Cystogram Before Removal of Foley Catheter After Repair of Colovesical Fistula

NCT03525756 | Completed

• 1 other identifier: 171002-1
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colovesical Fistula

Keywords

cystogram; Foley catheter

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cystogram on Post-Op Day 2

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients meeting all inclusion and no exclusion criteria being cared for at Mount Carmel Health System

You may qualify if:

• 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

You may not qualify if:

• malignant disease
• Crohn's disease
• radiation-induced colovesical fistula
• current pregnancy

Sponsors & Collaborators

• Mount Carmel Health System: lead

Study Sites (1)

Mount Carmel Health System

Columbus, Ohio, 43213, United States

Location

MeSH Terms

Conditions

Intestinal Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaswant Madhavan, MD

  Mount Carmel Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 16, 2018
• Study Start: December 1, 2017
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

US (1)