Colovesical FistulaNCT05235204
Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair
A study testing Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery in people with Colovesical Fistula, run by Karim Alavi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colovesical Fistula
- What is being tested?
- Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2019to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 and over
- Undergoing surgical repair of diverticular colovesical fistula
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Memorial Medical Center Memorial Campus
Worcester, Massachusetts, 01605
About this study
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.
Read the 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.
- Conditions
- Colovesical Fistula
- Being tested
- Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery
- Medical subject headings
- Intestinal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 days post surgery
Secondary outcomes (6)
Foley catheter re-insertion
Participants who will require re-insertion of the foley catheter once it is removed on post-operative day 3
Measured: 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.
Measured: up to 30 days post discharge
Hospital re-admission
Patients who have required readmission to the hospital within 30 days after discharge.
Measured: 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.
Measured: up to days post discharge
Post operative urinary sepsis
Patients who have urinary sepsis either prior to discharge or within 30 days after discharge.
Measured: up to 30 days post discharge
Recurrence of colovesical fistula
Patients who had recurrence of their colovesical fistula within 30 days of discharge.
Measured: up to 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start13 Mar 2019
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colovesical FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karim Alavi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karim Alavi, University of Massachusetts, Worcester
- Investigators
- KArin Alavi, MD, MPH, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235204
- Sponsor's protocol ID
- H00016345
- Status last verified
- Jun 2025
- First submitted
- 16 Dec 2021
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair
- ClinicalTrials.gov ID
- NCT05235204
- Acronym / sponsor ID
- H00016345
- Conditions
- Colovesical Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Karim AlaviUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foley catheter removal day 2 or 3 post-operative procedure | Experimental | Procedure: Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgeryAccording 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 and over
- Undergoing surgical repair of diverticular colovesical fistula
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgeryAccording 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 or surgery | Foley catheter removal day 2 or 3 post-operative procedure |
Primary outcome
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.
6 secondary outcomes
Foley catheter re-insertion
Time frame: up to 5 days post-surgery
Re-operations within 30 days of initial surgery
Time frame: up to 30 days post discharge
Hospital re-admission
Time frame: up to 30 days post- discharge
Symptomatic post-operative urinary tract infection
Time frame: up to days post discharge
Post operative urinary sepsis
Time frame: up to 30 days post discharge
Recurrence of colovesical fistula
Time frame: up to 30 days post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KArin Alavi, MD, MPH principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery in people with Colovesical Fistula, run by Karim Alavi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of positive urine leak on post-operative day 3 cystogram (time frame: up to 3 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.