When investigators from the Penn State Milton S. Hershey Medical Center randomly allocated 144 women to robot-assisted or standard laparoscopic hysterectomy (n = 72 in each arm) and recorded complications for 12 weeks, they found no significant differences between groups in estimated blood loss.1 In addition, mean operative times (surgeon incision to surgeon stop, including docking in the robot-assisted group) were similar (73.9 min for robot-assisted surgery vs 74.9 min for standard laparoscopy), as were complication rates. In this trial, operative time was the primary outcome.
Pain was assessed at 2 postoperative hours and was found to be similar between groups.
Two intraoperative complications occurred in the robot-assisted group, compared with none for standard laparoscopy (P = .50). Six postoperative complications occurred in the robot-assisted group, compared with 9 in the standard laparoscopy group (P = 0.58).
Complications included: a need for reoperation/readmission (2 patients in each group; P = 1.00), infection (1 patient in each group; P = 1.00), hemorrhage/transfusion (4 in the standard laparoscopy group; P = 0.12), and vaginal cuff dehiscence (2 in the robot-assisted group vs 1 for standard laparoscopy; P = 1.00).
Investigators concluded that robot-assisted hysterectomy is “noninferior” to standard laparoscopy with regard to operative time when it is performed by experienced minimally invasive surgeons.
Gerald J. Harkins, MD, an author and primary surgeon of the trial, notes that it is the first randomized comparison involving surgeons with expertise in both robot-assisted and standard laparoscopic hysterectomy. As such, its findings represent Level I evidence. Dr. Harkins had completed more than 600 robot-assisted cases prior to initiation of the trial.
Cost was not analyzed in this study, the abstract of which won the Jay M. Cooper Award as the best paper on minimally invasive gynecology by a fellow and was presented on November 17 at the AAGL annual meeting in Las Vegas.