Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair

NCT05235204 | Completed

• 1 other identifier: H00016345
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Colovesical Fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Foley catheter re-insertion

  up to 5 days post-surgery

• Re-operations within 30 days of initial surgery

  up to 30 days post discharge

• Hospital re-admission

  up to 30 days post- discharge

• Symptomatic post-operative urinary tract infection

  up to days post discharge

• Post operative urinary sepsis

  up to 30 days post discharge

Study Arms (1)

Foley catheter removal day 2 or 3 post-operative procedure

EXPERIMENTAL

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

Interventions

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

Foley catheter removal day 2 or 3 post-operative procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karim Alavi: lead

Study Sites (1)

UMass Memorial Medical Center Memorial Campus

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Intestinal Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• KArin Alavi, MD, MPH

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: February 11, 2022
• Study Start: March 13, 2019
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2025-06

Locations

US (1)