Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair

NCT ID: NCT05235204

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-13

Study Completion Date

2026-07-31

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.

Conditions

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Colovesical Fistula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Foley catheter removal day 2 or 3 post-operative procedure

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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karim Alavi

OTHER

Sponsor Role lead

Responsible Party

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Karim Alavi

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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KArin Alavi, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UMass Chan Medical School

Locations

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UMass Memorial Medical Center Memorial Campus

Worcester, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Karim Alavi, MD, MPH

Role: CONTACT

508-334-8195

Facility Contacts

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Karim Alavi, MD

Role: primary

508-334-1312

Karen Berni-Giarusso, RN

Role: backup

5088561888

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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H00016345

Identifier Type: -

Identifier Source: org_study_id

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