title: Randomized controlled trial comparing operative times between standard and robot-assisted laparoscopic hysterectomy.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Minimally Invasive GYN Surgery, Department of Obstetrics and Gynecology, Milton S Hershey Medical Center, Penn State University, Hershey, PA, USA.
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Deimling
authors.affiliation: Division of Minimally Invasive GYN Surgery, Department of Obstetrics and Gynecology, Milton S Hershey Medical Center, Penn State University, Hershey, PA, USA.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Eldridge
authors.affiliation: Division of Minimally Invasive GYN Surgery, Department of Obstetrics and Gynecology, Milton S Hershey Medical Center, Penn State University, Hershey, PA, USA.
authors.forename: Kristin A
authors.initials: KA
authors.lastname: Riley
authors.affiliation: Division of Biostatistics and Bioinformatics, Department of Public Health Sciences, Milton S Hershey Medical Center, Penn State University, Hershey, PA, USA.
authors.forename: Allen R
authors.initials: AR
authors.lastname: Kunselman
authors.affiliation: Division of Minimally Invasive GYN Surgery, Department of Obstetrics and Gynecology, Milton S Hershey Medical Center, Penn State University, Hershey, PA, USA.
authors.forename: Gerald J
authors.initials: GJ
authors.lastname: Harkins
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000379:methods*; D010535:Laparoscopy / Q000379:methods*; D016015:Logistic Models; D008875:Middle Aged; D061646:Operative Time; D010414:Pennsylvania; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D065287:Robotic Surgical Procedures / Q000379:methods*
keywords: Hysterectomy; Laparoscopic; Minimally invasive; Operative time; Robotic-assisted