<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/NCT04400942</url>
  </required_header>
  <id_info>
    <org_study_id>NOM-MYOMA RES</org_study_id>
    <nct_id>NCT04400942</nct_id>
  </id_info>
  <brief_title>Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy</brief_title>
  <official_title>A Retrospective Study for Developing a Nomogram for Predicting Change of Complete Myoma Resection During Hysteroscopic Myomectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale Policlinico San Martino</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ospedale Policlinico San Martino</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 aim of this observational retrospective analysis is to evaluate predictive factors for&#xD;
      complete myoma resection during hysteroscopic myomectomy for developing and validating a&#xD;
      nomogram.&#xD;
&#xD;
      This tool can help clinicians to support the patient in making an informed decision about&#xD;
      therapeutic options for uterine submucous myomas by defining risk factors predicting a high&#xD;
      complexity myomectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overall, 10% of all uterine myomas are submucosal. These myomas spread into the uterine&#xD;
      cavity, lifting the endometrial mucosa, and are a common cause of abnormal uterine bleeding,&#xD;
      dysmenorrhea, early miscarriage and they may be a cause of infertility.&#xD;
&#xD;
      Hysteroscopic myomectomy is the surgical procedure of choice for the treatment of submucosal&#xD;
      myomas, because it is minimally invasive and has the advantage of preserving the integrity of&#xD;
      the uterine wall.&#xD;
&#xD;
      The characteristics of the myomas (size, number and location) enables the surgeon to choose&#xD;
      the surgical approach that will provide the best outcome for the patient, and may predict the&#xD;
      chances of a complete hysteroscopic resection of myomas in one procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with complete resection of myomas</measure>
    <time_frame>At the end of the hysteroscopic procedure</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Uterine Fibroids</condition>
  <condition>Uterine Myomas</condition>
  <arm_group>
    <arm_group_label>Women with uterine myomas undergoing hysteroscopic myomectomy</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transvaginal ultrasound</intervention_name>
    <description>Transvaginal ultrasonographic scan aims to evaluate number, size (diameter and volume), location and appearance of submucous uterine myomas, concomitant presence of adenomyosis</description>
    <arm_group_label>Women with uterine myomas undergoing hysteroscopic myomectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Anamnesis</intervention_name>
    <description>Anamnesis aims to collect data about age, BMI, previous hormonal therapies (such as ulipristal acetate or gonadotropin-releasing hormone agonists) with submucous uterine myomas</description>
    <arm_group_label>Women with uterine myomas undergoing hysteroscopic myomectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Operative hysteroscopy</intervention_name>
    <description>Operative hysteroscopy allows a direct evaluation of number, size (diameter and volume), location and appearance of submucous uterine myomas. This exam allows the resection of the myomas.</description>
    <arm_group_label>Women with uterine myomas undergoing hysteroscopic myomectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with trasonographic diagnosis of uterine myomas undergoing hysteroscopic&#xD;
        myomectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with ultrasonographic diagnosis of uterine myomas&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with previous incomplete hysteroscopic myoma resection;&#xD;
&#xD;
          -  patients undergoing additional surgical procedures performed by hysteroscopy (such as,&#xD;
             resection of endometrial polyps);&#xD;
&#xD;
          -  patients undergoing associated non-hysteroscopic surgical procedures;&#xD;
&#xD;
          -  patients with severe cardiovascular disease, decompensated diabetes and severe&#xD;
             hematologic disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Simone Ferrero, MD, PhD</last_name>
    <phone>0039010511525</phone>
    <email>simone.ferrero@unige.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>IRCCS Ospedale Policlinico San Martino</name>
      <address>
        <city>Genoa</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simone Ferrero</last_name>
      <phone>+39 010 511525</phone>
      <email>simone.ferrero@unige.it</email>
    </contact>
    <investigator>
      <last_name>Fabio Barra, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Vargas MV, Moawad GN, Sievers C, Opoku-Anane J, Marfori CQ, Tyan P, Robinson JK. Feasibility, Safety, and Prediction of Complications for Minimally Invasive Myomectomy in Women With Large and Numerous Myomata. J Minim Invasive Gynecol. 2017 Feb;24(2):315-322. doi: 10.1016/j.jmig.2016.11.014. Epub 2016 Dec 7.</citation>
    <PMID>27939896</PMID>
  </reference>
  <reference>
    <citation>Ferrero S, Tafi E, Racca A, Leone R, Maggiore U, Remorgida V, Venturini PL. Ulipristal Acetate Prior to High Complexity Hysteroscopic Myomectomy: Prospective Study. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S181. doi: 10.1016/j.jmig.2015.08.666. Epub 2015 Oct 15. No abstract available.</citation>
    <PMID>27678974</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ospedale Policlinico San Martino</investigator_affiliation>
    <investigator_full_name>Fabio Barra</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
    <mesh_term>Myoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT04400942
org study id: NOM-MYOMA RES
nct id: NCT04400942
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this observational retrospective analysis is to evaluate predictive factors for
      complete myoma resection during hysteroscopic myomectomy for developing and validating a
      nomogram.

      This tool can help clinicians to support the patient in making an informed decision about
      therapeutic options for uterine submucous myomas by defining risk factors predicting a high
      complexity myomectomy.
Overall, 10% of all uterine myomas are submucosal. These myomas spread into the uterine
      cavity, lifting the endometrial mucosa, and are a common cause of abnormal uterine bleeding,
      dysmenorrhea, early miscarriage and they may be a cause of infertility.

      Hysteroscopic myomectomy is the surgical procedure of choice for the treatment of submucosal
      myomas, because it is minimally invasive and has the advantage of preserving the integrity of
      the uterine wall.

      The characteristics of the myomas (size, number and location) enables the surgeon to choose
      the surgical approach that will provide the best outcome for the patient, and may predict the
      chances of a complete hysteroscopic resection of myomas in one procedure.
observational model: Cohort
time perspective: Retrospective
measure: Number of patients with complete resection of myomas
time frame: At the end of the hysteroscopic procedure
arm group label: Women with uterine myomas undergoing hysteroscopic myomectomy
intervention type: Diagnostic Test
intervention name: Transvaginal ultrasound
description: Transvaginal ultrasonographic scan aims to evaluate number, size (diameter and volume), location and appearance of submucous uterine myomas, concomitant presence of adenomyosis
arm group label: Women with uterine myomas undergoing hysteroscopic myomectomy
intervention type: Behavioral
intervention name: Anamnesis
description: Anamnesis aims to collect data about age, BMI, previous hormonal therapies (such as ulipristal acetate or gonadotropin-releasing hormone agonists) with submucous uterine myomas
arm group label: Women with uterine myomas undergoing hysteroscopic myomectomy
intervention type: Procedure
intervention name: Operative hysteroscopy
description: Operative hysteroscopy allows a direct evaluation of number, size (diameter and volume), location and appearance of submucous uterine myomas. This exam allows the resection of the myomas.
arm group label: Women with uterine myomas undergoing hysteroscopic myomectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
last name: Simone Ferrero, MD, PhD
phone: 0039010511525
email: simone.ferrero@unige.it
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
citation: Vargas MV, Moawad GN, Sievers C, Opoku-Anane J, Marfori CQ, Tyan P, Robinson JK. Feasibility, Safety, and Prediction of Complications for Minimally Invasive Myomectomy in Women With Large and Numerous Myomata. J Minim Invasive Gynecol. 2017 Feb;24(2):315-322. doi: 10.1016/j.jmig.2016.11.014. Epub 2016 Dec 7.
PMID: 27939896
citation: Ferrero S, Tafi E, Racca A, Leone R, Maggiore U, Remorgida V, Venturini PL. Ulipristal Acetate Prior to High Complexity Hysteroscopic Myomectomy: Prospective Study. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S181. doi: 10.1016/j.jmig.2015.08.666. Epub 2015 Oct 15. No abstract available.
PMID: 27678974
responsible party type: Principal Investigator
investigator affiliation: Ospedale Policlinico San Martino
investigator full name: Fabio Barra
investigator title: Principal Investigator
mesh term: Leiomyoma
mesh term: Myofibroma
mesh term: Myoma