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

Anismus Clinical Trial

— Endo-DC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04155307
• Other study ID #: 2018/347/HP
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: December 2021

Study information

• Verified date: June 2020
• Source: University Hospital, Rouen
• Contact: Laura BRIL, MD
• Phone: +3323288
• Email: laura.bril[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anismus
• Constipation
• Distal Constipation

Intervention

Device:
• Anal EndoFLIP®
Anal EndoFLIP® measure to evaluate anal compliance

Diagnostic Test:
• Anal Manometry
Anal Manometry done in standard care
• Defecography
Defecographydone in standard care
• Electromyogram
Electromyogram done in standard care

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus		30 min
Primary	Specificity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus		30 min