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/NCT05971875</url>
    </required_header>
    <id_info>
      <org_study_id>Vanolah</org_study_id>
      <nct_id>NCT05971875</nct_id>
    </id_info>
    <brief_title>RCT on 3 Types of Hysterectomy</brief_title>
    <acronym>VANOLAH</acronym>
    <official_title>CLINICAL TRIAL PROTOCOL VaNoLaH Trial: A Randomized Controlled Trial Comparing the Vaginal, vNOTES ( Vaginal Natural Orifice Transluminal Surgery) or Laparoscopic Approach for Hysterectomy in Women With Benign Gynaecological Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dr Jan Baekelandt, MD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Imelda Hospital, Bonheiden</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>
        A randomized controlled trial comparing the vaginal, vNOTES ( vaginal natural orifice&#xD;
        transluminal surgery) or laparoscopic approach for hysterectomy in women with benign&#xD;
        gynaecological disease&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Multi-center pragmatic non-blinded RCT including 1000 women 18-75 years in need of&#xD;
        hysterectomy for benign disease; comparing VH vs vNOTES or LH vs vNOTES.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">January 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>proportion of women leaving the hospital within 12 hours after surgery complications.</measure>
      <time_frame>12 hours</time_frame>
      <description>Day sugery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>conversion rates</measure>
      <time_frame>12 hours</time_frame>
      <description>conversion to different surgival technique</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>duration of the surgical procedure</measure>
      <time_frame>12 hours</time_frame>
      <description>from placement of Foley to last stich</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>postoperative complications,</measure>
      <time_frame>6 weeks</time_frame>
      <description>Clavien Dindo</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>re-admission requiring hospitalization for at least 24 hours</measure>
      <time_frame>6 weeks</time_frame>
      <description>Readminssion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The successful removal of adnexa or tubes by planned route of hysterectomy</measure>
      <time_frame>12 hours</time_frame>
      <description>adnexectomy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraoperative complications.</measure>
      <time_frame>12 hours</time_frame>
      <description>Complication</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Minimally Invasive Surgery</condition>
    <arm_group>
      <arm_group_label>vNOTES vs Vaginal Hysterectomy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group A: If VH is concidered safe and feasable; the patient is randomized between VH and vNOTES</description>
    </arm_group>
    <arm_group>
      <arm_group_label>vNOTES vs Laparoscopic Hysterectomy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>If VH is not concidered safe and feasable; The patient is randomized between LH and vNOTES</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>vNOTES vs Vaginal Hysterectomy</intervention_name>
      <description>Comparison of vNOTES vs VH</description>
      <arm_group_label>vNOTES vs Vaginal Hysterectomy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>vNOTES vs Laparoscopic Hysterectomy</intervention_name>
      <description>Comparison of vNOTES vs LH</description>
      <arm_group_label>vNOTES vs Laparoscopic Hysterectomy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • Women aged 18 to 75 years regardless of parity with benign indication for hysterectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women with a stage II+ prolapse in need of a hysterectomy as part of vaginal prolapse&#xD;
               repair&#xD;
  &#xD;
            -  hysterectomy due to suspected endometriosis&#xD;
  &#xD;
            -  subtotal hysterectomy&#xD;
  &#xD;
            -  history of rectal surgery&#xD;
  &#xD;
            -  suspected malignancy&#xD;
  &#xD;
            -  suspected obliteration of the pouch of Douglas following severe PID or other causes&#xD;
  &#xD;
            -  active lower genital tract infection&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  failure to provide written informed consent prior to surgery&#xD;
  &#xD;
            -  requirement of in-patient care due to other co-morbidities&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>JAn Baekelandt</last_name>
      <role>Principal Investigator</role>
      <affiliation>Imeldaziekenhuis</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jan Baekelandt, Prof</last_name>
      <phone>0032499471371</phone>
      <email>jan.baekelandt@imelda.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jan Baekelandt</last_name>
      <phone>0032499471371</phone>
      <email>jan.baekelandt@imelda.be</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Imelda Hospital, Bonheiden</investigator_affiliation>
      <investigator_full_name>Dr Jan Baekelandt, MD</investigator_full_name>
      <investigator_title>Prof</investigator_title>
    </responsible_party>
    <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/NCT05971875
  org study id: Vanolah
  nct id: NCT05971875
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A randomized controlled trial comparing the vaginal, vNOTES ( vaginal natural orifice
        transluminal surgery) or laparoscopic approach for hysterectomy in women with benign
        gynaecological disease
  Multi-center pragmatic non-blinded RCT including 1000 women 18-75 years in need of
        hysterectomy for benign disease; comparing VH vs vNOTES or LH vs vNOTES.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: proportion of women leaving the hospital within 12 hours after surgery complications.
  time frame: 12 hours
  description: Day sugery
  measure: conversion rates
  time frame: 12 hours
  description: conversion to different surgival technique
  measure: duration of the surgical procedure
  time frame: 12 hours
  description: from placement of Foley to last stich
  measure: postoperative complications,
  time frame: 6 weeks
  description: Clavien Dindo
  measure: re-admission requiring hospitalization for at least 24 hours
  time frame: 6 weeks
  description: Readminssion
  measure: The successful removal of adnexa or tubes by planned route of hysterectomy
  time frame: 12 hours
  description: adnexectomy
  measure: Intraoperative complications.
  time frame: 12 hours
  description: Complication
  arm group label: vNOTES vs Vaginal Hysterectomy
  arm group type: Active Comparator
  description: Group A: If VH is concidered safe and feasable; the patient is randomized between VH and vNOTES
  arm group label: vNOTES vs Laparoscopic Hysterectomy
  arm group type: Active Comparator
  description: If VH is not concidered safe and feasable; The patient is randomized between LH and vNOTES
  intervention type: Procedure
  intervention name: vNOTES vs Vaginal Hysterectomy
  description: Comparison of vNOTES vs VH
  arm group label: vNOTES vs Vaginal Hysterectomy
  intervention type: Procedure
  intervention name: vNOTES vs Laparoscopic Hysterectomy
  description: Comparison of vNOTES vs LH
  arm group label: vNOTES vs Laparoscopic Hysterectomy
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: JAn Baekelandt
  role: Principal Investigator
  affiliation: Imeldaziekenhuis
  last name: Jan Baekelandt, Prof
  phone: 0032499471371
  email: jan.baekelandt@imelda.be
  last name: Jan Baekelandt
  phone: 0032499471371
  email: jan.baekelandt@imelda.be
  responsible party type: Sponsor-Investigator
  investigator affiliation: Imelda Hospital, Bonheiden
  investigator full name: Dr Jan Baekelandt, MD
  investigator title: Prof
  sharing ipd: No