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Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair

Primary Purpose

Colovesical Fistula

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery
Sponsored by
Karim Alavi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colovesical Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UMass Memorial Medical Center Memorial CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Foley catheter removal day 2 or 3 post-operative procedure

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 16, 2021
Last Updated
May 24, 2023
Sponsor
Karim Alavi
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1. Study Identification

Unique Protocol Identification Number
NCT05235204
Brief Title
Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair
Official Title
Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karim Alavi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colovesical Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Foley catheter removal day 2 or 3 post-operative procedure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of positive urine leak on post-operative day 3 cystogram
Description
Participants cystograms will be reviewed to detect positive urine leak, 2 to 3 days post surgery.
Time Frame
up to 3 days post surgery
Secondary Outcome Measure Information:
Title
Foley catheter re-insertion
Description
Participants who will require re-insertion of the foley catheter once it is removed on post-operative day 3
Time Frame
up to 5 days post-surgery
Title
Re-operations within 30 days of initial surgery
Description
Patients who have required return to the OR within 30 days after discharge.
Time Frame
up to 30 days post discharge
Title
Hospital re-admission
Description
Patients who have required readmission to the hospital within 30 days after discharge.
Time Frame
up to 30 days post- discharge
Title
Symptomatic post-operative urinary tract infection
Description
Patients who have had a symptomatic urinary tract infection within 30 days after discharge.
Time Frame
up to days post discharge
Title
Post operative urinary sepsis
Description
Patients who have urinary sepsis either prior to discharge or within 30 days after discharge.
Time Frame
up to 30 days post discharge
Title
Recurrence of colovesical fistula
Description
Patients who had recurrence of their colovesical fistula within 30 days of discharge.
Time Frame
up to 30 days post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karim Alavi, MD, MPH
Phone
508-334-8195
Email
karim.alavi@umassmemorial.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KArin Alavi, MD, MPH
Organizational Affiliation
UMass Chan Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Memorial Medical Center Memorial Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Alavi, MD
Phone
508-334-1312
Email
karim.alavi@umassmemorial.org
First Name & Middle Initial & Last Name & Degree
Karen Berni-Giarusso, RN
Phone
5088561888
Email
karen.berni-giarusso@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Karim Alavi, MD

12. IPD Sharing Statement

Learn more about this trial

Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair

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