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

Colostomy Clinical Trial

— IrriQOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861443
• Other study ID #: LOCAL/2014/MP-01
• Status: Completed
• Phase: N/A
• First received: August 1, 2016
• Last updated: August 5, 2016
• Start date: August 2014
• Est. completion date: August 2015

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1120
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Colostomy

Intervention

Behavioral:
• practice of colonic irrigation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Practice of large bowel irrigation (yes/no)	Does the patient practice large bowel irrigation? (yes/no)	Day 0	No