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

NCT ID: NCT01946334

Last Updated: 2014-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anal Incontinence or Constipation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patients

Group Type EXPERIMENTAL

anorectal manometry and high-resolution three-dimensional

Intervention Type DEVICE

Interventions

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anorectal manometry and high-resolution three-dimensional

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LOIC MONDOLONI

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2013-13

Identifier Type: OTHER

Identifier Source: secondary_id

2013-A00507-38

Identifier Type: -

Identifier Source: org_study_id

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