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

Anal Incontinence or Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946334
• Other study ID #: 2013-A00507-38
• Secondary ID: 2013-13
• Status: Completed
• Phase: N/A
• First received: September 11, 2013
• Last updated: August 29, 2014
• Start date: June 2013
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anal Incontinence or Constipation
• Constipation
• Fecal Incontinence

Intervention

Device:
• anorectal manometry and high-resolution three-dimensional

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anal pressures measured by anorectal manometry and high-resolution three-dimensional	comparing two positions conventional position in the left lateral decubitus position with the feet.	12 months	No