Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection
NCT ID: NCT05249192
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
216 participants
INTERVENTIONAL
2022-02-15
2024-11-26
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Immediate UC removal
Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.
Immediate urinary catheter removal
Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.
Early UC removal
Urinary catheter removal on first postoperative day (6 a.m.) as per standard protocol
Early urinary catheter removal
urinary catheter removal on the first postoperative day (6 a.m)
Interventions
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Immediate urinary catheter removal
Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.
Early urinary catheter removal
urinary catheter removal on the first postoperative day (6 a.m)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Faenza Hospital
UNKNOWN
Ravenna Hospital
UNKNOWN
Humanitas Research Hospital IRCCS, Rozzano-Milan
OTHER
Humanitas University
UNKNOWN
Universita di Verona
OTHER
Azienda Ospedaliera Universitaria Integrata Verona
OTHER
Responsible Party
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Principal Investigators
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Corrado Pedrazzani, Professor
Role: PRINCIPAL_INVESTIGATOR
Universita di Verona
Locations
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Division of General and Hepatobiliary Surgery
Verona, Italy, Italy
Countries
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References
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Pedrazzani C, Montroni I, Conti C, Turri G, Foppa C, Carvello M, Taffurelli G, Ugolini G, Spinelli A. Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trial. Trials. 2022 Nov 22;23(1):956. doi: 10.1186/s13063-022-06894-6.
Other Identifiers
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EURiCaRe
Identifier Type: -
Identifier Source: org_study_id