NCT05032534

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Fecal Incontinence
• Constipation - Functional

Interventions

Type	Name	Description
DEVICE	Cone Small, Qufora A/S	Newly developed cone in a softer material and a design matching the use for transanal irrigation.
DEVICE	Colotip, Coloplast A/S	Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital.

Timeline

• Start date: 2021-09-20
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2021-09-02
• Last updated: 2022-08-09

Locations

2 sites across 1 country: Denmark