Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus? (Endo-DC)

University Hospital, Rouen

Status

Completed

Conditions

Distal Constipation

Anismus

Treatments

Diagnostic Test: Anal Manometry

Diagnostic Test: Electromyogram

Diagnostic Test: Defecography

Device: Anal EndoFLIP®

Study type

Interventional

Funder types

Other

Identifiers

NCT04155307

2018/0347/HP

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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