<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/NCT01695915</url>
  </required_header>
  <id_info>
    <org_study_id>DV-Rect-UL</org_study_id>
    <nct_id>NCT01695915</nct_id>
  </id_info>
  <brief_title>Diurnal Variation in Rectal Diameter</brief_title>
  <official_title>Diurnal Variation in Rectal Diameter Measured by Transabdominal Ultrasound in Healthy and Constipated Children.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Line Modin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vejle Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the diurnal variation of rectal diameter in healthy&#xD;
      and constipated children using transabdominal ultrasound.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rectal diameter</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>Transabdominal ultrasound</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Constipated</arm_group_label>
    <description>Transabdominal ultrasound</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transabdominal ultrasound</intervention_name>
    <description>Transabdominal ultrasound are applied to the subjects every third hour during the study and every hour for three hours after a bowel movement.</description>
    <arm_group_label>Constipated</arm_group_label>
    <arm_group_label>Healthy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Constipated children are recruited from the outpatient clinic at Kolding pediatric&#xD;
        department. A list of patients which have been given the diagnose constipation are drawn&#xD;
        from the computer and reviewed. Children between 4-12 years who fulfill the Rome III&#xD;
        criteria of constipation and have been taking PEG maintenance treatment at least 1 month,&#xD;
        are contacted by telephone for possible participation in the study.&#xD;
&#xD;
        Healthy participants without constipation or other diseases affecting the gastrointestinal&#xD;
        tract were recruited among the employees of the Department of Pediatrics at Kolding&#xD;
        Hospital.&#xD;
&#xD;
        Written informed consent was obtained from both parents before any procedures were&#xD;
        initiated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Constipated Inclusion Criteria:&#xD;
&#xD;
          -  Children from 4 to 12 years with previously diagnosed simple constipation defined by&#xD;
             ROME III criteria, which at inclusion is in maintenance therapy with PEG + E and has&#xD;
             been in treatment for at least 1 month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with known organic causes of constipation, including Hirschsprungs disease,&#xD;
             spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory&#xD;
             bowel disease, allergy and metabolic or endocrine diseases.&#xD;
&#xD;
          -  Children receiving drugs known to affect bowel function during a 2 month period before&#xD;
             initiation besides laxatives.&#xD;
&#xD;
        Healthy inclusion Criteria:&#xD;
&#xD;
          -  Children between 4 and 12 years of age.&#xD;
&#xD;
        Healthy exclusion Criteria:&#xD;
&#xD;
          -  Children with known organic causes of constipation, including Hirschsprungs disease,&#xD;
             spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory&#xD;
             bowel disease, allergy and metabolic or endocrine diseases.&#xD;
&#xD;
          -  Children receiving drugs known to affect bowel function during a 2 month period before&#xD;
             initiation.&#xD;
&#xD;
          -  Children with a previous history of constipation, fecal incontinence and / or urinary&#xD;
             tract infections.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Line Modin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kolding Sygehus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marianne Jakobsen, MD, phd</last_name>
    <role>Study Director</role>
    <affiliation>Kolding Sygehus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pediatric department, Kolding Hospital</name>
      <address>
        <city>Kolding</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>November 15, 2012</last_update_submitted>
  <last_update_submitted_qc>November 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Vejle Hospital</investigator_affiliation>
    <investigator_full_name>Line Modin</investigator_full_name>
    <investigator_title>Medical doctor</investigator_title>
  </responsible_party>
  <keyword>constipation</keyword>
  <keyword>children</keyword>
  <keyword>healthy</keyword>
  <keyword>rectal diameter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</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/NCT01695915
org study id: DV-Rect-UL
nct id: NCT01695915
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to determine the diurnal variation of rectal diameter in healthy
      and constipated children using transabdominal ultrasound.
observational model: Case-Control
time perspective: Prospective
measure: Rectal diameter
time frame: 24 hours
arm group label: Healthy
description: Transabdominal ultrasound
arm group label: Constipated
description: Transabdominal ultrasound
intervention type: Procedure
intervention name: Transabdominal ultrasound
description: Transabdominal ultrasound are applied to the subjects every third hour during the study and every hour for three hours after a bowel movement.
arm group label: Constipated
arm group label: Healthy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Line Modin, MD
role: Principal Investigator
affiliation: Kolding Sygehus
last name: Marianne Jakobsen, MD, phd
role: Study Director
affiliation: Kolding Sygehus
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Vejle Hospital
investigator full name: Line Modin
investigator title: Medical doctor
mesh term: Constipation