NCT06633133

Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

Comparing the Safety and Efficacy of Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: a Multicentre, Prospective, Open-label, Blinded Endpoint, PROBE Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 620 (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

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

Detailed description

This study is a national multicenter, large-sample, randomized controlled study

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-10
• Primary completion: 2026-12-01
• Completion: 2030-10-01
• First posted: 2024-10-09
• Last updated: 2024-10-16

Locations

1 site across 1 country: China