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

Not Applicable

Completed

• Conditions: Anal Incontinence or Constipation
• Interventions: Device: anorectal manometry and high-resolution three-dimensional

• Registration Number: NCT01946334
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-29
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients	anorectal manometry and high-resolution three-dimensional	-

Primary Outcome Measures

Name	Time	Method
anal pressures measured by anorectal manometry and high-resolution three-dimensional	12 months	comparing two positions conventional position in the left lateral decubitus position with the feet.

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France