Implementation and clinical evaluation of the Versius Robotic System in a multispecialty setting: an IDEAL 2a/b study.

Abstract

Introduction: There has been a steady diffusion of robotic assisted surgery into practice in the United Kingdom. As robotic platforms enter the market, it is imperative that robust and standardised evaluations using recognised frameworks take place to ensure clinical efficacy and safety. The Versius robot (Cambridge Medical Robotics) gained CE mark in 2019 and is the first robotic platform developed in the UK with early reports of successful implementation into clinical practice.

Methods: An IDEAL 2a/2b study was designed assessing the development (2a) and exploration (2b) in a multispecialty CMR programme, consisting of colorectal, hepatobiliary and general surgery.  All patients undergoing robotic surgery between February 2020 and November 2023 were included. Key robotic outcomes were reported in keeping with the RoboCOS core outcome set. Innovation outcomes were reported in keeping with the COHESIVE core outcome set.

Results: Ninety-three patients were included in this evaluation. There were 55 (59%) colorectal, 9 (10%) general surgery and 29 (31%) hepatobiliary procedures, with anterior resection (n=27, 29%) and cholecystectomy (n=24, 26%) as the most common procedures. The overall morbidity was 9% (n=8). There were no intraoperative complications. Seven patients (8%) required a return to theatre, with the predominant complication being anastomotic leak (n= 6, 6%). No complications were directly attributed to the robotic platform. In total, 77 (83%) of procedures were completed robotically. There were no reports of device malfunction, however expected disadvantages were encountered related to available instrumentation. Surgeons favourably reported on improved visualisation aiding with pelvic dissections.

Discussion: This study demonstrates that Versius can be successfully implemented into a multispecialty setting. Clinical evaluations using recognised frameworks should be universally applied to develop best practice, highlighting benefits and disadvantages of innovations, and to enable better evaluation of robotic assisted surgery at patient, organisation and population level.