Anal Motor Function in Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

Measure of Ano-rectal Motility in Fecal Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786317
• Other study ID #: 2012/171/HP
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: July 21, 2015
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• High resolution manometry
Anorectal High resoltion manometry using electronic sensors

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen	Normandy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anal squeezing pressure	measurement of anal squeezing pressure (mmhg)	Day 1	No
Secondary	anal tone pressure	measurement of anal tone pressure (mmhg)	day 1	No