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Incidence of Acute Urine Retention: Randomized Clinical Trial Comparing Early, Mid or Late Urinary Catheter Removal in Patients With Rectal Resection

NCT04751149 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2021-02-11

No results posted yet for this study

Summary

DESIGN:

Randomized, open-label and parallel clinical trial, assigned to early, mid, or late withdrawal of urinary catheter with a 1: 1: 1 allocation ratio.

POPULATION:

Patients undergoing anterior rectal resection, low rectal resection, or abdominoperineal amputation for any reason.

OBJECTIVES:

The main objective is to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection.

Secondary objectives are:

1. Incidence of urinary tract infection after urinary catheter removal.
2. Incidence of specific postoperative complications (Surgical wound infection, Respiratory infection, Anastomotic dehiscence, ileus).
3. Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale.

DESCRIPTION OF THE INTERVENTION:

In all patients, a Rectal Resection (anterior rectal resection, posterior pelvic exenteration or abdominoperineal amputation) will be performed. In group 1A, the urinary catheter will be removed on the 1st postoperative day. In group 1B patients, the urinary catheter will be removed on the 3rd postoperative day. In group 1C patients, the urinary catheter will be removed on the 5th postoperative day. All patients will have a urine culture taken at the time of withdrawal.

Conditions

Interventions

PROCEDURE

Removal of Urinary Catheter

Urinary catheter will be removed in aeseptic conditions. Before the removal a urinary culture will be obtained from the catheter.

Sponsors & Collaborators

  • Hospital Donostia

    lead OTHER

Principal Investigators

  • Jose Maria Enriquez-Navascues, PhD · H Donostia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2022-05-01
Completion
2022-12-01

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 NCT04751149 on ClinicalTrials.gov