Comparison of High-resolution Anorectal Manometry and 3D High-definition Anorectal Manometry in Diagnosis of Functional Disorders in Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Difference in Resting pressure of the anorectal area
研究概览
简要总结
Pressures measured by manometric solid-state catheters may differ according to the type of the catheter and specific anatomy and physiology of anorectum.
The aim of the study is to establish the difference in recordings between 2 types of anorectal catheters used in pediatric patients and to validate the most appropriate way to diagnose of functional disorders.
详细描述
Patients enrolled in study will be investigated by both types of anorectal catheters, first by anorectal high resolution flexible, thinner, solid-state catheter and after that with rigid, thicker, solid-state catheter. Both procedures will be undertaken during one session. There will be used standard protocol of the procedure that measures conventional manometric parameters (resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and recto anal inhibitory reflex threshold.
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
- 4 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Functional Constipation
- •Fecal Incontinence
- •Parental Agreement
排除标准
- •After surgery on lower gastrointestinal tract
- •Diagnosis of inflammatory bowel disorders
- •Diagnosis of other disorders present in anorectal area, that may influence anorectal pressures
- •Lack of parental agreement
研究组 & 干预措施
High resolution anorectal manometry
All subjects will be investigated by high-resolution anorectal manometry. At the beginning the anorectal cather will be used to record conventional parameters and after that 3D high-definition anorectal manometric catheter will be inserted in order to measure conventional parameters and 3D picture of anorectum.
干预措施: High-resolution anorectal manometry (Device)
结局指标
主要结局
Difference in Resting pressure of the anorectal area
时间窗: 20 seconds
Resting pressure will be measured after insertion catheter into anorectum. The software automatically record pressure while patient is lying on the bed. The parameter is recorded with 2 different types of anorectal catheters and the difference is evaluated.
次要结局
- Bear down manoeuver(1 min)
- Thresholds of sensation(1 min)
- Recto anal inhibitory reflex(5 min)
- Maximum squeeze pressure(1 min)
研究者
Marcin Banasiuk
PhD
Medical University of Warsaw