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/NCT05980910</url>
    </required_header>
    <id_info>
      <org_study_id>20236103RIND</org_study_id>
      <nct_id>NCT05980910</nct_id>
    </id_info>
    <brief_title>Protective and Risk Factors for QoR-15 for Major Abdominal Surgery</brief_title>
    <acronym>Q15MAS</acronym>
    <official_title>Investigation of Protective and Risk Factors for Quality of Recovery-15 (QoR-15) Score for Patients Undergoing Major Abdominal Surgery- an Multi-center Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Taiwan University Hospital Hsin-Chu Branch</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>National Taiwan 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>
        Investigation of post-operative recovery among adult patients receiving major abdominal&#xD;
        surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This prospective observational clinical trial aims to evaluate the postoperative recovery&#xD;
        status of patients undergoing major abdominal surgery using the Quality of Recovery-15&#xD;
        (QoR-15) questionnaire. The QoR-15 has been highly regarded for its importance and research&#xD;
        value in evaluating postoperative recovery in previous studies and has been validated in&#xD;
        numerous languages, including Mandarin. Furthermore, the QoR-15 is not only a reflection of&#xD;
        the subjective recovery quality but has also been found to be associated with objective&#xD;
        indicators such as postoperative complications. Therefore, establishing a database of&#xD;
        postoperative QoR-15 variations can play a significant role in improving healthcare quality&#xD;
        and serves as a validation indicator for many Enhanced Recovery After Surgery (ERAS)&#xD;
        outcomes. The study aims to contribute to improving postoperative care and inform future&#xD;
        research in the context of ERAS programs..&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 21, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</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>QoR-15 Scores at postoperative day one and day three</measure>
      <time_frame>72 hours</time_frame>
      <description>Measure the QoR-15(Quality of Recovery-15) scores on the first day and third day after major abdominal surgery. The QoR-15 score, derived from a 15-item questionnaire using an 11-point numeric rating scale, ranges from 0 to 150, with higher scores indicating better recovery quality.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Patients Undergoing Major Abdominal Surgery</condition>
    <arm_group>
      <arm_group_label>Major abdominal surgery</arm_group_label>
      <description>Patients undergoing elective major abdominal surgery. The definition of major surgery is the estimated surgery time &gt;= 2 hours.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Adult Patients receiving major abdominal surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (1) Age 18years and above.&#xD;
  &#xD;
            -  (2) Undergoing elective abdominal surgery with an expected surgical time of at least&#xD;
               two hours and an expected hospital stay of at least two days.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  (1) Age under 18 years. (2) Incapacity to give informed consent. (3) Emergency&#xD;
               surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Weihan Chou, MD.</last_name>
      <phone>*886-921815831</phone>
      <email>brokenarrowchou@yahoo.com.tw</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tsung Ta Wu, MD.</last_name>
      <phone>+886972654224</phone>
      <email>tsungta.wu@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>National Taiwan University Hosipital Hsin Chu Branch</name>
        <address>
          <city>HsinChu</city>
          <zip>302</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>TsungTa Wu, MD</last_name>
        <phone>886972654224</phone>
        <email>tsungta.wu@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <zip>100225</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Weihan Chou, MD.</last_name>
        <phone>*886-921815831</phone>
        <email>brokenarrowchou@yahoo.com.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <reference>
      <citation>Myles PS. More than just morbidity and mortality - quality of recovery and long-term functional recovery after surgery. Anaesthesia. 2020 Jan;75 Suppl 1:e143-e150. doi: 10.1111/anae.14786.</citation>
      <PMID>31903564</PMID>
    </reference>
    <reference>
      <citation>Johnson A, Rice AN, Titch JF, Gupta DK. Identifying Components Necessary for an Enhanced Recovery After Surgery Pathway for Elective Intracranial Surgery: An Improvement Project Using the Quality of Recovery-15 Score. World Neurosurg. 2019 Oct;130:e423-e430. doi: 10.1016/j.wneu.2019.06.108. Epub 2019 Jul 4.</citation>
      <PMID>31279110</PMID>
    </reference>
    <results_reference>
      <citation>Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.</citation>
      <PMID>23411725</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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/NCT05980910
  org study id: 20236103RIND
  nct id: NCT05980910
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Investigation of post-operative recovery among adult patients receiving major abdominal
        surgery.
  This prospective observational clinical trial aims to evaluate the postoperative recovery
        status of patients undergoing major abdominal surgery using the Quality of Recovery-15
        (QoR-15) questionnaire. The QoR-15 has been highly regarded for its importance and research
        value in evaluating postoperative recovery in previous studies and has been validated in
        numerous languages, including Mandarin. Furthermore, the QoR-15 is not only a reflection of
        the subjective recovery quality but has also been found to be associated with objective
        indicators such as postoperative complications. Therefore, establishing a database of
        postoperative QoR-15 variations can play a significant role in improving healthcare quality
        and serves as a validation indicator for many Enhanced Recovery After Surgery (ERAS)
        outcomes. The study aims to contribute to improving postoperative care and inform future
        research in the context of ERAS programs..
  observational model: Cohort
  time perspective: Prospective
  measure: QoR-15 Scores at postoperative day one and day three
  time frame: 72 hours
  description: Measure the QoR-15(Quality of Recovery-15) scores on the first day and third day after major abdominal surgery. The QoR-15 score, derived from a 15-item questionnaire using an 11-point numeric rating scale, ranges from 0 to 150, with higher scores indicating better recovery quality.
  arm group label: Major abdominal surgery
  description: Patients undergoing elective major abdominal surgery. The definition of major surgery is the estimated surgery time >= 2 hours.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Weihan Chou, MD.
  phone: *886-921815831
  email: brokenarrowchou@yahoo.com.tw
  last name: Tsung Ta Wu, MD.
  phone: +886972654224
  email: tsungta.wu@gmail.com
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  citation: Myles PS. More than just morbidity and mortality - quality of recovery and long-term functional recovery after surgery. Anaesthesia. 2020 Jan;75 Suppl 1:e143-e150. doi: 10.1111/anae.14786.
  PMID: 31903564
  citation: Johnson A, Rice AN, Titch JF, Gupta DK. Identifying Components Necessary for an Enhanced Recovery After Surgery Pathway for Elective Intracranial Surgery: An Improvement Project Using the Quality of Recovery-15 Score. World Neurosurg. 2019 Oct;130:e423-e430. doi: 10.1016/j.wneu.2019.06.108. Epub 2019 Jul 4.
  PMID: 31279110
  citation: Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
  PMID: 23411725
  responsible party type: Sponsor
  sharing ipd: No