Status:
UNKNOWN
Duration of Urinary Catheterization
Lead Sponsor:
University of Southern California
Conditions:
Colorectal Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is being conducted to determine the length of time a urinary catheter is needed to drain urine from the bladder after colorectal surgery. Urinary retention is a well known complication afte...
Detailed Description
Disease Background: Total mesorectal excision can be associated with transient post-operative urinary retention due to surgical disruption of pelvic autonomic nerves during procedure. These patients ...
Eligibility Criteria
Inclusion
- Elective procedures involving total mesorectal excision, including low anterior resection and abdominoperineal resection for rectal cancer as well as proctectomy for inflammatory bowel disease.
- All approaches (open, laparoscopic and robotic) will be included, as the approaches not differ in the total mesorectal excision technique.
- Patients who received neoadjuvant chemotherapy and/or radiation treatments will be included.
- Age ≥ 18 years.
- American Society of Anesthesiologists (ASA) class I-III.
- Ability to understand and the willingness to sign a written informed consent.
Exclusion
- Patients undergoing emergent or urgent surgery.
- Patients undergoing total mesorectal excision in combination with other major surgical procedures on the same day should be excluded from this study.
- Patients sustaining genitourinary tract injury during the procedure should be excluded postoperatively.
- History of urinary retention after previous procedure, surgery, or urinary catheter removal.
- History of urinary retention not being actively treated.
- Patients requiring prolonged duration or replacement of urinary catheter in the postoperative period for reasons other than urinary retention should be excluded.
- History of neurogenic bladder.
- Patients with chronic indwelling Foley catheterization or suprapubic catheterization.
- History of cystectomy and/or any surgically created urinary conduit, including neobladder and ileal conduit.
- Patients less than 18 years of age should be excluded from this study.
- Vulnerable patients including incarcerated patients or any patients unable or unwilling to provide informed consent will be excluded from this study.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04359069
Start Date
October 1 2020
End Date
December 1 2024
Last Update
May 12 2023
Active Locations (2)
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1
Keck Hospital of USC
Los Angeles, California, United States, 90033
2
Los Angeles County Hospital (LAC/USC)
Los Angeles, California, United States, 90033