<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/NCT04411004</url>
  </required_header>
  <id_info>
    <org_study_id>ENDO-SHAVING</org_study_id>
    <nct_id>NCT04411004</nct_id>
  </id_info>
  <brief_title>Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis</brief_title>
  <acronym>ENDO-SHAVING</acronym>
  <official_title>Persistence of Rectal Endometriosis After Laparoscopic Shaving of Rectovaginal Endometriosis Infiltrating the Rectum</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>
      When performing shaving of a rectal endometriotic nodule, the surgeon can use the macroscopic&#xD;
      appearance of the nodule and the tactile feedback provided by the laparoscopic instruments to&#xD;
      decide the area of the bowel that needs to be excised. Theoretically, compared with segmental&#xD;
      bowel resection, the shaving technique may expose the patients to a higher risk of&#xD;
      persistence of intestinal endometriosis. The objective of this ultrasonographic study was to&#xD;
      assess the risk of rectal endometriosis persistence following laparoscopic shaving of&#xD;
      rectovaginal nodules.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with rectal recurrence of endometriosis</measure>
    <time_frame>3 months after the surgical approach</time_frame>
    <description>Evaluated by ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with rectal recurrence of endometriosis</measure>
    <time_frame>6 months after the surgical approach</time_frame>
    <description>Evaluated by ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of patients to the previous surgical treatment</measure>
    <time_frame>3 months after the surgical approach</time_frame>
    <description>Evaluated by five-point Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of nodules in patients with rectal recurrence of endometriosis</measure>
    <time_frame>3 months after the surgical approach</time_frame>
    <description>Evaluated by ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of patients to the previous surgical treatment</measure>
    <time_frame>6 months after the surgical approach</time_frame>
    <description>Evaluated by five-point Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of nodules in patients with rectal recurrence of endometriosis</measure>
    <time_frame>6 months after the surgical approach</time_frame>
    <description>Evaluated by ultrasound</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Endometriosis, Rectum</condition>
  <arm_group>
    <arm_group_label>Women who underwent shaving for rectal endometriosis</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transvaginal ultrasound</intervention_name>
    <description>Transvaginal ultrasonographic scan to diagnosis the recurrence of rectal endometriosis</description>
    <arm_group_label>Women who underwent shaving for rectal endometriosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>5-point Likert scale</intervention_name>
    <description>Subjective scale to evaluate satisfaction to previous surgical treatment for rectal endometriosis</description>
    <arm_group_label>Women who underwent shaving for rectal endometriosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients underwent shaving of rectal endometriosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients underwent laparoscopic shaving of rectovaginal endometriosis infiltrating the&#xD;
             rectum&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients underwent previous bowel surgery (except appendectomy);&#xD;
&#xD;
          -  patients experienced postoperative complications (such as pelvic abscess, rectovaginal&#xD;
             fistula, ureteral injuries)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IRCCS Ospedale Policlinico San Martino</name>
      <address>
        <city>Genoa</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Alhayo S, Leonardi M, Lu C, Gosal P, Reid S, Barto W, Condous G. Ultrasound evaluation of pouch of Douglas obliteration and rectal deep endometriosis in women who have had previous combined colorectal and gynaecological laparoscopic surgery for rectal endometriosis: A pilot study. Aust N Z J Obstet Gynaecol. 2020 Apr;60(2):258-263. doi: 10.1111/ajo.13112. Epub 2020 Jan 9.</citation>
    <PMID>31919838</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</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>Endometriosis</mesh_term>
  </condition_browse>
  <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/NCT04411004
org study id: ENDO-SHAVING
nct id: NCT04411004
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
When performing shaving of a rectal endometriotic nodule, the surgeon can use the macroscopic
      appearance of the nodule and the tactile feedback provided by the laparoscopic instruments to
      decide the area of the bowel that needs to be excised. Theoretically, compared with segmental
      bowel resection, the shaving technique may expose the patients to a higher risk of
      persistence of intestinal endometriosis. The objective of this ultrasonographic study was to
      assess the risk of rectal endometriosis persistence following laparoscopic shaving of
      rectovaginal nodules.
observational model: Cohort
time perspective: Prospective
measure: Number of patients with rectal recurrence of endometriosis
time frame: 3 months after the surgical approach
description: Evaluated by ultrasound
measure: Number of patients with rectal recurrence of endometriosis
time frame: 6 months after the surgical approach
description: Evaluated by ultrasound
measure: Satisfaction of patients to the previous surgical treatment
time frame: 3 months after the surgical approach
description: Evaluated by five-point Likert scale
measure: Volume of nodules in patients with rectal recurrence of endometriosis
time frame: 3 months after the surgical approach
description: Evaluated by ultrasound
measure: Satisfaction of patients to the previous surgical treatment
time frame: 6 months after the surgical approach
description: Evaluated by five-point Likert scale
measure: Volume of nodules in patients with rectal recurrence of endometriosis
time frame: 6 months after the surgical approach
description: Evaluated by ultrasound
arm group label: Women who underwent shaving for rectal endometriosis
intervention type: Diagnostic Test
intervention name: Transvaginal ultrasound
description: Transvaginal ultrasonographic scan to diagnosis the recurrence of rectal endometriosis
arm group label: Women who underwent shaving for rectal endometriosis
intervention type: Behavioral
intervention name: 5-point Likert scale
description: Subjective scale to evaluate satisfaction to previous surgical treatment for rectal endometriosis
arm group label: Women who underwent shaving for rectal endometriosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
citation: Alhayo S, Leonardi M, Lu C, Gosal P, Reid S, Barto W, Condous G. Ultrasound evaluation of pouch of Douglas obliteration and rectal deep endometriosis in women who have had previous combined colorectal and gynaecological laparoscopic surgery for rectal endometriosis: A pilot study. Aust N Z J Obstet Gynaecol. 2020 Apr;60(2):258-263. doi: 10.1111/ajo.13112. Epub 2020 Jan 9.
PMID: 31919838
responsible party type: Principal Investigator
investigator affiliation: Ospedale Policlinico San Martino
investigator full name: Fabio Barra
investigator title: Principal Investigator
mesh term: Endometriosis
sharing ipd: Undecided