Effect of MiniGo As Add-on to Oral Laxatives for Children with Constipation and Fecal Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Fecal incontinence episodes
研究概览
简要总结
The goal of this clinical trial is to compare combination therapy with low volume trans anal irrigation (TAI) and oral laxatives to monotherapy with oral laxatives in children with functional constipation and fecal incontinence.
The main questions it aims to answer are:
- Can more efficient treatment be achieved with aforementioned combination therapy?
- Does the well-being of the children change, when they are well treated for their symptoms?
- Is low-volume trans anal irrigation a tolerable treatment method for children?
Participants will be randomized into 2 groups, where one group is treated with current standard treatment of PEG (oral laxatives), and the other group is treated with PEG + daily low volume TAI.
详细描述
Functional constipation and retentive fecal incontinence is a prevalent health issue in children. The current standard treatment regimen in Denmark consists mainly of behavioral interventions and oral laxative treatment. This treatment leaves a large group of non-responders. Suffering from constipation and fecal incontinence has a negative impact on well-being in children, wherefore treatment of this condition should be improved.
Earlier literature shows that trans anal irrigation (TAI) is an effective means of managing these symptoms, both in children and adults. However, conventional high volume TAI is time consuming (up to 45 minutes-an hour daily) and a cause of discomfort, or even pain. This can lead to low compliance and treatment failure.
Low volume TAI has the potential of bringing about all the positive effects of TAI, but with less time consumption (only few minutes daily) and less discomfort.
In this clinical trial, we will compare how children with functional constipation and fecal incontinence respond to treatment with 1) oral laxatives (PEG) alone versus 2) PEG and low volume TAI with the MiniGo-irrigation system.
The intervention period is 6 weeks, and the treatment takes place at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking not possible, since the add-on treatment requires training of parents and children and is a physical device to be handed out
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 4-14 years
- •medical history with fecal incontinence >1/week on a non-neurogenic but retentive basis (fulfills ROME-IV-criteria)
- •non-responsive after min. 2 months treatment with polyethylene glycols and behavioral interventions (set times for toilet use)
排除标准
- •Hirschsprungs disease
- •anorectal malformations
- •use of medications known to cause constipation (eg. anticholinergics)
- •former use of low or high volume TAI or enemas
- •Contraindications for use of MiniGo-irrigation device:
- •known stenosis of the rectum or intestinal tract
- •colorectal cancer prior to surgical removal
- •acute inflammatory bowel disease
- •acute diverticulitis
- •within 3 months of surgical procedures in the rectum or intestinal tract
- •within 4 weeks of endoscopic polypectomy
- •ischemic colitis
研究组 & 干预措施
Polyethylene glycols and low volume trans anal irrigation
This group consists of children who have already been treated with oral laxatives (PEG) for at least 2 months, but still experience symptoms of constipation and fecal incontinence. PEG dose will be adjusted in the same manner as in group a, but this group will also receive daily treatment with low volume trans anal irrigation.
干预措施: Polyethylene Glycols (Drug)
Polyethylene glycols
This group consists of children who have already been treated with oral laxatives (PEG) for at least 2 months, but still experience symptoms of constipation and fecal incontinence.
Their PEG dosage will be adjusted to the ideal dose for the individual child (this will be evaluated by a health care professional), with the minimum dosage being the maintenance dose of 0,5mg/kg/day, and the maximum dosage being the disimpaction dose of 1,5mg/kg/day
干预措施: Polyethylene Glycols (Drug)
Polyethylene glycols and low volume trans anal irrigation
This group consists of children who have already been treated with oral laxatives (PEG) for at least 2 months, but still experience symptoms of constipation and fecal incontinence. PEG dose will be adjusted in the same manner as in group a, but this group will also receive daily treatment with low volume trans anal irrigation.
干预措施: Low volume trans anal irrigation (Device)
结局指标
主要结局
Fecal incontinence episodes
时间窗: 6 weeks
Seeks to measure if there is any significant difference in the amount of fecal incontinence episodes between the two groups after the study period
次要结局
- Well-being(6 weeks)
- Constipation symptoms(6 weeks)
- Tolerability of low volume TAI(6 weeks)