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

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ClinicalTrials.gov Identifier: NCT02861443
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:

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).

Condition or disease Intervention/treatment
Colostomy Behavioral: practice of colonic irrigation

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Study Type : Observational
Actual Enrollment : 1120 participants
Time Perspective: Cross-Sectional
Official Title: Irrigation of the Large Intestine in the Patients With Colostomy : Epidemiology and Quality of Life
Study Start Date : August 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : August 2015



Primary Outcome Measures :
  1. Practice of large bowel irrigation (yes/no) [ Time Frame: Day 0 ]
    Does the patient practice large bowel irrigation? (yes/no)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02861443    
Other Study ID Numbers: LOCAL/2014/MP-01
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: July 2016