<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/NCT03283475</url>
  </required_header>
  <id_info>
    <org_study_id>13111987</org_study_id>
    <nct_id>NCT03283475</nct_id>
  </id_info>
  <brief_title>Different Surgical Modalities for Thigh Lipodystrophy Including Liposuction,Thigh Lift and Liposuction Assisted Thigh Lift</brief_title>
  <acronym>thigh lift</acronym>
  <official_title>Surgical Management of Thigh Lipodystrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      The sample will be divided into two groups:- - Control group which will include 60 adult&#xD;
      individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of&#xD;
      any thigh contour deformities or skin redundancy with no history of body weight fluctuations.&#xD;
      This group will be divided into two subgroups, 30 males and 30 females.&#xD;
&#xD;
      The following measurements will be recorded :- Weight, height, thigh length, hip&#xD;
      circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh&#xD;
      circumferences.&#xD;
&#xD;
      - Patient group which will include 40 patients suffering from thigh lipodystrophy and contour&#xD;
      deformities who will undergo surgical intervention after their assessment.&#xD;
&#xD;
      After assessment, one of the following techniques will be selected:-&#xD;
&#xD;
        -  Liposuction only.&#xD;
&#xD;
        -  thigh lift.&#xD;
&#xD;
        -  Liposuction assisted thigh lift.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preoperative assessment:- Patients will be assessed regarding skin redundancy, history of&#xD;
      weight loss and site of lipodystrophy whether deformity is proximal, distal or diffuse.&#xD;
&#xD;
      The same measurements mentioned above will be recorded for the patient group before surgery.&#xD;
&#xD;
      Preoperative photographs in anteroposterior, lateral and oblique positions will be taken.&#xD;
&#xD;
      Informed consent will be signed by the patient before surgery illustrating possible risks and&#xD;
      complications of the surgery.&#xD;
&#xD;
      Postoperative assessment:- The outcomes will be evaluated 3 months after surgery regarding&#xD;
      patient satisfaction and achievement of symmetry.&#xD;
&#xD;
      Early complications will be assessed within one week after surgery including hematoma,&#xD;
      seroma, surgical site infection and wound dehiscence.&#xD;
&#xD;
      Late complications will be assessed at 3 months follow up including asymmetry, conspicuous&#xD;
      scar and lymphedema.&#xD;
&#xD;
      Postoperative measurements and photographs will be recorded and compared with preoperative&#xD;
      ones.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 14, 2017</start_date>
  <completion_date type="Anticipated">April 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 22, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>The sample will be divided into two groups:- - Control group which will include 60 adult individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females.&#xD;
The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences.&#xD;
- Patient group which will include 40 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment.&#xD;
After assessment, one of the following techniques will be selected:-&#xD;
Liposuction only.&#xD;
thigh lift.&#xD;
Liposuction assisted thigh lift.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>regarding patient satisfaction and achievement of symmetry.</measure>
    <time_frame>3 months</time_frame>
    <description>questionnaire will be performed for the patient group to estimate degree of patient satisfaction with assessment of postoperative symmetry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>complication rates of different surgical techniques</measure>
    <time_frame>1 week and 3 months</time_frame>
    <description>Early complications will be assessed within one week after surgery including hematoma, seroma, surgical site infection and wound dehiscence.&#xD;
Late complications will be assessed at 3 months follow up including asymmetry, conspicuous scar and lymphedema.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Thigh Lipodystrophy</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>- Control group will include 60 adult individuals between 18 and 35 years old who have body mass index (BMI) between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females.&#xD;
The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patient group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>- Patient group will include 30 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment.&#xD;
After assessment, one of the following techniques will be selected:-&#xD;
Liposuction only.&#xD;
thigh lift.&#xD;
Liposuction assisted thigh lift.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>thigh lift</intervention_name>
    <description>liposuction-assisted medial avulsion thighplasty enables technically refined contouring of the thigh and the possible preservation of the local microvasculature, which results in reduced complication rates</description>
    <arm_group_label>patient group</arm_group_label>
    <other_name>thigh liposuction</other_name>
    <other_name>liposuction assisted thigh lift</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Individuals between18 and 35 years for control group and more than 18 years for&#xD;
             patient group .&#xD;
&#xD;
          2. Patients with BMI between 19 and 25 for control group and less than 35 for patient&#xD;
             group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals less than 18 years.&#xD;
&#xD;
          2. Patients undergoing bariatric surgery within a period of less than one year.&#xD;
&#xD;
          3. Patients with BMI more than 35.&#xD;
&#xD;
          4. Patients with systemic illness as cancer or mental disorders &amp; hepatic patients&#xD;
             (generally debilitating diseases) or any contraindication for anesthesia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71621</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Cabbabe SW. Plastic Surgery after Massive Weight Loss. Mo Med. 2016 May-Jun;113(3):202-6.</citation>
    <PMID>27443046</PMID>
  </reference>
  <results_reference>
    <citation>Schmidt M, Pollhammer MS, Januszyk M, Duscher D, Huemer GM. Concomitant Liposuction Reduces Complications of Vertical Medial Thigh Lift in Massive Weight Loss Patients. Plast Reconstr Surg. 2016 Jun;137(6):1748-1757. doi: 10.1097/PRS.0000000000002194.</citation>
    <PMID>27219231</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohammed Gamal</investigator_full_name>
    <investigator_title>plastic surgery department, Assiut University Hospital, Assiut, Egypt</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lipodystrophy</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/NCT03283475
org study id: 13111987
nct id: NCT03283475
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The sample will be divided into two groups:- - Control group which will include 60 adult
      individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of
      any thigh contour deformities or skin redundancy with no history of body weight fluctuations.
      This group will be divided into two subgroups, 30 males and 30 females.

      The following measurements will be recorded :- Weight, height, thigh length, hip
      circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh
      circumferences.

      - Patient group which will include 40 patients suffering from thigh lipodystrophy and contour
      deformities who will undergo surgical intervention after their assessment.

      After assessment, one of the following techniques will be selected:-

        -  Liposuction only.

        -  thigh lift.

        -  Liposuction assisted thigh lift.
Preoperative assessment:- Patients will be assessed regarding skin redundancy, history of
      weight loss and site of lipodystrophy whether deformity is proximal, distal or diffuse.

      The same measurements mentioned above will be recorded for the patient group before surgery.

      Preoperative photographs in anteroposterior, lateral and oblique positions will be taken.

      Informed consent will be signed by the patient before surgery illustrating possible risks and
      complications of the surgery.

      Postoperative assessment:- The outcomes will be evaluated 3 months after surgery regarding
      patient satisfaction and achievement of symmetry.

      Early complications will be assessed within one week after surgery including hematoma,
      seroma, surgical site infection and wound dehiscence.

      Late complications will be assessed at 3 months follow up including asymmetry, conspicuous
      scar and lymphedema.

      Postoperative measurements and photographs will be recorded and compared with preoperative
      ones.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: The sample will be divided into two groups:- - Control group which will include 60 adult individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females.
The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences.
- Patient group which will include 40 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment.
After assessment, one of the following techniques will be selected:-
Liposuction only.
thigh lift.
Liposuction assisted thigh lift.
primary purpose: Treatment
masking: None (Open Label)
measure: regarding patient satisfaction and achievement of symmetry.
time frame: 3 months
description: questionnaire will be performed for the patient group to estimate degree of patient satisfaction with assessment of postoperative symmetry
measure: complication rates of different surgical techniques
time frame: 1 week and 3 months
description: Early complications will be assessed within one week after surgery including hematoma, seroma, surgical site infection and wound dehiscence.
Late complications will be assessed at 3 months follow up including asymmetry, conspicuous scar and lymphedema.
arm group label: control group
arm group type: No Intervention
description: - Control group will include 60 adult individuals between 18 and 35 years old who have body mass index (BMI) between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females.
The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences.
arm group label: patient group
arm group type: Active Comparator
description: - Patient group will include 30 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment.
After assessment, one of the following techniques will be selected:-
Liposuction only.
thigh lift.
Liposuction assisted thigh lift.
intervention type: Procedure
intervention name: thigh lift
description: liposuction-assisted medial avulsion thighplasty enables technically refined contouring of the thigh and the possible preservation of the local microvasculature, which results in reduced complication rates
arm group label: patient group
other name: thigh liposuction
other name: liposuction assisted thigh lift
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
citation: Cabbabe SW. Plastic Surgery after Massive Weight Loss. Mo Med. 2016 May-Jun;113(3):202-6.
PMID: 27443046
citation: Schmidt M, Pollhammer MS, Januszyk M, Duscher D, Huemer GM. Concomitant Liposuction Reduces Complications of Vertical Medial Thigh Lift in Massive Weight Loss Patients. Plast Reconstr Surg. 2016 Jun;137(6):1748-1757. doi: 10.1097/PRS.0000000000002194.
PMID: 27219231
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohammed Gamal
investigator title: plastic surgery department, Assiut University Hospital, Assiut, Egypt
mesh term: Lipodystrophy
sharing ipd: No