NCT05249192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

2.4 years

First QC Date

February 9, 2022

Last Update Submit

November 26, 2024

Conditions

Surgical ComplicationColonic DiseasePostoperative ComplicationsUrinary Retention PostoperativeUrinary Tract Infections

Outcome Measures

Primary Outcomes (1)

  • Acute urinary retention rate

    Occurrence of urinary retention after removal of urinary catheter

    3 days postoperatively

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Immediate UC removal

EXPERIMENTAL

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

Device: Immediate urinary catheter removal

Early UC removal

ACTIVE COMPARATOR

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

Device: Early urinary catheter removal

Interventions

Immediate urinary catheter removalDEVICE

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

Immediate UC removal
Early urinary catheter removalDEVICE

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

Early UC removal

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of General and Hepatobiliary Surgery

Verona, Italy, 37134, Italy

Location

Related Publications (1)

  • 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.

    PMID: 36414969DERIVED

MeSH Terms

Conditions

Colonic DiseasesPostoperative ComplicationsUrinary Tract Infections

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Corrado Pedrazzani, Professor

    Universita di Verona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
patients and surgeons are blinded to group allocation until the end of surgical procedure
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: prospective, randomized, controlled, two-arm, multi-center trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 21, 2022

Study Start

February 15, 2022

Primary Completion

July 1, 2024

Study Completion

November 26, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)