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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post-discharge
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am an adult having surgery for a specific bowel-bladder connection.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Presence of positive urine leak on post-operative day 3 cystogram
Secondary outcome measures
Foley catheter re-insertion
Hospital re-admission
Post operative urinary sepsis
+3 moreTrial 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.
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Who is running the clinical trial?
Karim AlaviLead Sponsor
KArin Alavi, MD, MPHPrincipal InvestigatorUMass Chan Medical School
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I won't regain normal bladder function after surgery due to existing bladder issues.I need another surgery before my catheter can be removed.I am an adult having surgery for a specific bowel-bladder connection.I have an active and untreated cancer in my urinary or reproductive organs.I am unable to give consent for myself.My colovesical fistula is due to inflammatory bowel disease.
Research Study Groups:
This trial has the following groups:- Group 1: Foley catheter removal day 2 or 3 post-operative procedure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have enrolled in this research endeavor?
"Affirmative. The information available on clinicaltrials.gov attests to this trial's active recruitment process, having first been published on March 13th 2019 and most recently amended on June 7th 2022. It is currently seeking 48 participants from a single site for its study cohort."
Answered by AI
Are there presently any opportunities for patients to participate in this research?
"Evidenced by the information hosted on clinicaltrials.gov, this research is currently enrolling individuals. It was initially published on March 13th 2019 and its most recent update occurred June 7th 2022."
Answered by AI
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