First prospective comparison between Versius and DaVinci Xi for robotic radical prostatectomy: focus on operative room setup, surgical timing, troubleshooting, and surgeon satisfaction (COMPAR-P Trial)

摘要

BACKGROUND: The Versius system has emerged as a competitor of DaVinci in robot-assisted prostatectomy (RARP). Our study aimed to perform a head-to-head comparison of the two platforms, focusing on operative room setup, duration of surgical steps, troubleshooting, and surgeon's satisfaction. METHODS: The COMPAR-P Trial (Comparison of Outcomes of Multiple Platforms for Assisted Robotic surgery-Prostate) is a prospective post-market study (clinicaltrials.org NCT05766163). Patient enrollment commenced in March 2023, assigning individuals to either DaVinci or Versius for RARP without predefined selection criteria, for a total of up to 50 consecutive cases. The procedures were performed by two experienced surgeons employing the same technique. The evaluation centered on timing, learning curves, equipment malfunctions, complications, and user satisfaction. The cumulative summation analysis assessed the learning curve with Versius. RESULTS: Fifty patients each were enrolled for DaVinci and Versius RARP. Baseline features were balanced. DaVinci demonstrated significantly shorter durations for both "set-up" (37 vs. 59.5 minutes) and "console" (97 vs. 152 minutes) phases (P<0.001), with most steps being quicker. The longitudinal analysis showed "console" time reductions but not "set-up" with Versius. Learning curve analysis revealed a breakpoint after 30 procedures. Malfunctions were more frequent with Versius (38 vs. 4). DaVinci had higher satisfaction. Blood loss and complications were similar between groups. The study focused on experienced DaVinci users transitioning to Versius, limiting applicability to robotic-naïve centers. CONCLUSIONS: Versius used to perform RARP showed more malfunctions and longer operative times, but outcomes were like those of DaVinci, with trends of improvement supporting its adoption.