<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/NCT02194920</url>
  </required_header>
  <id_info>
    <org_study_id>06072011</org_study_id>
    <nct_id>NCT02194920</nct_id>
  </id_info>
  <brief_title>Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function</brief_title>
  <official_title>Arathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate safety and effectiveness of normal parathyroid&#xD;
      tissue reimplantation in forearm subcutaneous tissue in case of accidental removal of&#xD;
      parathyroid gland during thyroid surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of parathyroid tissue graft function by selective (left or right) parathormone measurement by vein blood sample</measure>
    <time_frame>up to 3 months</time_frame>
    <description>The primary outcome will be the assessment of reimplanted parathyroid function, evaluated by intact Parathormone (iPTH) measurement by separate blood samples (left and right arm) at 7 days, 1 month and 3 months after surgery. Ratio of 1.5 between the iPTH levels in the arm receiving graft and the opposite arm will be predictive of graft functionality</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Thyroid Goiter</condition>
  <condition>Thyroid Carcinoma</condition>
  <condition>Multinodular Goiter</condition>
  <condition>Graves Diseases</condition>
  <arm_group>
    <arm_group_label>Parathyroid reimplantation</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue</intervention_name>
    <arm_group_label>Parathyroid reimplantation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients receiving thyroid surgery with accidental removal or devascularization of&#xD;
        normal parathyroid gland&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients affected by benign thyroid disease undergoing thyroidectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>General Surgery Unit, ICOT Hospital</name>
      <address>
        <city>Latina</city>
        <zip>04100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>November 4, 2014</last_update_submitted>
  <last_update_submitted_qc>November 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Giuseppe Cavallaro</investigator_full_name>
    <investigator_title>Giuseppe Cavallaro, MD PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Graves Disease</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
    <mesh_term>Goiter</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parathyroid Hormone</mesh_term>
  </intervention_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/NCT02194920
org study id: 06072011
nct id: NCT02194920
lead sponsor: 
The purpose of this study is to evaluate safety and effectiveness of normal parathyroid
      tissue reimplantation in forearm subcutaneous tissue in case of accidental removal of
      parathyroid gland during thyroid surgery.
observational model: Cohort
time perspective: Prospective
measure: Assessment of parathyroid tissue graft function by selective (left or right) parathormone measurement by vein blood sample
time frame: up to 3 months
description: The primary outcome will be the assessment of reimplanted parathyroid function, evaluated by intact Parathormone (iPTH) measurement by separate blood samples (left and right arm) at 7 days, 1 month and 3 months after surgery. Ratio of 1.5 between the iPTH levels in the arm receiving graft and the opposite arm will be predictive of graft functionality
arm group label: Parathyroid reimplantation
intervention type: Procedure
intervention name: Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue
arm group label: Parathyroid reimplantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Giuseppe Cavallaro
investigator title: Giuseppe Cavallaro, MD PhD
mesh term: Thyroid Neoplasms
mesh term: Graves Disease
mesh term: Thyroid Diseases
mesh term: Goiter
mesh term: Parathyroid Hormone