- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01786317
Anal Motor Function in Fecal Incontinence
April 13, 2026 updated by: University Hospital, Rouen
Measure of Ano-rectal Motility in Fecal Incontinence
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Normandy
-
Rouen, Normandy, France, 76000
- Rouen University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Study Population
Heathy controls Patient with Fecal Incontience
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Fecal incontience
Patient with fecal incotinence who will be explored using high resoltuion manometry
|
Anorectal High resoltion manometry using electronic sensors
|
|
Healthy controls
Healthy volunteers who will be explored using high resoltuion manometry
|
Anorectal High resoltion manometry using electronic sensors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anal squeezing pressure
Time Frame: Day 1
|
measurement of anal squeezing pressure (mmhg)
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anal tone pressure
Time Frame: day 1
|
measurement of anal tone pressure (mmhg)
|
day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: guillaume Gourcerol, MD, PhD, University Hospital, Rouen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
February 5, 2013
First Submitted That Met QC Criteria
February 6, 2013
First Posted (Estimated)
February 7, 2013
Study Record Updates
Last Update Posted (Actual)
April 16, 2026
Last Update Submitted That Met QC Criteria
April 13, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012/171/HP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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