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

Army Medical University of People's Liberation Army

Status: Enrolling

Conditions: Rectal Cancer Patients; Robotic Surgical Procedures

Treatments: Procedure: Multi-port robotic total mesorectal excision; Procedure: Single-port robotic total mesorectal excision

Study type: Interventional

Funder types: Other

Identifiers

NCT06824688

SPORTS-02

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Single-port robotic total mesorectal excision

Experimental group

Description:

Single-port robotic total mesorectal excision

Treatment:

Procedure: Single-port robotic total mesorectal excision

Multi-port robotic total mesorectal excision

Active Comparator group

Description:

Multi-port robotic total mesorectal excision

Treatment:

Procedure: Multi-port robotic total mesorectal excision