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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05032534
Study type Interventional
Source University of Aarhus
Contact René F. Andersen, MD, PhD
Phone 0045 78 45 15 23
Email [email protected]
Status Recruiting
Phase N/A
Start date August 27, 2021
Completion date August 31, 2021

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