Optimal duration of urinary drainage after rectal resection: a randomized controlled trial.
S Benoist, Y Panis, C Denet...
https://pubmed.ncbi.nlm.nih.gov/10026745Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04359069
Optimal Duration of Urinary Catheterization After Total Mesorectal Excision A Prospective Randomized Trial Comparing Catheter Removal on Postoperative Day 1 Versus Day 3
Led by University of Southern California · Updated on 2026-02-05
176
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the optimal duration of urinary catheter use after pelvic colorectal surgery, specifically total mesorectal excision (TME). This study aims to compare whether removing the catheter on the first day after surgery is as safe as the current standard of removing it on the third day. The goal is to reduce complications like urinary retention, urinary tract infections, and longer hospital stays, while improving recovery. This is a prospective, randomized, non-inferiority trial conducted by the University of Southern California. Participants undergoing TME will be randomly assigned to two groups: one with catheter removal on postoperative day 1 (experimental group) and the other with removal on day 3 (control group). Catheter removal is scheduled at 9 AM on the assigned days. The study involves standard care during and after surgery, including intravenous fluids and monitoring. The main comparison focuses on urinary retention rates, while secondary measures include urinary tract infections and hospital stay length. During the hospital stay, researchers will monitor urinary retention by checking if patients can urinate within 6 hours after catheter removal and using bladder scans if needed. Urinary tract infections will be diagnosed based on symptoms and urine cultures, treated as standard. Data on patient demographics, surgery details, and outcomes will be collected until discharge, which marks the study endpoint. The average hospital stay is about 4 days, and no follow-up is required after discharge.
CONDITIONS
Brief Title
Duration of Urinary Catheterization
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Elective total mesorectal excision procedures, including low anterior resection, abdominoperineal resection for rectal cancer, and proctectomy for inflammatory bowel disease
- All surgical approaches included: open, laparoscopic, and robotic
- Patients who received neoadjuvant chemotherapy and/or radiation
- Age 18 years or older
- American Society of Anesthesiologists (ASA) class I to III
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Emergent or urgent surgery
- Total mesorectal excision combined with other major surgeries on the same day
- Genitourinary tract injury during surgery
- History of urinary retention after previous procedures or catheter removal
- Untreated history of urinary retention
- Need for prolonged or replacement urinary catheter for reasons other than urinary retention
- History of neurogenic bladder
- Chronic indwelling Foley or suprapubic catheter
- History of cystectomy or surgically created urinary conduit
- Patients under 18 years old
- Vulnerable patients unable or unwilling to provide informed consent, including incarcerated individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (perioperative)
Surgery and Immediate Post-operative Care
Duration - Day of surgery to postoperative day 1 or 3 (depending on group assignment)
Participants undergo total mesorectal excision surgery and receive urinary catheterization during and after surgery as part of standard care.
Hospital stay with daily monitoring
Treatment
Duration - Up to 3 days post-surgery until catheter removal and monitoring
Participants have their urinary catheter removed either on postoperative day 1 (experimental group) or postoperative day 3 (control group). They are monitored for urinary retention and urinary tract infections.
Hospital stay with daily assessments
Post-operative Follow-up
Duration - Until hospital discharge (average 4 days post-surgery)
Participants are observed in the hospital until discharge to monitor for urinary retention, urinary tract infections, and length of hospital stay.
Daily hospital visits and assessments until discharge
Trial Site Locations
Total: 2 locations
1
Keck Hospital of USC
Los Angeles, California, United States, 90033
Actively Recruiting
2
Los Angeles County Hospital (LAC/USC)
Los Angeles, California, United States, 90033
Actively Recruiting
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Research Team
S
Sarah Koller, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Early Removal of the Urinary Catheter After Total or Tumor-Specific Mesorectal Excision for Rectal Cancer Is Safe.
Byung Eun Yoo, Bong Hyeon Kye, Hyung Jin Kim...
https://pubmed.ncbi.nlm.nih.gov/26200683Early Urinary Catheter Removal Following Pelvic Colorectal Surgery: A Prospective, Randomized, Noninferiority Trial.
Devin N Patel, Seth I Felder, Michael Luu...
https://pubmed.ncbi.nlm.nih.gov/30192326Early removal of urinary catheters after rectal surgery is associated with increased urinary retention.
Mary R Kwaan, Janet T Lee, David A Rothenberger...
https://pubmed.ncbi.nlm.nih.gov/25751796Predictors of postoperative urinary retention after colorectal surgery.
Cindy Kin, Kim F Rhoads, Moe Jalali...
https://pubmed.ncbi.nlm.nih.gov/23652748How to do random allocation (randomization).
Jeehyoung Kim, Wonshik Shin
https://pubmed.ncbi.nlm.nih.gov/24605197Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.
Daniel Dindo, Nicolas Demartines, Pierre-Alain Clavien
https://pubmed.ncbi.nlm.nih.gov/15273542