Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair

Conditions
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Colovesical Fistula

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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foley catheter removal day 2 or 3 post-operative procedure<br>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. | Procedure: Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of positive urine leak on post-operative day 3 cystogram | Participants cystograms will be reviewed to detect positive urine leak, 2 to 3 days post surgery. | up to 3 days post surgery | 

Secondary Outcome Measures

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