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

NCT ID: NCT04155307

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2024-05-21

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.

Conditions

Anismus; Distal Constipation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Detection of anismus in patients with distal constipation

Group Type: EXPERIMENTAL

Anal EndoFLIP®

Intervention Type: DEVICE

Anal EndoFLIP® measure to evaluate anal compliance

Anal Manometry

Intervention Type: DIAGNOSTIC_TEST

Anal Manometry done in standard care

Defecography

Intervention Type: DIAGNOSTIC_TEST

Defecographydone in standard care

Electromyogram

Intervention Type: DIAGNOSTIC_TEST

Electromyogram done in standard care

Interventions

Anal EndoFLIP®

Anal EndoFLIP® measure to evaluate anal compliance

Intervention Type: DEVICE

Anal Manometry

Anal Manometry done in standard care

Intervention Type: DIAGNOSTIC_TEST

Defecography

Defecographydone in standard care

Intervention Type: DIAGNOSTIC_TEST

Electromyogram

Electromyogram done in standard care

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura BRIL, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Other Identifiers

2018/0347/HP

Identifier Type: -

Identifier Source: org_study_id