Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair

Colovesical Fistula Clinical Trial

Official title:

Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235204
• Other study ID #: H00016345
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2019
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: University of Massachusetts, Worcester
• Contact: Karim Alavi, MD, MPH
• Phone: 508-334-8195
• Email: karim.alavi[@]umassmemorial.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colovesical Fistula
• Fistula
• Intestinal Fistula

Intervention

Procedure:
• Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair 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.

Locations

Country	Name	City	State
United States	UMass Memorial Medical Center Memorial Campus	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Karim Alavi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 3 days post surgery
Secondary	Foley catheter re-insertion	Participants who will require re-insertion of the foley catheter once it is removed on post-operative day 3	up to 5 days post-surgery
Secondary	Re-operations within 30 days of initial surgery	Patients who have required return to the OR within 30 days after discharge.	up to 30 days post discharge
Secondary	Hospital re-admission	Patients who have required readmission to the hospital within 30 days after discharge.	up to 30 days post- discharge
Secondary	Symptomatic post-operative urinary tract infection	Patients who have had a symptomatic urinary tract infection within 30 days after discharge.	up to days post discharge
Secondary	Post operative urinary sepsis	Patients who have urinary sepsis either prior to discharge or within 30 days after discharge.	up to 30 days post discharge
Secondary	Recurrence of colovesical fistula	Patients who had recurrence of their colovesical fistula within 30 days of discharge.	up to 30 days post-discharge