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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Completed
• CT.gov ID: NCT02861443
• Collaborator: (none)
• Enrollment: 1,120
• Duration (Months): 12

Study Details

Study Description

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	Phase
Colostomy	Behavioral: practice of colonic irrigation

Study Design

• 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: Aug 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Outcome Measures

Primary Outcome Measures

1. Practice of large bowel irrigation (yes/no) [Day 0]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT02861443
• Other Study ID Numbers: LOCAL/2014/MP-01
• First Posted: Aug 10, 2016
• Last Update Posted: Aug 10, 2016
• Last Verified: Jul 1, 2016

Study Results

No Results Posted as of Aug 10, 2016