<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02236507</url>
  </required_header>
  <id_info>
    <org_study_id>Banasiuk2014 A</org_study_id>
    <nct_id>NCT02236507</nct_id>
  </id_info>
  <brief_title>Normal Values for 3D High Resolution Anorectal Manometry in Children</brief_title>
  <official_title>Evaluation of Anorectal Area in Children Using 3D High Resolution Anorectal Manometry.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <brief_summary>
    <textblock>
      Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry&#xD;
      equipment and has been recently introduced into clinical practice. It is the most precise&#xD;
      method to assess the anal sphincter pressure function and may be crucial for planning and&#xD;
      controlling surgical procedures of the anorectal area. Normal values in pediatric population&#xD;
      have not been established.&#xD;
&#xD;
      The aim of this study is complex evaluation of anorectal function in children without&#xD;
      symptoms from lower GI tract and establishment of normal values.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal</measure>
    <time_frame>up to 20 minutes</time_frame>
    <description>Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of Rectoanal Inhibitory Reflex</measure>
    <time_frame>up to 5 minutes</time_frame>
    <description>Amount of air in a balloon needed to elicit Rectoanal Inhibitory Reflex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of dyssynergic defecation</measure>
    <time_frame>up to 1 minute</time_frame>
    <description>Percent of children without constipation but with dyssynergic defecation pattern</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of Cough Reflex</measure>
    <time_frame>10 seconds</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of Ano-anal Reflex</measure>
    <time_frame>10 seconds</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of discomfort during the procedure</measure>
    <time_frame>up to 20 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Children</condition>
  <condition>Anorectal Disorder</condition>
  <arm_group>
    <arm_group_label>children without anorectal disorders</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All children will be investigated by 3D high resolution anorectal manometry procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D high resolution anorectal manometry</intervention_name>
    <description>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.</description>
    <arm_group_label>children without anorectal disorders</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  parental agreement&#xD;
&#xD;
          -  age: 1 to 18 yr&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parental disagreement&#xD;
&#xD;
          -  children younger than 1 yr&#xD;
&#xD;
          -  children after the surgery for anorectal malformations&#xD;
&#xD;
          -  children with constipation during the last 10 months&#xD;
&#xD;
          -  children with nonretentive fecal soiling&#xD;
&#xD;
          -  children with inflammatory bowel diseases or any other type of large bowel&#xD;
             inflammation&#xD;
&#xD;
          -  children with anal fissure, anal varices, inflammation of the anorectal area or any&#xD;
             other disease that may interfere with function of anorectum&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcin Banasiuk, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Pediatric Gastroenterology and Nutrition</name>
      <address>
        <city>Warsaw</city>
        <zip>01-184</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>December 22, 2015</last_update_submitted>
  <last_update_submitted_qc>December 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Marcin Banasiuk</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02236507
org study id: Banasiuk2014 A
nct id: NCT02236507
lead sponsor: 
collaborator: 
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: 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
description: Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible
measure: Presence of Rectoanal Inhibitory Reflex
time frame: up to 5 minutes
description: Amount of air in a balloon needed to elicit Rectoanal Inhibitory Reflex
measure: Presence of dyssynergic defecation
time frame: up to 1 minute
description: Percent of children without constipation but with dyssynergic defecation pattern
measure: Presence of Cough Reflex
time frame: 10 seconds
measure: Presence of Ano-anal Reflex
time frame: 10 seconds
measure: Presence of discomfort during the procedure
time frame: up to 20 minutes
arm group label: children without anorectal disorders
arm group type: Other
description: All children will be investigated by 3D high resolution anorectal manometry procedure
intervention type: Device
intervention name: 3D high resolution anorectal manometry
description: 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.
arm group label: children without anorectal disorders
criteria: 
gender: All
minimum age: 12 Months
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marcin Banasiuk, MD
role: Principal Investigator
affiliation: Medical University of Warsaw
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Marcin Banasiuk
investigator title: MD
mesh term: Rectal Diseases