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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Aalborg University Hospital | OTHER |
| Qufora A/S | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newly developed cone for 6 weeks the currently used cone for 6 weeks | Active Comparator | 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. |
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| Currently used cone for 6 weeks the newly developed cone for 6 weeks | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cone Small, Qufora A/S | Device | Newly developed cone in a softer material and a design matching the use for transanal irrigation. |
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| Measure | Description | Time Frame |
|---|---|---|
| The effect on fecal incontinence episode frequency | Evaluated by home recordings. | 12 weeks |
| Evaluation of discomfort and on pain assessed on a Visual Analog Scale | Evaluated by home recordings. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of constipation | Evaluated by home recordings and transabdominal rectal ultra sound. | 12 weeks |
| Evaluation of urinary incontinence episodes | Evaluated by home recordings. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Central Jutland | DK-8200 | Denmark | ||
| Aalborg University Hospital |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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The children will use either the old or the new cone for transanal irrigation for 6 weeks and then crossover to the contrary cone.
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| Colotip, Coloplast A/S | Device | Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital. |
|
| 12 weeks |
| Evaluation of compliance assessment using the different systems | Evaluated by home recordings. | 12 weeks |
| Estimation in changes of the child's well-being | Evaluated by home recordings using WHO-5 | 12 weeks |
| Aalborg |
| The North Denmark Region |
| DK-9000 |
| Denmark |