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

Integrated University Hospital Trust of Verona

Status: Completed

Conditions: Urinary Retention Postoperative; Postoperative Complications; Urinary Tract Infections; Colonic Disease; Surgical Complication

Treatments: Device: Immediate urinary catheter removal; Device: Early urinary catheter removal

Study type: Interventional

Funder types: Other

Identifiers

NCT05249192

EURiCaRe

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups

Immediate UC removal

Experimental group

Description:

Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.

Treatment:

Device: Immediate urinary catheter removal

Early UC removal

Active Comparator group

Description:

Urinary catheter removal on first postoperative day (6 a.m.) as per standard protocol

Treatment:

Device: Early urinary catheter removal