Duration of Urinary Catheterization
Optimal Duration of Urinary Catheterization After Total Mesorectal Excision
1 other identifier
interventional
176
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
February 5, 2026
February 1, 2026
7.3 years
April 20, 2020
February 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of urinary retention
From time of surgery to time of discharge from the hospital, an average of 4 days
Secondary Outcomes (2)
Rate of urinary tract infection
From time of surgery to time of discharge from the hospital, an average of 4 days
Length of hospital stay
From time of surgery to time of discharge from the hospital, an average of 4 days
Study Arms (2)
Urinary catheter removal on postoperative day 1
EXPERIMENTALUrinary catheter removal on postoperative day 3
ACTIVE COMPARATORInterventions
Urinary catheter will be removed on day 1 (experimental) instead of day 3 (standard of care).
Urinary catheter will be removed on day 3 (standard of care)
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Keck Hospital of USC
Los Angeles, California, 90033, United States
Los Angeles County Hospital (LAC/USC)
Los Angeles, California, 90033, United States
Related Publications (7)
Benoist S, Panis Y, Denet C, Mauvais F, Mariani P, Valleur P. Optimal duration of urinary drainage after rectal resection: a randomized controlled trial. Surgery. 1999 Feb;125(2):135-41.
PMID: 10026745BACKGROUNDYoo BE, Kye BH, Kim HJ, Kim G, Kim JG, Cho HM. Early Removal of the Urinary Catheter After Total or Tumor-Specific Mesorectal Excision for Rectal Cancer Is Safe. Dis Colon Rectum. 2015 Jul;58(7):686-91. doi: 10.1097/DCR.0000000000000386.
PMID: 26200683BACKGROUNDPatel DN, Felder SI, Luu M, Daskivich TJ, N Zaghiyan K, Fleshner P. Early Urinary Catheter Removal Following Pelvic Colorectal Surgery: A Prospective, Randomized, Noninferiority Trial. Dis Colon Rectum. 2018 Oct;61(10):1180-1186. doi: 10.1097/DCR.0000000000001206.
PMID: 30192326BACKGROUNDKwaan MR, Lee JT, Rothenberger DA, Melton GB, Madoff RD. Early removal of urinary catheters after rectal surgery is associated with increased urinary retention. Dis Colon Rectum. 2015 Apr;58(4):401-5. doi: 10.1097/DCR.0000000000000317.
PMID: 25751796BACKGROUNDKin C, Rhoads KF, Jalali M, Shelton AA, Welton ML. Predictors of postoperative urinary retention after colorectal surgery. Dis Colon Rectum. 2013 Jun;56(6):738-46. doi: 10.1097/DCR.0b013e318280aad5.
PMID: 23652748BACKGROUNDKim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14.
PMID: 24605197BACKGROUNDDindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PMID: 15273542BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Surgery
Study Record Dates
First Submitted
April 20, 2020
First Posted
April 24, 2020
Study Start
October 1, 2020
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2029
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share