Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT06633133
Status:
RECRUITING
Last Update Posted:
2024-10-16
First Post:
2024-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision
Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
* 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: