Clinical trial NCT03525756: Cystogram Before Removal of Foley Catheter After Repair of Colovesical Fistula
Official title: Cystogram for Early Foley Catheter Removal Post Colovesical Fistula Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colovesical Fistula
Keywords: cystogram
Foley catheter
Lead sponsor: Mount Carmel Health System
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients meeting all inclusion and no exclusion criteria being cared for at Mount Carmel Health System

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.


Eligibility criteria: 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

Primary outcomes:
measure: Successful Foley Catheter Removal at Day 2
timeFrame: 16 Hours After Foley Catheter Removal
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Mount Carmel Health System
state: Ohio
Study officials:
affiliation: Mount Carmel Health System
name: Jaswant Madhavan, MD
role: PRINCIPAL_INVESTIGATOR
References: