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/NCT05991570</url>
    </required_header>
    <id_info>
      <org_study_id>AssiutCTS</org_study_id>
      <nct_id>NCT05991570</nct_id>
    </id_info>
    <brief_title>Thoracoscopic Exploration in Comparison to Exploratory Thoracotomy in Chest Trauma</brief_title>
    <official_title>Uni-portal Thoracoscopic Exploration in Comparison to Exploratory Thoracotomy in Hemodynamically Stable Thoracic Trauma Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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>
        Video-assisted thoracic surgery has a standard role in diagnosis and therapy in thoracic&#xD;
        surgery, In the past, most patients necessitating surgical treatment secondary to chest&#xD;
        trauma was exposed to open thoracotomy, which was the most morbid of surgical incisions&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Video-assisted thoracoscopic surgery has become a popular and acceptable method for diagnosis&#xD;
        of intra-thoracic lesions since 1990s with the developments in surgical techniques. It is&#xD;
        also used for treatment of retained pleural collections, it is a simple alternative to open&#xD;
        thoracotomy. Although it's multiple advantages, timing of surgery and its effects on&#xD;
        patients' results are not well elucidated. Multiple studies report that prognosis of patients&#xD;
        is better with the earlier interventions in injured chest. However, there is so many&#xD;
        differences for the optimal time for surgery in these studies .&#xD;
  &#xD;
        Indications of VATS have been extended for management of diagnosis and treatment of chest&#xD;
        trauma since 1990. This approach has multiple advantages as chest tube setting, minimally&#xD;
        invasive surgery, less postoperative pain, and chest exploration. Today, VATS is used for&#xD;
        empyema, persistent pneumothorax, retained haemothorax, mediastinal and diaphragmatic&#xD;
        exploration, pleuro-pericardial ruptures, surgery for thoracic duct injury and aspiration of&#xD;
        symptomatic foreign bodies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">January 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 30, 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>
      <intervention_model_description>cohort study</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Duration of airleak, lung expansion and post operative bleeding.</measure>
      <time_frame>2 weaks postoperative</time_frame>
      <description>• Duration of complete healing: By&#xD;
  Radiological (chest x-ray ant-post view and lat view &amp; MSCT chest post-operative.&#xD;
  Clinical examination post operative.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Thoracic Injury</condition>
    <arm_group>
      <arm_group_label>case</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Use of vedio assisted thoracoscopic surgery in exploration in diagnosis and treatment of chest trauma patients whos heamodynamically stable</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>exploratory thoracotomy inchest trauma patients in failure of vedio assisted thoracoscopic surgery or in haemodynamically instable patients</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Video Assisted Thoracoscopic Surgery (VATS)</intervention_name>
      <description>VATS is minimally invasive procedure for exploration to diagnose and treat thoracic injuries alternative to exploratory thoracotomy.</description>
      <arm_group_label>case</arm_group_label>
      <arm_group_label>control</arm_group_label>
      <other_name>Thoracoscopic Exploration</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. patient aged more than 13 yards old&#xD;
  &#xD;
            2. Hemo-dynamically stable patients with chest trauma&#xD;
  &#xD;
            3. Willing and able to provide written informed consent and comply with study&#xD;
               requirements.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. patient aged less than 13 yards old.&#xD;
  &#xD;
            2. Hemo-dynamically instable patients&#xD;
  &#xD;
            3. Head trauma patients.&#xD;
  &#xD;
            4. missing informed consent&#xD;
  &#xD;
            5. Participation in another clinical research.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Mohammed Hussein Rushdi</investigator_full_name>
      <investigator_title>Assistant Lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thoracic Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>through international publication</ipd_description>
    </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/NCT05991570
  org study id: AssiutCTS
  nct id: NCT05991570
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Video-assisted thoracic surgery has a standard role in diagnosis and therapy in thoracic
        surgery, In the past, most patients necessitating surgical treatment secondary to chest
        trauma was exposed to open thoracotomy, which was the most morbid of surgical incisions
  Video-assisted thoracoscopic surgery has become a popular and acceptable method for diagnosis
        of intra-thoracic lesions since 1990s with the developments in surgical techniques. It is
        also used for treatment of retained pleural collections, it is a simple alternative to open
        thoracotomy. Although it's multiple advantages, timing of surgery and its effects on
        patients' results are not well elucidated. Multiple studies report that prognosis of patients
        is better with the earlier interventions in injured chest. However, there is so many
        differences for the optimal time for surgery in these studies .
  
        Indications of VATS have been extended for management of diagnosis and treatment of chest
        trauma since 1990. This approach has multiple advantages as chest tube setting, minimally
        invasive surgery, less postoperative pain, and chest exploration. Today, VATS is used for
        empyema, persistent pneumothorax, retained haemothorax, mediastinal and diaphragmatic
        exploration, pleuro-pericardial ruptures, surgery for thoracic duct injury and aspiration of
        symptomatic foreign bodies.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: cohort study
  primary purpose: Diagnostic
  masking: Single (Participant)
  measure: Duration of airleak, lung expansion and post operative bleeding.
  time frame: 2 weaks postoperative
  description: • Duration of complete healing: By
  Radiological (chest x-ray ant-post view and lat view & MSCT chest post-operative.
  Clinical examination post operative.
  arm group label: case
  arm group type: Other
  description: Use of vedio assisted thoracoscopic surgery in exploration in diagnosis and treatment of chest trauma patients whos heamodynamically stable
  arm group label: control
  arm group type: Other
  description: exploratory thoracotomy inchest trauma patients in failure of vedio assisted thoracoscopic surgery or in haemodynamically instable patients
  intervention type: Procedure
  intervention name: Video Assisted Thoracoscopic Surgery (VATS)
  description: VATS is minimally invasive procedure for exploration to diagnose and treat thoracic injuries alternative to exploratory thoracotomy.
  arm group label: case
  arm group label: control
  other name: Thoracoscopic Exploration
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Mohammed Hussein Rushdi
  investigator title: Assistant Lecturer
  mesh term: Thoracic Injuries
  sharing ipd: No
  ipd description: through international publication