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/NCT05992948</url>
    </required_header>
    <id_info>
      <org_study_id>2192/2019</org_study_id>
      <nct_id>NCT05992948</nct_id>
    </id_info>
    <brief_title>Endosonograpic Monitoring of Injury to the Anal Sphincter After Transanal Stapled Anastomosis</brief_title>
    <official_title>Endosonograpic Monitoring of Injury to the Anal Sphincter After Transanal Stapled Anastomosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Vienna</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of Vienna</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Investigation of the sphincter muscles after low anterior or anterior rectum resection, and&#xD;
        sigma resection operation by endoluminal ultrasound and manometrical examination.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2020</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>EAUS</measure>
      <time_frame>3 months postoperative</time_frame>
      <description>Change in thickness of the anal sphincter muscles in mm from baseline to 3 months</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Endoanal manometry</measure>
      <time_frame>3 months postoperative</time_frame>
      <description>Change in Anal pressure in mmHg from baseline to 3 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EAUS2</measure>
      <time_frame>3 months postoperative</time_frame>
      <description>Change in the defect grade of anal sphincter muscles from baseline to 3 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EAUS2-2</measure>
      <time_frame>12 months postoperative</time_frame>
      <description>Change in thickness of the anal sphincter muscles in mm from baseline to 12 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EAUS2-2</measure>
      <time_frame>12 months postoperative</time_frame>
      <description>Change in the defect grade of anal sphincter muscles from baseline to 12 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Endoanal manometry2</measure>
      <time_frame>12 months postoperative</time_frame>
      <description>Change in Anal pressure in mmHg from baseline to 12 months</description>
    </secondary_outcome>
    <other_outcome>
      <measure>LARS Score</measure>
      <time_frame>3 months postoperative</time_frame>
      <description>Change in LARS Score from baseline to 3 months</description>
    </other_outcome>
    <other_outcome>
      <measure>LARS Score2</measure>
      <time_frame>12 months postoperative</time_frame>
      <description>Change in LARS Score from baseline to 12 months</description>
    </other_outcome>
    <other_outcome>
      <measure>LARS2</measure>
      <time_frame>12 months postoperative</time_frame>
      <description>Change in LARS Score from baseline to 12 months</description>
    </other_outcome>
    <other_outcome>
      <measure>Vaizey Score</measure>
      <time_frame>3 months postoperative</time_frame>
      <description>Change in Vaizey Score from baseline to 3 months</description>
    </other_outcome>
    <other_outcome>
      <measure>Vaizey Score2</measure>
      <time_frame>12 months postoperative</time_frame>
      <description>Change in Vaizey Score from baseline to 12 months</description>
    </other_outcome>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Transanal Stapled Anastomosis</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transanal stapling device</intervention_name>
      <description>Transanal stapling device used in low anterior- or anterior rectum resection, sigma resection, left hemicolectomy and intestinal reconstruction operations</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients requiring transanal stapled anastomosis due to various reasons will be enrolled in&#xD;
          this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Age 18 - 90 years, undergoing transanal stapled anastomosis at the Department of General&#xD;
          Surgery, Medical University of Vienna&#xD;
  &#xD;
            -  Ability and willingness to understand and comply with study interventions and&#xD;
               restrictions.&#xD;
  &#xD;
            -  Voluntarily signed informed consent after full explanation of the study to the&#xD;
               participant.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any physical or mental disorder, which could interfere with the participant's safety&#xD;
               during the clinical trial or with the study objectives&#xD;
  &#xD;
            -  Inability to communicate well with the investigator due to language problems or&#xD;
               reduced mental development&#xD;
  &#xD;
            -  Inability or unwillingness to give written informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Christopher Dawoud, MD</last_name>
      <phone>0043 1 40400 56220</phone>
      <email>christopher.dawoud@muv.ac.at</email>
    </overall_contact>
    <location>
      <facility>
        <name>Medical University of Vienna</name>
        <address>
          <city>Vienna</city>
          <zip>1090</zip>
          <country>Austria</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Christopher Dawoud, MD</last_name>
        <phone>+43 660 280 48 39</phone>
        <email>christopher.dawoud@meduniwien.ac.at</email>
      </contact>
      <contact_backup>
        <last_name>Stefan Riss, Prof.MD</last_name>
        <phone>+43 1 40400 56210</phone>
        <email>stefan.riss@meduniwien.ac.at</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Austria</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
      <investigator_full_name>Dr. Christopher Dawoud</investigator_full_name>
      <investigator_title>Principal Investigator; MD</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/NCT05992948
  org study id: 2192/2019
  nct id: NCT05992948
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Investigation of the sphincter muscles after low anterior or anterior rectum resection, and
        sigma resection operation by endoluminal ultrasound and manometrical examination.
  observational model: Case-Only
  time perspective: Prospective
  measure: EAUS
  time frame: 3 months postoperative
  description: Change in thickness of the anal sphincter muscles in mm from baseline to 3 months
  measure: Endoanal manometry
  time frame: 3 months postoperative
  description: Change in Anal pressure in mmHg from baseline to 3 months
  measure: EAUS2
  time frame: 3 months postoperative
  description: Change in the defect grade of anal sphincter muscles from baseline to 3 months
  measure: EAUS2-2
  time frame: 12 months postoperative
  description: Change in thickness of the anal sphincter muscles in mm from baseline to 12 months
  measure: EAUS2-2
  time frame: 12 months postoperative
  description: Change in the defect grade of anal sphincter muscles from baseline to 12 months
  measure: Endoanal manometry2
  time frame: 12 months postoperative
  description: Change in Anal pressure in mmHg from baseline to 12 months
  measure: LARS Score
  time frame: 3 months postoperative
  description: Change in LARS Score from baseline to 3 months
  measure: LARS Score2
  time frame: 12 months postoperative
  description: Change in LARS Score from baseline to 12 months
  measure: LARS2
  time frame: 12 months postoperative
  description: Change in LARS Score from baseline to 12 months
  measure: Vaizey Score
  time frame: 3 months postoperative
  description: Change in Vaizey Score from baseline to 3 months
  measure: Vaizey Score2
  time frame: 12 months postoperative
  description: Change in Vaizey Score from baseline to 12 months
  intervention type: Device
  intervention name: Transanal stapling device
  description: Transanal stapling device used in low anterior- or anterior rectum resection, sigma resection, left hemicolectomy and intestinal reconstruction operations
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Christopher Dawoud, MD
  phone: 0043 1 40400 56220
  email: christopher.dawoud@muv.ac.at
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Austria
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of Vienna
  investigator full name: Dr. Christopher Dawoud
  investigator title: Principal Investigator; MD
  sharing ipd: No