Randomized controlled trial comparing operative times between standard and robot-assisted laparoscopic hysterectomy
Timothy A Deimling, Jennifer L Eldridge, Kristin A Riley, Allen R Kunselman, Gerald J Harkins, Timothy A Deimling, Jennifer L Eldridge, Kristin A Riley, Allen R Kunselman, Gerald J Harkins
Abstract
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.
Keywords: Hysterectomy; Laparoscopic; Minimally invasive; Operative time; Robotic-assisted.
Conflict of interest statement
G.J.H. was a proctor for Ethicon and Intuitive Surgical during the study period. A.R.K. owns stock in Merck. The authors have no other conflicts of interest.
© 2016 International Federation of Gynecology and Obstetrics.
Figures
Source: PubMed