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.