Single-port Versus Multi-port Robotic Surgery for Rectal Cancer

Efficacy and Safety Assessment of Single-port Versus Multi-port Robotic Surgery for Rectal Cancer: a Phase 2 Non-randomized Controlled Study Based on the IDEAL Framework

Single-port versus multi-port robotic surgery for rectal cancer

This study is a stage 2 clinical trial based on the IDEAL framework, which aims to evaluate the safety and short-term clinical efficacy of single-port robotic total mesorectal excision by comparing it with multi-port robotic total mesorectal excision. The primary endpoint is short-term clinical efficacy, including intraoperative complications, blood loss, conversion rate, operation time, postoperative complications within 30 days, time to first flatus after surgery, and postoperative hospital stay. Secondary endpoints include incision length, visual analog scale (VAS) scores for postoperative pain on days 1-3, completeness of mesorectal excision grading, positive circumferential resection margin rate, positive distal resection margin rate, and the number of harvested lymph nodes.

This study was conducted in two phases:

Phase I (Stage 2a): A single-arm study of single-port robotic radical resection for rectal cancer (n=20) Phase II (Stage 2b): A prospective non-randomized controlled study comparing single-port (n=100) versus multi-port (n=100) robotic radical resection for rectal cancer

Inclusion criteria comprised: (1) MRI-confirmed distal tumor margin <15 cm from the anal verge, (2) biopsy-proven adenocarcinoma, (3) clinical stage I-III (AJCC 8th edition) with potential downstaging post-neoadjuvant therapy, (4) intent-to-treat with sphincter preservation and primary anastomosis, (5) documented informed consent, and (6) adult patients (≥18 years).