The following is the summary of “An Early Prospective Clinical Study to Evaluate the Safety and Performance of the Versius Surgical System in Robot-Assisted Cholecystectomy” published in the January 2023 issue of Surgery by Kelkar, et al.
This research aimed to prove that cholecystectomy could be performed with the Versius Surgical System with minimal risk to the patient. With input from surgeons, the technology was designed to improve upon the shortcomings of traditional laparoscopy, making the procedure more comfortable for the surgeon and yielding better results for the patient. This paper reports findings from a completed early clinical trial of cholecystectomy, which was planned to closely parallel Stage 2b of the Idea, Development, Exploration, Assessment, Long-term Follow-up framework for surgical innovation.
Between March 2019 and September 2020, procedures were carried out by surgical teams composed of a chief surgeon and OR helpers. Men and women who needed a cholecystectomy and were at least 18 years old were included. The major outcome measure was the frequency with which robot-assisted procedures were unexpectedly changed to laparoscopic or open procedures. A third-party Clinical Expert Committee used video recordings of surgeries and patient studies to make decisions about reports of adverse events (AEs) and significant AEs. In conclusion, 134 out of 143 (or 93.7% of total) cholecystectomies were accomplished without incident. About 7 of the 9 (6.3% of the total) conversions to an alternative surgical modality were determined to be device-related.
About 8 patients (5.6%) experienced adverse events, including six significant AEs and three AEs, leading to 4 readmissions (2.8% of patients) within 30 days following surgery and one death. The results of this study show that the device allows for cholecystectomy to be performed with the same level of safety and effectiveness as traditional laparoscopy, and they lend support to the device’s widespread use (subject to necessary modifications to the instruments used), which is in keeping with the third stage of the invention process (idea, development, exploration, assessment, and long-term follow-up) (Assessment).