Recruiting

Observational Study

Sponsor:

University of Southern California

Code:

NCT04359069

Conditions

Colorectal Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Urinary catheter removal on postoperative day 1

Urinary catheter removal on postoperative day 3

Study Details

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 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).

Conditions

Colorectal Surgery

Study ID

NCT04359069

Start date

Oct 1, 2020

Status verified date

Feb, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Urinary catheter removal on postoperative day 1

active comparator: Urinary catheter removal on postoperative day 3

Interventions

Urinary catheter removal on postoperative day 1

Urinary catheter will be removed on day 1 (experimental) instead of day 3 (standard of care).

Urinary catheter removal on postoperative day 3

Urinary catheter will be removed on day 3 (standard of care)

Primary outcome measure

  • Rate of urinary retention [ Time Frame: From time of surgery to time of discharge from the hospital, an average of 4 days ]

Central Contacts and Locations

Central contacts

Sarah Koller, MD

(323) 865-3690sarah.koller@med.usc.edu

Locations

Keck Hospital of USC

Recruiting

Los Angeles, California, United States, 90033

Contacts

Sarah Koller, MD

302-249-6118Sarah.koller@med.usc.edu

Principal Investigator:

Sarah Koller, MD

Los Angeles County Hospital (LAC/USC)

Recruiting

Los Angeles, California, United States, 90033

Contacts

Sarah Koller, MD

302-249-6118Sarah.koller@med.usc.edu

Principal Investigator:

Sarah Koller, MD

More Information

Sponsor

University of Southern California

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-02-05.