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临床试验/NCT01946334
NCT01946334已完成不适用

Does Body Position Influence Pressure Recording by High-resolution Manometry ?

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
anal pressures measured by anorectal manometry and high-resolution three-dimensional

研究概览

简要总结

The anorectal manometry is the gold standard in the evaluation of anorectal function.

Several techniques are currently used (balloons, perfused catheters) and are always performed in the supine position.

Few studies have reported the evaluation of sphincter function in the upright position, whereas symptoms of fecal incontinence occur in this position.

Recently developed, high-resolution manometry, thanks to its many mechanical sensors, allows topographic analysis and evaluation of anorectal function more acurate. In addition, the rigid nature of the probe should allow stability measures / recording, which is not possible with probes perfused catheters example.

We therefore propose to compare anal sphincter pressure in supine and standing, measured in high-resolution manometry.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Man or woman over the age of 18 years
  • Patient referred for endoscopic ultrasound and anal manometry anorectal HR-3D which is an indication of fecal incontinence or dyschesia

排除标准

  • Patient age 18 Less
  • Patient trust, guardianship, judicial protection
  • No Written Consent
  • Lack of social insurance
  • History of anorectal surgery
  • A presence of anal stenosis
  • A setting evidence of anorectal lesion preventing the realization of the Screening
  • Motor disability preventing the realization of the anorectal manometry 3D HR-standing situation

研究组 & 干预措施

patients

Experimental

干预措施: anorectal manometry and high-resolution three-dimensional (Device)

结局指标

主要结局

anal pressures measured by anorectal manometry and high-resolution three-dimensional

时间窗: 12 months

comparing two positions conventional position in the left lateral decubitus position with the feet.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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