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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 January 2016 |
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Main ID: |
NCT02236507 |
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Date of registration:
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31/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Normal Values for 3D High Resolution Anorectal Manometry in Children
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Scientific title:
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Evaluation of Anorectal Area in Children Using 3D High Resolution Anorectal Manometry. |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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61 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02236507 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Poland
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Contacts
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Name:
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Marcin Banasiuk, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Warsaw |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- parental agreement
- age: 1 to 18 yr
Exclusion Criteria:
- parental disagreement
- children younger than 1 yr
- children after the surgery for anorectal malformations
- children with constipation during the last 10 months
- children with nonretentive fecal soiling
- children with inflammatory bowel diseases or any other type of large bowel
inflammation
- children with anal fissure, anal varices, inflammation of the anorectal area or any
other disease that may interfere with function of anorectum
Age minimum:
12 Months
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anorectal Disorder
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Children
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Intervention(s)
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Device: 3D high resolution anorectal manometry
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Primary Outcome(s)
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Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal
[Time Frame: up to 20 minutes]
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Secondary Outcome(s)
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Presence of discomfort during the procedure
[Time Frame: up to 20 minutes]
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Presence of Cough Reflex
[Time Frame: 10 seconds]
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Presence of dyssynergic defecation
[Time Frame: up to 1 minute]
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Presence of Rectoanal Inhibitory Reflex
[Time Frame: up to 5 minutes]
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Presence of Ano-anal Reflex
[Time Frame: 10 seconds]
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Secondary ID(s)
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Banasiuk2014 A
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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