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/NCT06036888</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A00126-39</org_study_id>
      <nct_id>NCT06036888</nct_id>
    </id_info>
    <brief_title>DEFILE-QoL5 - Evaluation of the Long-term Surgical Management of the Thoraco-brachial Displacement Syndrome</brief_title>
    <acronym>DEFILE-QoL5</acronym>
    <official_title>DEFILE-QoL5 - Evaluation de la Prise en Charge Chirurgicale à 5 Ans du Syndrome du défilé Thoraco-brachial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Angers</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Angers</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>
        The study concerns patients hospitalized in vascular and thoracic surgery in 2016 at the&#xD;
        University Hospital of Angers for the management of a thoraco-brachial outlet syndrome. It&#xD;
        includes all vascular and neurological manifestations related to intermittent or permanent&#xD;
        compression of the vasculo-nervous bundle of the upper limb. Before and after the operation,&#xD;
        these patients had agreed to complete the quality of life questionnaires, the Disabilities of&#xD;
        the Arm, Shoulder and Hand questionary (DASH) and the Short-Form 12 (SF-12). The objective of&#xD;
        the present study is to evaluate the long-term quality of life, using the questionnaires&#xD;
        mentioned above, completed by 54 patients treated surgically for thoraco-brachial outlet&#xD;
        syndrome and who participated in the DEFILE-QoL study in 2016.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All patients included in the DEFILE-QoL study (in 2016) receive an information letter.&#xD;
        Without opposition from them after 4 weeks, they are contacted by telephone. The telephone&#xD;
        interview begins with an explanation of the study and a time to answer any questions from the&#xD;
        patient.&#xD;
  &#xD;
        If they agree to participate, they answer the DASH and the SF-12 questionnaires, for an&#xD;
        estimated duration of 15 minutes. Following the telephone interview, the patient's&#xD;
        participation in the study was terminated.&#xD;
  &#xD;
        The date of the information and the patient's non-objection are documented in the patient's&#xD;
        source file.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">March 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 15, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Quality of life scores</measure>
      <time_frame>at least 5 years after surgery</time_frame>
      <description>Assess the quality of life, using standardized questionnaires, of patients treated surgically for thoraco-brachial outlet syndrome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Factors associated with poor long-term clinical outcome</measure>
      <time_frame>at least 5 years after surgery</time_frame>
      <description>Identify factors associated with poor long-term clinical outcome (DEFILE-QoL in 2016) : clinical presentation of Syndrome, its severity, the imaging examinations performed and the various scores collected</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Thoracic Outlet Syndrome</condition>
    <arm_group>
      <arm_group_label>thoracobrachial outlet syndrome</arm_group_label>
      <description>Patient :&#xD;
  adult&#xD;
  with thoraco-brachial outlet syndrome&#xD;
  who has participated to DEFILE-QoL study in 2016&#xD;
  who accept to participate and is able to complete questionaries</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>questionaries completion</intervention_name>
      <description>Answer to the DASH and SF-12 questionaries, for an estimated duration of 15 minutes.</description>
      <arm_group_label>thoracobrachial outlet syndrome</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients followed for thoraco-brachial outlet syndrome and treated surgically in the&#xD;
          department of university Angers hospital in 2016&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult&#xD;
  &#xD;
            -  having participated in the initial study : &quot;DEFILE-QoL&quot;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  opposing participation in the research&#xD;
  &#xD;
            -  unable to answer questionnaires&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cécile Jaglin-Grimonprez</last_name>
      <role>Study Director</role>
      <affiliation>University hospital of Angers</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Myriam AMMI, Dr</last_name>
      <phone>(0)2 41 35 58 97</phone>
      <phone_ext>33</phone_ext>
      <email>Myriam.Ammi@chu-angers.fr</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thoracic Outlet Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <!-- 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/NCT06036888
  org study id: 2023-A00126-39
  nct id: NCT06036888
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study concerns patients hospitalized in vascular and thoracic surgery in 2016 at the
        University Hospital of Angers for the management of a thoraco-brachial outlet syndrome. It
        includes all vascular and neurological manifestations related to intermittent or permanent
        compression of the vasculo-nervous bundle of the upper limb. Before and after the operation,
        these patients had agreed to complete the quality of life questionnaires, the Disabilities of
        the Arm, Shoulder and Hand questionary (DASH) and the Short-Form 12 (SF-12). The objective of
        the present study is to evaluate the long-term quality of life, using the questionnaires
        mentioned above, completed by 54 patients treated surgically for thoraco-brachial outlet
        syndrome and who participated in the DEFILE-QoL study in 2016.
  All patients included in the DEFILE-QoL study (in 2016) receive an information letter.
        Without opposition from them after 4 weeks, they are contacted by telephone. The telephone
        interview begins with an explanation of the study and a time to answer any questions from the
        patient.
  
        If they agree to participate, they answer the DASH and the SF-12 questionnaires, for an
        estimated duration of 15 minutes. Following the telephone interview, the patient's
        participation in the study was terminated.
  
        The date of the information and the patient's non-objection are documented in the patient's
        source file.
  observational model: Case-Only
  time perspective: Prospective
  measure: Quality of life scores
  time frame: at least 5 years after surgery
  description: Assess the quality of life, using standardized questionnaires, of patients treated surgically for thoraco-brachial outlet syndrome
  measure: Factors associated with poor long-term clinical outcome
  time frame: at least 5 years after surgery
  description: Identify factors associated with poor long-term clinical outcome (DEFILE-QoL in 2016) : clinical presentation of Syndrome, its severity, the imaging examinations performed and the various scores collected
  arm group label: thoracobrachial outlet syndrome
  description: Patient :
  adult
  with thoraco-brachial outlet syndrome
  who has participated to DEFILE-QoL study in 2016
  who accept to participate and is able to complete questionaries
  intervention type: Other
  intervention name: questionaries completion
  description: Answer to the DASH and SF-12 questionaries, for an estimated duration of 15 minutes.
  arm group label: thoracobrachial outlet syndrome
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Cécile Jaglin-Grimonprez
  role: Study Director
  affiliation: University hospital of Angers
  last name: Myriam AMMI, Dr
  phone: (0)2 41 35 58 97
  phone ext: 33
  email: Myriam.Ammi@chu-angers.fr
  responsible party type: Sponsor
  mesh term: Thoracic Outlet Syndrome
  mesh term: Syndrome