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Anal Motor Function in Fecal Incontinence

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: February 5, 2013
Last updated: July 21, 2015
Last verified: July 2015
Traditionnal measurment of anorectal function is perfomed with manometric device using 2 to 3 pressure sensors. The investigators aim to evaluate the usefulness of high resolution manometry to measure anorectal motility

Condition Intervention
Fecal Incontinence
Device: High resolution manometry

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Measure of Ano-rectal Motility in Fecal Incontinence

Resource links provided by NLM:

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Anal squeezing pressure [ Time Frame: Day 1 ]
    measurement of anal squeezing pressure (mmhg)

Secondary Outcome Measures:
  • anal tone pressure [ Time Frame: day 1 ]
    measurement of anal tone pressure (mmhg)

Enrollment: 60
Study Start Date: January 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fecal incontience
Patient with fecal incotinence who will be explored using high resoltuion manometry
Device: High resolution manometry
Anorectal High resoltion manometry using electronic sensors
Healthy controls
Healthy volunteers who will be explored using high resoltuion manometry
Device: High resolution manometry
Anorectal High resoltion manometry using electronic sensors

Detailed Description:
Measurment of anorectal function is traditionnaly made using manometric device composed of perfused or ballon catheters. This allows the recording of anorectal pressure on 2-3 sites. Recently, high resolution manometryu devices using > 36 pressure channels have been developped. The investigators therefore aim to evaluate the usefullness of the high resolution manometry in patient with fecal incontinence in terms of feasability and diagnosis accuracy

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Heathy controls Patient with Fecal Incontience

Inclusion Criteria:

  • patient with fecal incontinence (group "fecal incontinence"
  • subject without significant medical or surgical hisotry (group healthy controls)

Exclusion Criteria:

  • pregnacy
  • unable to speack/understand French language
  • not affilitated to the French healthcare system
  • history of anorectal disease (for the group of healthy controls) including fecal incontinence, or protocologic surgery
  • constipation
  • diarrhea
  Contacts and Locations
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Please refer to this study by its identifier: NCT01786317

Rouen University Hospital
Rouen, Normandy, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: guillaume Gourcerol, MD, PhD Rouen University Hospital
  More Information

Responsible Party: University Hospital, Rouen Identifier: NCT01786317     History of Changes
Other Study ID Numbers: 2012/171/HP
Study First Received: February 5, 2013
Last Updated: July 21, 2015

Keywords provided by University Hospital, Rouen:
Fecal incontinence, ano-rectal manometry

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on May 23, 2017