3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation 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
- Correlation between percent of dyssynergic defecation diagnosed by the manometry and BET.
研究概览
简要总结
Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that measures pressures along the anal canal in a very detailed manner. It provides complete data about pressure profile of anorectum and may indicate impaired defecation dynamics. Balloon expulsion test (BET) is a cheap, easy way to diagnose constipation as the result of outlet obstruction.
Our aim is to compare this two methods of diagnosis of dyssynergic defecation and to find the correlation between this diagnostic equipment.
详细描述
Patients with the diagnosis of constipation will be enrolled in the study. Each patient will be investigated by anorectal manometry and after the procedure BET will be performed at the same day.
During anorectal manometry conventional manometric parameters will be recorded, such as resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded.
After the manometry standard BET will be performed. The balloon will be inserted into the rectum and patient will be asked to expel it in private during 1 min.
Data from manometry will be correlated with the success rate of BET.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Constipation
- •Parental agreement
排除标准
- •after surgery on lower gastrointestinal tract
- •diagnosis of inflammatory bowel disease
- •diagnosis of other disorder that may affect anorectum function
- •parental disagreement
研究组 & 干预措施
Manometry
All patients will be investigated by anorectal manometry and after the procedure with balloon expulsion test as previously described.
干预措施: Manometry (Device)
结局指标
主要结局
Correlation between percent of dyssynergic defecation diagnosed by the manometry and BET.
时间窗: 30 min
Percent of patients with the diagnosis of dyssynergic defecation made by BET and according to manometric equipment.
次要结局
- Bear down manoeuver pressure differential(1 min)
- puborectalis muscle pressure(1 min)
研究者
Marcin Banasiuk
PhD
Medical University of Warsaw