Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-29 @ 1:42 AM
Study NCT ID:
NCT05235204
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2021-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair
Sponsor:
Karim Alavi
Organization:
Study Overview
Official Title:
Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair
Status:
RECRUITING
Status Verified Date:
2025-06
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:
Patients undergoing surgical repair of colovesical fistula will have have "early" (post-operative day 3) cystogram and removal of bladder catheter. Outcomes from the "early" group will be compared to historical "late" group data to determine if early bladder catheter removal is safe.
Detailed Description:
There is defined time for foley/bladder catheter removal after colovesical fistula repair in the current surgical literature. This study will be a prospective cohort study evaluating outcomes after early foley catheter removal (on post-operative day 3), specifically bladder leak, 30-day readmissions and adverse events. This cohort will be compared to a retrospective "late" group, who had foley catheter removal later in their hospital course.
Study Oversight
Has Oversight DMC:
False
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?: