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/NCT05966779</url>
    </required_header>
    <id_info>
      <org_study_id>OE36/2023</org_study_id>
      <nct_id>NCT05966779</nct_id>
    </id_info>
    <brief_title>Physical Therapy in Lipedema Surgery</brief_title>
    <official_title>Physical Therapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alcala</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Alcala</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this observational study or clinical trial is to know evaluate the effects of a&#xD;
        modified Complete Decongestive Therapy protocol using the Godoy Method in the postoperative&#xD;
        period following lipedema surgery.&#xD;
  &#xD;
        The main question it aims to answer are:&#xD;
  &#xD;
          -  if the treatment is effective on pain reduction, edema resorption, mobility improvement&#xD;
             in short term and follow-up at 90 days&#xD;
  &#xD;
          -  if the treatment is effective on preventing complications of these participants after&#xD;
             surgery&#xD;
  &#xD;
        Participants have been treated in the lasts years and authors recover information of the&#xD;
        effects of the treatment.&#xD;
  &#xD;
        Researchers will compare sub-groups of participants depending on the number of physical&#xD;
        therapy sessions received&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Lipedema is an adipose tissue disorder in women, with an abnormal fat deposition&#xD;
        in lower limbs and occasionally upper limbs. The patients present pain, bruising, heaviness,&#xD;
        and mobility impairment. It affects them physically and psychologically. Purpose: This study&#xD;
        aims to evaluate the effects of a modified CDT protocol using the Godoy Method in the&#xD;
        postoperative period following lipedema surgery.&#xD;
  &#xD;
        Outcomes: pain (VAS), edema resorption, complications, mobility and patient satisfaction.&#xD;
  &#xD;
        A descriptive statistical analysis will be performed using means and standard deviation&#xD;
        (quantitative outcomes) and percentages (dichotomous and categorical outcomes). An&#xD;
        inferential analysis will be carried out using paired and unpaired T-tests as One-way and&#xD;
        repeated measures ANOVA to search for differences between quantitative outcomes. Pearson&#xD;
        chi-square will also be used to relate dichotomous and categorical variables in a transversal&#xD;
        analysis. All missing values will be excluded from the analysis. In all cases, a P&lt;0.05 value&#xD;
        and a 95% confidence interval will be determined forstatistical significance. All statistical&#xD;
        analysis will be performed using the Stata® version 14.2 package for MS Windows® version 10.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Actual">July 12, 2023</completion_date>
    <primary_completion_date type="Actual">July 12, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Pain VAS scale</measure>
      <time_frame>2018-2022</time_frame>
      <description>VAS</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>edema resorption - volume</measure>
      <time_frame>2018-2022</time_frame>
      <description>lower limb edema is measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>complications reported - binary outcome</measure>
      <time_frame>2018-2022</time_frame>
      <description>seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mobility - scale</measure>
      <time_frame>2018-2022</time_frame>
      <description>1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>patient satisfaction</measure>
      <time_frame>2018-2022</time_frame>
      <description>binary outcome</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">293</enrollment>
    <condition>Assessment</condition>
    <condition>Lipedema</condition>
    <condition>Vascular Diseases</condition>
    <condition>Dermatologic Complication</condition>
    <arm_group>
      <arm_group_label>modified CDT physical therapy protocol, based on Godoy's Method</arm_group_label>
      <description>A complete physical therapy assessment was done. All sociodemographic data were recruited as well as body mass index (BMI), the month of intervention, kind of surgery, extracted liters, psychological treatment, physical therapy sessions, pain, mobility, complications (seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema), compression, smoking, satisfaction with the treatment received.&#xD;
  A modified CDT physical therapy protocol, based on Godoy's Method, was applied to all study participants. This protocol comprised of&#xD;
  Cervical Stimuli 15min&#xD;
  MLD based on Godoy&#xD;
  Mechanical lymphatic drainage with RA Godoy® device&#xD;
  Compression therapy with multilayer and multicomponent bandages during the mechanical lymphatic drainage.&#xD;
  Skin care - before and after the bandages- and therapeutic education.&#xD;
  Put on compression garments&#xD;
  Active movement if possible.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>modified CDT physical therapy protocol, based on Godoy's Method</intervention_name>
      <description>modified CDT physical therapy protocol</description>
      <arm_group_label>modified CDT physical therapy protocol, based on Godoy's Method</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          females from undergon a surgical proceeding for lipedema in two private hospitals in Madrid&#xD;
          and were treated in a private physical therapy center. After surgery they were recommended&#xD;
          to receive CDT by their surgeons. All participants received the same physical therapy&#xD;
          treatment. The study was approved by the Clinical Research Committee of Hospital&#xD;
          Universitario Principe de Asturias (CEIm 36/2023).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  female subject who underwent a lipedema surgery&#xD;
  &#xD;
            -  recommendation of the surgeon to receive physical therapy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  unilateral surgery&#xD;
  &#xD;
            -  lack of data in the clinical history&#xD;
  &#xD;
            -  only 1-2 physical therapy sessions&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ester Cerezo Tellez</name>
        <address>
          <city>Alcalá de Henares</city>
          <state>Madrid</state>
          <zip>28823</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Alcala</investigator_affiliation>
      <investigator_full_name>Ester Cerezo-Téllez</investigator_full_name>
      <investigator_title>PhD., Professor</investigator_title>
    </responsible_party>
    <keyword>Lipedema, physical therapy,liposuction,complications,treatment,assessment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vascular Diseases</mesh_term>
      <mesh_term>Lipedema</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/NCT05966779
  org study id: OE36/2023
  nct id: NCT05966779
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study or clinical trial is to know evaluate the effects of a
        modified Complete Decongestive Therapy protocol using the Godoy Method in the postoperative
        period following lipedema surgery.
  
        The main question it aims to answer are:
  
          -  if the treatment is effective on pain reduction, edema resorption, mobility improvement
             in short term and follow-up at 90 days
  
          -  if the treatment is effective on preventing complications of these participants after
             surgery
  
        Participants have been treated in the lasts years and authors recover information of the
        effects of the treatment.
  
        Researchers will compare sub-groups of participants depending on the number of physical
        therapy sessions received
  Background: Lipedema is an adipose tissue disorder in women, with an abnormal fat deposition
        in lower limbs and occasionally upper limbs. The patients present pain, bruising, heaviness,
        and mobility impairment. It affects them physically and psychologically. Purpose: This study
        aims to evaluate the effects of a modified CDT protocol using the Godoy Method in the
        postoperative period following lipedema surgery.
  
        Outcomes: pain (VAS), edema resorption, complications, mobility and patient satisfaction.
  
        A descriptive statistical analysis will be performed using means and standard deviation
        (quantitative outcomes) and percentages (dichotomous and categorical outcomes). An
        inferential analysis will be carried out using paired and unpaired T-tests as One-way and
        repeated measures ANOVA to search for differences between quantitative outcomes. Pearson
        chi-square will also be used to relate dichotomous and categorical variables in a transversal
        analysis. All missing values will be excluded from the analysis. In all cases, a P<0.05 value
        and a 95% confidence interval will be determined forstatistical significance. All statistical
        analysis will be performed using the Stata® version 14.2 package for MS Windows® version 10.
  observational model: Ecologic or Community
  time perspective: Retrospective
  measure: Pain VAS scale
  time frame: 2018-2022
  description: VAS
  measure: edema resorption - volume
  time frame: 2018-2022
  description: lower limb edema is measured
  measure: complications reported - binary outcome
  time frame: 2018-2022
  description: seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema
  measure: mobility - scale
  time frame: 2018-2022
  description: 1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement
  measure: patient satisfaction
  time frame: 2018-2022
  description: binary outcome
  arm group label: modified CDT physical therapy protocol, based on Godoy's Method
  description: A complete physical therapy assessment was done. All sociodemographic data were recruited as well as body mass index (BMI), the month of intervention, kind of surgery, extracted liters, psychological treatment, physical therapy sessions, pain, mobility, complications (seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema), compression, smoking, satisfaction with the treatment received.
  A modified CDT physical therapy protocol, based on Godoy's Method, was applied to all study participants. This protocol comprised of
  Cervical Stimuli 15min
  MLD based on Godoy
  Mechanical lymphatic drainage with RA Godoy® device
  Compression therapy with multilayer and multicomponent bandages during the mechanical lymphatic drainage.
  Skin care - before and after the bandages- and therapeutic education.
  Put on compression garments
  Active movement if possible.
  intervention type: Other
  intervention name: modified CDT physical therapy protocol, based on Godoy's Method
  description: modified CDT physical therapy protocol
  arm group label: modified CDT physical therapy protocol, based on Godoy's Method
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: University of Alcala
  investigator full name: Ester Cerezo-Téllez
  investigator title: PhD., Professor
  mesh term: Vascular Diseases
  mesh term: Lipedema