This study evaluated the safety and efficacy of the newly developed Revo-i (Meerecompany, Yongin, Republic of Korea) robotic surgical system during robot-assisted cholecystectomy. This prospective, phase I clinical study involved 15 patients with gallbladder-related disease. The primary outcome evaluated was the intraoperative safety of the Revo-i; the secondary outcomes measured were the 30-day postoperative complications and patient satisfaction with the Revo-i's performance. Between August 17 and December 23, 2016, we performed 15 robot-assisted cholecystectomies. The operations were successfully completed, without any conversions to open or laparoscopic approaches. The mean patient age (53.07 years), mean operative time (115.3 ± 17.31 min [± standard deviation]), docking time (10.6 ± 3.16 min), console time (49.7 ± 15.41 min), actual dissection time (33.1 ± 10.53 min), and estimated blood loss (3.33 ± 6.17 mL) were determined. There were no intra- or postoperative complications, including gallbladder perforations. The mean hospital stay was 2.0 ± 1.00 days. Most patients reported satisfaction with the Revo-i's performance. Performing robot-assisted cholecystectomies using the Revo-i is feasible and safe. This report describes the first clinical study of the Revo-i robotic surgical system in human patients.
Keywords: Cholecystectomy; Revo-i; Robot; da Vinci.