Francesco Maneschi

Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial.

BACKGROUNDnPelvic lymph nodes are the most common site of extrauterine tumor spread in early-stage endometrial cancer, but the clinical impact of lymphadenectomy has not been addressed in randomized studies. We conducted a randomized clinical trial to determine whether the addition of pelvic systematic lymphadenectomy to standard hysterectomy with bilateral salpingo-oophorectomy improves overall and disease-free survival.nnnMETHODSnFrom October 1, 1996, through March 31, 2006, 514 eligible patients with preoperative International Federation of Gynecology and Obstetrics stage I endometrial carcinoma were randomly assigned to undergo pelvic systematic lymphadenectomy (n = 264) or no lymphadenectomy (n = 250). Patients clinical data, pathological tumor characteristics, and operative and early postoperative data were recorded at discharge from hospital. Late postoperative complications, adjuvant therapy, and follow-up data were collected 6 months after surgery. Survival was analyzed by use of the log-rank test and a Cox multivariable regression analysis. All statistical tests were two-sided.nnnRESULTSnThe median number of lymph nodes removed was 30 (interquartile range = 22-42) in the pelvic systematic lymphadenectomy arm and 0 (interquartile range = 0-0) in the no-lymphadenectomy arm (P < .001). Both early and late postoperative complications occurred statistically significantly more frequently in patients who had received pelvic systematic lymphadenectomy (81 patients in the lymphadenectomy arm and 34 patients in the no-lymphadenectomy arm, P = .001). Pelvic systematic lymphadenectomy improved surgical staging as statistically significantly more patients with lymph node metastases were found in the lymphadenectomy arm than in the no-lymphadenectomy arm (13.3% vs 3.2%, difference = 10.1%, 95% confidence interval [CI] = 5.3% to 14.9%, P < .001). At a median follow-up of 49 months, 78 events (ie, recurrence or death) had been observed and 53 patients had died. The unadjusted risks for first event and death were similar between the two arms (hazard ratio [HR] for first event = 1.10, 95% CI = 0.70 to 1.71, P = .68, and HR for death = 1.20, 95% CI = 0.70 to 2.07, P = .50). The 5-year disease-free and overall survival rates in an intention-to-treat analysis were similar between arms (81.0% and 85.9% in the lymphadenectomy arm and 81.7% and 90.0% in the no-lymphadenectomy arm, respectively).nnnCONCLUSIONnAlthough systematic pelvic lymphadenectomy statistically significantly improved surgical staging, it did not improve disease-free or overall survival.

Early cervical carcinoma

Although parametrectomy is the most difficult step in the surgical treatment of cervical carcinoma and is the main cause of postoperative complications, little attention has been given to the patterns of parametrial spread.

Surgery by minilaparotomy in benign gynecologic disease

A new, minimally invasive technique for the management of benign gynecologic disease is proposed. With the patient in a steep Trendelenburg position, access to the pelvis is gained through a minimal suprapubic incision (4–9 cm) beneath the pubic hair line. The subcutaneous fat is incised in a cranial direction and the abdominal fascia is opened 2–3 cm above the skin incision. The peritoneum is opened manually and two or three Deaver retractors replace the traditional self-retaining retractor. Continuous repositioning of the retractors permits the operative window to be focused always on the surgical field. This technique can be performed only if the following criteria are met: use of narrow and light instruments; exteriorization of the affected organs; combined, unidirectional maneuvering of all the retractors; and prompt hemostasis by electrocoagulating forceps. Among 78 inpatients with benign gynecologic diseases who underwent surgical treatment with this approach, the feasibility rate was 96% and no intraoperative complications or severe postoperative morbidity were observed. Pelvic surgery by minilaparotomy is a feasible and safe approach in the treatment of benign gynecologic disease.

The pelvic retroperitoneal approach in the treatment of advanced ovarian carcinoma

Objective To evaluate the feasibility, complications, and clinical role of pelvic cytoreduction using the retroperitoneal approach in the treatment of advanced ovarian cancer. Methods We studied 66 women with previously untreated advanced ovarian cancer who underwent pelvic retroperitoneal surgery. The possibility of achieving extrapelvic cytoreduction (residual disease less than 2 cm), involvement of the Douglas cul-de-sac or vesicouterine fold, or the presence of a frozen pelvis were indications for the retroperitoneal approach. Operative time, blood loss and transfusions, perioperative complications, and postoperative stay were analyzed prospectively. The performance status of each patient was assessed preoperatively and postoperatively. Results The pelvic retroperitoneal approach was used in 66 of 147 (45%) consecutive patients who underwent primary surgery with intent of cytoreduction. This approach was necessary in 60 of 94 (64%) patients with residual tumor less than 0.5 cm and contributed to achieving such a minimal residual disease in 36 of 38 (95%) stage IIB-IIIB and 58 of 109 (53%) IIIC-IV patients. Severe morbidity, but with no longterm sequelae, occurred in six (9%) patients. Before surgery, only ten (15%) of these patients had performance status grade 0–1,21 (32%) had grade 2, and 35 (53%) grade 3–4. After surgery, These figures were 52 (79%), 14 (21%), and 0, respectively. The 5-year survival rate was 37%, with a median survival and follow-up time of 27 months (range 4–98) and 43 months, respectively. Conclusion If the proper technique is used, complete pelvic cytoreduction is always feasible and morbidity is acceptable. In our series, it was necessary to approach the pelvis retroperitoneally in 64% of optimally cytoreduced patients, which suggests that this technique has an importent clinical role in the treatment of patients with advanced ovarian cencer.

PELVIC AND AORTIC LYMPHADENECTOMY

Pelvic and aortic lymphadenectomy for gynecologic malignancies has changed from a random picking of some pelvic and aortic lymph nodes to a well-established technique based on adequate knowledge of the patterns of spread of the primary tumor. The identification of the node groups to remove, the number of nodes to count, and the border of dissection in the different clinical situations make pelvic and aortic lymphadenectomy a reproducible surgical intervention. The large experience accumulated over the years has greatly improved the technique and perioperative and complication management. The improved knowledge of the natural history of gynecologic tumors has refined the indications for lymph node dissection. Today, pelvic and aortic lymphadenectomy is primarily a staging procedure. The therapeutic value of lymphadenectomy is recognized in the surgical treatment of cervical cancer, but it is still under evaluation in ovarian and endometrial tumors.