3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal
研究概览
简要总结
3D high resolution anorectal manometry (3DHRAM) is the most precise tool to assess function and 3D topographic picture of pressures along the anal canal.
Until now, it has been used only in adult population to evaluate defecatory disorders.
Congenital anorectal disorders are severe conditions and may present wide spectrum of symptoms from gastrointestinal tract.
The usefulness of the 3DHRAM hasn't been evaluated in children after surgery for anorectal disorders such as Hirschsprung's disease and anorectal malformations.
It may help for better understanding of pathophysiology of anorectal area and allow for planning improved procedures in these patients.
Moreover, the investigators study may elucidate the real usefulness of the procedure in management of disorders of gastrointestinal tract in pediatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age:1-18 yr
- •after surgery for Hirschsprung's disease,
- •after surgery for Anorectal malformations,
- •after total procto/colectomy
- •with parental agreement for the procedure
排除标准
- •parental disagreement
- •children <12 months of age and >18 years
研究组 & 干预措施
surgery for Hirschsprung's disease
children after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure
干预措施: 3D high resolution anorectal manometry (Device)
surgery for anorectal malformation
children after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure
干预措施: 3D high resolution anorectal manometry (Device)
surgery for other disorders
children after surgery for other disorders will undergo 3D high resolution anorectal manometry procedure
干预措施: 3D high resolution anorectal manometry (Device)
结局指标
主要结局
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal
时间窗: 20 minutes
pressures will be recorded in mmHg
次要结局
- Presence of ano-anal reflex(10 seconds)
- Presence of cough reflex(10 seconds)
- Presence of sphincteric lesion in 3D picture of anal canal(30 seconds)
- Presence of rectoanal inhibitory reflex(5 minutes)
- Presence of discomfort during procedure(20 minutes)
- Presence of dyssynergic defecation(2 minutes)
研究者
Marcin Banasiuk
M.D.
Medical University of Warsaw