<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/NCT04412512</url>
  </required_header>
  <id_info>
    <org_study_id>VATS for pulmonary hydatid</org_study_id>
    <nct_id>NCT04412512</nct_id>
  </id_info>
  <brief_title>VATS Versus Thoracotomy for Pulmonary Hydatid Disease</brief_title>
  <acronym>VATS</acronym>
  <official_title>VATS Versus Thoracotomy for Pulmonary Hydatid Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hassan II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hassan II 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 aim of this study is to evaluate the efficacy and safety of minimally invasive surgery&#xD;
      and compare the outcomes with patients undergoing thoracotomy in treatment of Pulmonary&#xD;
      Hydatid Cyst.&#xD;
&#xD;
      Disease : pulmonary hydatid cyst.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
        -  Group 1 : VATS approach.&#xD;
&#xD;
        -  Group 2 : thoracotomy approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After being informed about the study and the approach, all patients giving written informed&#xD;
      consent to determine eligibility for study entry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">April 2020</completion_date>
  <primary_completion_date type="Actual">December 2019</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>
    <intervention_model_description>study the effect of a treatment and evaluate outcome postoperative</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>30 days</time_frame>
    <description>evaluate the complication at 30 days</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Pulmonary Hydatid Cyst</condition>
  <arm_group>
    <arm_group_label>VATS approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients treated by VATS technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thoracotomy approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients treated by Thoracotomy technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>VATS approach</intervention_name>
    <description>video-assisted thoracic surgery approach</description>
    <arm_group_label>VATS approach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thoracotomy approach</intervention_name>
    <arm_group_label>Thoracotomy approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - all patients underwent surgery for pulmonary hydatid cyst&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>81 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>sara WAGUAF</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hassan II University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hassan II University</name>
      <address>
        <city>Casablanca</city>
        <zip>20000</zip>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Morocco</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hassan II University</investigator_affiliation>
    <investigator_full_name>Sara WAGUAF</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>pulmonary hydatid cyst</keyword>
  <keyword>video-assisted thoracic surgery</keyword>
  <keyword>thoracotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Echinococcosis</mesh_term>
    <mesh_term>Echinococcosis, Pulmonary</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/NCT04412512
org study id: VATS for pulmonary hydatid
nct id: NCT04412512
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the efficacy and safety of minimally invasive surgery
      and compare the outcomes with patients undergoing thoracotomy in treatment of Pulmonary
      Hydatid Cyst.

      Disease : pulmonary hydatid cyst.

      Intervention:

        -  Group 1 : VATS approach.

        -  Group 2 : thoracotomy approach.
After being informed about the study and the approach, all patients giving written informed
      consent to determine eligibility for study entry.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: study the effect of a treatment and evaluate outcome postoperative
primary purpose: Treatment
masking: Single (Investigator)
measure: Postoperative complications
time frame: 30 days
description: evaluate the complication at 30 days
arm group label: VATS approach
arm group type: Experimental
description: patients treated by VATS technique.
arm group label: Thoracotomy approach
arm group type: Active Comparator
description: patients treated by Thoracotomy technique
intervention type: Procedure
intervention name: VATS approach
description: video-assisted thoracic surgery approach
arm group label: VATS approach
intervention type: Procedure
intervention name: Thoracotomy approach
arm group label: Thoracotomy approach
criteria: 
gender: All
minimum age: 6 Years
maximum age: 81 Years
healthy volunteers: Accepts Healthy Volunteers
last name: sara WAGUAF
role: Principal Investigator
affiliation: Hassan II University
facility: 
country: Morocco
responsible party type: Principal Investigator
investigator affiliation: Hassan II University
investigator full name: Sara WAGUAF
investigator title: Principal Investigator
mesh term: Echinococcosis
mesh term: Echinococcosis, Pulmonary