Anal Motor Function in Fecal Incontinence

Completed

• Conditions: Fecal Incontinence
• Interventions: Device: High resolution manometry

• Registration Number: NCT01786317
• Lead Sponsor: 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

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-07
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-21
• Last Update Posted: 2015-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fecal incontience	High resolution manometry	Patient with fecal incotinence who will be explored using high resoltuion manometry
Healthy controls	High resolution manometry	Healthy volunteers who will be explored using high resoltuion manometry

Primary Outcome Measures

Name	Time	Method
Anal squeezing pressure	Day 1	measurement of anal squeezing pressure (mmhg)

Secondary Outcome Measures

Name	Time	Method
anal tone pressure	day 1	measurement of anal tone pressure (mmhg)

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, Normandy, France