<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/NCT03776214</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0133</org_study_id>
    <nct_id>NCT03776214</nct_id>
  </id_info>
  <brief_title>Surgery in Addition to the Medical Treatment of Lymphedema</brief_title>
  <acronym>LYMPHOSPIR</acronym>
  <official_title>LYMPHOSPIR : Impact of Surgery in Addition to Optimal Management of Lymphedema.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Reconstructive surgery, UH Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of vascular medecine, UH Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      Lymphedema is a chronic pathology with a real impact on the quality of life of patients.&#xD;
      Despite optimal medical management of patients, some patients still have no pitting edema on&#xD;
      which the medical treatment has no effect.&#xD;
&#xD;
      It is adipose tissue secondary to the evolution of lymphedema. It is often painful and&#xD;
      important in terms of volume with the resulting functional consequences. The investigators&#xD;
      propose to these patients a surgical management complementary to the optimal medical&#xD;
      treatment by microlipoaspiration associated or not with a dermolipectomy. This surgical&#xD;
      management began in 2014 in our service. The investigators want to evaluate the impact on&#xD;
      quality of life of patients in this surgical management in addition to medical care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detailed Description:&#xD;
&#xD;
      This is a monocentric, observational cohort study.&#xD;
&#xD;
      Main judgment criteria:&#xD;
&#xD;
      Evolution of the quality of life score of the LYMQOL self-questionnaire between preoperative&#xD;
      and postoperative (at 3.6 and 12 months) The investigators used a French translation of&#xD;
      Keeley's LYMQOL (Quality Of Life Measure for Limb Lymphoedema) self-administered&#xD;
      questionnaire in 2010 (2) to assess the quality of life of patients. This is a lymphedema&#xD;
      specific questionnaire for which there is one version for the upper limb and one for the&#xD;
      lower limb. Limb function, lymphedema symptoms, body image and mood are assessed&#xD;
      independently. It allows to obtain a score between 1 and 4 which corresponds to the&#xD;
      discomfort felt. The higher the score, the better the quality of life. It also includes, in&#xD;
      the last question, a numerical scale allowing the patient to note her quality of life between&#xD;
      0 and 10.&#xD;
&#xD;
      Since 2016, patients have systematically completed quality of life questionnaires. Perimeter&#xD;
      measurements are also done systematically at each visit, these data are available in the&#xD;
      patient's computerized medical records (Dx Care).&#xD;
&#xD;
      Secondary judgment criterion:&#xD;
&#xD;
      Difference in the volume of the limb operated between preoperative and postoperative (3, 6&#xD;
      and 12 months)&#xD;
&#xD;
      The volume is calculated on the basis of stepped circumferential measurements (every 10 cm&#xD;
      starting from the patella for the lower limb and every 5 cm starting from the bend of the&#xD;
      elbow for the upper limb). These measures are taken at each consultation by our&#xD;
      physiotherapists, specialized nurses or vascular doctors.&#xD;
&#xD;
      It is therefore a question of retrospectively analyzing the data collected.&#xD;
&#xD;
      The data will then be anonymised by a two-letter code and a number and will be entered on a&#xD;
      Excel file available on a secure directory of the CHU for analysis.&#xD;
&#xD;
      A dedicated support protocol is already implemented in the Cf Appendix service. There are no&#xD;
      special modalities for patients not included in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>quality of life (self questionnaire LYMQOL)</measure>
    <time_frame>1 day</time_frame>
    <description>To evaluate the impact of surgery in addition to the medical management of lymphedema on the quality of life of operated patients between preoperative and postoperative</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>volume of operated limb</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluate the effectiveness of surgery in addition to medical management in terms of volume reduction of the operated limb between preoperative and postoperative.</description>
  </secondary_outcome>
  <enrollment type="Actual">1000</enrollment>
  <condition>Optimal Treatment of Lymphedema</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with lymphedema (primary or secondary) of arm or limb selected by the medical and&#xD;
        chirurgical staff (no pitting edema, optimal medical treatment, good therapeutic&#xD;
        compliance) for an liposuccion or dermolipectomia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no pitting edema&#xD;
&#xD;
          -  good therapeutic compliance&#xD;
&#xD;
          -  weight stability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - under 18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MESTRE GODIN Sandrine</last_name>
    <role>Principal Investigator</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>March 2020</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>No pitting edema</keyword>
  <keyword>After medical and surgical evaluation</keyword>
  <keyword>Microlipoaspiration</keyword>
  <keyword>surgery</keyword>
  <keyword>lymphedema</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphedema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT03776214
org study id: RECHMPL18_0133
nct id: NCT03776214
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lymphedema is a chronic pathology with a real impact on the quality of life of patients.
      Despite optimal medical management of patients, some patients still have no pitting edema on
      which the medical treatment has no effect.

      It is adipose tissue secondary to the evolution of lymphedema. It is often painful and
      important in terms of volume with the resulting functional consequences. The investigators
      propose to these patients a surgical management complementary to the optimal medical
      treatment by microlipoaspiration associated or not with a dermolipectomy. This surgical
      management began in 2014 in our service. The investigators want to evaluate the impact on
      quality of life of patients in this surgical management in addition to medical care.
Detailed Description:

      This is a monocentric, observational cohort study.

      Main judgment criteria:

      Evolution of the quality of life score of the LYMQOL self-questionnaire between preoperative
      and postoperative (at 3.6 and 12 months) The investigators used a French translation of
      Keeley's LYMQOL (Quality Of Life Measure for Limb Lymphoedema) self-administered
      questionnaire in 2010 (2) to assess the quality of life of patients. This is a lymphedema
      specific questionnaire for which there is one version for the upper limb and one for the
      lower limb. Limb function, lymphedema symptoms, body image and mood are assessed
      independently. It allows to obtain a score between 1 and 4 which corresponds to the
      discomfort felt. The higher the score, the better the quality of life. It also includes, in
      the last question, a numerical scale allowing the patient to note her quality of life between
      0 and 10.

      Since 2016, patients have systematically completed quality of life questionnaires. Perimeter
      measurements are also done systematically at each visit, these data are available in the
      patient's computerized medical records (Dx Care).

      Secondary judgment criterion:

      Difference in the volume of the limb operated between preoperative and postoperative (3, 6
      and 12 months)

      The volume is calculated on the basis of stepped circumferential measurements (every 10 cm
      starting from the patella for the lower limb and every 5 cm starting from the bend of the
      elbow for the upper limb). These measures are taken at each consultation by our
      physiotherapists, specialized nurses or vascular doctors.

      It is therefore a question of retrospectively analyzing the data collected.

      The data will then be anonymised by a two-letter code and a number and will be entered on a
      Excel file available on a secure directory of the CHU for analysis.

      A dedicated support protocol is already implemented in the Cf Appendix service. There are no
      special modalities for patients not included in the study.
observational model: Cohort
time perspective: Other
measure: quality of life (self questionnaire LYMQOL)
time frame: 1 day
description: To evaluate the impact of surgery in addition to the medical management of lymphedema on the quality of life of operated patients between preoperative and postoperative
measure: volume of operated limb
time frame: 1 day
description: Evaluate the effectiveness of surgery in addition to medical management in terms of volume reduction of the operated limb between preoperative and postoperative.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: MESTRE GODIN Sandrine
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Lymphedema
sharing ipd: Undecided
ipd description: NC