NCT01786317

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

February 5, 2013

Last Update Submit

April 13, 2026

Conditions

Fecal Incontinence

Keywords

Fecal incontinence, ano-rectal manometry

Outcome Measures

Primary Outcomes (1)

  • Anal squeezing pressure

    measurement of anal squeezing pressure (mmhg)

    Day 1

Secondary Outcomes (1)

  • anal tone pressure

    day 1

Interventions

High resolution manometryDEVICE

Anorectal High resoltion manometry using electronic sensors

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient with fecal incontinence (group "fecal incontinence"
  • subject without significant medical or surgical hisotry (group healthy controls)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, Normandy, 76000, France

Location

Related Publications (1)

  • 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.

    PMID: 26670599RESULT

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • guillaume Gourcerol, MD, PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
PARTICIPANT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

FR(1)