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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Anal Incontinence or Constipation

Treatments

Device: anorectal manometry and high-resolution three-dimensional

Study type

Interventional

Funder types

Other

Identifiers

NCT01946334
2013-A00507-38
2013-13 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

patients
Experimental group
Treatment:
Device: anorectal manometry and high-resolution three-dimensional

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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