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/NCT05988151</url>
    </required_header>
    <id_info>
      <org_study_id>2022/25</org_study_id>
      <nct_id>NCT05988151</nct_id>
    </id_info>
    <brief_title>New Surgical Approach in Labioplasty</brief_title>
    <official_title>New Surgical Approach in Labioplasty: Inspired by the Fibonacci Ratio</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Batman Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Batman Training and Research Hospital</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 data of patients who underwent labiaplasty + vaginoplasty between 2020 and 2022 by a&#xD;
        single surgeon in our clinic were analyzed. Preoperative and postoperative FSFI (Female&#xD;
        sexual function index) questionnaire scores were used to compare the results of the classical&#xD;
        surgical approach and the new surgical approach technique designed according to the Fibonacci&#xD;
        ratio in the early postoperative period such as operating time, bleeding amount, etc.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The data of patients who underwent labiaplasty + vaginoplasty between 2020-2022 for reasons&#xD;
        such as vaginal laxity, personal hygiene problems, recurrent vaginal infections were analyzed&#xD;
        retrospectively. The data of the patients who underwent fibonacci ratio, which is a new&#xD;
        surgical approach technique( by Okuyan E. M.D), and the patients who underwent classical&#xD;
        surgical technique were taken from their files and analyzed. Data including age, body mass&#xD;
        index, number of live births, preoperative FSFI, FGSIS and postoperative one month FSFI&#xD;
        (Female sexual function index) and FGSIS (The Female Genital Self-Image Scale) scores were&#xD;
        recorded and compared between both groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 12, 2022</start_date>
    <completion_date type="Actual">August 2, 2023</completion_date>
    <primary_completion_date type="Actual">July 1, 2023</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>Patients who gave informed consent preoperatively and accepted the surgical technique using the fibonacci ratio approach and patients who underwent the classical surgical technique were divided into 2 groups.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To be able to standardize genital harmony using fibonacci ratio.</measure>
      <time_frame>Postoperative 1 month</time_frame>
      <description>To standardize the genital harmony with a holistic approach with the Fibonacci ratio with a purely mathematical ratio outside the existing classification systems (in contrast to Banwell, Motakeff classifications).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To adapt the fibonacci ratio to female genital cosmetic surgery</measure>
      <time_frame>Postoperative 1 month</time_frame>
      <description>To adapt the fibonacci ratio applied in breast and facial aesthetics to female genital aesthetic surgery procedures.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">100</enrollment>
    <condition>Gynecologic Disease</condition>
    <condition>Surgery-Complications</condition>
    <arm_group>
      <arm_group_label>New surgical approach (Fibonacci ratio)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Agroup of 60 patients who underwent VaGinoplasti+ labioplasty ( wedge resection) with fibonacci ratio surgical ratio.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Classical surgical approach (control group)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>A group of 30 patients who underwent Vaginoplasty + Labioplasty( wedge resection) with classical surgical approach.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>New surgical approach</intervention_name>
      <description>Patients were included in the study after obtaining informed consent for the new surgical approach inspired by the Fibonacci ratio.</description>
      <arm_group_label>New surgical approach (Fibonacci ratio)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. No history of any disease&#xD;
  &#xD;
            2. The presence of at least 2 of the reasons such as dislike of cosmetic appearance,&#xD;
               vaginal abundance, personal hygiene disorder, difficulty in wearing underwear.&#xD;
  &#xD;
            3. Body mass index between 15-25&#xD;
  &#xD;
            4. Informed consent has been obtained for the new surgical approach technique.&#xD;
  &#xD;
            5. Not taking any medication continuously&#xD;
  &#xD;
            6. Willing to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Absence of at least 2 of the reasons such as dislike of cosmetic appearance, vaginal&#xD;
  &#xD;
               abundance, personal hygiene disorder, difficulty in wearing underwear.&#xD;
  &#xD;
            2. History of continuous medication, alcohol and/or smoking.&#xD;
  &#xD;
            3. History of chronic diseases (Asthma, Diabetes mellitus, Cardiac disease, Psychiatric&#xD;
               disease etc.)&#xD;
  &#xD;
            4. Body mass index outside the range of 15-25.&#xD;
  &#xD;
            5. Not wanting to be included in the study or wanting to leave the study after inclusion.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Erhan Okuyan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Batman Training and Research Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Batman Training and Research Hospital</name>
        <address>
          <city>Batman</city>
          <zip>72000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Batman Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Erhan Okuyan,M.D</investigator_full_name>
      <investigator_title>M.D Obstetrics and Gynecology specialist</investigator_title>
    </responsible_party>
    <keyword>Labioplasty</keyword>
    <keyword>Vaginoplasty</keyword>
    <keyword>Fibonacci ratio</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Genital Diseases, Female</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Share after publication</ipd_description>
    </patient_data>
    <!-- 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/NCT05988151
  org study id: 2022/25
  nct id: NCT05988151
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The data of patients who underwent labiaplasty + vaginoplasty between 2020 and 2022 by a
        single surgeon in our clinic were analyzed. Preoperative and postoperative FSFI (Female
        sexual function index) questionnaire scores were used to compare the results of the classical
        surgical approach and the new surgical approach technique designed according to the Fibonacci
        ratio in the early postoperative period such as operating time, bleeding amount, etc.
  The data of patients who underwent labiaplasty + vaginoplasty between 2020-2022 for reasons
        such as vaginal laxity, personal hygiene problems, recurrent vaginal infections were analyzed
        retrospectively. The data of the patients who underwent fibonacci ratio, which is a new
        surgical approach technique( by Okuyan E. M.D), and the patients who underwent classical
        surgical technique were taken from their files and analyzed. Data including age, body mass
        index, number of live births, preoperative FSFI, FGSIS and postoperative one month FSFI
        (Female sexual function index) and FGSIS (The Female Genital Self-Image Scale) scores were
        recorded and compared between both groups.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  intervention model description: Patients who gave informed consent preoperatively and accepted the surgical technique using the fibonacci ratio approach and patients who underwent the classical surgical technique were divided into 2 groups.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: To be able to standardize genital harmony using fibonacci ratio.
  time frame: Postoperative 1 month
  description: To standardize the genital harmony with a holistic approach with the Fibonacci ratio with a purely mathematical ratio outside the existing classification systems (in contrast to Banwell, Motakeff classifications).
  measure: To adapt the fibonacci ratio to female genital cosmetic surgery
  time frame: Postoperative 1 month
  description: To adapt the fibonacci ratio applied in breast and facial aesthetics to female genital aesthetic surgery procedures.
  arm group label: New surgical approach (Fibonacci ratio)
  arm group type: Active Comparator
  description: Agroup of 60 patients who underwent VaGinoplasti+ labioplasty ( wedge resection) with fibonacci ratio surgical ratio.
  arm group label: Classical surgical approach (control group)
  arm group type: No Intervention
  description: A group of 30 patients who underwent Vaginoplasty + Labioplasty( wedge resection) with classical surgical approach.
  intervention type: Other
  intervention name: New surgical approach
  description: Patients were included in the study after obtaining informed consent for the new surgical approach inspired by the Fibonacci ratio.
  arm group label: New surgical approach (Fibonacci ratio)
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Erhan Okuyan
  role: Principal Investigator
  affiliation: Batman Training and Research Hospital
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Batman Training and Research Hospital
  investigator full name: Erhan Okuyan,M.D
  investigator title: M.D Obstetrics and Gynecology specialist
  mesh term: Genital Diseases, Female
  sharing ipd: No
  ipd description: Share after publication