Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection

Study Overview
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Brief Summary
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The primary aim of this study is to compare the rate of acute urinary retention (AUR) after immediate compared to early (24-hours) removal of urinary catheter (UC) in patients undergoing minimally invasive colorectal resection. The study hypothesis is that immediate UC removal is non-inferior to 24-hours UC removal in terms of AUR rate. The secondary outcomes focus on goals that could be positively impacted by the immediate removal of the UC at the end of the surgery. In particular, the rate of urinary tract infections, perception of pain, time-to-return of bowel and physical functions, postoperative complications and postoperative length of stay will all be measured.

Official Title
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Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection: Study Protocol for a Randomized, Multicenter, Non-inferiority Trial

Conditions
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Surgical Complication, Colonic Disease, Postoperative Complications, Urinary Retention Postoperative, Urinary Tract Infections

Intervention / Treatment
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* Device: Immediate urinary catheter removal
* Device: Early urinary catheter removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 years and 80 years old Patients scheduled to undergo minimally invasive resection of the colon under general anesthesia Willingness to participate Compliance to study purpose Written informed consent Exclusion Criteria: Need for an anastomosis below the anterior peritoneal reflection Need for a major resection other than colorectal Need for post-operative intensive care monitoring or intensive care unit (ICU) stay Anesthesia time longer than 300 minutes Presence of chronic indwelling UC Presence of an entero-vesical fistula Need for ureteral stent placement, bladder resection or repair A previous and unsolved history of AUR or overt voiding dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, controlled, two-arm, multi-center trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate UC removal<br>Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room. | Device: Immediate urinary catheter removal<br>* Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.<br>|
| Active Comparator: Early UC removal<br>Urinary catheter removal on first postoperative day (6 a.m.) as per standard protocol | Device: Early urinary catheter removal<br>* urinary catheter removal on the first postoperative day (6 a.m)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute urinary retention rate | Occurrence of urinary retention after removal of urinary catheter | 3 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary tract infections | Occurrence of urinary tract infections | 30 days postoperatively | 
| UC reinsertion | need for urinary catheter reinsertion after first removal | 30 days postoperatively | 
| Pain scores | Numeric Rating Scores (NRS) for abdominal pain (0-10) | 6,12,24,48 and 72 hours after surgery | 
| Bowel function | Time for return of bowel function as for flatus and stools postoperatively | 10 days postoperatively | 
| Mobilization | Return to passive and active mobilization postoperatively | 10 days postoperatively | 
| Morbility | Postoperative morbility according to the Clavien-Dindo classification | first 30 days after surgery | 
| Length of hospital stay | postoperative stay | 30 days postoperatively |