A prospective randomized comparative trial of da Vinci SP versus da Vinci Xi in colon and rectosigmoid cancer surgery: a single-center, open-label study protocol.

BACKGROUND: Colorectal cancer surgery increasingly emphasizes not only oncological outcomes but also postoperative recovery and patient-centered outcomes. Robotic-assisted surgery has gained widespread acceptance, and the da Vinci Single-Port (SP) system has emerged as a novel platform that may further reduce surgical invasiveness compared with the conventional multi-port da Vinci Xi system. However, current evidence comparing these platforms in colon cancer surgery remains limited to retrospective studies. METHODS: This study is a single-center, open-label, prospective randomized controlled trial designed to compare the da Vinci SP and Xi systems inpatients undergoing curative robot-assisted surgery for clinical stage 0-III colon or rectosigmoid adenocarcinoma. A total of 200 patients will be randomly assigned in a 1:1 ratio to the SP or Xi group. The primary endpoint is postoperative pain assessed using the Numerical Rating Scale on postoperative days 1 and 3. Secondary endpoints include operative variables, postoperative complications, inflammatory markers, pathological outcomes, and patient satisfaction. CONCLUSIONS: This trial is expected to provide prospective evidence on the clinical value of the SP platform and to support evidence-based decision-making in robotic colon cancer surgery. The trial has been registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR: R000065814). TRIAL REGISTRATION: UMIN-CTR R000065814 (2025/4/13) Saitama Medical University International Medical Center.