<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/NCT03031457</url>
  </required_header>
  <id_info>
    <org_study_id>39855</org_study_id>
    <nct_id>NCT03031457</nct_id>
  </id_info>
  <brief_title>Microsurgical Breast Reconstruction &amp; VTE</brief_title>
  <official_title>Microsurgical Breast Reconstruction - Identifying Procedure-Specific Risk Factors for Venous Thromboembolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford 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>
      Venous thromboembolism (VTE) encompasses pulmonary embolism (PE) and deep venous thrombosis&#xD;
      (DVT) and continues to be a major patient safety issue after reconstructive plastic surgery.&#xD;
      Significant morbidity and mortality is associated with VTE events. This disease entity&#xD;
      represents the most common cause of preventable in-hospital death as evidenced by over&#xD;
      100,000 annual VTE-related deaths in the U.S. The associated economic burden is substantial,&#xD;
      with annual costs to the U.S. healthcare system in excess of $7 billion.&#xD;
&#xD;
      Cancer patients have been identified as a particularly vulnerable patient population. Of&#xD;
      these, breast cancer patients represent the largest group treated by plastic surgeons. An&#xD;
      increasing number of breast reconstructions are performed in the U.S. with a documented 35%&#xD;
      increase in the annual number of breast reconstructions since 2000. Over 106,000 breast&#xD;
      reconstructions were performed in 2015 alone.&#xD;
&#xD;
      Of all reconstructive modalities, autologous breast reconstruction using abdominal flaps is&#xD;
      associated with the highest risk for VTE. We believe that a key element rendering these&#xD;
      patients susceptible to postoperative VTE is inadequate duration of chemoprophylaxis. This is&#xD;
      supported by the observation that VTE risk remains elevated for up to 12 weeks&#xD;
      postoperatively. We hypothesize that lower extremity deep venous system stasis is a&#xD;
      procedure-specific key contributing factor to postoperative VTE risk.&#xD;
&#xD;
      This study examines the duration of postoperative lower extremity venous stasis to identify&#xD;
      patients who might benefit from extended chemoprophylaxis. We will use Duplex imaging&#xD;
      technology to examine the lower extremity deep venous system preoperatively, on postoperative&#xD;
      day 1, and on the day of discharge to determine if patients display radiographic evidence of&#xD;
      lower extremity venous stasis at the time of hospital discharge.&#xD;
&#xD;
      A better understanding of pathophysiologic mechanisms that contribute to the development of&#xD;
      VTE as well as surgical means that reduce VTE risk factors have the potential to optimize VTE&#xD;
      prophylaxis, thus, favorably impacting clinical outcome in a large patient population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Vessel diameter (in cm)</measure>
    <time_frame>1 Day of discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cross-sectional area (in cm^2)</measure>
    <time_frame>1 Day of discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Flow velocity (in cm/sec)</measure>
    <time_frame>1 Day of discharge</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>90-day VTE event</measure>
    <time_frame>90-day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal hernia/bulge rate at 1 year postop</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Breast Reconstruction</condition>
  <condition>Venous Thromboembolism</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>Patients undergo primary fascial closure of abdominal donor-site</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Duplex ultrasound</intervention_name>
    <description>Duplex ultrasound of lower extremity venous system</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult (age ≥18 years) female patients who are scheduled to undergo autologous breast&#xD;
        reconstruction following mastectomy. Only patients who undergo breast reconstruction with&#xD;
        free abdominal flaps that require violation of the anterior rectus sheath, i.e. MS-TRAM and&#xD;
        DIEP flaps, will be included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  see study population description&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Superficial inferior epigastric artery flaps&#xD;
&#xD;
          -  Donor-sites other than the abdomen&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
          -  Liver disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arash Momeni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>April 29, 2018</last_update_submitted>
  <last_update_submitted_qc>April 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Arash Momeni</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03031457
org study id: 39855
nct id: NCT03031457
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Venous thromboembolism (VTE) encompasses pulmonary embolism (PE) and deep venous thrombosis
      (DVT) and continues to be a major patient safety issue after reconstructive plastic surgery.
      Significant morbidity and mortality is associated with VTE events. This disease entity
      represents the most common cause of preventable in-hospital death as evidenced by over
      100,000 annual VTE-related deaths in the U.S. The associated economic burden is substantial,
      with annual costs to the U.S. healthcare system in excess of $7 billion.

      Cancer patients have been identified as a particularly vulnerable patient population. Of
      these, breast cancer patients represent the largest group treated by plastic surgeons. An
      increasing number of breast reconstructions are performed in the U.S. with a documented 35%
      increase in the annual number of breast reconstructions since 2000. Over 106,000 breast
      reconstructions were performed in 2015 alone.

      Of all reconstructive modalities, autologous breast reconstruction using abdominal flaps is
      associated with the highest risk for VTE. We believe that a key element rendering these
      patients susceptible to postoperative VTE is inadequate duration of chemoprophylaxis. This is
      supported by the observation that VTE risk remains elevated for up to 12 weeks
      postoperatively. We hypothesize that lower extremity deep venous system stasis is a
      procedure-specific key contributing factor to postoperative VTE risk.

      This study examines the duration of postoperative lower extremity venous stasis to identify
      patients who might benefit from extended chemoprophylaxis. We will use Duplex imaging
      technology to examine the lower extremity deep venous system preoperatively, on postoperative
      day 1, and on the day of discharge to determine if patients display radiographic evidence of
      lower extremity venous stasis at the time of hospital discharge.

      A better understanding of pathophysiologic mechanisms that contribute to the development of
      VTE as well as surgical means that reduce VTE risk factors have the potential to optimize VTE
      prophylaxis, thus, favorably impacting clinical outcome in a large patient population.
observational model: Cohort
time perspective: Prospective
measure: Vessel diameter (in cm)
time frame: 1 Day of discharge
measure: Cross-sectional area (in cm^2)
time frame: 1 Day of discharge
measure: Flow velocity (in cm/sec)
time frame: 1 Day of discharge
measure: 90-day VTE event
time frame: 90-day
measure: Abdominal hernia/bulge rate at 1 year postop
time frame: 1 year
arm group label: 1
description: Patients undergo primary fascial closure of abdominal donor-site
intervention type: Diagnostic Test
intervention name: Duplex ultrasound
description: Duplex ultrasound of lower extremity venous system
arm group label: 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Arash Momeni, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Arash Momeni
investigator title: Assistant Professor of Surgery
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
sharing ipd: No