<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/NCT03777618</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0239</org_study_id>
    <nct_id>NCT03777618</nct_id>
  </id_info>
  <brief_title>Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting</brief_title>
  <official_title>Retrospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circuferential Body Lift</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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 development of bariatric surgery, its effectiveness and the reduction of complications&#xD;
      are at the origin of massive weight loss, the corollary of which has been a clear increase in&#xD;
      the demands of treatment of sequelae of weight loss.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">October 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 15, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>evaluate gluteal volume</measure>
    <time_frame>1 day</time_frame>
    <description>evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera between the preoperative and at 2 months after surgery and 3 months after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical complication</measure>
    <time_frame>1 day</time_frame>
    <description>Surgical complication during hospitalization, then 15 days after the operation and 1 month after the operation</description>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Weight Loss</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>gluteal augmentation with flap in circumferential body lift</intervention_name>
    <description>classic circumferential bodylift surgery, using two differents well-known flaps for gluteal augmentation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients after massiv weight loss who come in toulouse or montpellier hospital to take care&#xD;
        of slimming effects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  12 months minimum delay with bariatric surgery&#xD;
&#xD;
          -  female, BMI&lt;30kg/m2&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
          -  Stable weight for more than 6 months&#xD;
&#xD;
          -  lack of volume in gluetal region&#xD;
&#xD;
          -  agree with clinical trial&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patient under tutorship or curatorship&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  hemoglobinemia&lt; 12g/dL&#xD;
&#xD;
          -  Albuminemia&lt;3,5g/dL&#xD;
&#xD;
          -  active smoking more than 1 month before surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Farid BEKARA, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>November 18, 2019</last_update_submitted>
  <last_update_submitted_qc>November 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>plastic and reconstructive surgery</keyword>
  <keyword>gluteal ptosis</keyword>
  <keyword>platipygia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</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/NCT03777618
org study id: RECHMPL18_0239
nct id: NCT03777618
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The development of bariatric surgery, its effectiveness and the reduction of complications
      are at the origin of massive weight loss, the corollary of which has been a clear increase in
      the demands of treatment of sequelae of weight loss.
observational model: Cohort
time perspective: Retrospective
measure: evaluate gluteal volume
time frame: 1 day
description: evaluate the gluteal volume after augmentation with a parasacral flap using a 3D camera between the preoperative and at 2 months after surgery and 3 months after surgery
measure: Surgical complication
time frame: 1 day
description: Surgical complication during hospitalization, then 15 days after the operation and 1 month after the operation
intervention type: Procedure
intervention name: gluteal augmentation with flap in circumferential body lift
description: classic circumferential bodylift surgery, using two differents well-known flaps for gluteal augmentation
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Farid BEKARA, MD
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Weight Loss