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

NCT ID: NCT02861443

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Colostomy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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practice of colonic irrigation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Boutry E, Bertrand MM, Ripoche J, Alonso S, Bastide S, Prudhomme M; French Federation of Ostomy. Quality of life in colostomy patients practicing colonic irrigation: An observational study. J Visc Surg. 2021 Feb;158(1):4-10. doi: 10.1016/j.jviscsurg.2020.07.003. Epub 2020 Aug 8.

Reference Type RESULT
PMID: 32782085 (View on PubMed)

Other Identifiers

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LOCAL/2014/MP-01

Identifier Type: -

Identifier Source: org_study_id

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