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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03525756
Other study ID # 171002-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date October 18, 2022

Study information

Verified date October 2023
Source Mount Carmel Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Colovesical fistulas are well-recognized but relatively uncommon pathology to both the general and colorectal surgeon. It is a complication arising from an underlying primary acute to chronic inflammatory process. Although colovesical fistulas are uncommon, they are associated with significant morbidity, affect quality of life, and may lead to death, usually secondary to urosepsis. Early diagnosis and management is essential. The purpose of the study is to determine the objective use of cystographic evaluation on postoperative day two to guide early Foley catheter removal post colovesical fistula takedown. The hypothesis is that a cystogram showing no extravasation of contrast on postoperative day two will predict safe removal without increased morbidity. This is an uncontrolled, single arm trial. Patients who meet criteria to undergo either minimally invasive or open colovesical fistula takedown with sigmoid colectomy, without evidence of the need for bladder repair will be eligible to participate. An indwelling Foley catheter is placed intraoperative and continued postoperative. All patients who consent to participate would undergo a cystogram on postoperative day two. The cystogram will be conducted by a radiologist and technician well-trained in the techniques and interpretation of the study. The colorectal surgery enhanced recovery protocol will be followed on all patients with the exception of the cystogram being conducted on post-op day two. If there is no evidence of extravasation of dye is seen on the cystogram the Foley catheter will be removed. Patients will be monitored closely following catheter removal to ensure self-diuresis.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 18, 2022
Est. primary completion date October 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - adult patients with clinical, radiographic, or endoscopic confirmation of a colovesical fistula - patients undergoing either minimally invasive or open colovesical fistula takedown with sigmoid colectomy, without evidence of the need for bladder repair Exclusion Criteria: - malignant disease - Crohn's disease - radiation-induced colovesical fistula - current pregnancy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mount Carmel Health System Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Mount Carmel Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successful Foley Catheter Removal at Day 2 Defined as no evidence of extravasation of dye is seen on the cystogram on day two, followed by successful self diuresis within 16 hours of Foley catheter removal. 16 Hours After Foley Catheter Removal
See also
  Status Clinical Trial Phase
Recruiting NCT05235204 - Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair N/A