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Patients undergoing surgical repair of colovesical fistula will have have "early" (post-operative day 3) cystogram and removal of bladder catheter. Outcomes from the "early" group will be compared to historical "late" group data to determine if early bladder catheter removal is safe.
There is defined time for foley/bladder catheter removal after colovesical fistula repair in the current surgical literature. This study will be a prospective cohort study evaluating outcomes after early foley catheter removal (on post-operative day 3), specifically bladder leak, 30-day readmissions and adverse events. This cohort will be compared to a retrospective "late" group, who had foley catheter removal later in their hospital course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foley catheter removal day 2 or 3 post-operative procedure | Experimental | According to review of internal clinical practices, the average duration of catheterization after Colovesical Fistula (CVF) repair is 10.8 days after CVF repair. The intervention in this study removes the Foley Catheter at 2 to 3 days post CVF repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery | Procedure | According to review of internal clinical practices, the average duration of catheterization after Colovesical Fistula (CVF) repair is 10.8 days after CVF repair. The intervention in this study removes the Foley Catheter at 2 to 3 days post CVF repair. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of positive urine leak on post-operative day 3 cystogram | Participants cystograms will be reviewed to detect positive urine leak, 2 to 3 days post surgery. | up to 3 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Foley catheter re-insertion | Participants who will require re-insertion of the foley catheter once it is removed on post-operative day 3 | up to 5 days post-surgery |
| Re-operations within 30 days of initial surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KArin Alavi, MD, MPH | UMass Chan Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Memorial Medical Center Memorial Campus | Worcester | Massachusetts | 01605 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2022 | Jun 7, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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Patients who have required return to the OR within 30 days after discharge.
| up to 30 days post discharge |
| Hospital re-admission | Patients who have required readmission to the hospital within 30 days after discharge. | up to 30 days post- discharge |
| Symptomatic post-operative urinary tract infection | Patients who have had a symptomatic urinary tract infection within 30 days after discharge. | up to days post discharge |
| Post operative urinary sepsis | Patients who have urinary sepsis either prior to discharge or within 30 days after discharge. | up to 30 days post discharge |
| Recurrence of colovesical fistula | Patients who had recurrence of their colovesical fistula within 30 days of discharge. | up to 30 days post-discharge |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |