Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center Memorial Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karim Alavi
• Investigators: Principal Investigator: KArin Alavi, MD, MPH, UMass Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Actual): January 31, 2026
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Signs and Symptoms; Intestinal Fistula
• Other Study ID Numbers: H00016345

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No