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NCT03525756 · ClinicalTrials.gov registry record
Cystogram Before Removal of Foley Catheter After Repair of Colovesical Fistula
A clinical trial, sponsored by Mount Carmel Health System.
- Completed
- Registry status
- 24
- Enrollment target
NCT03525756: Completed study, sponsored by Mount Carmel Health System.
NCT03525756 is a clinical trial that has completed, run by Mount Carmel Health System. The registered enrollment target is 24 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03525756 has completed, sponsored by Mount Carmel Health System.
- COMPLETED
- Registry status
- 24 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2022-10-18 |
What the finished NCT03525756 record still lists
NCT03525756 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03525756 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03525756 about?
NCT03525756 is a clinical study titled "Cystogram Before Removal of Foley Catheter After Repair of Colovesical Fistula". 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 morbi...
What is the current status of trial NCT03525756?
This trial is currently completed. The enrollment target is 24 participants. The study started on 2017-12-01. Estimated completion is 2022-10-18.
Who is sponsoring clinical trial NCT03525756?
This trial is sponsored by Mount Carmel Health System, which has 8 total clinical trials registered on ClinicalTrials.gov.
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