Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence

University of Aarhus

Status: Completed

Conditions: Constipation - Functional; Fecal Incontinence

Treatments: Device: Colotip, Coloplast A/S; Device: Cone Small, Qufora A/S

Study type: Interventional

Funder types: Other

Identifiers

NCT05032534

Højt skyl

Details and patient eligibility

About

The aim of this study is to investigate if a new irrigation system for transanal irrigation (TAI) is effective and more tolerable than the currently used system at the Pediatric Ward at Aarhus University Hospital.

Full description

This is a randomized, controlled study.

This study will be performed at Aarhus University Hospital (Denmark) and Aalborg University Hospital (Denmark) following the same protocol.

According to the initial randomization, children will be allocated to treatment with the new system (group A) or with the currently used system (group B). After a period of 6 weeks the child will crossover to use the contrary system.

The hypothesis is that A TAI system specifically developed for children will enhance the child's toleration of irrigation due to fewer reports on pain at insertion which will lead to better compliance. This outcome will induce a comparable or better effect on their fecal incontinence and reduce the needed follow-up period due to fewer incontinence relapse.

Enrollment: 14 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fecal incontinence on neurogenic or non-neurogenic basis, where transanal irrigation is indicated.

Exclusion criteria

• Morbus Hirschsprungs disease.
• Anorectal malformations.
• Use of medication that are known to cause constipation (e.g. anticholinergics)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Newly developed cone for 6 weeks the currently used cone for 6 weeks

Active Comparator group

Description:

Starts off with treatment with the newly developed cone for transanal irrigation for 6 weeks and are then instructed to crossover to the contrary system, the currently used, for additional 6 weeks.

Treatment:

Device: Colotip, Coloplast A/S

Device: Cone Small, Qufora A/S

Currently used cone for 6 weeks the newly developed cone for 6 weeks

Active Comparator group

Description:

Starts off with treatment with the currently used cone for transanal irrigation for 6 weeks and are then instructed to crossover to the contrary system, the currently used, for additional 6 weeks.

Treatment:

Device: Colotip, Coloplast A/S

Device: Cone Small, Qufora A/S