The TransEnterix European Patient Registry for Robotic-Assisted Laparoscopic Procedures in Urology, Abdominal, Thoracic, and Gynecologic Surgery (“TRUST”)

Abstract

Introduction: Robotic surgery was first introduced in the mid-1980s, and at the end of the '90s, the da Vinci® System (Intuitive Surgical Inc., Sunnyvale, California) was introduced in Europe and held a monopoly for years afterward. In 2016, Senhance™ digital laparoscopic platform (Asensus Surgical, Durham, North Carolina) came to the market. This new platform is based on laparoscopic movements and is designed for laparoscopic surgeons. This study shows the surgical outcomes of patients after different visceral, colorectal, gynecological, and urological surgical procedures done with the Senhance™ digital laparoscopic platform with a focus on safety. Materials and Methods: The study population consists of 871 patients who underwent robotic surgery with the Senhance™ platform. The most common procedures were hernia repairs (unilateral and bilateral), cholecystectomies, and prostatectomies. The procedures were performed in five centers in Europe between February 2017 and July 2020 by experienced laparoscopic surgeons. Results: 220 (25.3 %) out of 871 patients had a unilateral hernia repair, 70 (8.0%) a bilateral hernia repair, 159 (18.3%) underwent a cholecystectomy, and 168 (19.3%) a prostatectomy. The other procedures included visceral, colorectal, and gynecological surgery procedures. The median docking time was 7.46 minutes for the four most common procedures. The duration of surgery varied from 32 to 313 minutes, the average time was 114.31 minutes. Adverse events were rare overall. There were 48 (5.5 %) adverse events out of 871 patients, 24 of them (2.8 % of all cases) were severe. Out of all 24 severe adverse events, five events (20.8%) were likely related to the robot, 17 events (70.8%) were unlikely related to the robot, and two events (8.3%) could not be categorized. Regarding complications following unilateral hernia repairs, data from 212 patients was available. Thirteen (6.1%) complications occurred, and six of those (2.8%) were serious. Out of 68 patients with a bilateral hernia repair, six patients (8.8%) developed complications, three of which were severe (4.4%). The complication rate was 2.8% in the patients following a cholecystectomy (4/144); two of them serious. After prostatectomy, six out of 141 patients (4.3 %) had complications; one serious (0.7%) No mortality was observed. Data about unplanned conversions to laparoscopic surgery could be collected from 761 patients which is a rate of 3.7%. There were 12 conversions out of 760 procedures to open surgery (1.6%). Conclusions: Our series shows these procedures are safe and reproducible. The findings suggest that the surgical results after robotic surgery with the Senhance™ system are promising. Long-term data regarding complication rates should be the subject of future studies.