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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155307
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.


Condition or disease Intervention/treatment Phase
Anismus Distal Constipation Device: Anal EndoFLIP® Diagnostic Test: Anal Manometry Diagnostic Test: Defecography Diagnostic Test: Electromyogram Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus?
Actual Study Start Date : January 14, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

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




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155307


Contacts
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Contact: Laura BRIL, MD +3323288 ext 8990 laura.bril@chu-rouen.fr
Contact: Julien BLOT +3323288 ext 8265 julien.blot@chu-rouen.fr

Locations
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France
Rouen University Hospital Recruiting
Rouen, France
Contact: Laura BRIL, MD         
Sub-Investigator: Anne-Marie LEROI, Pr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Laura BRIL, MD Rouen University Hospital
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT04155307    
Other Study ID Numbers: 2018/347/HP
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive