<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/NCT02234219</url>
  </required_header>
  <id_info>
    <org_study_id>Anastomosis in Hirschsprung</org_study_id>
    <nct_id>NCT02234219</nct_id>
  </id_info>
  <brief_title>Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial</brief_title>
  <official_title>Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial</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>
      Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 30, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative cure rate</measure>
    <time_frame>two years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complication rate</measure>
    <time_frame>two years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Circular Anastomosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Heart-shaped Anastomosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Heart-shape anastomosis</intervention_name>
    <description>a new operation approach for Hirschsprung disease</description>
    <arm_group_label>Circular Anastomosis</arm_group_label>
    <arm_group_label>Heart-shaped Anastomosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age&lt;14 years&#xD;
&#xD;
          2. Hirschsprung's disease diagnosed by biopsy&#xD;
&#xD;
          3. Surgical indication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age&gt;14 years&#xD;
&#xD;
          2. Not Hirschsprung's disease&#xD;
&#xD;
          3. Surgical contraindication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>Zhi Li, MD PhD</last_name>
      <phone>13387664883</phone>
      <email>lizhimdphd@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</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>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hirschsprung Disease</mesh_term>
    <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/NCT02234219
org study id: Anastomosis in Hirschsprung
nct id: NCT02234219
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Postoperative cure rate
time frame: two years
measure: Postoperative complication rate
time frame: two years
arm group label: Circular Anastomosis
arm group type: Active Comparator
arm group label: Heart-shaped Anastomosis
arm group type: Active Comparator
intervention type: Procedure
intervention name: Heart-shape anastomosis
description: a new operation approach for Hirschsprung disease
arm group label: Circular Anastomosis
arm group label: Heart-shaped Anastomosis
criteria: 
gender: All
minimum age: N/A
maximum age: 14 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Jiexiong Feng
investigator title: Professor
mesh term: Hirschsprung Disease
mesh term: Constipation