<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/NCT03295617</url>
  </required_header>
  <id_info>
    <org_study_id>2017/xx</org_study_id>
    <nct_id>NCT03295617</nct_id>
  </id_info>
  <brief_title>Management of Giant Thoracic Disc Hernias by Thoracoscopy: Experience of 52 Cases</brief_title>
  <acronym>GHTT</acronym>
  <official_title>Management of Giant Thoracic Disc Hernias by Thoracoscopy: Experience of 52 Cases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <has_dmc>No</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>
      Introduction: Giant thoracic disc herniation is a rare condition for which surgical treatment&#xD;
      is indicated when there are signs of spinal cord injury. To date, several surgical techniques&#xD;
      have been described in the treatment of this condition on small patient series. The main&#xD;
      objective is to evaluate the long-term results of a series of 53 patients treated with a&#xD;
      minimally invasive endoscopic procedure. The secondary objective is to explain our&#xD;
      pre-operative planning and the technical details of our procedure. METHOD: Retrospective&#xD;
      monocentric study on a cohort of patients treated in our department. The following medical&#xD;
      data from our database are analyzed: Morbidity of operative gesture (duration of procedure,&#xD;
      bleeding, postoperative complications), clinical results at the last follow-up visit&#xD;
      (thoracic Japanese Orthopedic Association (JOA) score, Frankel score, parietal pain , ability&#xD;
      to walk, wish to carry out the same intervention again if necessary). On the radiological&#xD;
      level, we evaluated the quality of the resection (total, subtotal, incomplete and&#xD;
      impossible), the reappearance of a border of cerebrospinal fluid perimedullary and the&#xD;
      presence of an intramedullary T2 hyperintense signal MRI post- operative. All these data are&#xD;
      collected and analyzed anonymously. Expected Results: We believe we can demonstrate that&#xD;
      thoracoscopy is a valid therapeutic option in the treatment of thoracic disc herniation&#xD;
      responsible for spinal cord compression. This with a low morbidity given the minimally&#xD;
      invasive nature of the approach.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">July 30, 2017</completion_date>
  <primary_completion_date type="Actual">July 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Japanese Orthopedic Association Score</measure>
    <time_frame>30 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frankel score</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parietal pain measured by visual analogic scale</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">52</enrollment>
  <condition>Giant Thoracic Herniation</condition>
  <condition>Myelopathy</condition>
  <arm_group>
    <arm_group_label>spinal thoracic herniation</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thoracoscopy</intervention_name>
    <description>Thoracoscopy surgery</description>
    <arm_group_label>spinal thoracic herniation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient operated on giant thoracic thoracic disc herniation between May 2001 and October&#xD;
        2016&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient operated on giant thoracic thoracic disc herniation between May 2001 and&#xD;
             October 2016&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Brauge, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spinal thoracic herniation</keyword>
  <keyword>surgery</keyword>
  <keyword>endoscopic approach</keyword>
  <keyword>thoracic spine</keyword>
  <keyword>minimal invasive access</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Diseases</mesh_term>
    <mesh_term>Hernia</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/NCT03295617
org study id: 2017/xx
nct id: NCT03295617
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction: Giant thoracic disc herniation is a rare condition for which surgical treatment
      is indicated when there are signs of spinal cord injury. To date, several surgical techniques
      have been described in the treatment of this condition on small patient series. The main
      objective is to evaluate the long-term results of a series of 53 patients treated with a
      minimally invasive endoscopic procedure. The secondary objective is to explain our
      pre-operative planning and the technical details of our procedure. METHOD: Retrospective
      monocentric study on a cohort of patients treated in our department. The following medical
      data from our database are analyzed: Morbidity of operative gesture (duration of procedure,
      bleeding, postoperative complications), clinical results at the last follow-up visit
      (thoracic Japanese Orthopedic Association (JOA) score, Frankel score, parietal pain , ability
      to walk, wish to carry out the same intervention again if necessary). On the radiological
      level, we evaluated the quality of the resection (total, subtotal, incomplete and
      impossible), the reappearance of a border of cerebrospinal fluid perimedullary and the
      presence of an intramedullary T2 hyperintense signal MRI post- operative. All these data are
      collected and analyzed anonymously. Expected Results: We believe we can demonstrate that
      thoracoscopy is a valid therapeutic option in the treatment of thoracic disc herniation
      responsible for spinal cord compression. This with a low morbidity given the minimally
      invasive nature of the approach.
observational model: Cohort
time perspective: Retrospective
measure: Japanese Orthopedic Association Score
time frame: 30 minutes
measure: Frankel score
time frame: 30 minutes
measure: Parietal pain measured by visual analogic scale
time frame: 30 minutes
arm group label: spinal thoracic herniation
intervention type: Procedure
intervention name: Thoracoscopy
description: Thoracoscopy surgery
arm group label: spinal thoracic herniation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: David Brauge, MD
role: Principal Investigator
affiliation: Hopital Foch
facility: 
country: France
responsible party type: Sponsor
mesh term: Spinal Cord Diseases
mesh term: Hernia