Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair

Karim Alavi

Status: Enrolling

Conditions: Colovesical Fistula

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05235204

H00016345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Foley catheter removal day 2 or 3 post-operative procedure

Experimental group

Description:

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.

Treatment:

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