Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection

Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05249192
• Other study ID #: EURiCaRe
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colonic Disease
• Colonic Diseases
• Postoperative Complications
• Surgical Complication
• Urinary Retention
• Urinary Retention Postoperative
• Urinary Tract Infections

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