Comparison of Anorectal Manometry and 3D Manometry in Diagnosis of Functional Disorders in Children

Study Overview
=================
Brief Summary
-----------------
Pressures measured by manometric solid-state catheters may differ according to the type of the catheter and specific anatomy and physiology of anorectum. The aim of the study is to establish the difference in recordings between 2 types of anorectal catheters used in pediatric patients and to validate the most appropriate way to diagnose of functional disorders.

Detailed Description
-----------------
Patients enrolled in study will be investigated by both types of anorectal catheters, first by anorectal high resolution flexible, thinner, solid-state catheter and after that with rigid, thicker, solid-state catheter. Both procedures will be undertaken during one session. There will be used standard protocol of the procedure that measures conventional manometric parameters (resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and recto anal inhibitory reflex threshold.

Official Title
-----------------
Comparison of High-resolution Anorectal Manometry and 3D High-definition Anorectal Manometry in Diagnosis of Functional Disorders in Children

Conditions
-----------------
Constipation, Children, Fecal Incontinence

Intervention / Treatment
-----------------
* Device: High-resolution anorectal manometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Functional Constipation Fecal Incontinence Parental Agreement Exclusion Criteria: After surgery on lower gastrointestinal tract Diagnosis of inflammatory bowel disorders Diagnosis of other disorders present in anorectal area, that may influence anorectal pressures Lack of parental agreement

Ages Eligible for Study
-----------------
Minimum Age: 4 Months
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High resolution anorectal manometry<br>All subjects will be investigated by high-resolution anorectal manometry. At the beginning the anorectal cather will be used to record conventional parameters and after that 3D high-definition anorectal manometric catheter will be inserted in order to measure conventional parameters and 3D picture of anorectum. | Device: High-resolution anorectal manometry<br>* Recording of conventional manometric parameters after insertion of the catheters.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Resting pressure of the anorectal area | Resting pressure will be measured after insertion catheter into anorectum. The software automatically record pressure while patient is lying on the bed. The parameter is recorded with 2 different types of anorectal catheters and the difference is evaluated. | 20 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum squeeze pressure | Pressure is recorded after the patient is asked to squeeze anorectum for 20 s (repeated 3 times). | 1 min | 
| Bear down manoeuver | Pressures are recorded after the patient is asked to bear down for 20 s (repeated 2 times) | 1 min | 
| Thresholds of sensation | The balloon at the top of the catheter is being filled with air until a patient is able to report sensation, urge and discomfort. | 1 min | 
| Recto anal inhibitory reflex | The balloon at the top of the catheter is being filled with air until the relaxation of anal sphincter is observed. | 5 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
manometry, children, constipation, functional disorders