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Completed

NCT Number: NCT05235204

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Memorial Medical Center Memorial Campus

Worcester, Massachusetts, 01605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Presence of positive urine leak on post-operative day 3 cystogram

    Time frame: up to 3 days post surgery

    Participants cystograms will be reviewed to detect positive urine leak, 2 to 3 days post surgery.

Secondary outcomes

  1. Foley catheter re-insertion

    Time frame: up to 5 days post-surgery

    Participants who will require re-insertion of the foley catheter once it is removed on post-operative day 3

  2. Re-operations within 30 days of initial surgery

    Time frame: up to 30 days post discharge

    Patients who have required return to the OR within 30 days after discharge.

  3. Hospital re-admission

    Time frame: up to 30 days post- discharge

    Patients who have required readmission to the hospital within 30 days after discharge.

  4. Symptomatic post-operative urinary tract infection

    Time frame: up to days post discharge

    Patients who have had a symptomatic urinary tract infection within 30 days after discharge.

  5. Post operative urinary sepsis

    Time frame: up to 30 days post discharge

    Patients who have urinary sepsis either prior to discharge or within 30 days after discharge.

  6. Recurrence of colovesical fistula

    Time frame: up to 30 days post-discharge

    Patients who had recurrence of their colovesical fistula within 30 days of discharge.

Sponsors and collaborators

Lead sponsor

Karim Alavi

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2022
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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