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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Urinary Tract Infections; Surgical Complication; Urinary Retention Postoperative; Colonic Disease
• Intervention / Treatment: Device: Immediate urinary catheter removal; Device: Early urinary catheter removal

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corrado Pedrazzani, Professor; Phone Number: +390458126719; Email: corrado.pedrazzani@gmail.com

Study Locations

• Italy
  • Verona, Italy, 37134
    • Recruiting
    • Division of General and Hepatobiliary Surgery
    • Contact: Corrado Pedrazzani, Professor; Phone Number: 00390458126719; Email: corrado.pedrazzani@univr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
• Collaborators: Universita di Verona; Faenza Hospital; Ravenna Hospital; IRCCS Humanitas Research Hospital; Humanitas University
• Investigators: Principal Investigator: Corrado Pedrazzani, Professor, Universita di Verona

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Urologic Diseases; Gastrointestinal Diseases; Urination Disorders; Intestinal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Tract Infections; Postoperative Complications; Urinary Retention; Colonic Diseases
• Other Study ID Numbers: EURiCaRe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No