Duration of Urinary Catheterization

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT04359069
Status
Recruiting
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Conditions

  • Colorectal Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Urinary catheter removal on postoperative day 1 — OTHER
    Urinary catheter will be removed on day 1 (experimental) instead of day 3 (standard of care).
  • Urinary catheter removal on postoperative day 3 — OTHER
    Urinary catheter will be removed on day 3 (standard of care)

Study Details

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 Dates

Start date
Oct 1, 2020
Status verified
Feb 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Urinary catheter removal on postoperative day 1
  • Active Comparator: Urinary catheter removal on postoperative day 3

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

Locations (2)

FacilityCityStateZIPSite coordinators
Keck Hospital of USCLos AngelesCalifornia90033
Sarah Koller, MD
[email protected]
302-249-6118
Jordan Wlodarczk, MD (SUB_INVESTIGATOR)
Sarah Koller, MD (PRINCIPAL_INVESTIGATOR)
Los Angeles County Hospital (LAC/USC)Los AngelesCalifornia90033
Sarah Koller, MD
[email protected]
302-249-6118
Jordan Wlodarczk, MD (SUB_INVESTIGATOR)
Sarah Koller, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Keck Hospital of USC· Los Angeles, CALos Angeles County Hospital (LAC/USC)· Los Angeles, CA

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