Anal Motor Function in Fecal Incontinence

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01786317
First received: February 5, 2013
Last updated: September 2, 2013
Last verified: September 2013
  Purpose

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 ] [ Designated as safety issue: No ]
    measurement of anal squeezing pressure (mmhg)


Secondary Outcome Measures:
  • anal tone pressure [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    measurement of anal tone pressure (mmhg)


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786317

Contacts
Contact: Guillaume Gourcerol + 33 2 32 88 89 90 ext 68039

Locations
France
Rouen University Hospital Recruiting
Rouen, Normandy, France, 76000
Contact: guillaume Gourcerol    + 33 2 32 88 89 90 ext 68039    secretariat.physio-digestive@chu-rouen.fr   
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: guillaume Gourcerol, MD, PhD Rouen University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01786317     History of Changes
Other Study ID Numbers: 2012/171/HP
Study First Received: February 5, 2013
Last Updated: September 2, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on August 28, 2014