Evaluation of Anorectal Area in Children Using 3D High Resolution Anorectal Manometry.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 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
Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry equipment and has been recently introduced into clinical practice. It is the most precise method to assess the anal sphincter pressure function and may be crucial for planning and controlling surgical procedures of the anorectal area. Normal values in pediatric population have not been established.
The aim of this study is complex evaluation of anorectal function in children without symptoms from lower GI tract and establishment of normal values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •parental agreement
- •age: 1 to 18 yr
排除标准
- •parental disagreement
- •children younger than 1 yr
- •children after the surgery for anorectal malformations
- •children with constipation during the last 10 months
- •children with nonretentive fecal soiling
- •children with inflammatory bowel diseases or any other type of large bowel inflammation
- •children with anal fissure, anal varices, inflammation of the anorectal area or any other disease that may interfere with function of anorectum
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: up to 20 minutes
Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible
次要结局
- Presence of Ano-anal Reflex(10 seconds)
- Presence of Rectoanal Inhibitory Reflex(up to 5 minutes)
- Presence of dyssynergic defecation(up to 1 minute)
- Presence of Cough Reflex(10 seconds)
- Presence of discomfort during the procedure(up to 20 minutes)
研究者
Marcin Banasiuk
MD
Medical University of Warsaw