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
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of rectal cancer confirmed by pathology

• Age ≥ 18 years

• Total mesorectal excision (TME) surgical procedures and colon-rectum or colon-anal anastomosis:1.anterior resection (AR/ PME), 2. low anterior resection (LAR) , 3.intersphincteric abdominoperineal resection (ISR), 4.transanal total mesorectal excision (TaTME)

• Signed informed consent

• Ability to understand the nature and risks of participating in the trial

Locations
Other Locations
China
Daping Hospital, Third Military Medical University
RECRUITING
Chongqing
Contact Information
Primary
fan li, PhD
levinecq@163.com
18696539200
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2030-10-01
Participants
Target number of participants: 620
Treatments
Experimental: 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.
No_intervention: Diverting ileostomy
Diverting ileostomy (DI) is a common fecal diversion procedure performed in patients undergoing total mesorectal excision (TME) procedure for rectal cancer to protect the anastomosis and reduce the risk of complications.
Related Therapeutic Areas
Sponsors
Leads: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

This content was sourced from clinicaltrials.gov