<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/NCT04406155</url>
  </required_header>
  <id_info>
    <org_study_id>BP-3DRWC-TVS-RECTOSIG</org_study_id>
    <nct_id>NCT04406155</nct_id>
  </id_info>
  <brief_title>Bowel Preparation Before 3D Rectal Water Contrast Transvaginal Ultrasonography for Rectosigmoid Endometriosis</brief_title>
  <official_title>Bowel Preparation Before Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography for Diagnosing the Presence and Describing the Characteristics of Rectosigmoid Endometriosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia</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>
      Three-dimensional (3D) rendering may be employed during transvaginal rectal water-contrast&#xD;
      transvaginal ultrasonography (RWC-TVS) for detecting the presence and describe the&#xD;
      characteristics of rectosigmoid endometriosis. This study aims to evaluate the impact of&#xD;
      bowel preparation on the diagnostic parameters of 3D-RWC-TVS in women with suspicion of&#xD;
      rectosigmoid endometriosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An accurate diagnosis of the presence, location and extent of the rectosigmoid endometriosis&#xD;
      is of paramount importance for the clinicians in order to inform the patients on the&#xD;
      potential surgical or medical treatments. It is well established that transvaginal&#xD;
      ultrasonography is the first-line investigation in patients with suspicion of deep&#xD;
      infiltrating endometriosis. An improvement in the performance of transvaginal ultrasonography&#xD;
      in diagnosing rectosigmoid endometriosis may be obtained by using rectal water contrast&#xD;
      during transvaginal ultrasonographic scan. In the last years, three-dimensional (3D)&#xD;
      rendering has been employed during transvaginal ultrasound for benign gynecological diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 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>To compare the accuracy of 3D-RWC-TVS with and without bowel preparation in the diagnosis of rectosigmoid endometriosis.</measure>
    <time_frame>At maximum 6 months before laparoscopic surgical approach</time_frame>
    <description>The results of imaging will be compared with surgical and histological findings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To compare the precision of 3D-RWC-TVS with and without bowel preparation in estimating the length (mid-sagittal diameter) of the rectosigmoid endometriotic nodules</measure>
    <time_frame>At maximum 6 months before laparoscopic surgical approach</time_frame>
    <description>The results of imaging will be compared with surgical and histological findings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the accuracy of 3D-RWC-TVS with and without bowel preparation in the diagnosis of multifocal rectosigmoid endometriosis.</measure>
    <time_frame>At maximum 6 months before laparoscopic surgical approach</time_frame>
    <description>The results of imaging will be compared with surgical and histological findings.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Endometriosis, Rectum</condition>
  <arm_group>
    <arm_group_label>Patients with suspicion of rectosigmoid endometriosis</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>3D-RWC-TVS with bowel preparation</intervention_name>
    <description>Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution. Three-dimensional reconstructions convert standard 2D grayscale ultrasound acquisitions into a volumetric dataset.&#xD;
Bowel preparation is based on a low-residue diet given in the two days before the examination and a rectal enema administered a few hours before the procedure.</description>
    <arm_group_label>Patients with suspicion of rectosigmoid endometriosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>3D-RWC-TVS without bowel preparation</intervention_name>
    <description>Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution. Three-dimensional reconstructions convert standard 2D grayscale ultrasound acquisitions into a volumetric dataset.</description>
    <arm_group_label>Patients with suspicion of rectosigmoid endometriosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with suspicion of rectosigmoid endometriosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - pain and intestinal symptoms suggestive of rectosigmoid endometriosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous surgical diagnosis of intestinal endometriosis&#xD;
&#xD;
          -  previous radiological diagnosis of intestinal endometriosis (based on Magnetic&#xD;
             Resonance or double-contrast barium enema&#xD;
&#xD;
          -  history of colorectal surgery (except appendectomy)&#xD;
&#xD;
          -  contraindications to bowel preparation or computed colonography (such as non--&#xD;
             compliant patients and rectal malformations)&#xD;
&#xD;
          -  previous bilateral ovariectomy&#xD;
&#xD;
          -  psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Simone Ferrero, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>IRRCS Ospedale Policlinico San Martino</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IRCCS Ospedale Policlinico San Martino</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Ferrero S, Barra F, Stabilini C, Vellone VG, Leone Roberti Maggiore U, Scala C. Does Bowel Preparation Improve the Performance of Rectal Water Contrast Transvaginal Ultrasonography in Diagnosing Rectosigmoid Endometriosis? J Ultrasound Med. 2019 Apr;38(4):1017-1025. doi: 10.1002/jum.14790. Epub 2018 Sep 24.</citation>
    <PMID>30246880</PMID>
  </reference>
  <reference>
    <citation>Ferrero S, Scala C, Stabilini C, Vellone VG, Barra F, Leone Roberti Maggiore U. Transvaginal sonography with vs without bowel preparation in diagnosis of rectosigmoid endometriosis: prospective study. Ultrasound Obstet Gynecol. 2019 Mar;53(3):402-409. doi: 10.1002/uog.19194. Epub 2019 Feb 6.</citation>
    <PMID>30079504</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia</investigator_affiliation>
    <investigator_full_name>Simone Ferrero</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>rectosigmoid endometriosis</keyword>
  <keyword>bowel preparation</keyword>
  <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/NCT04406155
org study id: BP-3DRWC-TVS-RECTOSIG
nct id: NCT04406155
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Three-dimensional (3D) rendering may be employed during transvaginal rectal water-contrast
      transvaginal ultrasonography (RWC-TVS) for detecting the presence and describe the
      characteristics of rectosigmoid endometriosis. This study aims to evaluate the impact of
      bowel preparation on the diagnostic parameters of 3D-RWC-TVS in women with suspicion of
      rectosigmoid endometriosis.
An accurate diagnosis of the presence, location and extent of the rectosigmoid endometriosis
      is of paramount importance for the clinicians in order to inform the patients on the
      potential surgical or medical treatments. It is well established that transvaginal
      ultrasonography is the first-line investigation in patients with suspicion of deep
      infiltrating endometriosis. An improvement in the performance of transvaginal ultrasonography
      in diagnosing rectosigmoid endometriosis may be obtained by using rectal water contrast
      during transvaginal ultrasonographic scan. In the last years, three-dimensional (3D)
      rendering has been employed during transvaginal ultrasound for benign gynecological diseases.
observational model: Cohort
time perspective: Prospective
measure: To compare the accuracy of 3D-RWC-TVS with and without bowel preparation in the diagnosis of rectosigmoid endometriosis.
time frame: At maximum 6 months before laparoscopic surgical approach
description: The results of imaging will be compared with surgical and histological findings.
measure: To compare the precision of 3D-RWC-TVS with and without bowel preparation in estimating the length (mid-sagittal diameter) of the rectosigmoid endometriotic nodules
time frame: At maximum 6 months before laparoscopic surgical approach
description: The results of imaging will be compared with surgical and histological findings.
measure: To compare the accuracy of 3D-RWC-TVS with and without bowel preparation in the diagnosis of multifocal rectosigmoid endometriosis.
time frame: At maximum 6 months before laparoscopic surgical approach
description: The results of imaging will be compared with surgical and histological findings.
arm group label: Patients with suspicion of rectosigmoid endometriosis
intervention type: Procedure
intervention name: 3D-RWC-TVS with bowel preparation
description: Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution. Three-dimensional reconstructions convert standard 2D grayscale ultrasound acquisitions into a volumetric dataset.
Bowel preparation is based on a low-residue diet given in the two days before the examination and a rectal enema administered a few hours before the procedure.
arm group label: Patients with suspicion of rectosigmoid endometriosis
intervention type: Procedure
intervention name: 3D-RWC-TVS without bowel preparation
description: Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution. Three-dimensional reconstructions convert standard 2D grayscale ultrasound acquisitions into a volumetric dataset.
arm group label: Patients with suspicion of rectosigmoid endometriosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
last name: Simone Ferrero, MD, PhD
role: Study Director
affiliation: IRRCS Ospedale Policlinico San Martino
facility: 
country: Italy
citation: Ferrero S, Barra F, Stabilini C, Vellone VG, Leone Roberti Maggiore U, Scala C. Does Bowel Preparation Improve the Performance of Rectal Water Contrast Transvaginal Ultrasonography in Diagnosing Rectosigmoid Endometriosis? J Ultrasound Med. 2019 Apr;38(4):1017-1025. doi: 10.1002/jum.14790. Epub 2018 Sep 24.
PMID: 30246880
citation: Ferrero S, Scala C, Stabilini C, Vellone VG, Barra F, Leone Roberti Maggiore U. Transvaginal sonography with vs without bowel preparation in diagnosis of rectosigmoid endometriosis: prospective study. Ultrasound Obstet Gynecol. 2019 Mar;53(3):402-409. doi: 10.1002/uog.19194. Epub 2019 Feb 6.
PMID: 30079504
responsible party type: Principal Investigator
investigator affiliation: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
investigator full name: Simone Ferrero
investigator title: Principal Investigator
mesh term: Endometriosis
sharing ipd: Undecided