Irrigation of the Large Intestine in the Patients With Co... | NCT02861443

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

NCT02861443

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Jun 25, 2026Actual

Enrollment

1,120Actual

Phase

Not provided

Conditions

Colostomy

Interventions

practice of colonic irrigation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 7, 2015Actual

Primary Completion Date

Jun 30, 2015Actual

Completion Date

Jun 30, 2015Actual

First Submitted Date

Aug 1, 2016

First Submission Date that Met QC Criteria

Aug 5, 2016

First Posted Date

Aug 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2026

Last Update Posted Date

Jun 25, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,120Actual

Name	Type	Description	Arm Group Labels	Other Names
practice of colonic irrigation	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Practice of large bowel irrigation (yes/no)	Does the patient practice large bowel irrigation? (yes/no)	Day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nîmes		Nîmes	Gard	30029	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32782085	Result	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.