An observational study in Colovesical Fistula, sponsored by Mount Carmel Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Mount Carmel Health System · Observational
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.
18 studies on the registry are indexed under Intestinal Fistula; 2 are open to participants now.
Browse Intestinal Fistula studies →Mount Carmel Health System is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Patients meeting all inclusion and no exclusion criteria being cared for at Mount Carmel Health System
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Exclusion Criteria:
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.
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.
Time frame: 16 Hours After Foley Catheter Removal
Ran from Dec 2017 to primary completion in Oct 2022, 58 months.
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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