Ano-rectal 3D High Resolution Manometry: Normal Values and Comparison With Ultrasound Examination in Healthy Volunteers, Patients With Fecal Incontinence and Patients With Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Anal pressure pattern at rest, during voluntary maximal squeezing and bear down Anal pressure pattern at rest, during voluntary maximal squeezing and bear down
研究概览
简要总结
Ano-rectal manometry is indicative in patients with either fecal incontinence or constipation. Recently anorectal 3D- high resolution manometry has been developed. Pressure variations are measured circumferentially along the anal canal. It may allow a better understanding of anorectal disorders by displaying anal pressure asymmetry and it could be useful to assess the functional anatomy of the pelvic floor better than conventional manometry.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ARM 1 Healthy Volunteers
Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
干预措施: Dynamic anorectal endosonography (sagittal and radial) (Procedure)
ARM 1 Healthy Volunteers
Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
干预措施: Anorectal 3D-high resolution manometry (Procedure)
ARM 1 Healthy Volunteers
Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
干预措施: Anorectal radial endosonography (rotative 360° probe) (Procedure)
ARM 2: Patients with fecal incontinence
Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
干预措施: Anorectal 3D-high resolution manometry (Procedure)
ARM 2: Patients with fecal incontinence
Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
干预措施: Anorectal radial endosonography (rotative 360° probe) (Procedure)
ARM 2: Patients with fecal incontinence
Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
干预措施: Dynamic anorectal endosonography (sagittal and radial) (Procedure)
ARM 3 Patients with constipation
Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
干预措施: Anorectal 3D-high resolution manometry (Procedure)
ARM 3 Patients with constipation
Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
干预措施: Anorectal radial endosonography (rotative 360° probe) (Procedure)
ARM 3 Patients with constipation
Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
干预措施: Dynamic anorectal endosonography (sagittal and radial) (Procedure)
结局指标
主要结局
Anal pressure pattern at rest, during voluntary maximal squeezing and bear down Anal pressure pattern at rest, during voluntary maximal squeezing and bear down
时间窗: during procedure
Following parameters will be measured at the level of anal sphincter: * Minimal pressure (amplitude and location) * Maximal pressure (amplitude and location) * Mean pressure * Asymmetry
次要结局
- presence of ano-rectal reflex.(during procedure)
- Ano-rectal radial endosonography(During procedure)
- Dynamic ano-rectal endoconography(During procedure)