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OpenTrials
Completed

NCT Number: NCT04155307

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anal EndoFLIP®

Device

Anal EndoFLIP® measure to evaluate anal compliance

Anal Manometry

Diagnostic Test

Anal Manometry done in standard care

Defecography

Diagnostic Test

Defecographydone in standard care

Electromyogram

Diagnostic Test

Electromyogram done in standard care

Primary outcomes

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

    Time frame: 30 min

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

    Time frame: 30 min

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: Endo-DC

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2019
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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