xml: <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/NCT05985564</url>
    </required_header>
    <id_info>
      <org_study_id>ysong</org_study_id>
      <nct_id>NCT05985564</nct_id>
    </id_info>
    <brief_title>Retrospective Comparative Study on Imaging Between the Bochdalek Hernia and Congenital Diaphragmatic Eventration</brief_title>
    <official_title>Retrospective Comparative Study on Imaging Between the Bochdalek Hernia and Congenital Diaphragmatic Eventration</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Hospital of Chongqing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's Hospital of Chongqing Medical University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The imaging manifestations of diaphragmatic hernia and diaphragmatic distension were&#xD;
        retrospectively analyzed and summarized, combined with the surgical findings, to summarize&#xD;
        the differences in indirect signs of diaphragmatic hernia and diaphragmatic distension, so as&#xD;
        to achieve the purpose of differential diagnosis.Research contents: (1) To summarize the&#xD;
        characteristics of indirect imaging signs in patients with diaphragmatic hernia, to sum up&#xD;
        the incidence of each sign, to find new signs and the prognosis of each sign; (2) Summarize&#xD;
        the characteristics of indirect imaging signs in patients with diaphragmatic distension,&#xD;
        summarize the incidence of each sign, and search for new signs and the prognosis of each&#xD;
        sign; (3) To summarize the differences in indirect signs of diaphragmatic hernia and&#xD;
        diaphragmatic distension, as well as the differences in their incidence, and combined with&#xD;
        their surgical findings, to summarize their image identification points&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 18, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The position of the stomach</measure>
      <time_frame>1 day during the test</time_frame>
      <description>The position of the stomach through imaging examination and operation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The position of the small intestine</measure>
      <time_frame>1 day during the test</time_frame>
      <description>The position of the small intestine through imaging examination and operation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The morphology of the small intestine</measure>
      <time_frame>1 day during the test</time_frame>
      <description>The normal morphology, dilation and stenosis of the small intestine through imaging examination</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The position of the colon</measure>
      <time_frame>1 day during the test</time_frame>
      <description>The position of the colon through imaging examination and operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The morphology of the colon</measure>
      <time_frame>1 day during the test</time_frame>
      <description>The normal morphology, dilation and stenosis of the colon through imaging examination</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Congenital Diaphragmatic Hernia</condition>
    <arm_group>
      <arm_group_label>The Bochdalek hernia group</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>the congenital diaphragmatic eventration group</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>imaging diagnosis</intervention_name>
      <description>no intervention</description>
      <arm_group_label>The Bochdalek hernia group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The Bochdalek hernia and the congenital diaphragmatic eventration were included in the&#xD;
          study. They had undergone surgical treatment.The imaging results and the surgical results&#xD;
          were analysis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of diaphragmatic hernia with surgical treatment&#xD;
  &#xD;
            -  Clinical diagnosis of congenital diaphragmatic eventration with surgical treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diaphragmatic hernia or congenital diaphragmatic eventration without surgical&#xD;
               treatment&#xD;
  &#xD;
            -  Diaphragmatic hernia or congenital diaphragmatic eventration without imaging&#xD;
               examination&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>song yan</last_name>
      <phone>13637921652</phone>
      <email>doctorsongyan@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>shi yuan</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Children's Hospital of Chongqing Medical University</name>
        <address>
          <city>Chongqing</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>song yan</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Alamo L, Gudinchet F, Meuli R. Imaging findings in fetal diaphragmatic abnormalities. Pediatr Radiol. 2015 Dec;45(13):1887-900. doi: 10.1007/s00247-015-3418-5. Epub 2015 Aug 9.</citation>
      <PMID>26255159</PMID>
    </reference>
    <reference>
      <citation>Brown BP, Clark MT, Wise RL, Timsina LR, Reher TA, Vandewalle RJ, Brown JJ, Saenz ZM, Gray BW. A multifactorial severity score for left congenital diaphragmatic hernia in a high-risk population using fetal magnetic resonance imaging. Pediatr Radiol. 2019 Dec;49(13):1718-1725. doi: 10.1007/s00247-019-04478-2. Epub 2019 Aug 14.</citation>
      <PMID>31414145</PMID>
    </reference>
    <reference>
      <citation>Goodfellow T, Hyde I, Burge DM, Freeman NV. Congenital diaphragmatic hernia: the prognostic significance of the site of the stomach. Br J Radiol. 1987 Oct;60(718):993-5. doi: 10.1259/0007-1285-60-718-993.</citation>
      <PMID>3676659</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Children's Hospital of Chongqing Medical University</investigator_affiliation>
      <investigator_full_name>yan song</investigator_full_name>
      <investigator_title>doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diaphragmatic Eventration</mesh_term>
      <mesh_term>Hernias, Diaphragmatic, Congenital</mesh_term>
      <mesh_term>Hernia</mesh_term>
      <mesh_term>Hernia, Diaphragmatic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985564
  org study id: ysong
  nct id: NCT05985564
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The imaging manifestations of diaphragmatic hernia and diaphragmatic distension were
        retrospectively analyzed and summarized, combined with the surgical findings, to summarize
        the differences in indirect signs of diaphragmatic hernia and diaphragmatic distension, so as
        to achieve the purpose of differential diagnosis.Research contents: (1) To summarize the
        characteristics of indirect imaging signs in patients with diaphragmatic hernia, to sum up
        the incidence of each sign, to find new signs and the prognosis of each sign; (2) Summarize
        the characteristics of indirect imaging signs in patients with diaphragmatic distension,
        summarize the incidence of each sign, and search for new signs and the prognosis of each
        sign; (3) To summarize the differences in indirect signs of diaphragmatic hernia and
        diaphragmatic distension, as well as the differences in their incidence, and combined with
        their surgical findings, to summarize their image identification points
  observational model: Case-Control
  time perspective: Retrospective
  measure: The position of the stomach
  time frame: 1 day during the test
  description: The position of the stomach through imaging examination and operation
  measure: The position of the small intestine
  time frame: 1 day during the test
  description: The position of the small intestine through imaging examination and operation
  measure: The morphology of the small intestine
  time frame: 1 day during the test
  description: The normal morphology, dilation and stenosis of the small intestine through imaging examination
  measure: The position of the colon
  time frame: 1 day during the test
  description: The position of the colon through imaging examination and operation
  measure: The morphology of the colon
  time frame: 1 day during the test
  description: The normal morphology, dilation and stenosis of the colon through imaging examination
  arm group label: The Bochdalek hernia group
  arm group label: the congenital diaphragmatic eventration group
  intervention type: Other
  intervention name: imaging diagnosis
  description: no intervention
  arm group label: The Bochdalek hernia group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 14 Years
  healthy volunteers: No
  last name: song yan
  phone: 13637921652
  email: doctorsongyan@163.com
  last name: shi yuan
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Alamo L, Gudinchet F, Meuli R. Imaging findings in fetal diaphragmatic abnormalities. Pediatr Radiol. 2015 Dec;45(13):1887-900. doi: 10.1007/s00247-015-3418-5. Epub 2015 Aug 9.
  PMID: 26255159
  citation: Brown BP, Clark MT, Wise RL, Timsina LR, Reher TA, Vandewalle RJ, Brown JJ, Saenz ZM, Gray BW. A multifactorial severity score for left congenital diaphragmatic hernia in a high-risk population using fetal magnetic resonance imaging. Pediatr Radiol. 2019 Dec;49(13):1718-1725. doi: 10.1007/s00247-019-04478-2. Epub 2019 Aug 14.
  PMID: 31414145
  citation: Goodfellow T, Hyde I, Burge DM, Freeman NV. Congenital diaphragmatic hernia: the prognostic significance of the site of the stomach. Br J Radiol. 1987 Oct;60(718):993-5. doi: 10.1259/0007-1285-60-718-993.
  PMID: 3676659
  responsible party type: Principal Investigator
  investigator affiliation: Children's Hospital of Chongqing Medical University
  investigator full name: yan song
  investigator title: doctor
  mesh term: Diaphragmatic Eventration
  mesh term: Hernias, Diaphragmatic, Congenital
  mesh term: Hernia
  mesh term: Hernia, Diaphragmatic
  sharing ipd: No