Colonic Disease, Postoperative Complications, Surgical Complication, Urinary Retention Postoperative, Urinary Tract Infections
Conditions
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.
Interventions
Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.
urinary catheter removal on the first postoperative day (6 a.m)
Sponsors
Faenza Hospital
Ravenna Hospital
Humanitas Research Hospital IRCCS, Rozzano-Milan
Humanitas University
Universita di Verona
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
patients and surgeons are blinded to group allocation until the end of surgical procedure
Intervention model description
prospective, randomized, controlled, two-arm, multi-center trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute urinary retention rate | 3 days postoperatively | Occurrence of urinary retention after removal of urinary catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Urinary tract infections | 30 days postoperatively | Occurrence of urinary tract infections |
| Morbility | first 30 days after surgery | Postoperative morbility according to the Clavien-Dindo classification |
| Length of hospital stay | 30 days postoperatively | postoperative stay |
| Mobilization | 10 days postoperatively | Return to passive and active mobilization postoperatively |
Countries
Italy
Outcome results
None listed