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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-23

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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

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Rectal Cancer Patients Robotic Surgical Procedures

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single-port robotic total mesorectal excision

Group Type EXPERIMENTAL

Single-port robotic total mesorectal excision

Intervention Type PROCEDURE

Single-port robotic total mesorectal excision

Multi-port robotic total mesorectal excision

Group Type ACTIVE_COMPARATOR

Multi-port robotic total mesorectal excision

Intervention Type PROCEDURE

Multi-port robotic total mesorectal excision

Interventions

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Single-port robotic total mesorectal excision

Intervention Type PROCEDURE

Multi-port robotic total mesorectal excision

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No