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Randomized controlled trial comparing operative times between standard and robot‐assisted laparoscopic hysterectomy
Author(s) -
Deimling Timothy A.,
Eldridge Jennifer L.,
Riley Kristin A.,
Kunselman Allen R.,
Harkins Gerald J.
Publication year - 2017
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1002/ijgo.12001
Subject(s) - medicine , interquartile range , laparoscopic hysterectomy , randomized controlled trial , hysterectomy , laparoscopy , confidence interval , surgery , laparoscopic surgery
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