Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- The effect on fecal incontinence episode frequency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fecal incontinence on neurogenic or non-neurogenic basis, where transanal irrigation is indicated.
排除标准
- •Morbus Hirschsprungs disease.
- •Anorectal malformations.
- •Use of medication that are known to cause constipation (e.g. anticholinergics)
研究组 & 干预措施
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.
干预措施: Cone Small, Qufora A/S (Device)
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.
干预措施: Colotip, Coloplast A/S (Device)
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.
干预措施: Cone Small, Qufora A/S (Device)
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.
干预措施: Colotip, Coloplast A/S (Device)
结局指标
主要结局
The effect on fecal incontinence episode frequency
时间窗: 12 weeks
Evaluated by home recordings.
Evaluation of discomfort and on pain assessed on a Visual Analog Scale
时间窗: 12 weeks
Evaluated by home recordings.
次要结局
- Extent of constipation(12 weeks)
- Estimation in changes of the child's well-being(12 weeks)
- Evaluation of urinary incontinence episodes(12 weeks)
- Evaluation of compliance assessment using the different systems(12 weeks)