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Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

NCT06633133 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2024-10-16

No results posted yet for this study

Summary

The goal of this clinical trial is to learn to compare the safety and efficacy of virtual ileostomy versus diverting ileostomy in patients undergoing sphincter-saving surgery for rectal cancer. The main questions it aims to answer are:

* Is the virtual ileostomy a safe and effective alternative to the ileostomy?
* Is it scientifically reasonable to perform diverting ileostomy intraoperatively? Researchers will compare virtual ileostomy to diverting ileostomy to see if the virtual ileostomy works to reduce rates of stoma.

Participants will:

* Performing diverting ileostomy or virtual ileostomy undergoing sphincter-saving surgery for rectal cancer
* Continuous follow-up of their complications after the first surgery

Conditions

Interventions

PROCEDURE

Virtual ileostomy

A pre-stage ileostomy, anchored under the abdominal wall by a vascular sling or rubber tape through the mesenteric window, is delivered to the outside of the abdomen, where the VI is pulled through the abdominal wall.

Sponsors & Collaborators

  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    lead OTHER

Principal Investigators

  • fan li · Daping Hospital, Third Military Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2026-12-01
Completion
2030-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06633133 on ClinicalTrials.gov