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OpenTrials
Completed

NCT Number: NCT01946334

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

anorectal manometry and high-resolution three-dimensional

Device

Primary outcomes

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

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2013
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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