Abstract
BACKGROUND: Robotic surgery has been a revolution for colon cancer (CC) patients, with the increasing availability of different competitive robotic systems, but evidence of relevant oncologic outcomes is indeed scarce. Our goal was to compare the surgical quality and short-term oncologic outcomes of the Kangduo Surgical Robotic System and the da Vinci Si Robotic System in patients with CC. METHODS: These are results from a subcohort of a multicenter randomized controlled noninferiority trial performed in three centers in China. Enrolled patients were randomly assigned to undergo surgery using either the KD-SR-01 system (KD group) or the da Vinci Si (DV) robotic system (DV group). Neither investigators nor patients were masked to treatment allocation, but assessment of pathological outcomes was masked to treatment allocation. The primary endpoint was surgical success rate. The secondary endpoints were surgical outcomes, pathologic outcomes, and postoperative outcomes. The study is registered at www.chictr.org.cn (ChiCTR2200063172). Although the long-term follow-up results were not a predefined endpoint for this study, late-stage work is in progress. RESULTS: A total of 58 CC patients were included in this study, 28 in the KD group and 30 in the DV group. All patients were successfully operated without any intermediate open/conventional laparoscopic surgery and the success rate of surgery was 100%. Assessment of equipment docking task load and intraoperative operating sensation score were similar between the two groups. Adverse events and Clavien-Dindo grade II or higher grade complication rates were comparable between the two groups. Device arm docking time, robotic arm operation time, and intraoperative bleeding were not significantly different between the two groups. Similar results were obtained from postoperative pathological outcomes and internal environment indexes. CONCLUSIONS: The efficacy and safety of the Kangduo Robotic Surgical System has been proved, operation of the Kangduo Robotic System by experienced surgeons for CC is not less effective than the da Vinci robotic System.