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/NCT05998746</url>
    </required_header>
    <id_info>
      <org_study_id>OS-UH23</org_study_id>
      <nct_id>NCT05998746</nct_id>
    </id_info>
    <brief_title>Comparison of ASA and CFS in Anesthesiology</brief_title>
    <acronym>CACA</acronym>
    <official_title>Comparison of ASA and CFS in Predicting Peri- and Postoperative Outcomes in Elective Patients Older Than 65 Years</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Osijek University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Osijek University Hospital</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>
        In addition to the regular ASA classification, patients would also be assigned the Clinical&#xD;
        frailty scale (CFS) during preoperative examinations in anesthesiology clinics. The aim is to&#xD;
        compare the usefulness of ASA and CFS categorization for predicting perioperative and&#xD;
        postoperative complications and length of postoperative stay in elective surgeries.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        CFS significantly correlates with complications in patients treated in emergency department.&#xD;
        This study is expected to provide information on how CFS correlates with complications and&#xD;
        length of stay in elective surgeries.&#xD;
  &#xD;
        In addition to the regular ASA classification, patients would also be assigned the Clinical&#xD;
        frailty scale (CFS) during preoperative examinations in anesthesiology clinics.&#xD;
  &#xD;
        The respondents are all elective patients over 65 years of age who have not had previously&#xD;
        recorded mental difficulties that interfere with their daily life. Patients suffering from&#xD;
        senile dementia would not be excluded from this study.&#xD;
  &#xD;
        After the treatment was completed, the medical history of each patient would be reviewed and&#xD;
        statistically processed.&#xD;
  &#xD;
        The aim is to compare the usefulness of ASA and CFS categorization for predicting&#xD;
        perioperative and postoperative complications and length of postoperative stay in elective&#xD;
        surgeries.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 17, 2023</start_date>
    <completion_date type="Anticipated">June 3, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>2 Months</target_duration>
    <primary_outcome>
      <measure>Peri- and postoperative complications</measure>
      <time_frame>During 2 months after elective operation</time_frame>
      <description>Peri- and postoperative complications depending on CFS and ASA</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Length of stay in hospital</measure>
      <time_frame>During 2 months after elective operation</time_frame>
      <description>Length of stay in hospital after elective operation depending on CFS and ASA</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Frailty</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Study population is all elective patients of the Osijek University Hospital older then 65&#xD;
          years who were included during the preoperative examination.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All elective patients older then 65 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Earlier mental difficulties that affect everyday life, senile dementia is not&#xD;
               exclusion criteria&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Slavica Kvolik, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Osijek University Hospital; Medical Faculty Osijek</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Josip Kajan, Student</last_name>
      <phone>+385 98 1309 408</phone>
      <email>jkajan@mefos.hr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Slavica Kvolik, M.D. Ph.D.</last_name>
      <phone>098723925</phone>
      <email>slavica.kvolik@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital Centre Osijek</name>
        <address>
          <city>Osijek</city>
          <zip>31000</zip>
          <country>Croatia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Slavica Kvolik, Prof.</last_name>
        <phone>+38598723925</phone>
        <email>skvolik@mefos.hr</email>
      </contact>
    </location>
    <location_countries>
      <country>Croatia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>American Society of Anesthesiologists physical status;</keyword>
    <keyword>Clinical frailty</keyword>
    <keyword>Elderly</keyword>
    <keyword>Treatment outcome</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <!-- 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/NCT05998746
  org study id: OS-UH23
  nct id: NCT05998746
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In addition to the regular ASA classification, patients would also be assigned the Clinical
        frailty scale (CFS) during preoperative examinations in anesthesiology clinics. The aim is to
        compare the usefulness of ASA and CFS categorization for predicting perioperative and
        postoperative complications and length of postoperative stay in elective surgeries.
  CFS significantly correlates with complications in patients treated in emergency department.
        This study is expected to provide information on how CFS correlates with complications and
        length of stay in elective surgeries.
  
        In addition to the regular ASA classification, patients would also be assigned the Clinical
        frailty scale (CFS) during preoperative examinations in anesthesiology clinics.
  
        The respondents are all elective patients over 65 years of age who have not had previously
        recorded mental difficulties that interfere with their daily life. Patients suffering from
        senile dementia would not be excluded from this study.
  
        After the treatment was completed, the medical history of each patient would be reviewed and
        statistically processed.
  
        The aim is to compare the usefulness of ASA and CFS categorization for predicting
        perioperative and postoperative complications and length of postoperative stay in elective
        surgeries.
  observational model: Cohort
  time perspective: Prospective
  measure: Peri- and postoperative complications
  time frame: During 2 months after elective operation
  description: Peri- and postoperative complications depending on CFS and ASA
  measure: Length of stay in hospital
  time frame: During 2 months after elective operation
  description: Length of stay in hospital after elective operation depending on CFS and ASA
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Slavica Kvolik, MD
  role: Study Chair
  affiliation: Osijek University Hospital; Medical Faculty Osijek
  last name: Josip Kajan, Student
  phone: +385 98 1309 408
  email: jkajan@mefos.hr
  last name: Slavica Kvolik, M.D. Ph.D.
  phone: 098723925
  email: slavica.kvolik@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Croatia
  responsible party type: Sponsor
  mesh term: Frailty