NCT06824688

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 2a Non-randomized Controlled Study Based on the IDEAL Framework

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Rectal Cancer Patients
• Robotic Surgical Procedures

Interventions

Type	Name	Description
PROCEDURE	Single-port robotic total mesorectal excision	Single-port robotic total mesorectal excision
PROCEDURE	Multi-port robotic total mesorectal excision	Multi-port robotic total mesorectal excision

Timeline

• Start date: 2024-10-23
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-02-13
• Last updated: 2025-09-19

Locations

1 site across 1 country: China