Randomized controlled trial comparing operative times between standard and robot‐assisted laparoscopic hysterectomy

摘要

OBJECTIVE: To compare the operative time between robot-assisted laparoscopic hysterectomies and standard laparoscopic hysterectomies. METHODS: A prospective, randomized controlled trial enrolled women aged 18-80 years attending Penn State Hershey Medical Center between April 23 and October 20, 2014 to undergo hysterectomy. Participants were randomized using a random number generator to undergo either robot-assisted or standard laparoscopic hysterectomy. The primary outcome was the total operative time (surgeon incision to surgeon stop, including robot docking time, if applicable). Intention-to-treat analyses were performed and the operative time was compared between the two treatments for non-inferiority, defined as a difference in operative time of no longer than 15 minutes. RESULTS: There were 72 patients randomized to each treatment arm. The mean operative time was 73.9 minutes (median 67.0 minutes; interquartile range 59.0-83.0 minutes) in the robot-assisted hysterectomy group and 74.9 minutes (median 65.5 minutes; interquartile range 57.0-90.5 minutes) in the standard laparoscopic hysterectomy group. The upper bound of the 95% confidence interval of the difference in operative time was 6.6 minutes, below the 15-minute measure of non-inferiority. CONCLUSION: When performed by a surgeon experienced in both techniques, the operative time for robot-assisted laparoscopic hysterectomy was non-inferior to that achieved with standard laparoscopic hysterectomy. CLINICALTRIALS.GOV: NCT02118974.