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

Not Applicable

Completed

• Conditions: Urinary Retention Postoperative; Colonic Disease; Postoperative Complications; Surgical Complication; Urinary Tract Infections
• Interventions: Device: Immediate urinary catheter removal; Device: Early urinary catheter removal

• Registration Number: NCT05249192
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-09
• Study Start: 2022-02-15
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-02-21
• Primary Completion: 2024-07-01
• Status Verified: 2024-11
• Study Completion: 2024-11-26
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate UC removal	Immediate urinary catheter removal	Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.
Early UC removal	Early urinary catheter removal	Urinary catheter removal on first postoperative day (6 a.m.) as per standard protocol

Primary Outcome Measures

Name	Time	Method
Acute urinary retention rate	3 days postoperatively	Occurrence of urinary retention after removal of urinary catheter

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of General and Hepatobiliary Surgery; 🇮🇹 Verona, Italy