Early removal of bladder catheter after surgery for colovesical fistula
Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair
This study is testing if taking out the bladder catheter just three days after surgery for a colovesical fistula is safe and leads to better recovery compared to keeping it in longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT05235204 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and outcomes of early removal of the bladder catheter on post-operative day 3 following surgical repair of diverticular colovesical fistula. Patients will undergo a cystogram to assess bladder leak, and outcomes such as 30-day readmissions and adverse events will be monitored. The results from this prospective cohort will be compared to historical data from a retrospective group that had later catheter removal. The goal is to determine if early catheter removal is a safe practice.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who are scheduled for surgical repair of diverticular colovesical fistula.
Not a fit: Patients with active genitourinary cancers, inflammatory bowel disease, or those not expected to regain normal bladder function will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced hospital stays and improved recovery times for patients undergoing colovesical fistula repair.
How similar studies have performed: While this specific approach is being evaluated, similar studies on catheter management post-surgery have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Worcester, Massachusetts
- UMass Memorial Medical Center Memorial Campus — Worcester, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: KArin Alavi, MD, MPH — UMass Chan Medical School
- Study coordinator: Karim Alavi, MD, MPH
- Email: karim.alavi@umassmemorial.org
- Phone: 508-334-8195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.