Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cystogram Before Removal of Foley Catheter After Repair of Colovesical Fistula

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03525756
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
Mount Carmel Health System

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Colovesical Fistula

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cystogram for Early Foley Catheter Removal Post Colovesical Fistula Resection
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Successful Foley Catheter Removal at Day 2 [ Time Frame: 16 Hours After Foley Catheter Removal ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients meeting all inclusion and no exclusion criteria being cared for at Mount Carmel Health System
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525756


Contacts
Layout table for location contacts
Contact: Theresa Colbert, DNP 614-309-9325 tcolbert264@gmail.com
Contact: Lynn Shaffer, PhD 614-234-3625 Lynn.Shaffer@mchs.com

Locations
Layout table for location information
United States, Ohio
Mount Carmel Health System Recruiting
Columbus, Ohio, United States, 43213
Contact: Theresa Colbert, DNP    614-309-9325    tcolbert264@gmail.com   
Sponsors and Collaborators
Mount Carmel Health System
Investigators
Layout table for investigator information
Principal Investigator: Jaswant Madhavan, MD Mount Carmel Health System
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Mount Carmel Health System
ClinicalTrials.gov Identifier: NCT03525756    
Other Study ID Numbers: 171002-1
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mount Carmel Health System:
cystogram
Foley catheter
Additional relevant MeSH terms:
Layout table for MeSH terms
Intestinal Fistula
Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
 Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases