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Prospective, Controlled, Randomized Multicentric Study on the Management of the Vesical Catheter in Colon Surgery.

NCT04070898 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2021-11-16

No results posted yet for this study

Summary

INTRODUCTION: Recommendations for peroperative bladder catheterization remain a controversial issue since it is a procedure that is not without complications. Most of the current suggestions derive from open surgery data that have been extrapolated to Enhanced Recovery After Surgery (ERAS) or Fast-Track programs ranging between 24-48 hours.

The objective of the present study is to find the perfect balance with a better degree of evidence than the current one between the reduction of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery.

Methods: Multicenter, prospective, controlled, randomized non-inferiority study on the management of the bladder catheter in patients undergoing scheduled laparoscopic colon surgery, randomized in two study groups: experimental group (removal of the bladder catheter after surgery ) and control group (removal of the catheter at 24 hours) after the surgical intervention.

The main objective of the present study is to reduce the permanence of the bladder catheter trying to find the balance of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery As secondary objectives we will consider the decrease in the incidence of urinary tract infections within the first 30 days as well as the reduction in hospital stay and morbidity related to the bladder catheter.

Conditions

Interventions

PROCEDURE

Remove urinary catheter after surgery

Remove bladder catheter after surgery

Sponsors & Collaborators

  • Corporacion Parc Tauli

    lead OTHER

Principal Investigators

  • Xavier Serra-Aracil, MD, PhD · Corporacio Parc Tauli. Parc Tauli University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-15
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04070898 on ClinicalTrials.gov