Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633133
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision
Sponsor:
None
Organization:
None
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:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None