Irrigation of the Large Intestine in the Patients With Colostomy : Epidemiology and Quality of Life (IrriQOL)

November 18, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

The main objective of this study was to determine the frequency of the practice of colonic irrigation (CI) among patients with a colostomy,.

Other objectives are:

  • To compare the quality of life between a group of patients with a colostomy and practicing CI versus a group of patients with a colostomy without CI.
  • To determine the causes of non-realization of the CI or failure.
  • To determine the conditions of realization of colonic irrigation by the return of user experience (time of day when the CI is practiced, amount and type of fluid used, time spent in the bathroom, time to recurrence of stool, media used between two irrigations).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The target population is composed of adults with end colostomy. The sample is drawn from adult members of "la Federation des stomisés de France" who have a terminal colostomy.

Description

Inclusion Criteria:

  • The subject was informed about the implementation of the study's objectives, constraints and the rights of the subject
  • The subject is aged at least 18 years
  • The subject is a member of the Ostomy Federation of France
  • The subject has had a terminal colostomy for more than 6 months

Exclusion Criteria:

  • The subject is under guardianship or curatorship
  • The subject is under judicial protection
  • The subject formalizes his/her opposition
  • It is not possible to inform the subject

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Practice of large bowel irrigation (yes/no)
Time Frame: Day 0
Does the patient practice large bowel irrigation? (yes/no)
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

June 30, 2015

Study Completion (Actual)

June 30, 2015

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 5, 2016

First Posted (Estimated)

August 10, 2016

Study Record Updates

Last Update Posted (Estimated)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • LOCAL/2014/MP-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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