NCT04155307

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anismus
• Distal Constipation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-14
• Primary completion: 2024-05-21
• Completion: 2024-05-21
• First posted: 2019-11-07
• Last updated: 2025-09-11

Locations

1 site across 1 country: France