<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/NCT03838302</url>
  </required_header>
  <id_info>
    <org_study_id>FSF-TVE</org_study_id>
    <nct_id>NCT03838302</nct_id>
  </id_info>
  <brief_title>Evaluation of Sexual Functions With Validated Measurement Scale After Transvaginal Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation (FSF-TVE)</brief_title>
  <acronym>FSF-TVE</acronym>
  <official_title>Evaluation of Female Sexual Functions With Validated Measurement Scale (Female Sexual Function Index) After Transvaginal Versus Trocars Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi dell'Insubria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi dell'Insubria</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 retrieval of tissues removed by laparoscopic surgery larger than trocars caliber, with&#xD;
      preservation of the uterus, required for a long time intraperitoneal electromechanical&#xD;
      morcellation, until the Food and Drug Administration expressed concern about intraperitoneal&#xD;
      dissemination of malignant cells, in the case of unrecognized sarcomas.&#xD;
&#xD;
      Transvaginal contained tissue extraction via a posterior colpotomy and manual morcellation in&#xD;
      the bag is one of the possible alternatives.&#xD;
&#xD;
      Available data suggested the effectiveness and safety of this technique, also in terms of&#xD;
      time and costs, without a increased risk intra and post-operative complications.&#xD;
&#xD;
      The available evidence shows the lack of sequelae also on fertility and sexual function.&#xD;
&#xD;
      Nevertheless, sexual function has never been evaluated qualitatively in all its aspects nor&#xD;
      quantitatively with a validated measurement scale, which can allow us to inform the&#xD;
      consequences on the real risk of implications on sexual function determined by vaginal&#xD;
      incision. In view of these elements, the aim of the investigator's study is to compare&#xD;
      patients in whom laparoscopic tissue removal has been carried out with posterior colpotomy or&#xD;
      without it with removal from the trocars.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 2023</start_date>
  <completion_date type="Anticipated">June 2027</completion_date>
  <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Female Sexual Function Index</measure>
    <time_frame>Change from baseline (before surgery) and 2 months after surgery</time_frame>
    <description>The Female Sexual Function Index (FSFI) is a brief questionnaire measure of sexual functioning in women.&#xD;
Score range: minimum 2.0, maximum 36.0. Higher values represent a better outcome.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Transvaginal Tissue Extraction</condition>
  <arm_group>
    <arm_group_label>Transvaginal retrieval</arm_group_label>
    <description>Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transabdominal retrieval</arm_group_label>
    <description>Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transvaginal tissue retrieval via a posterior colpotomy</intervention_name>
    <description>Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation</description>
    <arm_group_label>Transvaginal retrieval</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transabdominal retrieval via trocar</intervention_name>
    <description>Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation</description>
    <arm_group_label>Transabdominal retrieval</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergoing laparoscopic management for myomas or adnexal disease and with specimen&#xD;
        retrieval by transvaginal extraction or transbdominal extraction through trocar.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Benign uterine and adnexal pathology&#xD;
&#xD;
          -  Preservation of the uterus&#xD;
&#xD;
          -  Sexually active women&#xD;
&#xD;
          -  Premenopausal women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pelvic inflammatory disease, endometriosis and pre-existing dyspareunia or chronic&#xD;
             pelvic pain of any origin&#xD;
&#xD;
          -  Previous Hysterectomy&#xD;
&#xD;
          -  Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune,&#xD;
             neoplastic diseases, psychopathology, mental and sensory-motor disabilities)&#xD;
             comorbidities&#xD;
&#xD;
          -  Language barrier&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Simone Laganà, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università degli Studi dell'Insubria</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antonio Simone Laganà, M.D.</last_name>
    <phone>+393296279579</phone>
    <email>antoniosimone.lagana@asst-settelaghi.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>&quot;Filippo Del Ponte&quot; Hospital</name>
      <address>
        <city>Varese</city>
        <zip>21100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Antonio Simone Laganà, M.D.</last_name>
      <phone>+393296279579</phone>
      <email>antoniosimone.lagana@asst-settelaghi.it</email>
    </contact>
    <investigator>
      <last_name>Fabio Ghezzi, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jvan Casarin, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Simone Garzon, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>February 9, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi dell'Insubria</investigator_affiliation>
    <investigator_full_name>Antonio Simone Laganà</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Sexual functioning</keyword>
  <keyword>Laparoscopy</keyword>
  <keyword>Colpotomy</keyword>
  <keyword>Specimen retrieval</keyword>
  <keyword>Transvaginal extraction</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03838302
org study id: FSF-TVE
nct id: NCT03838302
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The retrieval of tissues removed by laparoscopic surgery larger than trocars caliber, with
      preservation of the uterus, required for a long time intraperitoneal electromechanical
      morcellation, until the Food and Drug Administration expressed concern about intraperitoneal
      dissemination of malignant cells, in the case of unrecognized sarcomas.

      Transvaginal contained tissue extraction via a posterior colpotomy and manual morcellation in
      the bag is one of the possible alternatives.

      Available data suggested the effectiveness and safety of this technique, also in terms of
      time and costs, without a increased risk intra and post-operative complications.

      The available evidence shows the lack of sequelae also on fertility and sexual function.

      Nevertheless, sexual function has never been evaluated qualitatively in all its aspects nor
      quantitatively with a validated measurement scale, which can allow us to inform the
      consequences on the real risk of implications on sexual function determined by vaginal
      incision. In view of these elements, the aim of the investigator's study is to compare
      patients in whom laparoscopic tissue removal has been carried out with posterior colpotomy or
      without it with removal from the trocars.
observational model: Case-Control
time perspective: Prospective
measure: Female Sexual Function Index
time frame: Change from baseline (before surgery) and 2 months after surgery
description: The Female Sexual Function Index (FSFI) is a brief questionnaire measure of sexual functioning in women.
Score range: minimum 2.0, maximum 36.0. Higher values represent a better outcome.
arm group label: Transvaginal retrieval
description: Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation
arm group label: Transabdominal retrieval
description: Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation
intervention type: Procedure
intervention name: Transvaginal tissue retrieval via a posterior colpotomy
description: Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation
arm group label: Transvaginal retrieval
intervention type: Procedure
intervention name: Transabdominal retrieval via trocar
description: Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation
arm group label: Transabdominal retrieval
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Antonio Simone Laganà, M.D.
role: Principal Investigator
affiliation: Università degli Studi dell'Insubria
last name: Antonio Simone Laganà, M.D.
phone: +393296279579
email: antoniosimone.lagana@asst-settelaghi.it
facility: 
contact: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi dell'Insubria
investigator full name: Antonio Simone Laganà
investigator title: Principal Investigator
sharing ipd: Undecided