Duration of Urinary Catheterization

Recruiting now · Not applicable

Conditions studied: Colorectal Surgery

In brief

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 after pelvic colorectal surgery, and current practice is to continue urinary catheterization for 3- days following pelvic colorectal surgery in an effort to avoid this complication. However, prolonged urinary catheterization is associated with increased risk of urinary tract infections as well as longer hospital stays. The investigators hypothesize that postoperative urinary catheters may be safely removed on postoperative day 1 without increased urinary retention rates. The purpose of this study is to evaluate whether a shorter duration of urinary catheterization (1 day) is non-inferior when compared to standard duration (3 days) in regards to postoperative urinary retention. The investigators plan to perform a prospective, randomized, non-inferiority trial comparing the urinary catheter duration of 1 day and 3 days with the primary endpoint of postoperative urinary retention. Secondary endpoints are urinary tract infection and length of hospital stay. The participants will be randomly assigned to the control group (catheter removal on postoperative day 3) or the experimental group (catheter removal on postoperative day 1).

Key facts

Study ID

NCT04359069

Run by

University of Southern California

People needed

176

Starts

2020-10-01

Expected to finish

2029-01-01

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Keck Hospital of USC — Los Angeles, California, United States (enrolling)
• Los Angeles County Hospital (LAC/USC) — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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