<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/NCT02212054</url>
  </required_header>
  <id_info>
    <org_study_id>101</org_study_id>
    <nct_id>NCT02212054</nct_id>
  </id_info>
  <brief_title>A Trial on Treatments of Hirschsprung Allied Disease</brief_title>
  <official_title>A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Children With Hirschsprung Allied Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study was designed to compare the efficacy of conservative treatment to operative&#xD;
      treatment for improvement of constipation symptoms in children with Hirschsprung allied&#xD;
      disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study was designed to compare the efficacy of conservative treatment,such as anal&#xD;
      dilatation, colonic lavage and so on, to operative treatment for improvement of constipation&#xD;
      symptoms in children with Hirschsprung allied disease&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">May 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the change of defecation frequency</measure>
    <time_frame>6~12 months</time_frame>
    <description>the changes of defecation frequency at 6~12 months after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>stool pattern</measure>
    <time_frame>6~12 months</time_frame>
    <description>stool pattern as hard stool or loose stool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>controlling stool ability</measure>
    <time_frame>6~12 months</time_frame>
    <description>whether patients' controlling stool ability is better or not after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complications</measure>
    <time_frame>6~12 months</time_frame>
    <description>complications were suffered by patients or not</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Complications of Treatment</condition>
  <condition>Complication of Surgical Procedure</condition>
  <condition>Megacolon, Not Hirschsprung</condition>
  <arm_group>
    <arm_group_label>conservative &amp; operative treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>anal dilation; colon lavage; probiotics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>operative treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>one stage pull- through radical colectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>conservative</intervention_name>
    <description>anal dilatation; colonic lavage; oral probiotic</description>
    <arm_group_label>conservative &amp; operative treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>operative</intervention_name>
    <description>one stage pull through radical colectomy</description>
    <arm_group_label>operative treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hard or firm stools for twice or less per week&#xD;
&#xD;
          -  a predicting score of less than 5 refer to literature: Wu, X.J., et al., A new&#xD;
             diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's&#xD;
             disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J&#xD;
             Colorectal Dis, 2013. 28(5): p. 689-96&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  functional constipation&#xD;
&#xD;
          -  a predicting score of more than 5 refer to literature: Wu, X.J., et al., A new&#xD;
             diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's&#xD;
             disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J&#xD;
             Colorectal Dis, 2013. 28(5): p. 689-96&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qi T Zhu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>department of pediatric surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiong J Feng, MD,PhD</last_name>
    <phone>0086-27-83665309</phone>
    <email>31699788@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Pediatric Surgery</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>Feng Jiexiong</investigator_full_name>
    <investigator_title>Chief of pediatric surgery department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Megacolon</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/NCT02212054
org study id: 101
nct id: NCT02212054
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study was designed to compare the efficacy of conservative treatment to operative
      treatment for improvement of constipation symptoms in children with Hirschsprung allied
      disease
The present study was designed to compare the efficacy of conservative treatment,such as anal
      dilatation, colonic lavage and so on, to operative treatment for improvement of constipation
      symptoms in children with Hirschsprung allied disease
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the change of defecation frequency
time frame: 6~12 months
description: the changes of defecation frequency at 6~12 months after treatment
measure: stool pattern
time frame: 6~12 months
description: stool pattern as hard stool or loose stool
measure: controlling stool ability
time frame: 6~12 months
description: whether patients' controlling stool ability is better or not after treatment
measure: complications
time frame: 6~12 months
description: complications were suffered by patients or not
arm group label: conservative & operative treatment
arm group type: Experimental
description: anal dilation; colon lavage; probiotics
arm group label: operative treatment
arm group type: Active Comparator
description: one stage pull- through radical colectomy
intervention type: Behavioral
intervention name: conservative
description: anal dilatation; colonic lavage; oral probiotic
arm group label: conservative & operative treatment
intervention type: Procedure
intervention name: operative
description: one stage pull through radical colectomy
arm group label: operative treatment
criteria: 
gender: All
minimum age: 1 Year
maximum age: 14 Years
healthy volunteers: No
last name: Qi T Zhu, PhD
role: Principal Investigator
affiliation: department of pediatric surgery
last name: Xiong J Feng, MD,PhD
phone: 0086-27-83665309
email: 31699788@qq.com
facility: 
status: Recruiting
country: China
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Feng Jiexiong
investigator title: Chief of pediatric surgery department
mesh term: Megacolon