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

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05249192
• Collaborator: Faenza Hospital (Other), Ravenna Hospital (Other), IRCCS Humanitas Research Hospital (Other), Humanitas University (Other), Universita di Verona (Other)
• Enrollment: 216
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.5
• Patients Per Site Per Month: 20.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Complication; Colonic Disease; Postoperative Complications; Urinary Retention Postoperative; Urinary Tract Infections	Device: Immediate urinary catheter removal; Device: Early urinary catheter removal	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 216 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: prospective, randomized, controlled, two-arm, multi-center trialprospective, randomized, controlled, two-arm, multi-center trial
• Masking: Double (Participant, Care Provider)
• Masking Description: patients and surgeons are blinded to group allocation until the end of surgical procedure
• Primary Purpose: Prevention
• Official Title: Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection: Study Protocol for a Randomized, Multicenter, Non-inferiority Trial
• Anticipated Study Start Date: Feb 15, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Acute urinary retention rate [3 days postoperatively]

   Occurrence of urinary retention after removal of urinary catheter

Secondary Outcome Measures

1. Urinary tract infections [30 days postoperatively]

   Occurrence of urinary tract infections

2. UC reinsertion [30 days postoperatively]

   need for urinary catheter reinsertion after first removal

3. Pain scores [6,12,24,48 and 72 hours after surgery]

   Numeric Rating Scores (NRS) for abdominal pain (0-10)

4. Bowel function [10 days postoperatively]

   Time for return of bowel function as for flatus and stools postoperatively

5. Mobilization [10 days postoperatively]

   Return to passive and active mobilization postoperatively

6. Morbility [first 30 days after surgery]

   Postoperative morbility according to the Clavien-Dindo classification

7. Length of hospital stay [30 days postoperatively]

   postoperative stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age between 18 years and 80 years old

2. Patients scheduled to undergo minimally invasive resection of the colon under general anesthesia

3. Willingness to participate

4. Compliance to study purpose

5. Written informed consent

Exclusion Criteria:

1. Need for an anastomosis below the anterior peritoneal reflection

2. Need for a major resection other than colorectal

3. Need for post-operative intensive care monitoring or intensive care unit (ICU) stay

4. Anesthesia time longer than 300 minutes

5. Presence of chronic indwelling UC

6. Presence of an entero-vesical fistula

7. Need for ureteral stent placement, bladder resection or repair

8. A previous and unsolved history of AUR or overt voiding dysfunction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of General and Hepatobiliary Surgery	Verona		Italy	37134

Sponsors and Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona
• Faenza Hospital
• Ravenna Hospital
• IRCCS Humanitas Research Hospital
• Humanitas University
• Universita di Verona

Investigators

• Principal Investigator: Corrado Pedrazzani, Professor, Universita di Verona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Azienda Ospedaliera Universitaria Integrata Verona
• ClinicalTrials.gov Identifier: NCT05249192
• Other Study ID Numbers: EURiCaRe
• First Posted: Feb 21, 2022
• Last Update Posted: Feb 21, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Tract Infections; Colonic Diseases; Urinary Retention; Postoperative Complications

Study Results

No Results Posted as of Feb 21, 2022