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

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.

Study Overview

• Status: Unknown
• Conditions: Anismus; Distal Constipation
• Intervention / Treatment: Device: Anal EndoFLIP®; Diagnostic test: Anal Manometry; Diagnostic test: Defecography; Diagnostic test: Electromyogram

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura BRIL, MD; Phone Number: 8990 +3323288; Email: laura.bril@chu-rouen.fr

Study Locations

• France
  • Rouen, France
    • Recruiting
    • ROUEN university hospital
    • Contact: Laura BRIL, MD
    • Sub-Investigator: Anne-Marie LEROI, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Laura BRIL, MD, ROUEN university hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 2018/347/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No