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

NCT02861443 | Completed

• 1 other identifier: LOCAL/2014/MP-01
• Study Type: observational
• Target: 1,120
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Colostomy

Outcome Measures

Primary Outcomes (1)

• Practice of large bowel irrigation (yes/no)

  Does the patient practice large bowel irrigation? (yes/no)

  Day 0

Interventions

practice of colonic irrigation BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Related Publications (1)

• 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.

  PMID: 32782085 RESULT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 10, 2016
• Study Start: August 1, 2014
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: November 21, 2025

Record last verified: 2016-07