• Dhananjay S Kelkar, Utkrant Kurlekar, Lewis Stevens, Gajanan D Wagholikar, and Mark Slack.
• Deenanath Mangeshkar Hospital and Research Center, Pune, Maharashtra, India.
• Ann. Surg. 2023 Jan 1; 277 (1): 9179-17.

ObjectiveThe aim of this study was to demonstrate the ability of the Versius Surgical System to successfully and safely complete cholecystectomy.BackgroundThe system has been developed in-line with surgeon feedback to overcome limitations of conventional laparoscopy to enhance surgeon experience and patient outcomes. Here we present results from the cholecystectomy cohort from a completed early clinical trial, which was designed to broadly align with Stage 2b of the Idea, Development, Exploration, Assessment, Long-term follow-up framework for surgical innovation.MethodsProcedures were performed between March 2019 and September 2020 by surgical teams consisting of a lead surgeon and operating room (OR) assistants. Male or female patients aged 18 years and over and requiring cholecystectomy were enrolled. The primary endpoint was the rate of unplanned conversion from robot-assisted surgery to conventional laparoscopic or open surgery. Adverse events (AEs) and serious AEs were adjudicated by video review of the surgery and patient study reports by an independent Clinical Expert Committee.ResultsOverall, 134/143 (93.7%) cholecystectomies were successfully completed using the device. Of the 9 (6.3%) conversions to another surgical modality, 7 were deemed to be related to the device. A total of 6 serious AEs and 3 AEs occurred in 8 patients (5.6%), resulting in 4 (2.8%) readmissions to hospital within 30 days of surgery and 1 death.ConclusionsThis study demonstrates cholecystectomy performed using the device is as safe and effective as conventional laparoscopy and supports the implementation of the device on a wider scale, pending instrument modifications, in alignment with Idea, Development, Exploration, Assessment, Long-term follow-up Stage 3 (Assessment).Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

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