1. Preclinical Evaluation of the Versius Surgical System, a New Robot-assisted Surgical Device for Use in Minimal Access Renal and Prostate Surgery
- Author
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Thomas, BC, Slack, M, Hussain, M, Barber, N, Pradhan, A, Dinneen, E, Stewart, GD, Thomas, BC, Slack, M, Hussain, M, Barber, N, Pradhan, A, Dinneen, E, and Stewart, GD
- Abstract
BACKGROUND: Minimal access surgery (MAS) is well-established in urological surgery. However, MAS is technically demanding and associated with a prolonged learning curve. Robot-assisted laparoscopy has made progress in overcoming these challenges. OBJECTIVE: The aim of this study was to evaluate the feasibility of a new robot-assisted surgical system (the Versius Surgical System; CMR Surgical, Cambridge, UK) for renal and prostate procedures in a preclinical setting, at the IDEAL-D phase 0. DESIGN, SETTING, AND PARTICIPANTS: Cadaveric sessions were conducted to evaluate the ability of the system to complete all surgical steps required for a radical nephrectomy, prostatectomy, and pelvic lymph node dissection. A live animal (porcine) model was also used to assess the surgical device in performing radical nephrectomy safely and effectively. Procedures were performed by experienced renal and prostate surgeons, supported by a full operating room team. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Surgical access and reach were evaluated by the lead surgeon using a visual analogue scale. The precise surgical steps conducted to make the assessment that the procedures could be completed fully were recorded, as well as instruments used (including manual laparoscopic instruments) and endoscope angle. RESULTS AND LIMITATIONS: In total, all 24 procedures were completed successfully in cadavers by eight different lead surgeons. Positioning of the ports and bedside units reflected the lead surgeon's preferred laparoscopic set-up and enabled good surgical access and reach, as quantified by a median visual analogue score of ≥6.5. Radical nephrectomies performed in pigs were all completed successfully, with no device- or non-device-related intraoperative complications recorded. Testing in human cadavers and pig models balances the bias introduced by each model; however, it is impossible to completely replicate the experience and performance of the robot for surgery in live humans.
- Published
- 2021