Robot-assisted radical resection of colorectal cancer using the KangDuo surgical robot versus the da Vinci Xi robotic system: short-term outcomes of a multicentre randomised controlled noninferiority trial.

Abstract

The KangDuo surgical robot (KD-SR-01) was recently developed in China. This study aims to evaluate the short-term outcomes of KD-SR-01 for colorectal cancer surgery. This is a multicentre randomised controlled noninferiority trial conducted in three centers in China. Enrolled patients were randomly assigned at a 1:1 ratio to receive surgery using the KD-SR-01 system (KD group) or the da Vinci Xi (DV) robotic system (DV group). The primary endpoint was the success rate of operation. The second endpoints were surgical outcomes, pathological outcomes, and postoperative outcomes. Between July 2022 and May 2023. A total of 100 patients were included in the trial and randomly assigned to the KD group (50 patients) and the DV group (50 patients). All cases were completed successfully without conversion to laparoscopic surgery. The time to flatus and the incidence of postoperative complications of Clavien-Dindo grade II or higher grade were comparable between the two groups. Surgeons reported a high level of comfort with the KD-SR-01 system. In the subgroup analysis of different operative procedures, there were no significant differences in docking time, console time, blood loss, and the length of the incision for extraction between the two groups. There were no differences in pathological outcomes including maximum tumor diameter, circumferential resection margin, distal resection margin, and number of harvested lymph nodes. The KD-SR-01 system was a viable option for colorectal cancer robotic surgery, with acceptable short-term outcomes comparable to the da Vinci Xi robotic system.