Does Body Position Influence Pressure Recording by High-resolution Manometry ?
Primary Purpose
Anal Incontinence or Constipation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
anorectal manometry and high-resolution three-dimensional
Sponsored by
About this trial
This is an interventional diagnostic trial for Anal Incontinence or Constipation
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients
Arm Description
Outcomes
Primary Outcome Measures
anal pressures measured by anorectal manometry and high-resolution three-dimensional
comparing two positions conventional position in the left lateral decubitus position with the feet.
Secondary Outcome Measures
Full Information
NCT ID
NCT01946334
First Posted
September 11, 2013
Last Updated
August 29, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01946334
Brief Title
Does Body Position Influence Pressure Recording by High-resolution Manometry ?
Official Title
Does Body Position Influence Pressure Recording by High-resolution Manometry ?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Incontinence or Constipation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
anorectal manometry and high-resolution three-dimensional
Primary Outcome Measure Information:
Title
anal pressures measured by anorectal manometry and high-resolution three-dimensional
Description
comparing two positions conventional position in the left lateral decubitus position with the feet.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LOIC MONDOLONI
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
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Does Body Position Influence Pressure Recording by High-resolution Manometry ?
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