Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence
NCT ID: NCT05032534
Last Updated: 2022-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2021-09-20
2022-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Newly developed cone for 6 weeks the currently used cone for 6 weeks
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.
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.
Currently used cone for 6 weeks the newly developed cone for 6 weeks
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Anorectal malformations.
* Use of medication that are known to cause constipation (e.g. anticholinergics)
5 Years
17 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Qufora A/S
INDUSTRY
University of Aarhus
OTHER
Responsible Party
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Locations
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Aarhus University Hospital
Aarhus, Central Jutland, Denmark
Aalborg University Hospital
Aalborg, The North Denmark Region, Denmark
Countries
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Other Identifiers
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Højt skyl
Identifier Type: -
Identifier Source: org_study_id
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