<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/NCT02216994</url>
  </required_header>
  <id_info>
    <org_study_id>TJCD-D-13-00074</org_study_id>
    <secondary_id>tj2014701</secondary_id>
    <nct_id>NCT02216994</nct_id>
  </id_info>
  <brief_title>A New Scoring System Improves Diagnostic Accuracy of Intestinal Dysganglionosis --a Prospective Study</brief_title>
  <official_title>Efficacy and Accuracy of a New Diagnostic Scoring System to Differentiate Hirschsprung Disease From Hirschsprung Disease Allied Disorders in the Patients With Suspected Intestinal Dysganglinosis: a Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jiangxi Province Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tongji Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. The investigators previously reported a simple diagnostic scoring system to&#xD;
           differentiate Hirschsprung disease (HD) from Hirschsprung disease allied disorders (HAD)&#xD;
           in the patients with suspected intestinal dysganglionosis. In the retrospective study,&#xD;
           the investigators concluded that the patients with a predicting score of more than 5 are&#xD;
           more likely to be diagnosed with HD, whereas a score less than 5 is mostly indicative of&#xD;
           HAD.&#xD;
&#xD;
        2. Since it is essential to confirm the accuracy and efficacy of the scoring system in a&#xD;
           prospective manner before it is used as a standard procedure, this prospective study is&#xD;
           designed and performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Patients have hard or firm stools for 2 or less per week, and with ages from newborn to&#xD;
           3 years old are recruited in this study.&#xD;
&#xD;
        2. The recruited patients is undergoing preoperative work-up including barium enema (BE),&#xD;
           anorectal manometry (ARM) and histochemical acetylcholinesterase (AChE) staining of&#xD;
           rectal mucosa. Known risk factors for intestinal dysganglionosis (IDs) are recorded. The&#xD;
           predicting score is calculated by summing the scores of the risk factors and 3&#xD;
           preoperative tests.&#xD;
&#xD;
        3. The patients with a predicting score of more than 5 are diagnosed with HD, and are&#xD;
           performed surgery to remove the aganglionic bowel.&#xD;
&#xD;
        4. The patients with a score less than 5 are mostly indicative of HAD, and receive&#xD;
           conservative therapies that included colonic irrigation, enema, high dose lactulose, and&#xD;
           oral paraffin oil for at least 6 months. When there is no clinical improvement, patients&#xD;
           are consented for surgical procedures to remove the dysganglionic bowel segments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>the predicting score calculation</measure>
    <time_frame>6-12 months</time_frame>
    <description>The recruited patients is undergoing preoperative work-up including barium enema (BE), anorectal manometry (ARM) and histochemical acetylcholinesterase (AChE) staining of rectal mucosa. Known risk factors for IDs are recorded. The predicting score is calculated by summing the scores of the risk factors and 3 preoperative tests.&#xD;
The patients with a predicting score of more than 5 are diagnosed with HD, and are performed surgery to remove the aganglionic bowel.&#xD;
The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pathological diagnosis</measure>
    <time_frame>12-18 months</time_frame>
    <description>The intestinal specimens were reviewed by 3 experienced pathologists all of whom had participated in a consensus meeting on diagnostic criteria of IDs.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Hirschsprung Disease</condition>
  <arm_group>
    <arm_group_label>surgery treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patients with a predicting score of more than 5 are diagnosed with HD, and are performed surgery to remove the aganglionic bowel. The patients with a score less than 5 are mostly indicative of HAD, and receive conservative treatments that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments. one stage pull through procedure to remove the dysganglionic bowel segments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>high dose lactulose</intervention_name>
    <description>The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.</description>
    <arm_group_label>surgery treatment</arm_group_label>
    <other_name>Duphalac®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>conservative treatment</intervention_name>
    <description>The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.</description>
    <arm_group_label>surgery treatment</arm_group_label>
    <other_name>colonic irrigation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paraffin oil</intervention_name>
    <description>The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.</description>
    <arm_group_label>surgery treatment</arm_group_label>
    <other_name>Shilayou®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hard or firm stools for 2 or less per week&#xD;
&#xD;
          -  Age are from newborn to 3 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children&gt;3 years of age&#xD;
&#xD;
          -  Patients presented severe inflammation or malnutrition, unconsciousness or perforation&#xD;
             of intestine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiexiong Feng, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji Medical College,Huazhong University of Science and Technology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hongyi Zhang, MD</last_name>
    <phone>27-83665209</phone>
    <phone_ext>01186</phone_ext>
    <email>zhanghongyidoc@foxmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tongji Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongyi Zhang, MD</last_name>
      <phone>27-83665209</phone>
      <phone_ext>01186</phone_ext>
      <email>zhanghongyidoc@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jiexiong Feng, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jinshi Huang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>October 27, 2014</last_update_submitted>
  <last_update_submitted_qc>October 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>Jiexiong Feng</investigator_full_name>
    <investigator_title>Director of pediatric surgery department</investigator_title>
  </responsible_party>
  <keyword>Intestinal dysganglinosis</keyword>
  <keyword>Hirschsprung disease</keyword>
  <keyword>Hirschsprung disease allied disorders</keyword>
  <keyword>diagnostic scoring system</keyword>
  <keyword>Prospective study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hirschsprung Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mineral Oil</mesh_term>
    <mesh_term>Lactulose</mesh_term>
  </intervention_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/NCT02216994
org study id: TJCD-D-13-00074
secondary id: tj2014701
nct id: NCT02216994
lead sponsor: 
collaborator: 
has dmc: Yes
1. The investigators previously reported a simple diagnostic scoring system to
           differentiate Hirschsprung disease (HD) from Hirschsprung disease allied disorders (HAD)
           in the patients with suspected intestinal dysganglionosis. In the retrospective study,
           the investigators concluded that the patients with a predicting score of more than 5 are
           more likely to be diagnosed with HD, whereas a score less than 5 is mostly indicative of
           HAD.

        2. Since it is essential to confirm the accuracy and efficacy of the scoring system in a
           prospective manner before it is used as a standard procedure, this prospective study is
           designed and performed.
1. Patients have hard or firm stools for 2 or less per week, and with ages from newborn to
           3 years old are recruited in this study.

        2. The recruited patients is undergoing preoperative work-up including barium enema (BE),
           anorectal manometry (ARM) and histochemical acetylcholinesterase (AChE) staining of
           rectal mucosa. Known risk factors for intestinal dysganglionosis (IDs) are recorded. The
           predicting score is calculated by summing the scores of the risk factors and 3
           preoperative tests.

        3. The patients with a predicting score of more than 5 are diagnosed with HD, and are
           performed surgery to remove the aganglionic bowel.

        4. The patients with a score less than 5 are mostly indicative of HAD, and receive
           conservative therapies that included colonic irrigation, enema, high dose lactulose, and
           oral paraffin oil for at least 6 months. When there is no clinical improvement, patients
           are consented for surgical procedures to remove the dysganglionic bowel segments.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: the predicting score calculation
time frame: 6-12 months
description: The recruited patients is undergoing preoperative work-up including barium enema (BE), anorectal manometry (ARM) and histochemical acetylcholinesterase (AChE) staining of rectal mucosa. Known risk factors for IDs are recorded. The predicting score is calculated by summing the scores of the risk factors and 3 preoperative tests.
The patients with a predicting score of more than 5 are diagnosed with HD, and are performed surgery to remove the aganglionic bowel.
The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.
measure: pathological diagnosis
time frame: 12-18 months
description: The intestinal specimens were reviewed by 3 experienced pathologists all of whom had participated in a consensus meeting on diagnostic criteria of IDs.
arm group label: surgery treatment
arm group type: Other
description: The patients with a predicting score of more than 5 are diagnosed with HD, and are performed surgery to remove the aganglionic bowel. The patients with a score less than 5 are mostly indicative of HAD, and receive conservative treatments that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments. one stage pull through procedure to remove the dysganglionic bowel segments.
intervention type: Drug
intervention name: high dose lactulose
description: The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.
arm group label: surgery treatment
other name: Duphalac®
intervention type: Behavioral
intervention name: conservative treatment
description: The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.
arm group label: surgery treatment
other name: colonic irrigation
intervention type: Drug
intervention name: paraffin oil
description: The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.
arm group label: surgery treatment
other name: Shilayou®
criteria: 
gender: All
minimum age: 1 Day
maximum age: 3 Years
healthy volunteers: No
last name: Jiexiong Feng, MD, PhD
role: Principal Investigator
affiliation: Tongji Medical College,Huazhong University of Science and Technology
last name: Hongyi Zhang, MD
phone: 27-83665209
phone ext: 01186
email: zhanghongyidoc@foxmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Jiexiong Feng
investigator title: Director of pediatric surgery department
mesh term: Hirschsprung Disease
mesh term: Mineral Oil
mesh term: Lactulose