return to full activity and work, and a higher level of satisfaction with their treatment.

There is as yet no published, prospective, randomized trial comparing laparotomy with laparoscopy for treating endometrial cancer. The Gynecologic Oncology Group LAP-2 protocol is an ongoing phase III randomized trial of laparoscopic lymph node sampling with vaginal hysterectomy and bilateral salpingo-oophorectomy versus laparotomy with lymph node sampling, abdominal hysterectomy, and bilateral salpingo-oophorectomy in patients with clinical stage I and stage IIa endometrial adenocarcinoma. The purpose of this study is to compare the incidence of surgical complications, morbidity and mortality, length of stay, quality of life, and incidence of recurrence.

Triage and Preoperative Issues

Obesity is a major impediment to the completion of laparoscopic procedures. Because obesity is one of the major predisposing risk factors for developing endometrial cancer, a large proportion of the patients who ultimately need surgical staging are well above their ideal body weight. Several studies have addressed this issue. In one study, 42 women with clinical stage I endometrial cancer and a body mass index (BMI) of 28.0 or greater who were offered laparoscopic staging were compared with a group of matched controls who underwent abdominal procedures during the same time period.⁴ The mean BMI for all patients was 35.8, but conversion to laparotomy occurred in only 7.5% of patients. There was no difference in surgical complications, total cost per case, postoperative pain perception, or patient satisfaction. Women undergoing laparoscopy had a greater number of lymph nodes retrieved, smaller changes in postoperative hematocrit, decreased pain medication requirements, and shorter hospital stays, but operative time was significantly longer.

Elderly patients were evaluated for their ability to withstand laparoscopic surgery in a retrospective study of 125 subjects with endometrial cancer.⁵ Sixty-seven patients underwent planned laparoscopic staging. They were compared with 45 patients who underwent laparotomy and 13 patients who underwent vaginal hysterectomy. Of the patients who underwent laparoscopic staging, the procedure was completed in 77.6% of the patients but could not be performed in 10.4% secondary to obesity. When compared with the women who had staging at laparotomy, the elderly patients who underwent laparoscopic surgery had significantly shorter hospital stays, fewer postoperative fevers, lower likelihood of postoperative ileus, and fewer wound complications.

Controversies

A frequent criticism of laparoscopic surgery is high surgical cost due to prolonged operative time, complex equipment, and expensive disposable instruments. Spirtos et al⁶ compared cost and quality of life associated with surgical treatment of early-stage endometrial cancers managed with laparoscopy versus laparotomy in 30 women. Patients undergoing laparoscopy had higher operating room and anesthesia costs, but nonetheless had significantly lower overall medical costs ($13,809 versus $19,158); this was attributed primarily to longer hospital stays among patients who had staging at laparotomy. Improved quality of life was defined by decreased pain medication requirements and faster return to normal activity.

Concerns raised about laparoscopic staging include increased incidence of positive peritoneal cytology, vaginal-cuff recurrences, and port-site metastases (see the “Ovarian Cancer” section). A retrospective review of patients with low-risk endometrial cancer compared 131 patients with laparoscopic staging to 246 who underwent laparotomy.⁷ The incidence of positive peritoneal cytology in patients undergoing laparoscopy was 10.3% compared with 2.8% undergoing laparotomy, presumably because of the intrauterine manipulator placed for laparoscopic procedures. There are no data yet to suggest that positive cytology in this setting increases the risk of metastatic disease.

One case report raised the possibility that laparoscopic staging may lead to an increase in the number of women presenting with vaginal-cuff recurrence.⁸ The author presented 3 patients with stage I noninvasive or minimally invasive endometrial cancer who developed vaginal-cuff recurrence within 9 months of undergoing laparoscopically assisted vaginal hysterectomy. It is not yet known whether laparoscopy increases the risk of vaginal apex recurrence.

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OVARIAN CANCER

Ovarian cancer is the deadliest gynecologic malignancy. The accepted approach for treatment of ovarian cancer is surgical staging and debulking, followed in most cases by adjuvant chemotherapy based on tumor type and disease stage. Epithelial ovarian cancers are the most common type, with malignant germ cell and stromal tumors each accounting for about 5% of the total. Epithelial cancers are most prevalent in perimenopausal women and are typically detected in advanced stages, whereas germ cell and stromal malignancies are usually unilateral and occur predominately in young, reproductive-aged women. These variations in natural history affect the surgical approach. For example, a young woman presenting with a unilateral, early-stage germ cell malignancy would more likely be treated with unilateral salpingo-oophorectomy and staging, with preservation of fertility as an option; she would generally be a good candidate for laparoscopic staging. On the other hand, a postmenopausal woman presenting with a disseminated ovarian epithelial carcinoma would require radical debulking, for which laparoscopy is ill suited.

Feasibility

To demonstrate feasibility, the laparoscopic approach must allow for assessment, biopsy, and/or resection of all areas within the abdomen that would normally be accessible at laparotomy, including pelvic and para-aortic lymphadenectomy, omentectomy, peritoneal staging biopsies, washings, and evaluation of the bowel and mesentery. In the last 13 years, a number of small, retrospective series have been published demonstrating the feasibility of laparoscopic staging for ovarian cancer.^9-11 In one early series where 138 patients underwent laparoscopic staging for ovarian cancer, laparoscopic detection of abdominal and lymphatic metastases was equivalent to historical controls for staging by laparotomy. Eight percent were converted to laparotomy, while 50% underwent full laparoscopic staging.

Another recent series evaluated 30 incompletely staged cases with prior removal of an ovary who were later found to have tumors of low malignant potential.11 These patients underwent laparoscopic restaging. All had successful laparoscopic staging, with a mean operative time of 165 minutes, a 7% major complication rate, and a 2.7-day mean length of stay. Of note, 26.6% of patients had an upward revision of staging. There are as yet no published, prospective, randomized comparisons of laparoscopy with laparotomy for staging and treatment of ovarian cancer. Laparoscopy has also been advocated for second-look assessment following chemotherapy, and for evaluation of equivocal diagnostic imaging findings suggesting recurrent disease.¹²

Triage and Preoperative Issues

Preoperative selection of patients who may be candidates for laparoscopic staging of ovarian cancer depends on tumor assessment, individual medical issues, and the surgeon’s qualifications. Tumor assessment includes size, morphology by diagnostic imaging, and physical findings. Although there is no absolute upper limit of mass size for laparoscopy, laparotomy is indicated if the size and position of the mass precludes safe placement of ports. Masses with a significant solid component or multiple septations are not amenable to removal through a laparoscopic port because they cannot be readily reduced in size without likely spillage into the peritoneal cavity. Intra-abdominal morcellation to remove a large, complex mass of this type is contraindicated because published reports document dissemination of intraperitoneal carcinomatosis.^13-16 Deliberate puncture of an ovarian mass in situ is discouraged for several reasons, including the potential for dissemination of disease and the iatrogenic upstaging of disease in the event of capsule rupture. Inadvertent rupture of an ovarian cystic mass in the abdomen at the time of definitive surgical staging does not appear to worsen prognosis,^13,17,18 but rupture of a malignant cyst with a delay until definitive surgery increases the likelihood of carcinomatosis and worsens survival.^13-15 If preoperative physical findings suggest a fixed mass, nodules in the cul-de-sac, omental caking, or ascites, then laparoscopy is generally contraindicated. Medical considerations that have an impact on case selection for laparoscopy include ability to tolerate the Trendelenburg position during the procedure, obesity, and likelihood of intra-abdominal adhesions based on prior surgical history or history of infection.¹⁹

The qualifications of the surgeon are critical. First, it is well documented that operative laparoscopy has a lengthy learning curve before competence is high and complication rates are reduced.²⁰ To maximize patient safety, training and awarding of credentials for advanced operative laparoscopy must have a high priority. Secondly, several published reports document increases in accuracy of surgical staging, likelihood of optimal debulking, and prolongation of survival for ovarian cancer patients who undergo staging by a gynecologic oncologist. Based on this evidence, the National Cancer Institute has recommended that women with masses having a significant risk of malignancy should have the option of surgery performed by a gynecologic oncologist.²¹

Controversies

There is a relative paucity of data on long-term follow-up for laparoscopically treated ovarian cancer. Potential hazards associated with the laparoscopic approach for ovarian cancer include port-site metastasis, possible alterations of tumor growth by insufflation with carbon dioxide, rupture of malignant ovarian cysts, and surgical injury. Port-site metastasis is reported to occur in 1% to 2% of cases, and may be associated with implantations caused by surgical technique, positive intra-abdominal pressure causing leakage around port sites (chimney effect), and pneumoperitoneum effects on local immune reactions and tumor cells.²² Techniques to prevent port-site metastases have been proposed, but are unproved. Several studies of the effect of insufflation gases on ovarian cancer in vivo and in vitro suggest that carbon dioxide does not worsen the disease process.²³ Again, deliberate puncture of any ovarian cyst that may be malignant is discouraged unless the ovary is first contained in a laparoscopic specimen bag to prevent spillage. Very large masses that cannot be placed in such a bag are therefore not appropriate for laparoscopic removal unless a very low risk of malignancy is confirmed first. Published criteria for preoperative triage have been shown to correctly predict benign pathology in most cases.^24,25 Surgical injuries associated with operative laparoscopy have been reported extensively,²⁶ but with careful technique, appropriate patient selection, up-to-date equipment, and well-trained surgeons, the risk of serious injury is just 0.19% to 0.8%.²⁷

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CERVICAL CANCER

Cervical cancer is the seventh most common cancer among women in the United States, but is the second most common cancer among women worldwide. In 1987, Dargent²⁸ described laparoscopic pelvic lymphadenectomy prior to performing a radical vaginal hysterectomy for cervical cancer. Many groups have subsequently published data demonstrating the feasibility of this approach for women with early cervical carcinoma.^29-31 Laparoscopically-assisted radical vaginal hysterectomy was completed in the majority of cases with intraoperative and postoperative complication rates comparable to those for abdominal radical hysterectomy. Shorter hospital stay, decreased operative blood loss, decreased postoperative pain, and earlier return to full activity were also noted. Recurrence and survival rates in women managed with laparoscopy are similar to those for traditional radical abdominal hysterectomy.

In a study of 200 laparoscopically-assisted radical vaginal hysterectomies, 100% of planned pelvic lymphadenectomies were completed, plus 85% of planned para-aortic lymphadenectomies.³² Thirteen percent of patients were found to have lymph nodes positive for malignancy. Major intraoperative complications occurred in 6% of cases, including ureteral, vascular, and bowel injuries. The projected 5-year survival rate after a median 40-month follow-up was 83%. Patients with clear margins and lymph nodes and no lymph-vascular space involvement had a projected 5-year survival rate of 98%.

Total radical laparoscopic hysterectomy and lymphadenectomy was first described by Canis and Nezhat.^33,34 In a series of 50 patients who underwent this procedure, mean operating time was 258 minutes, with an average blood loss of 200 mL.³⁵ Surgical margins were clear in all cases, and 4 patients were found to have micrometastases in nodes. Complications included one of each of the following: trocar site evisceration, vaginal evisceration, and brachial plexus injury. Delayed ureteral stenosis, vesicovaginal fistula, and chronic neurogenic inguinal pain also occurred. The median follow-up in this series was 44 months, with an overall survival rate of 96%.

In a series of 78 women with stage IA2 and IB cervical carcinoma, all but 5 procedures were completed laparoscopically.³⁶ Mean operative time was 205 minutes, with an average blood loss of 225 mL. Intraoperative complications included 3 cystotomies and 2 instances of bleeding that required conversion to laparotomy. One patient developed a ureterovaginal fistula. Lymph node metastases were detected in 11.5% of cases.

Laparoscopy is also being utilized in patients with advanced cervical carcinoma. The use of a laparoscopic approach for surgical staging of women with locally advanced tumors is under investigation to help plan radiotherapy with concurrent chemotherapy for radiation sensitization.^37,38 In a study of laparoscopic staging in 98 women with locally advanced cervical cancers, each patient underwent peritoneal washing for cytology, laparoscopic abdominal exploration with biopsy of any suspicious lesions, pelvic lymphadenectomy, and para-aortic lymphadenectomy in the presence of macroscopic disease.³⁹ Staging was possible in 84 of 91 patients, and 38 were found to have positive nodes. In 38 patients whose preoperative computed tomographic findings indicated no suspicion of lymph node involvement, 48% were ultimately found to have malignant lymph nodes. These studies suggest that surgical staging of women with locally advanced cervical cancer may offer better prognostic information and improved treatment planning, although these procedures are generally performed in a research setting unless data confirm improvement of survival.

Reproductive-aged women with small stage I cervical cancers have been treated with laparoscopic lymphadenectomy followed by radical vaginal trachelectomy; this procedure removes the entire cervix, upper vagina, and parametrium, but leaves the uterus intact for placement of permanent cerclage. Dargent et al¹⁶ have reported a 5-year survival rate of 100% in patients with tumors of less than 2 cm in diameter. Thirty-three successful pregnancies were reported in 154 patients who underwent radical trachelectomy.⁴⁰

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CONCLUSION

Rapid progress in the field of laparoscopy is changing the way that many gynecologic cancers are treated. Although clinical trials are still in progress to confirm equivalence of laparoscopy to traditional laparotomy for several oncologic procedures, there is strong evidence that laparoscopy can be used safely and effectively for appropriately selected patients with endometrial, ovarian, and cervical cancers.
Training and awarding of credentials for surgeons in gynecologic oncology and many other advanced laparoscopic procedures is important for both patient safety and optimization of outcomes. At the University of Michigan Medical School, for example, a five-tier system is utilized to document physician training and experience for the purposes of awarding privileges (Table). In addition to completing this comprehensive education, the gynecologic surgeon must also be familiar with the latest literature on appropriate selection of candidates for laparoscopic management of gynecologic malignancies.

View this table

Table. University of Michigan Medical School Guidelines for Surgical Privileges in Operative Laparoscopy (2002)

References:

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