Anal Motor Function in Fecal Incontinence

Sponsor

University Hospital, Rouen (Other)

Overall Status

Completed

CT.gov ID

NCT01786317

Collaborator

(none)

Enrollment

Location

28.9

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

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 :

Jan 1, 2013

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Anal squeezing pressure [Day 1]
measurement of anal squeezing pressure (mmhg)

Secondary Outcome Measures

anal tone pressure [day 1]
measurement of anal tone pressure (mmhg)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Rouen University Hospital	Rouen	Normandy	France	76000

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator: guillaume Gourcerol, MD, PhD, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT01786317

Other Study ID Numbers:

2012/171/HP

First Posted:

Feb 7, 2013

Last Update Posted:

Jul 22, 2015

Last Verified:

Jul 1, 2015

Keywords provided by University Hospital, Rouen

Fecal incontinence, ano-rectal manometry

Additional relevant MeSH terms:

Fecal Incontinence

Study Results

No Results Posted as of Jul 22, 2015