Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus? (Endo-DC)
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|ClinicalTrials.gov Identifier: NCT04155307|
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : June 29, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Anismus Distal Constipation||Device: Anal EndoFLIP® Diagnostic Test: Anal Manometry Diagnostic Test: Defecography Diagnostic Test: Electromyogram||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus?|
|Actual Study Start Date :||January 14, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
|Experimental: Detection of anismus in patients with distal constipation||
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
- Sensitivity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus [ Time Frame: 30 min ]
- Specificity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus [ Time Frame: 30 min ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155307
|Contact: Laura BRIL, MD||+3323288 ext firstname.lastname@example.org|
|Contact: Julien BLOT||+3323288 ext email@example.com|
|Rouen University Hospital||Recruiting|
|Contact: Laura BRIL, MD|
|Sub-Investigator: Anne-Marie LEROI, Pr|
|Principal Investigator:||Laura BRIL, MD||Rouen University Hospital|