← Back to Search

Early Catheter Removal for Colovesical Fistula

N/A

Recruiting

Led By KArin Alavi, MD, MPH

Research Sponsored by Karim Alavi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults aged 18 and over undergoing surgical repair of diverticular colovesical fistula

Be older than 18 years old

Must not have

Individuals who are not yet adults (infants, children, teenagers less than 18 years old)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days post-discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it is safe to remove a patients' bladder catheter on the third day after surgery to repair a colovesical fistula.

Who is the study for?

This trial is for adults over 18 who are having surgery to fix a diverticular colovesical fistula, which is an abnormal connection between the colon and bladder. It's not for those with bowel inflammation diseases, untreated genital cancers, pregnant women, prisoners, minors or anyone unable to consent.

What is being tested?

The study tests if removing the Foley catheter (a tube inserted into the bladder) early—2 to 3 days after surgery—is safe compared to later removal. Outcomes will be measured against past data from patients who had their catheters removed later.

What are the potential side effects?

Potential side effects may include discomfort or pain where the catheter was placed, possible urinary tract infections from earlier removal of the catheter, and risks associated with cystograms like radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult having surgery for a specific bowel-bladder connection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Select...

I won't regain normal bladder function after surgery due to existing bladder issues.

Select...

I need another surgery before my catheter can be removed.

Select...

I have an active and untreated cancer in my urinary or reproductive organs.

Select...

I am unable to give consent for myself.

Select...

My colovesical fistula is due to inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to days post discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to days post discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to days post discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Foley catheter re-insertion

Hospital re-admission

Post operative urinary sepsis

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Foley catheter removal day 2 or 3 post-operative procedureExperimental Treatment1 Intervention

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.

0 / 7Eligibility criteria met