Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair

Not Applicable

Recruiting

• Conditions: Colovesical Fistula
• Interventions: Procedure: Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery

• Registration Number: NCT05235204
• Lead Sponsor: Karim Alavi

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 Timeline

• Study Start: 2019-03-13
• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-11
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-26
• Primary Completion: 2024-04
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Adults aged 18 and over
• Undergoing surgical repair of diverticular colovesical fistula

Exclusion Criteria

• Patients with active and untreated genitourinary cancers
• Subjects with known or suspected Inflammatory Bowel Disease as the cause of colovesical fistula.
• Individuals who are not expected to regain normal bladder function after surgery as defined by either pre-existing bladder dysfunction with chronic indwelling urinary catheter, supra-pubic catheter, or surgical urinary diversion
• Individuals who require re-operation prior to Foley removal
• Adults unable to consent
• Pregnant women
• Prisoners
• Individuals who are not yet adults (infants, children, teenagers less than 18 years old)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Foley catheter removal day 2 or 3 post-operative procedure	Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery	According to review of internal clinical practices, the average duration of catheterization after Colovesical Fistula (CVF) repair is 10.8 days after CVF repair. The intervention in this study removes the Foley Catheter at 2 to 3 days post CVF repair.

Primary Outcome Measures

Name	Time	Method
Presence of positive urine leak on post-operative day 3 cystogram	up to 3 days post surgery	Participants cystograms will be reviewed to detect positive urine leak, 2 to 3 days post surgery.

Secondary Outcome Measures

Name	Time	Method
Foley catheter re-insertion	up to 5 days post-surgery	Participants who will require re-insertion of the foley catheter once it is removed on post-operative day 3
Hospital re-admission	up to 30 days post- discharge	Patients who have required readmission to the hospital within 30 days after discharge.
Re-operations within 30 days of initial surgery	up to 30 days post discharge	Patients who have required return to the OR within 30 days after discharge.
Symptomatic post-operative urinary tract infection	up to days post discharge	Patients who have had a symptomatic urinary tract infection within 30 days after discharge.
Post operative urinary sepsis	up to 30 days post discharge	Patients who have urinary sepsis either prior to discharge or within 30 days after discharge.
Recurrence of colovesical fistula	up to 30 days post-discharge	Patients who had recurrence of their colovesical fistula within 30 days of discharge.

Trial Locations

Locations (1)

UMass Memorial Medical Center Memorial Campus; 🇺🇸 Worcester, Massachusetts, United States