NCT05249192

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Complication
• Colonic Disease
• Postoperative Complications
• Urinary Retention Postoperative
• Urinary Tract Infections

Interventions

Type	Name	Description
DEVICE	Immediate urinary catheter removal	Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.
DEVICE	Early urinary catheter removal	urinary catheter removal on the first postoperative day (6 a.m)

Timeline

• Start date: 2022-02-15
• Primary completion: 2024-07-01
• Completion: 2024-11-26
• First posted: 2022-02-21
• Last updated: 2024-11-29

Locations

1 site across 1 country: Italy