Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection: Study Protocol for a Randomized, Multicenter, Non-inferiority Trial
| Registry | NCT05249192 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 216 (Actual) |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona (Other); collaborators: Faenza Hospital, Ravenna Hospital, Humanitas Research Hospital IRCCS, Rozzano-Milan, Humanitas University, Universita di Verona |
| Conditions | Surgical Complication, Colonic Disease, Postoperative Complications, Urinary Retention Postoperative, Urinary Tract Infections |
| Interventions | Immediate urinary catheter removal, Early urinary catheter removal (Device) |
| Dates | start 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 in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Surgical Complication All trials for Colonic Disease All trials of Immediate urinary catheter removal All trials of Early urinary catheter removal
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Immediate UC removal | Experimental | Device: Immediate urinary catheter removal | Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room. |
| Early UC removal | Active comparator | Device: Early urinary catheter removal | Urinary catheter removal on first postoperative day (6 a.m.) as per standard protocol |
Sex: All, ages: 18 Years to 80 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Division of General and Hepatobiliary Surgery | Verona, Italy | Italy |