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Anal Motor Function in Fecal Incontinence

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ClinicalTrials.gov Identifier: NCT01786317
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
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 or disease Intervention/treatment
Fecal Incontinence Device: High resolution manometry

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

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Measure of Ano-rectal Motility in Fecal Incontinence
Study Start Date : January 2013
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



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


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



Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786317


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

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01786317     History of Changes
Other Study ID Numbers: 2012/171/HP
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 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