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COMPLETED
NCT04155307
NA

Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus?

Sponsor: University Hospital, Rouen

View on ClinicalTrials.gov

Summary

Terminal constipation affects 13 to 20% of the french population. Anismus is defined by an absence of relaxation or a paradoxical contraction of the striated anal sphincter muscle during defecation. Anismus is one of the main causes of terminal constipation. Anismus diagnosis is retained if 2 out of 3 examinations (manometry, electromyogram, defecography) are positive. EndoFLIP® is a new medical device developed to measure distensibility of a hollow organ. Anal EndoFLIP® l could be a more sensitive and specific tool for detecting anismus in patients with distal constipation. 60 patients suffering from distal constipation will be included in order to perform, in addition to the usual examinations, an anal EndoFlip in order to test the sensitivity and specificity of this method for the diagnosis of anismus.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

61

Start Date

2020-01-14

Completion Date

2024-05-21

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DEVICE

Anal EndoFLIP®

Anal EndoFLIP® measure to evaluate anal compliance

DIAGNOSTIC_TEST

Anal Manometry

Anal Manometry done in standard care

DIAGNOSTIC_TEST

Defecography

Defecographydone in standard care

DIAGNOSTIC_TEST

Electromyogram

Electromyogram done in standard care

Locations (1)

Rouen University Hospital

Rouen, France