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Early Catheter Removal After Colorectal Surgery

N/A
Recruiting
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
American Society of Anesthesiologists (ASA) class I-III
Elective procedures involving total mesorectal excision, including low anterior resection and abdominoperineal resection for rectal cancer as well as proctectomy for inflammatory bowel disease
Must not have
History of urinary retention after previous procedure, surgery, or urinary catheter removal
Patients requiring prolonged duration or replacement of urinary catheter in the postoperative period for reasons other than urinary retention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if removing the urinary catheter shortly after colorectal surgery is as safe as removing it later. It targets patients who have had TME surgery to see if early removal can prevent urine buildup without increasing complications. The goal is to reduce infections and shorten hospital stays.

Who is the study for?
Adults over 18 undergoing elective colorectal surgery for rectal cancer or inflammatory bowel disease, who can sign consent. It's open to all surgical approaches and includes those with prior chemo/radiation treatments. Excludes emergency surgeries, combined major procedures, previous urinary issues like retention or injuries during surgery.
What is being tested?
The study is testing if removing the urinary catheter on day 1 after colorectal surgery is as safe as the standard practice of removal on day 3. The goal is to see if early removal reduces urinary infections and hospital stays without increasing the risk of urine retention.
What are the potential side effects?
Potential side effects include an increased risk of postoperative urinary retention when the catheter is removed earlier than usual, and possible urinary tract infections associated with prolonged catheter use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My health is good to moderate, as rated by an anesthesiologist.
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I am scheduled for or have had surgery for rectal cancer or inflammatory bowel disease.
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I am 18 years old or older.
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I have had chemotherapy or radiation before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had trouble urinating after a past surgery or catheter removal.
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I need a long-term urinary catheter after surgery for reasons other than not being able to urinate.
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I am having surgery soon due to an emergency.
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I have had surgery to remove my bladder or create a new urine passage.
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I am having a major rectal surgery along with other big surgeries on the same day.
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I have had issues with not being able to empty my bladder fully but am not currently receiving treatment for it.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Urinary catheter removal on postoperative day 1Experimental Treatment1 Intervention
Group II: Urinary catheter removal on postoperative day 3Active Control1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
In colorectal surgery, urinary catheterization is used to prevent urinary retention by draining urine from the bladder. However, prolonged catheterization can increase the risk of urinary tract infections (UTIs). The timing of catheter removal is critical to balance these risks. Shorter catheterization durations (e.g., 1 day) aim to reduce infection risk while still preventing retention, whereas standard durations (e.g., 3 days) may be used to ensure complete bladder emptying. This balance is essential for optimizing postoperative recovery and minimizing complications in colorectal surgery patients.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
941 Previous Clinical Trials
1,603,993 Total Patients Enrolled

Media Library

Urinary catheter removal on postoperative day 1 Clinical Trial Eligibility Overview. Trial Name: NCT04359069 — N/A
Colorectal Surgery Research Study Groups: Urinary catheter removal on postoperative day 3, Urinary catheter removal on postoperative day 1
Colorectal Surgery Clinical Trial 2023: Urinary catheter removal on postoperative day 1 Highlights & Side Effects. Trial Name: NCT04359069 — N/A
Urinary catheter removal on postoperative day 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT04359069 — N/A
~4 spots leftby Dec 2024