NCT02861443

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,120

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

August 1, 2016

Last Update Submit

June 23, 2026

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 irrigationBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, Gard, 30029, France

Location

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: 32782085RESULT

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

April 7, 2015

Primary Completion

June 30, 2015

Study Completion

June 30, 2015

Last Updated

June 25, 2026

Record last verified: 2026-06

Locations

FR(1)