What side effects are associated with this type of intervention?

Common treatments for colorectal surgery, particularly involving urinary catheterization, can lead to several side effects. Prolonged use of urinary catheters is associated with an increased risk of urinary tract infections, urine leakage, and urethral strictures. Additionally, extended catheterization can result in longer hospital stays. These risks highlight the importance of balancing the duration of catheter use to minimize complications while effectively managing urinary retention.

What prior FDA approvals exist?

FDA approvals for treatments related to colorectal surgery often focus on managing postoperative complications and enhancing recovery. For instance, the use of tamsulosin, an alpha-blocker, has been studied to prevent acute voiding difficulty after rectal cancer surgery, although it did not show significant efficacy. Additionally, antibiotics are commonly used to prevent infections, and the timing of urinary catheter removal is critical to balance the risks of urinary retention and infection. While specific drugs for this purpose may not be highlighted, the general approach involves careful postoperative management to optimize patient outcomes.

What other types of research exist?

Promising novel alternatives for the timing of urinary catheter removal in colorectal surgery patients include removing the catheter on postoperative day 1 instead of the standard day 3. This approach aims to reduce the risk of urinary tract infections and shorten hospital stays without increasing urinary retention rates. Ongoing trials are evaluating the efficacy and safety of this earlier removal strategy.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

0 / 11Eligibility criteria met

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.