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

Primary Purpose

Surgical Complication, Colonic Disease, Postoperative Complications

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Immediate urinary catheter removal

Early urinary catheter removal

About this trial

This is an interventional prevention trial for Surgical Complication

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Division of General and Hepatobiliary SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate UC removal

Early UC removal

Arm Description

Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.

Urinary catheter removal on first postoperative day (6 a.m.) as per standard protocol

Outcomes

Primary Outcome Measures

Acute urinary retention rate

Occurrence of urinary retention after removal of urinary catheter

Secondary Outcome Measures

Urinary tract infections

Occurrence of urinary tract infections

UC reinsertion

need for urinary catheter reinsertion after first removal

Pain scores

Numeric Rating Scores (NRS) for abdominal pain (0-10)

Bowel function

Time for return of bowel function as for flatus and stools postoperatively

Mobilization

Return to passive and active mobilization postoperatively

Morbility

Postoperative morbility according to the Clavien-Dindo classification

Length of hospital stay

postoperative stay

Full Information

NCT ID

NCT05249192

First Posted

February 9, 2022

Last Updated

July 20, 2023

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Collaborators

Faenza Hospital, Ravenna Hospital, IRCCS Humanitas Research Hospital, Humanitas University, Universita di Verona

1. Study Identification

Unique Protocol Identification Number

NCT05249192

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 15, 2022 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Collaborators

Faenza Hospital, Ravenna Hospital, IRCCS Humanitas Research Hospital, Humanitas University, Universita di Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Complication, Colonic Disease, Postoperative Complications, Urinary Retention Postoperative, Urinary Tract Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

prospective, randomized, controlled, two-arm, multi-center trial

Masking

ParticipantCare Provider

Masking Description

patients and surgeons are blinded to group allocation until the end of surgical procedure

Allocation

Randomized

Enrollment

216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immediate UC removal

Arm Type

Experimental

Arm Description

Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.

Arm Title

Early UC removal

Arm Type

Active Comparator

Arm Description

Urinary catheter removal on first postoperative day (6 a.m.) as per standard protocol

Intervention Type

Device

Intervention Name(s)

Immediate urinary catheter removal

Intervention Description

Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.

Intervention Type

Device

Intervention Name(s)

Early urinary catheter removal

Intervention Description

urinary catheter removal on the first postoperative day (6 a.m)

Primary Outcome Measure Information:

Title

Acute urinary retention rate

Description

Occurrence of urinary retention after removal of urinary catheter

Time Frame

3 days postoperatively

Secondary Outcome Measure Information:

Title

Urinary tract infections

Description

Occurrence of urinary tract infections

Time Frame

30 days postoperatively

Title

UC reinsertion

Description

need for urinary catheter reinsertion after first removal

Time Frame

30 days postoperatively

Title

Pain scores

Description

Numeric Rating Scores (NRS) for abdominal pain (0-10)

Time Frame

6,12,24,48 and 72 hours after surgery

Title

Bowel function

Description

Time for return of bowel function as for flatus and stools postoperatively

Time Frame

10 days postoperatively

Title

Mobilization

Description

Return to passive and active mobilization postoperatively

Time Frame

10 days postoperatively

Title

Morbility

Description

Postoperative morbility according to the Clavien-Dindo classification

Time Frame

first 30 days after surgery

Title

Length of hospital stay

Description

postoperative stay

Time Frame

30 days postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Corrado Pedrazzani, Professor

Phone

+390458126719

corrado.pedrazzani@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Corrado Pedrazzani, Professor

Organizational Affiliation

Universita di Verona

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of General and Hepatobiliary Surgery

City

Verona

ZIP/Postal Code

37134

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Corrado Pedrazzani, Professor

Phone

00390458126719

corrado.pedrazzani@univr.it

12. IPD Sharing Statement

Plan to Share IPD

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

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