Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650085
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PROtective IleoStomy Versus ProtectivE Colostomy in Anterior Rectal ResectIon - a Multicenter Open-label Randomized ConTrolled StudY PROSPERITY
Status:
NOT_YET_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:
PROSPERITY
Brief Summary:
Loop ileostomy and loop colostomy are both used as protective stomas after anterior resection There is a lack of evidence on the superiority of loop ileostomy versus loop colostomy This is a multicenter open-label superiority individually randomized controlled trial including patients undergoing anterior rectal resection with primary anastomosis and a protective stoma Patients scheduled for anterior rectal resection are randomized 11 to loop ileostomy or loop colostomy intraoperatively Primary outcome is cumulative stoma-related adverse events within 60 days post-primary surgery scored using Comprehensive Complication Index CCI
Detailed Description:
None
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