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/NCT06002776</url>
    </required_header>
    <id_info>
      <org_study_id>Sisli Hamidiye Etfal TRH</org_study_id>
      <nct_id>NCT06002776</nct_id>
    </id_info>
    <brief_title>Our Anesthesia Experiences in Hepatopancreatobiliary Surgery Practices: a Retrospective Study</brief_title>
    <official_title>Our Anesthesia Experiences in Hepatopancreatobiliary Surgery Practices: a Retrospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sisli Hamidiye Etfal Training and Research 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>
        Has the evolving anesthetic management in major abdominal surgeries had a positive impact on&#xD;
        patients' one-year postoperative mortality and length of hospital stay? Which of the&#xD;
        anesthetic management parameters have influenced mortality and hospital stay duration in&#xD;
        these patients? To address these questions, we have planned to retrospectively review&#xD;
        patients who underwent surgery at our center.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In our study, we aimed to compile our practices over the last 5 years by evaluating the&#xD;
        impact of perioperative and postoperative anesthetic management on morbidity and mortality in&#xD;
        hepatopancreatobiliary surgical patients. Our primary outcome was to form a comprehensive&#xD;
        understanding of our anesthesia experiences during the preoperative, perioperative, and&#xD;
        postoperative periods in this patient group. Our secondary outcome was to assess the&#xD;
        influence of preoperative and perioperative anesthetic management on the morbidity and&#xD;
        mortality of these patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 20, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>form a comprehensive understanding of our anesthesia experiences during the preoperative, perioperative, and postoperative periods in this patient group</measure>
      <time_frame>october2017-february2022</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>assess the influence of preoperative and perioperative anesthetic management on the morbidity and mortality of these patients.</measure>
      <time_frame>october2017-february2022</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">6</enrollment>
    <condition>Experience, Life</condition>
    <arm_group>
      <arm_group_label>preoperative and perioperative anaesthetic management</arm_group_label>
      <description>We have planned to retrospectively review data for patients aged 18 and above who underwent major abdominal surgery at our center between October 2017 and February 2022. The study aims to record data regarding the administration of thromboprophylaxis, preoperative hemoglobin values, and Revised Cardiac Risk Index scores and their impact on one-year postoperative mortality. Additionally, we intend to examine the effects of the amount of fluid administered during the perioperative period, the application of epidural analgesia, and the use of blood products on hospital stay duration and one-year postoperative mortality.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>a retrospective study</intervention_name>
      <description>a retrospective study</description>
      <arm_group_label>preoperative and perioperative anaesthetic management</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          data from all patients aged 18 and above who underwent major abdominal surgery with&#xD;
          diagnoses of liver malignancy, cholangiocarcinoma, and pancreatic malignancy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The study will include data from patients who have undergone their first operation&#xD;
               with the diagnoses of liver malignancy, cholangiocarcinoma, and pancreatic malignancy&#xD;
               during the period from October 2017 to February 2022.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Data from patients who were deemed inoperable during the perioperative period after&#xD;
               being taken into surgery with their current diagnosis, as well as data from patients&#xD;
               who underwent repeat operations, were excluded from the study for their second and&#xD;
               subsequent hospitalizations.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Sisli Hamidiye Etfal Training and Researching Hospital</name>
        <address>
          <city>Istanbul</city>
          <state>Sarıyer</state>
          <zip>34396</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Merve Gökçe, Ass. Dr.</last_name>
        <phone>+905301414222</phone>
        <email>merve__duman@hotmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Ayşe Surhan Çınar, Prof. Dr.</last_name>
        <phone>+905326850929</phone>
        <email>asurhan@yahoo.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Snowden C, Prentis J. Anesthesia for hepatobiliary surgery. Anesthesiol Clin. 2015 Mar;33(1):125-41. doi: 10.1016/j.anclin.2014.11.008. Epub 2014 Dec 31.</citation>
      <PMID>25701932</PMID>
    </reference>
    <reference>
      <citation>Hemmerling TM. Pain management in abdominal surgery. Langenbecks Arch Surg. 2018 Nov;403(7):791-803. doi: 10.1007/s00423-018-1705-y. Epub 2018 Oct 3.</citation>
      <PMID>30284029</PMID>
    </reference>
    <reference>
      <citation>von der Forst M, Weiterer S, Dietrich M, Loos M, Lichtenstern C, Weigand MA, Siegler BH. [Perioperative fluid management in major abdominal surgery]. Anaesthesist. 2021 Feb;70(2):127-143. doi: 10.1007/s00101-020-00867-7. German.</citation>
      <PMID>33034685</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 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>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Merve Gokce</investigator_full_name>
      <investigator_title>Assistant Doctor</investigator_title>
    </responsible_party>
    <keyword>major abdominal surgery</keyword>
    <keyword>Revised Cardiac Risk Index</keyword>
    <keyword>Epidural analgesia</keyword>
    <keyword>perioperative fluid management</keyword>
    <keyword>ERAS protocols</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>All patient data will be kept confidential.</ipd_description>
    </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/NCT06002776
  org study id: Sisli Hamidiye Etfal TRH
  nct id: NCT06002776
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Has the evolving anesthetic management in major abdominal surgeries had a positive impact on
        patients' one-year postoperative mortality and length of hospital stay? Which of the
        anesthetic management parameters have influenced mortality and hospital stay duration in
        these patients? To address these questions, we have planned to retrospectively review
        patients who underwent surgery at our center.
  In our study, we aimed to compile our practices over the last 5 years by evaluating the
        impact of perioperative and postoperative anesthetic management on morbidity and mortality in
        hepatopancreatobiliary surgical patients. Our primary outcome was to form a comprehensive
        understanding of our anesthesia experiences during the preoperative, perioperative, and
        postoperative periods in this patient group. Our secondary outcome was to assess the
        influence of preoperative and perioperative anesthetic management on the morbidity and
        mortality of these patients.
  observational model: Other
  time perspective: Retrospective
  measure: form a comprehensive understanding of our anesthesia experiences during the preoperative, perioperative, and postoperative periods in this patient group
  time frame: october2017-february2022
  measure: assess the influence of preoperative and perioperative anesthetic management on the morbidity and mortality of these patients.
  time frame: october2017-february2022
  arm group label: preoperative and perioperative anaesthetic management
  description: We have planned to retrospectively review data for patients aged 18 and above who underwent major abdominal surgery at our center between October 2017 and February 2022. The study aims to record data regarding the administration of thromboprophylaxis, preoperative hemoglobin values, and Revised Cardiac Risk Index scores and their impact on one-year postoperative mortality. Additionally, we intend to examine the effects of the amount of fluid administered during the perioperative period, the application of epidural analgesia, and the use of blood products on hospital stay duration and one-year postoperative mortality.
  intervention type: Other
  intervention name: a retrospective study
  description: a retrospective study
  arm group label: preoperative and perioperative anaesthetic management
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  contact: 
  contact backup: 
  country: Turkey
  citation: Snowden C, Prentis J. Anesthesia for hepatobiliary surgery. Anesthesiol Clin. 2015 Mar;33(1):125-41. doi: 10.1016/j.anclin.2014.11.008. Epub 2014 Dec 31.
  PMID: 25701932
  citation: Hemmerling TM. Pain management in abdominal surgery. Langenbecks Arch Surg. 2018 Nov;403(7):791-803. doi: 10.1007/s00423-018-1705-y. Epub 2018 Oct 3.
  PMID: 30284029
  citation: von der Forst M, Weiterer S, Dietrich M, Loos M, Lichtenstern C, Weigand MA, Siegler BH. [Perioperative fluid management in major abdominal surgery]. Anaesthesist. 2021 Feb;70(2):127-143. doi: 10.1007/s00101-020-00867-7. German.
  PMID: 33034685
  responsible party type: Principal Investigator
  investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
  investigator full name: Merve Gokce
  investigator title: Assistant Doctor
  sharing ipd: No
  ipd description: All patient data will be kept confidential.