Anal Motor Function in Fecal Incontinence | NCT01786317

Studies
Anal Motor Function in Fecal Incontinence

NCT01786317

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

Apr 16, 2026Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Fecal Incontinence

Interventions

High resolution manometry

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Feb 5, 2013

First Submission Date that Met QC Criteria

Feb 6, 2013

First Posted Date

Feb 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2026

Last Update Posted Date

Apr 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High resolution manometry	Device	Anorectal High resoltion manometry using electronic sensors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anal squeezing pressure	measurement of anal squeezing pressure (mmhg)	Day 1

Secondary Outcomes

Measure	Description	Time Frame
anal tone pressure	measurement of anal tone pressure (mmhg)	day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
guillaume Gourcerol, MD, PhD	University Hospital, Rouen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rouen University Hospital		Rouen	Normandy	76000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26670599	Result	Gourcerol G, Granier S, Bridoux V, Menard JF, Ducrotte P, Leroi AM. Do endoflip assessments of anal sphincter distensibility provide more information on patients with fecal incontinence than high-resolution anal manometry? Neurogastroenterol Motil. 2016 Mar;28(3):399-409. doi: 10.1111/nmo.12740. Epub 2015 Dec 15.

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases