Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus? (Endo-DC)
Primary Purpose
Anismus, Distal Constipation
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Anal EndoFLIP®
Anal Manometry
Defecography
Electromyogram
Sponsored by
About this trial
This is an interventional diagnostic trial for Anismus
Eligibility 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
Sites / Locations
- Rouen University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Detection of anismus in patients with distal constipation
Arm Description
Outcomes
Primary Outcome Measures
Sensitivity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus
Specificity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus
Secondary Outcome Measures
Full Information
NCT ID
NCT04155307
First Posted
November 5, 2019
Last Updated
June 26, 2020
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT04155307
Brief Title
Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus?
Acronym
Endo-DC
Official Title
Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anismus, Distal Constipation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Detection of anismus in patients with distal constipation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Anal EndoFLIP®
Intervention Description
Anal EndoFLIP® measure to evaluate anal compliance
Intervention Type
Diagnostic Test
Intervention Name(s)
Anal Manometry
Intervention Description
Anal Manometry done in standard care
Intervention Type
Diagnostic Test
Intervention Name(s)
Defecography
Intervention Description
Defecographydone in standard care
Intervention Type
Diagnostic Test
Intervention Name(s)
Electromyogram
Intervention Description
Electromyogram done in standard care
Primary Outcome Measure Information:
Title
Sensitivity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus
Time Frame
30 min
Title
Specificity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus
Time Frame
30 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura BRIL, MD
Phone
+3323288
Ext
8990
Email
laura.bril@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Phone
+3323288
Ext
8265
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura BRIL, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura BRIL, MD
First Name & Middle Initial & Last Name & Degree
Anne-Marie LEROI, Pr
12. IPD Sharing Statement
Plan to Share IPD
No
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Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus?
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