Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection: Study Protocol for a Randomized, Multicenter, Non-inferiority Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Acute urinary retention rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Masking Description
patients and surgeons are blinded to group allocation until the end of surgical procedure
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 years and 80 years old
- •Patients scheduled to undergo minimally invasive resection of the colon under general anesthesia
- •Willingness to participate
- •Compliance to study purpose
- •Written informed consent
Exclusion Criteria
- •Need for an anastomosis below the anterior peritoneal reflection
- •Need for a major resection other than colorectal
- •Need for post-operative intensive care monitoring or intensive care unit (ICU) stay
- •Anesthesia time longer than 300 minutes
- •Presence of chronic indwelling UC
- •Presence of an entero-vesical fistula
- •Need for ureteral stent placement, bladder resection or repair
- •A previous and unsolved history of AUR or overt voiding dysfunction
Arms & Interventions
Immediate UC removal
Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.
Intervention: Immediate urinary catheter removal (Device)
Early UC removal
Urinary catheter removal on first postoperative day (6 a.m.) as per standard protocol
Intervention: Early urinary catheter removal (Device)
Outcomes
Primary Outcomes
Acute urinary retention rate
Time Frame: 3 days postoperatively
Occurrence of urinary retention after removal of urinary catheter
Secondary Outcomes
- Urinary tract infections(30 days postoperatively)
- UC reinsertion(30 days postoperatively)
- Pain scores(6,12,24,48 and 72 hours after surgery)
- Bowel function(10 days postoperatively)
- Mobilization(10 days postoperatively)
- Length of hospital stay(30 days postoperatively)
- Morbility(first 30 days after surgery)