Length of urinary catheter use after colorectal (pelvic) surgery
Optimal Duration of Urinary Catheterization After Total Mesorectal Excision
This trial tests whether removing the urinary catheter on postoperative day 1 instead of day 3 is safe for adults having total mesorectal excision for rectal disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT04359069 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, non-inferiority trial comparing urinary catheter removal on postoperative day 1 versus day 3 after elective total mesorectal excision (including low anterior resection, abdominoperineal resection, and proctectomy for IBD). Adult patients (≥18 years, ASA I-III) undergoing open, laparoscopic, or robotic approaches are randomized to early or standard catheter removal and monitored for postoperative urinary retention, urinary tract infections, and length of hospital stay. The trial excludes emergent surgeries, concurrent major procedures, genitourinary injuries, and patients with prior urinary retention, and follows patients through the immediate postoperative period to capture catheter-related outcomes. The goal is to determine if a shorter catheter duration avoids additional retention while reducing catheter-associated complications.
Who should consider this trial
Good fit: Adults (≥18 years) undergoing elective total mesorectal excision (low anterior resection, abdominoperineal resection, or proctectomy for IBD) of ASA class I–III, including those who had neoadjuvant therapy, are ideal candidates.
Not a fit: Patients having urgent/emergent surgery, combined major procedures, intraoperative genitourinary injury, or a history of postoperative urinary retention are excluded and unlikely to benefit from the protocol tested.
Why it matters
Potential benefit: If successful, earlier catheter removal could lower urinary tract infections and shorten hospital stays without increasing urinary retention.
How similar studies have performed: Prior research has been mixed: an older randomized trial showed higher retention with early removal, but recent retrospective data and a newer randomized non-inferiority trial using oral alpha-antagonists found early removal non-inferior with fewer UTIs and shorter stays.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Los Angeles, California and 1 other locations
- Keck Hospital of USC — Los Angeles, California, United States (Recruiting)
- Los Angeles County Hospital (LAC/USC) — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Sarah Koller, MD
- Email: sarah.koller@med.usc.edu
- Phone: (323) 865-3690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.