The Revo-i Robotic Surgical System in Advanced Pancreatic Surgery: A Second Non-Randomized Clinical Trial and Comparative Analysis to the da Vinci™ System

Abstract

Purpose: Numerous robot-assisted pancreatic surgery are being performed worldwide.This study aimed to evaluate the feasibility and safety of the Revo-i robot system (Meerecompany, Seoul, Republic of Korea) for advanced pancreatic surgery, and also compare this new system with the existing da Vinci TM robot system (Intuitive Surgical, Sunnyvale, CA, USA) in the context of robot-assisted pancreaticoduodenectomy (RPD). Materials and Methods:This study was a one-armed prospective clinical trial that assessed the Revo-i robot system for advanced pancreatic surgery.Ten patients aged 30 to 73 years were enrolled between December 2019 and August 2020.Postoperative outcomes were retrospectively compared with those of the da Vinci TM surgical system.From March 2017 to August 2020, a total of 47 patients who underwent RPD were analyzed retrospectively.Results: In the prospective clinical trial, pancreaticoduodenectomy was performed in nine patients and one patient underwent central pancreatectomy.Among the 10 study participants, the incidence of major complications was 0% in hospital stay.There were eight postoperative pancreatic fistula (POPF) biochemical leaks (80%).In the retrospective analysis that compared the Revo-i and da Vinci TM robotic systems, 10 patients underwent Revo-i RPD and 37 patients underwent da Vinci TM RPD, with no significant differences in complication or POPF incidence rates between the two groups (p=0.695, p=0.317). Conclusion:In this single-arm prospective study with short-term follow-up at a single institution, the Revo-i robotic surgical system was safe and effective for advanced pancreatic surgery.Revo-i RPD is comparable to the da Vinci TM RPD and is expected to have wide clinical application.