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

NCT04155307 | Completed

• 1 other identifier: 2018/0347/HP
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus

  30 min

• Specificity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus

  30 min

Study Arms (1)

Detection of anismus in patients with distal constipation

EXPERIMENTAL

Device: Anal EndoFLIP®; Diagnostic Test: Anal Manometry; Diagnostic Test: Defecography; Diagnostic Test: Electromyogram

Interventions

Anal EndoFLIP® DEVICE

Anal EndoFLIP® measure to evaluate anal compliance

Detection of anismus in patients with distal constipation

Anal Manometry DIAGNOSTIC_TEST

Anal Manometry done in standard care

Detection of anismus in patients with distal constipation

Defecography DIAGNOSTIC_TEST

Defecographydone in standard care

Detection of anismus in patients with distal constipation

Electromyogram DIAGNOSTIC_TEST

Electromyogram done in standard care

Detection of anismus in patients with distal constipation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 not understanding or reading French
• Patients under guardianship, curatorship, safeguard of justice
• Patient without liberty by administrative or judicial decision

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Interventions

Defecography; Electromyography

Intervention Hierarchy (Ancestors)

Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Myography

Study Officials

• Laura BRIL, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: January 14, 2020
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)