Effects of uterine manipulation on surgical outcomes in laparoscopic management of endometrial cancer: a prospective randomized clinical trial.

Lee, Maria; Kim, Young Tae; Kim, Sang Wun; Kim, Sunghoon; Kim, Jae Hoon; Nam, Eun Ji

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.