Optimal Duration of Urinary Catheterization After Right-Sided Colectomy
Optimal Duration of Urinary Catheterization After Right-Sided Colectomy: Prospective, Randomized, Non-inferiority Trial
The goal of this prospective, randomized trial is to determine the optimal duration of urinary catheterization in patients that receive elective, right-sided colectomy. The main objectives of this study are:
- To compare rates of urinary retention in patients with post operative urinary catheter duration of 0 days and 1 day following right-sided colectomy.
- To compare rates of urinary tract infection (UTI) in patients with postoperative urinary catheter duration of 0 days and 1 day following right-sided colectomy.
Enrolled participants will be randomized to one of two groups, immediate removal of urinary catheter at the conclusion of the operation or removal of urinary catheter on post operative day one.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Urinary catheterization is indicated for various operations conducted by colorectal surgeons. This process allows a tube to be inserted into the bladder to provide decompression while the patient is anesthetized. Prolonged urinary catheter placement is associated with urinary retention, urinary tract infections, and increased hospital length of stay. Clinical guidelines recommend urinary catheter discontinuation within 24 hours of operation but there is mixed evidence to support this recommendation. Further, there is a paucity of data that investigates optimal urinary catheter duration in specific colorectal surgery operations.
This prospective, randomized clinical trial aims to identify the optimal urinary catheter duration for patients undergoing elective, right-sided colectomy. Patients will be randomized into two groups: 1) urinary catheter discontinuation at the completion of surgery, or 2) urinary catheter discontinuation on post operative day 1. The primary objective is to compare rates of urinary retention between groups. The investigators hypothesize that patients with immediate urinary catheter discontinuation will have reduced rates of urinary retention and urinary tract infections compared to the group with urinary catheters maintained until post operative day 1.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sacha Broccard, MD
- Phone Number: 201-675-8256
- Email: Sacha.Broccard@med.usc.edu
Study Locations
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-
California
-
Los Angeles, California, United States, 90033
- Keck Medical Center of USC
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Contact:
- Annabah Glasser, MD
- Phone Number: 201-675-3256
- Email: Annabah.Glasser@med.usc.edu
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Los Angeles, California, United States, 90033
- Los Angeles General Medical Center
-
Contact:
- Annabah Glasser, MD
- Phone Number: 201-675-8256
- Email: Annabah.Glasser@med.usc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 years or older.
- Scheduled for elective ileocecectomy, right hemicolectomy, or extended right hemicolectomy using an open, laparoscopic, or robotic approach.
- American Society of Anesthesiologists physical status class I-III.
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- History of urinary tract malignancy.
- Emergent or urgent surgery.
- Right hemicolectomy performed with another major surgical procedure on the same day.
- Genitourinary tract injury during surgery that precludes participation.
- History of urinary retention following a previous procedure, surgery, or urinary catheter removal.
- History of urinary retention that is not being actively treated.
- Neurogenic bladder.
- Chronic indwelling Foley catheter or suprapubic catheter.
- History of cystectomy or a surgically created urinary conduit, including a neobladder or ileal conduit.
- Chronic kidney disease greater than stage 2.
- History of chronic urinary tract infection.
- Current extravesicular or enterourethral fistula.
- Perioperative epidural catheter placement.
- Incarceration.
- Inability or unwillingness to provide informed consent.
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Catheter Removal
Participants will undergo urinary catheter removal immediately after completion of surgery, in the operating room on post operative day 0. |
Removal of the urinary catheter immediately after elective right hemicolectomy before leaving the operating room.
Other Names:
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|
Active Comparator: Postoperative Day 1 Catheter Removal
Participants will undergo urinary catheter removal on post operative day 1. |
Removal of the intra-operatively placed Foley urinary catheter on the day after elective right-sided colectomy, post-operative day one.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants With Post Operative Urinary Retention
Time Frame: From initial post operative urinary catheter removal through hospital discharge, assessed up to 90 days.
|
Post operative urinary retention will be identified by inability to void within 8 hours after catheter removal, associated suprapubic fullness and/or tenderness, and a bladder scan volume greater than 300 mL; or by spontaneous voiding with urinary symptoms and a post-void residual volume greater than 300 mL. Symptoms include suprapubic pain or fullness, bladder pressure, incomplete emptying, or straining. |
From initial post operative urinary catheter removal through hospital discharge, assessed up to 90 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants With Urinary Tract Infection
Time Frame: From post operative day one through hospital discharge, assessed up to 90 days.
|
Urinary tract infection will be identified by clinical signs or symptoms such as suprapubic pain or tenderness, dysuria, hematuria, or urinary frequency, together with a urine culture showing more than 100,000 colony-forming units/mL of bacteria. Urinalysis and urine culture will be obtained only when infection is clinically suspected. |
From post operative day one through hospital discharge, assessed up to 90 days.
|
|
Postoperative Hospital Length of Stay
Time Frame: From post operative day one through hospital discharge, assessed up to 90 days.
|
Number of inpatient hospital days from the day of surgery to the day of discharge. |
From post operative day one through hospital discharge, assessed up to 90 days.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-25-00655
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Consent does not permit sharing; will revisit
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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