Randomized controlled trial of laparoscopic approach to carcinoma of the endometrium (LACE): Prevalence and risk factors for surgical complications.

Abstract

Objective: The Laparoscopic Approach to Cancer of the Endometrium (LACE) randomized trial aims to establish the equivalence of laparoscopic and open surgery (laparotomy) for early-stage endometrial cancer. Seven hundred sixty patients with clinical stage I endometrioid adenocarcinoma of the endometrium, ECOG status 0 or 1, were enrolled between 2005 and 2010. To date, 685 patients completed at least six months of follow-up; 319 were randomly allocated to total abdominal hysterectomy (TAH) and 366 to total laparoscopic hysterectomy (TLH). Three hundred seventy-three patients (49.4%) received pelvic and/or aortic lymph node dissection. Descriptive statistics were used to establish frequency of treatment crossovers (conversions). Serious adverse events or adverse events of grade 3+ were regarded as surgical complications (SCs), and X2 tests were used to examine differences in proportions. Variables that showed significant association with SCs were entered into a multivariate stepwise logistic regression to determine independent predictors of SCs. Result(s): Overall, 26 conversions (3.8%) were recorded, five from TAH to TLH because of patient decision after randomization, and 21 from TLH to TAH (13 for anatomical reasons: Sox needed an abdominal incision to remove the uterus, two for technical reasons, and six due to intraoperative complications). Overall, 112 patients (17%) developed at least one SC (TAH: 64/319, 20.1%; TLH: 48/366, 13.1%; P=0.014). Factors predictive of SCs were TAH (OR=2.1, 95% CI=1.3-3.3), history of myocardial infarction, congestive heart failure, general or systemic conditions, ECOG performance status of 1 and elevated alkaline phosphatase levels (shown in the table). Lymph node dissection was not associated with a greater risk of SCs. Conclusion(s): Within the LACE trial few conversions were observed, and of those, very few were due to surgical complications or anatomical restrictions. Patients receiving TAH experience twice as many SCs as patients who have a TLH. The surgical approach is the only potentially modifiable risk factor for the development of SCs in endometrial cancer surgery. (Table presented).