Effects of Uterine Manipulation on Surgical Outcomes in Laparoscopic Management of Endometrial Cancer: A Prospective Randomized Clinical Trial

Abstract

OBJECTIVE: This study aimed to evaluate the influence of intrauterine manipulation on the surgical outcome in patients with early-stage endometrial cancer treated with 2 different laparoscopic approaches. METHODS: In a randomized parallel trial, 110 patients with clinical stage I endometrial cancer were randomly assigned for laparoscopic staging surgery with (group A, 55) or without (group B, 55) the use of a uterine manipulator (RUMI), between June 2009 and June 2011. Two sets of peritoneal washings were obtained, 1 before and 1 after the insertion of the uterine manipulator. Primary end points were the rates of positive cytology and lymphovascular space invasion. RESULTS: No difference was detected in patient characteristics between the groups. Mean operative time, estimated blood loss, and postoperative complications were similar between the groups. Group A had a similar incidence of lymphovascular space invasion compared with group B (12.7% vs 9.1%, respectively; P = 0.761). Four patients (7.3%) in group A had positive peritoneal cytology in the initial washing. One of these patients was classified as stage IIIA. One patient in group B was positive in the second washing. The agreement rate between the 2 sets of washings for both groups was 98.2%. During the median follow-up of 19 months, 6 patients had tumor recurrence without significant difference between the groups. CONCLUSIONS: Despite concerns that the use of uterine manipulators may predispose the spread of early-stage disease, insertion of such uterine-manipulating systems did not increase rate of positive peritoneal cytology or lymphovascular space invasion in this study.