Colovesical Fistula
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURERemoval of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery
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.
Sponsors
Karim Alavi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 and over * Undergoing surgical repair of diverticular colovesical fistula
Exclusion criteria
* Patients with active and untreated genitourinary cancers * Subjects with known or suspected Inflammatory Bowel Disease as the cause of colovesical fistula. * Individuals who are not expected to regain normal bladder function after surgery as defined by either pre-existing bladder dysfunction with chronic indwelling urinary catheter, supra-pubic catheter, or surgical urinary diversion * Individuals who require re-operation prior to Foley removal * Adults unable to consent * Pregnant women * Prisoners * Individuals who are not yet adults (infants, children, teenagers less than 18 years old)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of positive urine leak on post-operative day 3 cystogram | up to 3 days post surgery | Participants cystograms will be reviewed to detect positive urine leak, 2 to 3 days post surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Foley catheter re-insertion | up to 5 days post-surgery | Participants who will require re-insertion of the foley catheter once it is removed on post-operative day 3 |
| Re-operations within 30 days of initial surgery | up to 30 days post discharge | Patients who have required return to the OR within 30 days after discharge. |
| Hospital re-admission | up to 30 days post- discharge | Patients who have required readmission to the hospital within 30 days after discharge. |
| Symptomatic post-operative urinary tract infection | up to days post discharge | Patients who have had a symptomatic urinary tract infection within 30 days after discharge. |
| Post operative urinary sepsis | up to 30 days post discharge | Patients who have urinary sepsis either prior to discharge or within 30 days after discharge. |
| Recurrence of colovesical fistula | up to 30 days post-discharge | Patients who had recurrence of their colovesical fistula within 30 days of discharge. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKArin Alavi, MD, MPH
UMass Chan Medical School
Outcome results
None listed