Clinical trial NCT05249192: Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection
Official title: Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection: Study Protocol for a Randomized, Multicenter, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Complication
Colonic Disease
Postoperative Complications
Urinary Retention Postoperative
Urinary Tract Infections
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
Collaborators: name: Faenza Hospital
name: Ravenna Hospital
name: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Humanitas University
name: Universita di Verona
First posted: 2022-02-21
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, controlled, two-arm, multi-center trial
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Acute urinary retention rate
timeFrame: 3 days postoperatively
Secondary outcomes:
measure: Urinary tract infections
timeFrame: 30 days postoperatively
measure: UC reinsertion
timeFrame: 30 days postoperatively
measure: Pain scores
timeFrame: 6,12,24,48 and 72 hours after surgery
measure: Bowel function
timeFrame: 10 days postoperatively
measure: Mobilization
timeFrame: 10 days postoperatively
measure: Morbility
timeFrame: first 30 days after surgery
measure: Length of hospital stay
timeFrame: 30 days postoperatively
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Division of General and Hepatobiliary Surgery
Study officials:
affiliation: Universita di Verona
name: Corrado Pedrazzani, Professor
role: PRINCIPAL_INVESTIGATOR
References: