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/NCT05962684</url>
    </required_header>
    <id_info>
      <org_study_id>ERAS Craniotomy</org_study_id>
      <nct_id>NCT05962684</nct_id>
    </id_info>
    <brief_title>A Greek-designed ERAS Protocol in Elective Craniotomy</brief_title>
    <acronym>ERAS</acronym>
    <official_title>A Greek-designed Enhanced Recovery After Surgery (ERAS) Protocol in Elective Cranial Neurosurgical Procedures: An Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Thessaly</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Thessaly</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>
        The implementation of ERAS protocol in elective cranial neurosurgical cases in a tertiary&#xD;
        hospital.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, the investigators have integrated the most current data from literature aiming&#xD;
        to investigate the effectiveness of a contemporary ERAS protocol for elective cranial&#xD;
        neurosurgical cases in a tertiary hospital. The hypothesis is that the implementation of such&#xD;
        protocol will shorten the postoperative length of stay, minimize the complication rates, and&#xD;
        improve the overall clinical status of patients undergoing elective craniotomy compared to&#xD;
        the standard perioperative care&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 31, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 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>Hospital Length of Stay</measure>
      <time_frame>up to 7 days</time_frame>
      <description>The days the patient stays in hospital</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain score</measure>
      <time_frame>Postoperative Day 1 to discharge, an average of 7 days</time_frame>
      <description>Pain intensity as measured by Visual Analogue Scale (VAS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mental status</measure>
      <time_frame>1 day at discharge</time_frame>
      <description>Mental status as measured by Glasgow Coma Scale (GCS) Minimum value : 3 Maximum value : 15 Higher scores mean a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's satisfaction</measure>
      <time_frame>1 day at discharge and 1 month postoperatively</time_frame>
      <description>Patient's satisfaction as measured by a Likert Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety and Depression</measure>
      <time_frame>Preoperatively, second postoperative day and one month postoperatively</time_frame>
      <description>Anxiety and Depression level as measured by Hospital Anxiety and Depression Scale (HADS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Personality Index</measure>
      <time_frame>Preoperatively, second postoperative day and one month postoperatively</time_frame>
      <description>Personality Index as measured by TIPI</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>ERAS</condition>
    <condition>Craniotomy</condition>
    <arm_group>
      <arm_group_label>ERAS</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>ERAS</intervention_name>
      <description>Implementation of ERAS protocol in elective craniotomy patients</description>
      <arm_group_label>ERAS</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients undergoing elective craniotomy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Medically suitable for elective craniotomy&#xD;
  &#xD;
            -  ASA-PS I-III&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  traumatic lesions&#xD;
  &#xD;
            -  pathology requiring emergent surgery&#xD;
  &#xD;
            -  preoperative loss of consciousness&#xD;
  &#xD;
            -  severe co-morbidities that may affect postoperative recovery (e.g. paralysis,&#xD;
               autoimmune diseases, myocardial or severe infarction, heart, liver or lung&#xD;
               malfunction, severe mental illness etc.)&#xD;
  &#xD;
            -  recurrent tumor&#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_official>
      <last_name>Eleni Arnaoutolglou, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>University of Thessaly</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Konstantinos Fountas, MD, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Thessaly</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eleni Arnaoutoglou, MD, PhD</last_name>
      <phone>+306974301352</phone>
      <email>earnaout@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Metaxia Bareka, MD, PhD</last_name>
      <phone>+306947845083</phone>
      <email>barekametaxia@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Thessaly</name>
        <address>
          <city>Larissa</city>
          <zip>41110</zip>
          <country>Greece</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eleni Arnaoutoglou, MD, PhD</last_name>
        <phone>+306974301352</phone>
        <email>earnaout@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Metaxia Bareka, MD, PhD</last_name>
        <phone>+306947845083</phone>
        <email>barekametaxia@hotmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Konstantinos Fountas, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Metaxia Bareka, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Eleni Arnaoutoglou, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Alexandros Brotis, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mary Solou, MD, MSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Greece</country>
    </location_countries>
    <results_reference>
      <citation>Wang L, Cai H, Wang Y, Liu J, Chen T, Liu J, Huang J, Guo Q, Zou W. Enhanced recovery after elective craniotomy: A randomized controlled trial. J Clin Anesth. 2022 Feb;76:110575. doi: 10.1016/j.jclinane.2021.110575. Epub 2021 Nov 2.</citation>
      <PMID>34739947</PMID>
    </results_reference>
    <results_reference>
      <citation>Wang Y, Xue YF, Zhao BF, Guo SC, Ji PG, Liu JH, Wang N, Chen F, Zhai YL, Wang Y, Xue YR, Gao GD, Qu Y, Wang L. Real-World Implementation of Neurosurgical Enhanced Recovery After Surgery Protocol for Gliomas in Patients Undergoing Elective Craniotomy. Front Oncol. 2022 May 24;12:860257. doi: 10.3389/fonc.2022.860257. eCollection 2022.</citation>
      <PMID>35686112</PMID>
    </results_reference>
    <results_reference>
      <citation>Elayat A, Jena SS, Nayak S, Sahu RN, Tripathy S. &quot;Enhanced recovery after surgery - ERAS in elective craniotomies-a non-randomized controlled trial&quot;. BMC Neurol. 2021 Mar 19;21(1):127. doi: 10.1186/s12883-021-02150-7.</citation>
      <PMID>33740911</PMID>
    </results_reference>
    <results_reference>
      <citation>Wang Y, Liu B, Zhao T, Zhao B, Yu D, Jiang X, Ye L, Zhao L, Lv W, Zhang Y, Zheng T, Xue Y, Chen L, Sankey E, Chen L, Wu Y, Li M, Ma L, Li Z, Li R, Li J, Yan J, Wang S, Zhao H, Sun X, Gao G, Qu Y, He S. Safety and efficacy of a novel neurosurgical enhanced recovery after surgery protocol for elective craniotomy: a prospective randomized controlled trial. J Neurosurg. 2018 Jun 1:1-12. doi: 10.3171/2018.1.JNS171552. Online ahead of print.</citation>
      <PMID>29932379</PMID>
    </results_reference>
    <results_reference>
      <citation>Stumpo V, Staartjes VE, Quddusi A, Corniola MV, Tessitore E, Schroder ML, Anderer EG, Stienen MN, Serra C, Regli L. Enhanced Recovery After Surgery strategies for elective craniotomy: a systematic review. J Neurosurg. 2021 May 7;135(6):1857-1881. doi: 10.3171/2020.10.JNS203160.</citation>
      <PMID>33962374</PMID>
    </results_reference>
    <results_reference>
      <citation>Agarwal P, Frid I, Singer J, Zalatimo O, Schirmer CM, Kimmell KT, Agarwal N. Neurosurgery perception of Enhanced Recovery After Surgery (ERAS) protocols. J Clin Neurosci. 2021 Oct;92:110-114. doi: 10.1016/j.jocn.2021.07.044. Epub 2021 Aug 7.</citation>
      <PMID>34509236</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Thessaly</investigator_affiliation>
      <investigator_full_name>Elena Arnaoutoglou</investigator_full_name>
      <investigator_title>Professor in Anesthesiology</investigator_title>
    </responsible_party>
    <keyword>ERAS</keyword>
    <keyword>Craniotomy</keyword>
    <keyword>Perioperative management</keyword>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05962684
  org study id: ERAS Craniotomy
  nct id: NCT05962684
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The implementation of ERAS protocol in elective cranial neurosurgical cases in a tertiary
        hospital.
  In this study, the investigators have integrated the most current data from literature aiming
        to investigate the effectiveness of a contemporary ERAS protocol for elective cranial
        neurosurgical cases in a tertiary hospital. The hypothesis is that the implementation of such
        protocol will shorten the postoperative length of stay, minimize the complication rates, and
        improve the overall clinical status of patients undergoing elective craniotomy compared to
        the standard perioperative care
  observational model: Cohort
  time perspective: Prospective
  measure: Hospital Length of Stay
  time frame: up to 7 days
  description: The days the patient stays in hospital
  measure: Pain score
  time frame: Postoperative Day 1 to discharge, an average of 7 days
  description: Pain intensity as measured by Visual Analogue Scale (VAS)
  measure: Mental status
  time frame: 1 day at discharge
  description: Mental status as measured by Glasgow Coma Scale (GCS) Minimum value : 3 Maximum value : 15 Higher scores mean a better outcome
  measure: Patient's satisfaction
  time frame: 1 day at discharge and 1 month postoperatively
  description: Patient's satisfaction as measured by a Likert Scale
  measure: Anxiety and Depression
  time frame: Preoperatively, second postoperative day and one month postoperatively
  description: Anxiety and Depression level as measured by Hospital Anxiety and Depression Scale (HADS)
  measure: Personality Index
  time frame: Preoperatively, second postoperative day and one month postoperatively
  description: Personality Index as measured by TIPI
  arm group label: ERAS
  intervention type: Other
  intervention name: ERAS
  description: Implementation of ERAS protocol in elective craniotomy patients
  arm group label: ERAS
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Eleni Arnaoutolglou, MD, PhD
  role: Study Director
  affiliation: University of Thessaly
  last name: Konstantinos Fountas, MD, PhD
  role: Study Chair
  affiliation: University of Thessaly
  last name: Eleni Arnaoutoglou, MD, PhD
  phone: +306974301352
  email: earnaout@gmail.com
  last name: Metaxia Bareka, MD, PhD
  phone: +306947845083
  email: barekametaxia@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Greece
  citation: Wang L, Cai H, Wang Y, Liu J, Chen T, Liu J, Huang J, Guo Q, Zou W. Enhanced recovery after elective craniotomy: A randomized controlled trial. J Clin Anesth. 2022 Feb;76:110575. doi: 10.1016/j.jclinane.2021.110575. Epub 2021 Nov 2.
  PMID: 34739947
  citation: Wang Y, Xue YF, Zhao BF, Guo SC, Ji PG, Liu JH, Wang N, Chen F, Zhai YL, Wang Y, Xue YR, Gao GD, Qu Y, Wang L. Real-World Implementation of Neurosurgical Enhanced Recovery After Surgery Protocol for Gliomas in Patients Undergoing Elective Craniotomy. Front Oncol. 2022 May 24;12:860257. doi: 10.3389/fonc.2022.860257. eCollection 2022.
  PMID: 35686112
  citation: Elayat A, Jena SS, Nayak S, Sahu RN, Tripathy S. "Enhanced recovery after surgery - ERAS in elective craniotomies-a non-randomized controlled trial". BMC Neurol. 2021 Mar 19;21(1):127. doi: 10.1186/s12883-021-02150-7.
  PMID: 33740911
  citation: Wang Y, Liu B, Zhao T, Zhao B, Yu D, Jiang X, Ye L, Zhao L, Lv W, Zhang Y, Zheng T, Xue Y, Chen L, Sankey E, Chen L, Wu Y, Li M, Ma L, Li Z, Li R, Li J, Yan J, Wang S, Zhao H, Sun X, Gao G, Qu Y, He S. Safety and efficacy of a novel neurosurgical enhanced recovery after surgery protocol for elective craniotomy: a prospective randomized controlled trial. J Neurosurg. 2018 Jun 1:1-12. doi: 10.3171/2018.1.JNS171552. Online ahead of print.
  PMID: 29932379
  citation: Stumpo V, Staartjes VE, Quddusi A, Corniola MV, Tessitore E, Schroder ML, Anderer EG, Stienen MN, Serra C, Regli L. Enhanced Recovery After Surgery strategies for elective craniotomy: a systematic review. J Neurosurg. 2021 May 7;135(6):1857-1881. doi: 10.3171/2020.10.JNS203160.
  PMID: 33962374
  citation: Agarwal P, Frid I, Singer J, Zalatimo O, Schirmer CM, Kimmell KT, Agarwal N. Neurosurgery perception of Enhanced Recovery After Surgery (ERAS) protocols. J Clin Neurosci. 2021 Oct;92:110-114. doi: 10.1016/j.jocn.2021.07.044. Epub 2021 Aug 7.
  PMID: 34509236
  responsible party type: Principal Investigator
  investigator affiliation: University of Thessaly
  investigator full name: Elena Arnaoutoglou
  investigator title: Professor in Anesthesiology
  sharing ipd: Undecided