Normal Values for 3D High Resolution Anorectal Manometry in Children

Study Overview
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Brief Summary
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Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry equipment and has been recently introduced into clinical practice. It is the most precise method to assess the anal sphincter pressure function and may be crucial for planning and controlling surgical procedures of the anorectal area. Normal values in pediatric population have not been established. The aim of this study is complex evaluation of anorectal function in children without symptoms from lower GI tract and establishment of normal values.

Official Title
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Evaluation of Anorectal Area in Children Using 3D High Resolution Anorectal Manometry.

Conditions
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Children, Anorectal Disorder

Intervention / Treatment
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* Device: 3D high resolution anorectal manometry


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: children without anorectal disorders<br>All children will be investigated by 3D high resolution anorectal manometry procedure | Device: 3D high resolution anorectal manometry<br>* Procedure will take about 15 min. During procedure resting, voluntary squeeze, bear down maneuver, cough reflex, ano-anal reflex and Rectoanal Inhibitory Reflex will be obtained, if possible.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal | Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible | up to 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Rectoanal Inhibitory Reflex | Amount of air in a balloon needed to elicit Rectoanal Inhibitory Reflex | up to 5 minutes | 
| Presence of dyssynergic defecation | Percent of children without constipation but with dyssynergic defecation pattern | up to 1 minute | 
| Presence of Cough Reflex |  | 10 seconds | 
| Presence of Ano-anal Reflex |  | 10 seconds | 
| Presence of discomfort during the procedure |  | up to 20 minutes |