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Objective: The standard treatment for stage IB-IIA cervical cancer over the past three decades has been the Piver-Rutledge type III radical hysterectomy. This surgery implies a high rate of urologic morbidity. The objective was to determine the role of class I radical hysterectomy compared to class III radical hysterectomy in terms of morbidity, overall survival, DFS and patterns of relapse in patients undergoing primary surgery., Materials and Methods: 125 patients with stage IB1 and IIA cervical cancer ≤ 4 cm were randomized between type I and type III hysterectomy. Clinical, pathologic and follow-up data were prospectively collected. Adjuvant radiotherapy was administered when indicated. Univariate and multivariate analyses were carried out., Results: Sixty-two patients were randomized to class I surgery and 63 to class III. No significant differences were observed regarding pathologic findings and adjuvant treatment. Morbidity rates were higher after class III surgery (84% versus 45%). Pelvic recurrences were equal in both groups (8 cases each one). Fifteen-year overall survival rate was 90 and 74% respectively (p = 0.11) and 76 and 80% when cervical size is ≤ 3 cm (p = 0.88)., Conclusions: There are no significant differences in terms of both recurrence rate and overall survival among patients with stage IB-IIA cervical cancer undergoing simple extrafascial hysterectomy (class I) or radical hysterectomy (class III). Morbidity is proportional to the extent of radicality. These data confirm the need of tailoring the extent of resection to the characteristics of the cervical neoplasia and open new interesting pathways to upcoming protocols for the conservative management of these tumors., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Background: Five percent to 20% of stage I endometrial cancer patients undergoing total abdominal hysterectomy and bilateral salpingo-oophorectomy develop vaginal and pelvic recurrences. Adjuvant radiotherapy can improve locoregional control but not survival. This randomized trial aimed to determine whether a modified radical (Piver-Rutledge class II) hysterectomy can improve survival and locoregional control compared to the standard extrafascial (Piver-Rutledge class I) hysterectomy., Methods: Eligible patients (n = 520) with stage I endometrial cancer were randomized to class I or class II hysterectomy. Primary endpoint was overall survival., Results: The median length of parametria and vagina removed were 15 and 5 vs. 20 mm and 15 mm for class I and class II hysterectomy, respectively (P > 0.001). Operating time and blood loss were statistically significantly higher for class II hysterectomy. At a median follow-up of 70 months, 51 patients had died. Five-year disease-free and overall survival were similar between arms (87.7 and 88.9% in the class I arm and 89.7 and 92.2% in the class II arm, respectively). The unadjusted hazard ratios for recurrence was 0.91 (95% confidence interval, 0.55-1.51, P = 0.72), and the hazard ratio for death was 0.77 (95% confidence interval, 0.44-1.33, P = 0.35)., Conclusions: Class II hysterectomy did not improve locoregional control and survival compared to class I hysterectomy, but when an adequate vaginal cuff transection is not feasible with class I hysterectomy, a modified radical hysterectomy allows to obtain an optimal vaginal and pelvic control of disease with a minimal increase in surgical morbidity.

Background: Pelvic 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., Methods: From 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., Results: The 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)., Conclusion: Although systematic pelvic lymphadenectomy statistically significantly improved surgical staging, it did not improve disease-free or overall survival.

Purpose: Neoadjuvant chemotherapy (NACT) and radical surgery (RS) have emerged as a possible alternative to conventional radiation therapy (RT) in locally advanced cervical carcinoma. In 1990, a phase III trial was undertaken to verify such a hypothesis in terms of survival and treatment-related morbidity., Patients and Methods: Patients with squamous cell, International Federation of Gynecology and Obstetrics stage IB2 to III cervical cancer were eligible for the study. They received cisplatin-based NACT followed by RS (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or external-beam RT (45 to 50 Gy) followed by brachyradiotherapy (20 to 30 Gy) (arm B)., Results: Of 441 patients randomly assigned to NACT+RS or RT, eligibility was confirmed in 210 and 199 patients, respectively. Treatment was administered according to protocol in 76% of arm A patients and 72% of arm B patients. Adjuvant treatment was delivered in 48 operated patients (29%). There was no evidence for any significant excess of severe morbidity in one of the two arms. The 5-year overall survival (OS) and progression-free survival (PFS) rates were 58.9% and 55.4% for arm A and 44.5% and 41.3% for arm B (P =.007 and P =.02), respectively. Subgroup survival analysis shows OS and PFS rates of 64.7% and 59.7% (stage IB2-IIB, NACT+RS), 46.4% and 46.7% (stage IB2-IIB, RT) (P =.005 andP =.02), 41.6% and 41.9% (stage III, NCAT+RS), 36.7% and 36.4% (stage III, RT) (P =.36 and P =.29), respectively. Treatment had a significant impact on OS and PFS., Conclusion: Although significant only for the stage IB2 to IIB group, a survival benefit seems to be associated with the NACT+RS compared with conventional RT.

Objective: The objective of this study was to determine the role of the extent of the radicality in the treatment of stage IB-IIA cervical carcinoma with respect to survival, pattern of relapse, and morbidity., Methods: Two-hundred forty-three patients with cervical carcinoma (FIGO stages IB and IIa) were enrolled in a prospective randomized study comparing two types of radical hysterectomy (Piver-Rutledge-Smith class II and class III) between April 1987 and December 1993, and 238 are evaluable. Disease-free survival, overall survival, pattern of recurrences, and morbidity were the endpoints of this study., Results: Mean operative time was significantly (P = 0. 05) shorter in the group of patients undergoing class II hysterectomy (135 min vs 180 min), whereas mean blood loss (530 ml vs 580 ml) and number of patients requiring transfusions (35% vs 43%) were similar in the two arms of treatment. Complications unrelated to the extent of the surgical dissection and mean postoperative stay were similar in the two arms of treatment. Late morbidity was significantly lower in patients in the class II arm (especially urologic morbidity, 13% vs 28%). Postoperative radiotherapy was administered to 64 patients (54%) in class II and to 65 patients (55%) in the class III arm. Recurrence rate (24% class II vs 26% class III) and number of patients dead of disease (18% class II vs 20% class III) were not significantly different in the two groups of treatment. Overall 5-year survival was 81 and 77% and disease-free survival was 75 and 73%, respectively. Multivariate analysis confirms that survival does not depend on the type of operation., Conclusions: Class II and class III radical hysterectomies are equally effective in surgical treatment of cervical carcinoma, but the former is associated with a lesser degree of late complications., (Copyright 2001 Academic Press.)

Objectives: To ascertain whether uterine shrinkage induced by a gonadotrophin releasing hormone agonist before hysterectomy for fibroids increases the possibility of a vaginal procedure., Design: A multicentre, prospective, randomised, controlled study., Participants: One hundred and twenty-seven premenopausal women with a uterine volume of 12 to 16 gestational weeks., Interventions: Twelve weeks of triptorelin depot treatment before hysterectomy or immediate surgery., Main Outcome Measures: Number of vaginal and abdominal hysterectomies, operating time, blood loss, degree of difficulty of the procedure, perioperative serum haemoglobin and haematocrit levels, hospital stay, and patients' overall satisfaction with treatment., Results: After randomisation, four women withdrew from the study, leaving 60 women in the triptorelin arm and 63 in the immediate surgery arm. At baseline evaluation a vaginal hysterectomy was indicated in seven women allocated to pre-operative medical therapy (12%), and in 10 of those allocated to immediate surgery (16%). Clinical assessment after the 12-week GnRH agonist course showed that abdominal hysterectomy was no longer indicated in 25/53 women (47%) as a vaginal procedure appeared appropriate. Thus the overall rate of indication for a vaginal procedure in the pre-operative medical treatment arm was 32/60 cases (53%), with a between-group difference of 37% (95% CI, 26% to 51%; chi2(1) = 19.18, P < 0.0001; OR 6.06; 95% CI, 2.60 to 14.10). Pre- and post-operative serum haemoglobin and haematocrit levels were significantly higher in the GnRH agonist than in the immediate surgery arm. No appreciable difference was observed between the groups in the other intra- and post-operative variables, including patients' satisfaction., Conclusions: Pre-operative GnRH agonist therapy increased the rate of vaginal hysterectomy in selected women with fibroids and uterine volume of 12 to 16 gestational weeks.

Objective: Our purpose was to evaluate the effects of two surgical techniques, closed vaginal vault with two layers of continous 3-0 polyglactin suture versus open vaginal vault with a locking 3-0 polyglactin suture, after abdominal hysterectomy., Study Design: A prospective, randomized trial was performed. During the hospital stay and 4 to 8 weeks after the operation patients were observed for evidence of morbidity., Results: Of the 273 evaluable subjects, 141 had the vaginal vault left open whereas 132 were closed. Ten (7.1%) and eight patients (6.1%) had infections at the operative site (pelvis or abdominal wound) (p = 0.92). A urinary tract infection was diagnosed in three (2.1%) and in four subjects (3.0%) (p = 0.46). A pelvic hematoma developed in two patients of each group (p = 0.66). Vault granulations were recorded in 11% and 12% of subjects (p = 0.97)., Conclusions: This study failed to show some benefit in favor of either of the two surgical policies. A careful surgical technique and antibiotic prophylaxis seem to remain the most important factors in the prevention of postoperative morbidity.

Autologous blood transfusion (ABT) is a safe and useful procedure in patients undergoing elective surgery, but it has not been recommended for radical hysterectomy with pelvic lymphadenectomy. We retrospectively evaluated the results of an ABT programme in 146 consecutive women undergoing radical hysterectomy and pelvic lymphadenectomy for cervical carcinoma at our institution. Forty women underwent autologous blood transfusion after predeposit; 23 underwent preoperative normovolemic haemodilution; 38 were eligible but could not receive autologous blood transfusion for logistic reasons; 45 were excluded for medical reasons. 126 units of blood were collected, of which 100 (80%) were reinfused. The donation procedure was well-tolerated and no transfusion reaction was observed. Homologous blood transfusion was needed in 13% of patients receiving predeposit or haemodilution (8/63), in 42% of patients that were eligible but not receiving autologous blood transfusion (16/(38), and in 71% of non-eligible patients (32/45). The total number of units of homologous blood required for transfusion was lower in patients undergoing predeposit or haemodilution (14) than in those included in the observation arm (43). Autologous blood transfusion is a safe practice which greatly reduces the need for homologous blood transfusion, and radical hysterectomy with pelvic lymphadenectomy represents an adequate indication for this procedure, as the majority of deposited blood is actually reinfused.

A prospective, randomized, multicenter study was conducted on the efficacy and safety of two prophylactic antibiotic regimens in both abdominal and vaginal hysterectomy. Patients received three intravenous doses of clindamycin (900 mg) plus either aztreonam (1 g) or cefotaxime (1 g); the doses were given at the induction of anesthesia and 8 and 16 hours later. A total of 170 patients undergoing abdominal hysterectomy and 142 patients undergoing vaginal hysterectomy completed the trial and were evaluated. Following abdominal hysterectomy infections occurred at the operative site in 1.2% of patients given a regimen including aztreonam and in 4.7% of those given a regimen including cefotaxime; the difference between the two groups was not significant. Neither were significant differences observed in the incidence of fever, the incidence of bacteriuria, the need for postoperative antibiotics, or the duration of postoperative hospitalization, although results were slightly better for patients receiving clindamycin plus aztreonam. Following vaginal hysterectomy, slightly but not significantly better results for the same parameters were obtained in the group given clindamycin plus cefotaxime. Diarrhea was the only adverse reaction attributable to antibiotic treatment and occurred more frequently in patients given cefotaxime. It was concluded that the two regimens were similarly effective and safe in preventing infections following hysterectomy.

A prospective randomized study was carried out on a total of 686 patients who underwent vaginal or abdominal hysterectomy. Of these, 338 were given prophylactic cefotetan (2 g) and 348 piperacillin (2 g). Both drugs were administered as i.v. bolus 30 min before operation. Findings confirm the higher risk of infection with abdominal hysterectomy and the advantages of the long half-life cephalosporin, cefotetan.

We have carried out a controlled, prospective, randomized study with the aim of evaluating the efficacy of a short-term antibiotic prophylaxis on patients undergoing simple total hysterectomy. 750 patients entered the trial, starting in September 1977, 260 underwent vaginal hysterectomy, 490 abdominal hysterectomy. The patients were subdivided randomly into four groups, which were homogeneous in number, age, weight, associated disease, indication for surgery and hormonal status: control group, without treatment; prophylaxis with Cefazolin; prophylaxis with Thiamphenicol; prophylaxis with Cefazolin plus Thiamphenicol. Each antibiotic was administered parenterally, at the dose of 1 g, 1 hour before surgery, and 5 and 12 hours later. Postoperative infectious morbidity was evaluated according to febrile morbidity, the need for antibiotic therapy during the postoperative period and the length of postoperative hospitalization. The incidence and severity of febrile morbidity was significantly reduced in the three groups of patients who received prophylaxis. The use of antibiotics in the postoperative period resulted significantly reduced and the period of hospitalization was shorter for the groups with prophylaxis than for the control group.