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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05032534
Other study ID # Højt skyl
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2021
Est. completion date July 31, 2022

Study information

Verified date August 2021
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 5 Years to 17 Years
Eligibility 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)

Study Design


Intervention

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

Locations

Country Name City State
Denmark Aalborg University Hospital Aalborg The North Denmark Region
Denmark Aarhus University Hospital Aarhus Central Denmark Region

Sponsors (4)

Lead Sponsor Collaborator
University of Aarhus Aalborg University Hospital, Aarhus University Hospital, Qufora A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary The effect on fecal incontinence episode frequency Evaluated by home recordings. 12 weeks
Primary Evaluation of discomfort and on pain assessed on a Visual Analog Scale Evaluated by home recordings. 12 weeks
Secondary Extent of constipation Evaluated by home recordings and transabdominal rectal ultra sound. 12 weeks
Secondary Evaluation of urinary incontinence episodes Evaluated by home recordings. 12 weeks
Secondary Evaluation of compliance assessment using the different systems Evaluated by home recordings. 12 weeks
Secondary Estimation in changes of the child's well-being Evaluated by home recordings using WHO-5 12 weeks
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