Transabdominal cerclage: a laparoscopic approach.

BACKGROUND: The placement of a transabdominal cervical cerclage has been regarded as considerably more morbid than a transvaginal cerclage, in part due to the need for two laparotomies. We describe a technique for the laparoscopic placement and removal of a transabdominal cerclage. CASES: Two cases of women with insufficient cervical tissue to place a transvaginal cerclage were managed with a transabdominal cerclage. In one case, the cerclage was placed laparoscopically; in the other, the band was removed, facilitating uterine evacuation following the diagnosis of a missed abortion. In both cases a laparotomy was avoided. CONCLUSION: Laparoscopic placement and removal of a transabdominal cerclage are promising options in the treatment of an incompetent cervix.

Laparoscopic staging of endometrial cancer: the learning experience.

OBJECTIVE: To evaluate our learning-curve experience with laparoscopic management of endometrial carcinoma. METHODS: Retrospective review of our first 125 patients with endometrial cancer who were managed laparoscopically. The patient population was reviewed in a chronological manner, noting patient demographics, operative procedure and times, estimated blood loss, hospital stay, complications, and pathology. RESULTS: Overall, the mean age was 68.6 years (range 29-89), the mean weight was 160 pounds (range 97-328), and the mean Quetelet index was 27.8 (range 17.8-56.4). Metastatic disease was discovered in 28.8% (17/59) of patients with grade 2 or 3 lesions. There was no statistically significant variation in any of these parameters throughout the study. Operative times for staging without lymphadenectomy decreased significantly from a mean of 163 minutes to 99 minutes (p < .001). Operative times for staging with lymphadenectomy decreased from a mean of 196 minutes to 128 minutes (p < 0.02). Hospital stay decreased from a mean of 3.2 days in the first quarter of our study to 1.8 days (p < .0001). The overall average complication rate of 4% (two enterotomies, two cystotomies, and a transected ureter) did not vary. However, the rate of conversion to laparotomy dropped significantly from 8% (2/25) to 0% (0/100). CONCLUSIONS: We found that operative times and hospital stays for laparoscopic staging of endometrial cancer continued to drop after 125 cases. While the ability to detect metastatic disease and the rate of major complications appear unrelated to length of the operator experience, the conversion rate to laparotomy decreases with operator experience. Learning-curve parameters must be recognized by physicians, patients, and researchers for a host of reasons.

Laparoscopic management of suspicious adnexal masses.

OBJECTIVE: Our aim was to evaluate the feasibility and applicability of operative laparoscopy in the management of adnexal masses that do not meet the standard serum CA 125 and ultrasonographic criteria for benignity. STUDY DESIGN: One hundred thirty-eight patients underwent operative laparoscopy for removal of suspicious adnexal masses. The CA 125 level was > 35 mlU/ml in 39 of 138 (28%) patients; ultrasonographic findings were abnormal in 127 of 138 (92%); masses were > 10 cm in 43 of 138 (32%) of patients. RESULTS: Malignancies were discovered in 14% (19/138) of patients. Eight percent (11/138) of the procedures were converted to laparotomy, six because of inability to dissect the mass laparoscopically and five for staging or debulking of carcinoma. Operative times ranged from 25 to 210 minutes, with a mean of 86. Three major complications were encountered-an enterotomy and a lacerated vena cava, both of which were repaired laparoscopically, and a small bowel herniation through a lateral port site that required reoperation. Hospital stays ranged from 0 to 11 days, with a mean of 1.5. In two patients with "apparent" stage I adnexal carcinomas recurrence was diagnosed 6 and 38 months after surgery. CONCLUSIONS: Laparoscopic management of suspicious adnexal masses is technically feasible, with a low rate of morbidity and a short hospital stay. Adnexal carcinomas can be identified and managed appropriately with staging and complete resection as indicated.

The role of laparoscopy in gynecologic oncology.

The use of laparoscopy in the management of gynecologic malignancies has significantly increased over the last 5 years. The safety and adequacy of pelvic and para-aortic lymphadenectomy has been established by several investigators. Patients with early carcinoma of the cervix are now undergoing Schauta (radical vaginal) hysterectomy after laparoscopic lymphadenectomy. Patients with carcinoma of the endometrium are treated by laparoscopically assisted vaginal hysterectomy in conjunction with laparoscopic pelvic and para-aortic lymphadenectomy. Staging and second-look procedures are now being performed laparoscopically in patients with carcinoma of the ovary. The Gynecologic Oncology Group is currently investigating the role of laparoscopic surgery for patients with carcinoma of the cervix, endometrium, and ovary in four Phase II trials. A randomized Phase III trial comparing laparoscopy to laparotomy for patients with carcinoma of the endometrium will begin soon.

Laparoscopic surgical staging of ovarian cancer.

The feasibility of laparoscopic staging in patients with ovarian cancer was undertaken prospectively to determine the ability to adequately evaluate both the intraperitoneal cavity and the retroperitoneal lymph nodes. Two groups of ovarian cancer patients were evaluated: those with optimally debulked advanced disease undergoing second-look procedures and those with presumed stage I disease undergoing surgical staging. Twenty-four of the 44 laparoscopic second-look procedures (56%) were positive for persistent disease. Five of these patients had microscopic disease only, in the omentum, washings, pelvic peritoneum, and in para-aortic lymph nodes (2 patients). In the group of 14 patients undergoing staging for presumed early ovarian carcinoma, metastatic disease was discovered in 8 (57%) patients. Two patients had peritoneal washings positive for adenocarcinoma; 3 had pelvic disease, 1 confined to a fallopian tube and 2 to the pelvic peritoneum; and 3 patients had para-aortic lymph nodes positive for metastatic adenocarcinoma. There were no serious complications in this category. The average hospital stay was 1.6 days. Laparoscopic staging appears to be an accurate staging technique, and further investigation into the validity of this approach is warranted.

Laparoscopic hysterectomy for persistent gestational trophoblastic neoplasia.

We performed laparoscopic hysterectomy in a woman with persistent gestational trophoblastic neoplasia. The procedure offered advantages over vaginal hysterectomy in that intraabdominal inspection was possible, morcellation was avoided, and the uterine arteries were transected before uterine manipulation to avoid potential tumor embolization. In addition, an abdominal incision was not required, and the patient had shorter hospitalization and less pain than she would have had with the standard abdominal procedure. Persistent, locally invasive gestational trophoblastic neoplasia (GTN) develops in 15% of women after dilatation and evacuation for molar pregnancy. Chemotherapy and hysterectomy are curative in virtually all patients. Numerous factors are considered in deciding the primary mode of therapy. Women in whom fertility is not an issue may choose hysterectomy, which decreases the amount of chemotherapy required to achieve cure. Traditionally, this has been performed with an abdominal approach. We performed laparoscopic hysterectomy to manage GTN.

Phase II study of 13-cis-retinoic acid plus interferon-alpha 2a in heavily pretreated squamous carcinoma of the cervix.

The combination of 13-cis-retinoic acid (13-cRA) and interferon (IFN)-alpha 2a has been reported to be highly active in previously untreated squamous carcinoma of the cervix. In this phase II study, 13-cRA was given at a dose of 1 mg/kg/day and IFN-alpha 2a was given subcutaneously at a dose of 3 million units/m2/day. Thirteen of 14 patients enrolled in this study are evaluable for response and toxicity. There were no complete or partial responses. Ten patients had progressive disease and the remaining three had stable disease. Principle toxicities were fatigue, nausea, and vomiting. This regimen appears cross-resistant with radiotherapy and/or platinum-based cytotoxic therapy in heavily pretreated patients with squamous carcinoma of the cervix.

Laparoscopic sacral colpopexy: a proposed technique.

This case report describes a laparoscopic sacral colpopexy using Mersilene mesh in a patient with complete vaginal vault prolapse. Mersilene mesh was placed as a hammock between the vaginal apex and the anterior surface of the sacrum, using intracorporeal needles and an extracorporeal knot tying technique. Minor modifications are made from the traditional abdominal approach, because the patient had previously undergone a pelvic lymphadenectomy and vaginal cuff radiation for a stage IB grade 1 adenocarcinoma of the endometrium.

Abdominal-wall tumor implantation after laparoscopy for malignant conditions.

OBJECTIVE: To determine the incidence of abdominal-wall tumor implantation after laparoscopic procedures in patients with known malignancies. METHODS: We reviewed 557 laparoscopic procedures performed by the Gynecologic Oncology Service between November 1990 and February 1994. In 105 procedures, malignancy was documented cytologically or histologically, 88 with intraperitoneal disease and 17 with retroperitoneal disease. Ovarian cancer represented 80% (70 of 88) of the procedures with intraperitoneal malignancy, and the remaining cases consisted of carcinoma of the fallopian tube (two), endometrium (11), cervix (one), breast (three), and stomach (one). Histologically, ovarian carcinomas ranged from low malignant potential to poorly differentiated. Among 88 patients with intraperitoneal disease, 77 had gross disease and 11 had microscopic disease. Four hundred thirty-seven different abdominal-wall puncture sites were used (38 Veress needle sites and 399 laparoscopic ports). RESULTS: One of the 437 (0.2%) abdominal-wall puncture sites developed implantation, a frequency of 1.0% (one in 105) per procedure; this developed after a second-look laparoscopic procedure for ovarian carcinoma in which only microscopic disease was present. If only intraperitoneal disease is considered, the incidence of implantation was 0.3% (one in 363) per abdominal puncture and 1.1% (one in 88) per procedure. CONCLUSION: Tumor implantation at the abdominal-wall puncture site is an infrequent occurrence after laparoscopy in patients with intraperitoneal and retroperitoneal carcinoma.

Laparoscopic staging of the patient with incompletely staged early adenocarcinoma of the endometrium.

OBJECTIVE: To determine the feasibility of laparoscopic staging in patients with presumed early stage but incompletely surgically staged adenocarcinoma of the endometrium. METHODS: Thirteen patients with incompletely staged adenocarcinoma of the endometrium underwent laparoscopic staging. The women ranged in age from 36-74 years (mean age 64) and weighed 132-201 lb (mean 147.5). The interval between hysterectomy and laparoscopic staging ranged from 14-63 days, for an average of 47. All patients underwent inspection of the entire intraperitoneal cavity, procurement of pelvic washings, and/or pelvic or para-aortic lymphadenectomy, and two patients had remaining ovaries removed. RESULTS: Extrauterine disease was found in three patients: One had intraperitoneal washings positive for adenocarcinoma, and two had pelvic lymph nodes positive for microscopic carcinoma. The average number of lymph nodes removed was 17.5. There were no intraoperative complications. Estimated blood loss averaged less than 50 mL, and the mean hospital stay was 1.5 days. CONCLUSION: Our initial experience indicates that this is a safe, effective procedure that offers a short hospital stay. We consider laparoscopic staging an attractive option for some patients with incompletely staged early adenocarcinoma of the endometrium.

Enhancement of regression of cervical intraepithelial neoplasia II (moderate dysplasia) with topically applied all-trans-retinoic acid: a randomized trial.

BACKGROUND: Retinoids enhance differentiation of most epithelial tissues. Epidemiologic studies have shown an inverse relationship between dietary intake or serum levels of vitamin A and the development of cervical dysplasia and/or cervical cancer. Pilot and phase I investigations demonstrated the feasibility of the local delivery of all-trans-retinoic acid (RA) to the cervix using a collagen sponge insert and cervical cap. A phase II trial produced a clinical complete response rate of 50%. PURPOSE: This randomized phase III trial was designed to determine whether topically applied RA reversed moderate cervical intraepithelial neoplasia (CIN) II or severe CIN. METHODS: Analyses were based on 301 women with CIN (moderate dysplasia, 151 women; severe dysplasia, 150 women), evaluated by serial colposcopy, Papanicolaou cytology, and cervical biopsy. Cervical caps with sponges containing either 1.0 mL of 0.372% beta-trans-RA or a placebo were inserted daily for 4 days when women entered the trial, and for 2 days at months 3 and 6. Patients receiving treatment and those receiving placebo were similar with respect to age, ethnicity, birth-control methods, histologic features of the endocervical biopsy specimen and koilocytotic atypia, and percentage of involvement of the cervix at study. Treatment effects were compared using Fisher's exact test and logistic regression methods. Side effects were recorded, and differences were compared using Fisher's exact test. RESULTS: RA increased the complete histologic regression rate of CIN II from 27% in the placebo group to 43% in the retinoic acid treatment group (P = .041). No treatment difference between the two arms was evident in the severe dysplasia group. More vaginal and vulvar side effects were seen in the patients receiving RA, but these effects were mild and reversible. CONCLUSIONS: A short course of locally applied RA can reverse CIN II, but not more advanced dysplasia, with acceptable local side effects. IMPLICATIONS: A derivative of vitamin A can reverse or suppress an epithelial preneoplasia, lending further support to the notion that chemoprevention of human cancer is feasible.

Phase II trial of amonafide in patients with advanced metastatic or recurrent endometrial adenocarcinoma. A Southwest Oncology Group study.

Amonafide, a benzisoquinoline-1,3-dione was administered to 38 patients with recurrent or metastatic, bidimensionally measurable endometrial cancer. There were 34 patients with no prior cytotoxic chemotherapy, performance status of 0-2, and normal bone marrow, renal, and hepatic function were eligible for response and toxicity evaluation. Amonafide, 300 mg/m2, was administered intravenously over 1 hour daily for 5 consecutive days. Courses were repeated every 21 days. The major grade 3 or 4 toxicities were hematologic with granulocytopenia in 18 patients (53%), thrombocytopenia in 6 patients (18%), and anemia in 8 patients (24%). Infectious complications occurred in 3 patients (9%). Other side effects included cardiac dysrhythmias, hypotension, pain and phlebitis at the site of injection, nausea, vomiting, and flu-like symptoms. The overall objective response rate was 6% (95% confidence interval of 1-20%); 2 patients had a complete response (6%), 9 patients had stable disease (26%) and 21 patients had progressive disease (62%). Two patients had insufficient follow-up for response determination and are assumed to be nonresponders. The median survival of the eligible patients was 8 months. With the toxicity observed and the low response rate, amonafide at this dose and schedule has no efficacy in the treatment of endometrial cancer.

Comparative exposure ratios: a non-parametric, multifactor technique for case-control studies.

The odds ratio in a two-by-two table is widely used in case-control studies to measure association between disease and a binary risk factor. In this article we propose a more general measure of association, the comparative exposure ratio (CER), which is the ratio of the number of case-control pairs where the case has greater exposure divided by the number where the control has greater exposure. In simple cases, the CER is an odds ratio or a weighted combination of odds ratios. In more general cases, a CER continues to measure association even when an odds ratio computation is not feasible. Moreover, CERs improve on odds ratios in several ways: they do not require binary risk factors, or a choice of the scale of measurement of continuous risk factors; they make it possible to investigate multiple risk factors simultaneously, without multivariate parametric assumptions; they also can be used to detect patterns that might indicate possible causal pathways. We illustrate how various choices of the definition of 'greater exposure' make the CER a powerful and flexible tool. We give expressions for confidence intervals for CERs, and verify in a pilot simulation that they are valid. Finally, we illustrate with a case-control study of cervical dysplasia how exploratory inference using CERs can be carried out.

Laparoscopic surgical staging of stage I primary squamous cell carcinoma of the vagina.

Vaginal carcinoma is an uncommon malignancy and one of the few gynecologic malignancies that is still clinically staged. Clinical staging, which can be difficult in some instances, is potentially inaccurate, as it has been shown to be in early endometrial and ovarian carcinoma. In addition, clinical staging can result in over- or undertreatment of the disease. The lack of standardization of treatment further compounds the issue, particularly for patients with small-volume disease. We report three patients with grade 2 or 3 small-volume primary squamous cell carcinoma of the vagina who underwent pelvic lymph node sampling for staging purposes. Each patient had lesions small enough to be considered for brachytherapy only. An average of 12 lymph nodes were removed with an average operative time of 72 minutes. All procedures were performed on an outpatient basis, and there were no intraoperative or postoperative complications. In one patient, teletherapy was added to the brachytherapy because a microscopic focus of squamous cell carcinoma was discovered in an obturator lymph node. Our initial experience indicates that laparoscopic sampling of lymph nodes in patients with early vaginal carcinoma may be helpful in preventing undertreatment of these women. Individualization of treatment can be accomplished quickly and safely on an outpatient basis, and initiation of treatment is not delayed. We believe further evaluation of laparoscopic staging of primary vaginal carcinoma is indicated.

Results of a Southwest Oncology Group phase III trial of carboplatin plus cyclophosphamide versus cisplatin plus cyclophosphamide in advanced ovarian cancer.

Cisplatin combined with cyclophosphamide has been considered a very active treatment for advanced ovarian cancer. Unfortunately, cisplatin is associated with dose-limiting neurotoxicity, as well as possible neuropathy, ototoxicity, and occasional renal dysfunction. Carboplatin, a cisplatin analogue, is active against advanced ovarian cancer, with a presumed lower incidence of emesis, ototoxicity, neuropathy, and renal dysfunction. The Southwest Oncology Group initiated a phase III randomized trial, in which 342 patients with stage III (suboptimal disease) and stage IV ovarian cancer were randomly assigned to treatment with six courses of intravenous cisplatin 100 mg/m2 plus cyclophosphamide 600 mg/m2 or carboplatin 300 mg/m2 plus cyclophosphamide 600 mg/m2. The median survival for the cisplatin arm was 17.4 months; for the carboplatin arm, median survival was 20.0 months. The null hypothesis of a 30% survival superiority with the cisplatin arm was rejected at the p = 0.02 level. Clinical response rates were 52% for the cisplatin arm and 61% for the carboplatin arm. There was less thrombocytopenia in the cisplatin arm (p < 0.001); however, there was less nausea and emesis (p < 0.001 for courses one to five), renal toxicity (p < 0.001), anemia (p < 0.001), hearing loss (p < 0.001), and neuromuscular toxicity (p < 0.001) in the carboplatin arm. Carboplatin/cyclophosphamide proved to have a significantly better therapeutic index than cisplatin/cyclophosphamide in these patients with advanced ovarian cancer.

Current status of operative laparoscopy in gynecologic oncology.

The role of laparoscopy in gynecologic oncology has expanded in the last few years to include a variety of situations and cancers. Patients with invasive cervical carcinoma can be spared radical hysterectomy if laparoscopy documents positive lymph nodes. Therapeutic laparoscopic pelvic lymphadenectomy has been performed successfully in patients with small cervical lesions. Laparoscopy can be used for staging in patients with advanced cervical cancer who are scheduled for definitive radiotherapy. Laparoscopically assisted surgical staging is also feasible, safe, and adequate in patients with clinical stage I endometrial cancer, and is being investigated in patients with stage I ovarian cancer. Second-look laparoscopy is proving useful in ovarian cancer patients who are candidates for a second-look procedure. Laparoscopic pelvic lymphadenectomy is being investigated in patients with small stage I vaginal carcinoma who are being considered for treatment with brachytherapy alone.

Laparoscopic para-aortic lymphadenectomy in gynecologic malignancies.

OBJECTIVE: To determine the feasibility, safety, limiting factors, and advantages of laparoscopic para-aortic lymphadenectomy in a series of patients with gynecologic malignancies. METHODS: During a 2-year period, 61 women underwent laparoscopic para-aortic lymph node dissection as part of their management for invasive gynecologic malignancies. A transperitoneal incision directly over the aorta was used. Initially, only the right-side infra-inferior mesenteric artery nodes were removed. The technique of removal of left-side low para-aortic nodes was then developed, followed by the technique for removal of right- and left-side nodes above the transverse duodenum. A total of 52 right para-aortic lymphadenectomies were performed, 12 of which were combined with left-side lymphadenectomies. A total of 17 left-side lymphadenectomies were performed, 12 of which were bilateral. Four patients had nodes removed above the inferior mesenteric artery. RESULTS: The procedure could not be performed in four instances because of obesity or adhesions. Twenty-four patients had their laparoscopic surgery combined with another procedure, which increased their hospital stays: radical hysterectomy (five), laparoscopy-assisted vaginal hysterectomy (17), transperineal interstitial irradiation (one), and anterior-posterior colporrhaphy (one). The remaining 33 patients had laparoscopic surgical staging only. One patient required laparotomy to control bleeding from the vena cava; however, the others had no short- or long-term complications, and the average hospital stay was 1.3 days. CONCLUSION: Laparoscopic para-aortic lymphadenectomy is a safe, effective procedure that allows a shorter hospitalization than traditional laparotomy.

Laparoscopic staging of Hodgkin's lymphoma.

A 57-year-old female with Hodgkin's lymphoma, diagnosed by a cervical lymph node biopsy and surgically staged laparoscopically, is presented. Staging included a pelvic and para-aortic lymphadenectomy as well as splenectomy. Laparoscopic staging of Hodgkin's lymphoma has not been previously reported. The procedure, its limitations, and potential modifications are discussed.

Laparoscopically assisted surgical staging (LASS) of endometrial cancer.

We report 59 patients who were considered candidates for laparoscopically assisted surgical staging (LASS) to manage their clinical stage I adenocarcinoma of the endometrium. Their ages ranged from 40 to 85 years, with a mean of 69; their weights ranged from 102 to 267 pounds, with a mean of 153 pounds. Patients with intraperitoneal disease were taken off study. Laparoscopic pelvic and para-aortic lymphadenectomies were performed based on the grade of the tumor and the depth of myometrial invasion. Six patients were discovered to have intraperitoneal disease. Of the remaining 53 patients, 29 underwent lymphadenectomy, 1 of whom had positive para-aortic nodes. Of the 24 patients who did not have laparoscopic lymphadenectomy, 2 should have, according to the study criteria; however, obesity precluded this from being performed. Eight patients had grade 3 lesions; of these, 4 lesions had metastasized. The remaining 3 patients with metastatic disease had grade 2 lesions. Complications were related to the laparoscopically assisted vaginal hysterectomy and resulted in two laparotomies: one for a transected ureter and the other for a cystotomy. Estimated blood loss was < 200 cc and the average hospital stay was 2.9 days. We feel that LASS is an attractive alternative to the traditional surgical approach in patients with stage I endometrial carcinoma.