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/NCT06041347</url>
    </required_header>
    <id_info>
      <org_study_id>Semmelweis University Szabó G</org_study_id>
      <nct_id>NCT06041347</nct_id>
    </id_info>
    <brief_title>Learning Curve for the Visualization of Sacral Plexus on TVS</brief_title>
    <acronym>PlexUS</acronym>
    <official_title>Evaluation of the Learning Curve for the Visualization of Sacral Nerve Roots and Sacral Plexus on Gynecological Transvaginal Ultrasound - PlexUS Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Semmelweis University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jagiellonian University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Charles University, Czech Republic</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>St John of God Hospital, Vienna</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Semmelweis University</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 purpose of this prospective study was to evaluate the learning curve of TVUS&#xD;
        (transvaginal ultrasound) for the visualization of sacral nerve roots and sacral plexus on&#xD;
        gynecological transvaginal ultrasound. The investigators aim to evaluate to evaluate the&#xD;
        number needed to gain competence or to review the level of competence.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        For each patient, the fellows are blinded to the clinical and surgical history. The&#xD;
        investigators will be aware that all patients were being evaluated for pelvic pain or&#xD;
        endometriosis. The expert sonographer assess the patient and visualized the sacral roots and&#xD;
        the sacral plexus first as part of the advanced TVUS examination for endometriosis.&#xD;
  &#xD;
        TVUS examination will conducted in six steps eas follows in six successive steps. All women&#xD;
        will be asked to empty their bladder prior to examination. TVUS scans will be performed in&#xD;
        the lithotomy position in a standardized fashion using a transvaginal probe Step 1: First the&#xD;
        probe will inserted into the anterior vaginal fornix. The uterus is examined in the&#xD;
        midsagittal view on the longitudinal section to identify the cervix and the uterine cavity.&#xD;
        The image is frozen with time displayed on the screen, which was marked as Time 1.&#xD;
  &#xD;
        Step 2: The image is unfrozen and at the level of the inner cervical meatus the transducer is&#xD;
        rotated 90 degrees counterclockwise to obtain a transverse scan.&#xD;
  &#xD;
        Step 3: Then the probe is immediately moved towards the right lateral fornix pointing towards&#xD;
        the uterine vessels, which appear as hypoechoic bands. Behind these structures, a thick&#xD;
        hyperechoic band - the left uterosacral ligament -appears, starting from the cervix and&#xD;
        pointing laterally in a semi horizontal direction. By rotating the probe the uterosacral&#xD;
        ligament is then followed from medial to lateral, up to the lateral pelvic wall. The&#xD;
        obturator internus muscle covers most of the lateral wall of the pelvis minor, which - in&#xD;
        transverse scan - is a hypoechoic thin band just lateral to the uterosacral ligament. On the&#xD;
        lateral side of the muscle a continuous bright white band is seen, corresponding to the body&#xD;
        of the ischium.&#xD;
  &#xD;
        Step 4: Sweeping the probe medially and pushing it superior the hypoechoic obturator internus&#xD;
        muscle and the hyperechoic ischium are followed ending at the greater sciatic foramen. At&#xD;
        this point transverse and oblique sections of the branches of the anterior division of the&#xD;
        internal iliac vessels became visible. Deeper to the vessels the hypoechoic muscle fiber&#xD;
        bundles with intervening echogenic perimysium, the piriformis muscle, and a bright white&#xD;
        line, the anterior surface of the sacrum are visualized. Between the vessels and the&#xD;
        piriformis muscle on conventional gray scale B mode the sacral roots of the sacral plexus&#xD;
        (SP) appear in longitudinal section, with a typical &quot;bundle of straw&quot; appearance: hypoechoic&#xD;
        bands, with echogenic septae. The hypoechoic areas correspond to nerve fascicles, while the&#xD;
        hyperechoic septae correspond to the inner and outer epineurium. In transverse section, the&#xD;
        nerves have a &quot;honeycomb&quot; shape echotexture.&#xD;
  &#xD;
        Step 5: Pushing the transducer superior color Doppler and pulse wave Doppler can be used to&#xD;
        differentiate blood vessels from the ureter on the lateral pelvic wall and to identify the&#xD;
        branching of the internal iliac artery. From the posterior division rises the superior&#xD;
        gluteal artery and from the anterior division originates the inferior gluteal artery. Both of&#xD;
        them exiting the pelvis between the ischium and the sacrum. The former runs between the&#xD;
        lumbosacral trunk and the ventral ramus of the S1 nerve and leaves the pelvis superior to the&#xD;
        piriformis muscle. The inferior gluteal artery passes usually posteriorly between S2 and S3&#xD;
        roots, and leaves the pelvis together with the sciatic nerve, inferior to the piriformis&#xD;
        muscle near to the transducer. When the sacral plexus was clearly visualized the image was&#xD;
        frozen again and Time 2 was marked. The total time required to complete the visualization of&#xD;
        the sacral plexus was calculated as Time 2 minus Time 1.&#xD;
  &#xD;
        The diameter of the SP is measured in all patients in a transverse section at the notional&#xD;
        intersection of the SP and a vertical line extending from the medial border of the obturator&#xD;
        internus muscle. The measurement is taken by placing the caliper on the outer edge of&#xD;
        hyperechoic epineurium. The same procedure is then repeated on the contralateral side.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2025</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>The number of scans to gain competency for the visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound</measure>
      <time_frame>12 months</time_frame>
      <description>The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>inter and intraobserver variability</measure>
      <time_frame>12 months</time_frame>
      <description>The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>differences between sonographers of different level of experience in the field of gynecological TVS.</measure>
      <time_frame>12 months</time_frame>
      <description>The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>differences between participating centers.</measure>
      <time_frame>12 months</time_frame>
      <description>The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate</description>
    </secondary_outcome>
    <enrollment type="Anticipated">480</enrollment>
    <condition>Endometriosis</condition>
    <condition>Nerve Sheath Tumor</condition>
    <condition>Radiculopathy</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Transvaginal ultrasound</intervention_name>
      <description>Preoperative detection with TVUS of proximity or the involvement of the sacral nerve roots in women diagnosed with deep endometriosis or other benign or malignant pelvic tumors would also contribute to the safety of surgical interventions (e.g laparoscopy, tru-cut biopsy) It aslo provides correct counseling and select the appropriate surgical team and assess the likely operative complexity of the surgery. Until now the diagnosis was based on MRI.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants are consecutive patients of the Gynecology and Endometriosis Ambulance of the&#xD;
          participating centres.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with pelvic pain scheduled for TVS&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  18 years&#xD;
  &#xD;
            -  Women who have never been sexually active&#xD;
  &#xD;
            -  (suspected) Pelvic malignancy for example gynecological, intestinal or urological&#xD;
               malignancy&#xD;
  &#xD;
            -  Premenarche&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Patients refusal to participate to the study&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gábor Szabó, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Semmelweis University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gábor Szabó, PhD</last_name>
      <phone>+36204554710</phone>
      <email>szabo.gabor6@med.semmelweis-univ.hu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Gábor Szabó</name>
        <address>
          <city>Budapest</city>
          <zip>1088</zip>
          <country>Hungary</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Hungary</country>
    </location_countries>
    <results_reference>
      <citation>Szabo G, Madar I, Hudelist G, Aranyi Z, Turtoczki K, Rigo J Jr, Acs N, Liptak L, Fancsovits V, Bokor A. Visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound: feasibility study. Ultrasound Obstet Gynecol. 2023 Aug;62(2):290-299. doi: 10.1002/uog.26204.</citation>
      <PMID>36938682</PMID>
    </results_reference>
    <results_reference>
      <citation>Fischerova D, Santos G, Wong L, Yulzari V, Bennett RJ, Dundr P, Burgetova A, Barsa P, Szabo G, Sousa N, Scovazzi U, Cibula D. Imaging in gynecological disease: clinical and ultrasound characteristics of benign retroperitoneal pelvic nerve sheath tumors. Ultrasound Obstet Gynecol. 2023 Apr 14. doi: 10.1002/uog.26223. Online ahead of print.</citation>
      <PMID>37058402</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nerve Sheath Neoplasms</mesh_term>
      <mesh_term>Radiculopathy</mesh_term>
      <mesh_term>Endometriosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06041347
  org study id: Semmelweis University Szabó G
  nct id: NCT06041347
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this prospective study was to evaluate the learning curve of TVUS
        (transvaginal ultrasound) for the visualization of sacral nerve roots and sacral plexus on
        gynecological transvaginal ultrasound. The investigators aim to evaluate to evaluate the
        number needed to gain competence or to review the level of competence.
  For each patient, the fellows are blinded to the clinical and surgical history. The
        investigators will be aware that all patients were being evaluated for pelvic pain or
        endometriosis. The expert sonographer assess the patient and visualized the sacral roots and
        the sacral plexus first as part of the advanced TVUS examination for endometriosis.
  
        TVUS examination will conducted in six steps eas follows in six successive steps. All women
        will be asked to empty their bladder prior to examination. TVUS scans will be performed in
        the lithotomy position in a standardized fashion using a transvaginal probe Step 1: First the
        probe will inserted into the anterior vaginal fornix. The uterus is examined in the
        midsagittal view on the longitudinal section to identify the cervix and the uterine cavity.
        The image is frozen with time displayed on the screen, which was marked as Time 1.
  
        Step 2: The image is unfrozen and at the level of the inner cervical meatus the transducer is
        rotated 90 degrees counterclockwise to obtain a transverse scan.
  
        Step 3: Then the probe is immediately moved towards the right lateral fornix pointing towards
        the uterine vessels, which appear as hypoechoic bands. Behind these structures, a thick
        hyperechoic band - the left uterosacral ligament -appears, starting from the cervix and
        pointing laterally in a semi horizontal direction. By rotating the probe the uterosacral
        ligament is then followed from medial to lateral, up to the lateral pelvic wall. The
        obturator internus muscle covers most of the lateral wall of the pelvis minor, which - in
        transverse scan - is a hypoechoic thin band just lateral to the uterosacral ligament. On the
        lateral side of the muscle a continuous bright white band is seen, corresponding to the body
        of the ischium.
  
        Step 4: Sweeping the probe medially and pushing it superior the hypoechoic obturator internus
        muscle and the hyperechoic ischium are followed ending at the greater sciatic foramen. At
        this point transverse and oblique sections of the branches of the anterior division of the
        internal iliac vessels became visible. Deeper to the vessels the hypoechoic muscle fiber
        bundles with intervening echogenic perimysium, the piriformis muscle, and a bright white
        line, the anterior surface of the sacrum are visualized. Between the vessels and the
        piriformis muscle on conventional gray scale B mode the sacral roots of the sacral plexus
        (SP) appear in longitudinal section, with a typical "bundle of straw" appearance: hypoechoic
        bands, with echogenic septae. The hypoechoic areas correspond to nerve fascicles, while the
        hyperechoic septae correspond to the inner and outer epineurium. In transverse section, the
        nerves have a "honeycomb" shape echotexture.
  
        Step 5: Pushing the transducer superior color Doppler and pulse wave Doppler can be used to
        differentiate blood vessels from the ureter on the lateral pelvic wall and to identify the
        branching of the internal iliac artery. From the posterior division rises the superior
        gluteal artery and from the anterior division originates the inferior gluteal artery. Both of
        them exiting the pelvis between the ischium and the sacrum. The former runs between the
        lumbosacral trunk and the ventral ramus of the S1 nerve and leaves the pelvis superior to the
        piriformis muscle. The inferior gluteal artery passes usually posteriorly between S2 and S3
        roots, and leaves the pelvis together with the sciatic nerve, inferior to the piriformis
        muscle near to the transducer. When the sacral plexus was clearly visualized the image was
        frozen again and Time 2 was marked. The total time required to complete the visualization of
        the sacral plexus was calculated as Time 2 minus Time 1.
  
        The diameter of the SP is measured in all patients in a transverse section at the notional
        intersection of the SP and a vertical line extending from the medial border of the obturator
        internus muscle. The measurement is taken by placing the caliper on the outer edge of
        hyperechoic epineurium. The same procedure is then repeated on the contralateral side.
  observational model: Cohort
  time perspective: Prospective
  measure: The number of scans to gain competency for the visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound
  time frame: 12 months
  description: The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate.
  measure: inter and intraobserver variability
  time frame: 12 months
  description: The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate
  measure: differences between sonographers of different level of experience in the field of gynecological TVS.
  time frame: 12 months
  description: The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate
  measure: differences between participating centers.
  time frame: 12 months
  description: The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate
  intervention type: Diagnostic Test
  intervention name: Transvaginal ultrasound
  description: Preoperative detection with TVUS of proximity or the involvement of the sacral nerve roots in women diagnosed with deep endometriosis or other benign or malignant pelvic tumors would also contribute to the safety of surgical interventions (e.g laparoscopy, tru-cut biopsy) It aslo provides correct counseling and select the appropriate surgical team and assess the likely operative complexity of the surgery. Until now the diagnosis was based on MRI.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gábor Szabó, PhD
  role: Principal Investigator
  affiliation: Semmelweis University
  last name: Gábor Szabó, PhD
  phone: +36204554710
  email: szabo.gabor6@med.semmelweis-univ.hu
  facility: 
  country: Hungary
  citation: Szabo G, Madar I, Hudelist G, Aranyi Z, Turtoczki K, Rigo J Jr, Acs N, Liptak L, Fancsovits V, Bokor A. Visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound: feasibility study. Ultrasound Obstet Gynecol. 2023 Aug;62(2):290-299. doi: 10.1002/uog.26204.
  PMID: 36938682
  citation: Fischerova D, Santos G, Wong L, Yulzari V, Bennett RJ, Dundr P, Burgetova A, Barsa P, Szabo G, Sousa N, Scovazzi U, Cibula D. Imaging in gynecological disease: clinical and ultrasound characteristics of benign retroperitoneal pelvic nerve sheath tumors. Ultrasound Obstet Gynecol. 2023 Apr 14. doi: 10.1002/uog.26223. Online ahead of print.
  PMID: 37058402
  responsible party type: Sponsor
  mesh term: Nerve Sheath Neoplasms
  mesh term: Radiculopathy
  mesh term: Endometriosis
  sharing ipd: No