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

Not Applicable

• Conditions: Distal Constipation; Anismus
• Interventions: Device: Anal EndoFLIP®; Diagnostic Test: Anal Manometry; Diagnostic Test: Defecography; Diagnostic Test: Electromyogram

• Registration Number: NCT04155307
• Lead Sponsor: University Hospital, Rouen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Study Start: 2020-01-14
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-29
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patient older than 18 years
• patient with distal constipation defined according to the Rome IV criteria, for at least 3 months and verified by a transit time study showing a predominant slowing of markers at the recto-sigmoid level.
• patient who read and signed the informed consent form

Exclusion Criteria

• Patients with a predominant right of left colonic constipation;
• Pregnant woman or woman with no effective contraception and of childbearing age
• Patient with inflammatory bowel disease, ischemic colitis, history of colon or rectal cancer, infectious colitis or proctologic disease.
• Patient with anorectal malformation
• Patient with an history of pelvic floor radiotherapy
• Patient with a digestive stoma
• Insertion of the probe impossible or painful
• Patient who has participated to a clinical trial within 30 days prior to the inclusion visit
• Patient not understanding or reading French
• Patients under guardianship, curatorship, safeguard of justice
• Patient without liberty by administrative or judicial decision

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Detection of anismus in patients with distal constipation	Anal EndoFLIP®	-
Detection of anismus in patients with distal constipation	Anal Manometry	-
Detection of anismus in patients with distal constipation	Defecography	-
Detection of anismus in patients with distal constipation	Electromyogram	-

Primary Outcome Measures

Name	Time	Method
Specificity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus	30 min
Sensitivity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus	30 min

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France