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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05249192
Other study ID # EURiCaRe
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2022
Est. completion date December 31, 2023

Study information

Verified date July 2023
Source Azienda Ospedaliera Universitaria Integrata Verona
Contact Corrado Pedrazzani, Professor
Phone +390458126719
Email corrado.pedrazzani@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 216
Est. completion date December 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Device:
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)

Locations

Country Name City State
Italy Division of General and Hepatobiliary Surgery Verona

Sponsors (6)

Lead Sponsor Collaborator
Azienda Ospedaliera Universitaria Integrata Verona Faenza Hospital, Humanitas University, IRCCS Humanitas Research Hospital, Ravenna Hospital, Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute urinary retention rate Occurrence of urinary retention after removal of urinary catheter 3 days postoperatively
Secondary Urinary tract infections Occurrence of urinary tract infections 30 days postoperatively
Secondary UC reinsertion need for urinary catheter reinsertion after first removal 30 days postoperatively
Secondary Pain scores Numeric Rating Scores (NRS) for abdominal pain (0-10) 6,12,24,48 and 72 hours after surgery
Secondary Bowel function Time for return of bowel function as for flatus and stools postoperatively 10 days postoperatively
Secondary Mobilization Return to passive and active mobilization postoperatively 10 days postoperatively
Secondary Morbility Postoperative morbility according to the Clavien-Dindo classification first 30 days after surgery
Secondary Length of hospital stay postoperative stay 30 days postoperatively
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