<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/NCT03799965</url>
  </required_header>
  <id_info>
    <org_study_id>KUGOKAEK 2017/369</org_study_id>
    <nct_id>NCT03799965</nct_id>
  </id_info>
  <brief_title>The Effect of Advanced Improvement Program (ERAS) on Postoperative Outcomes in Patients Undergoing Open Heart Surgery</brief_title>
  <official_title>Investigation of the Effect of Enhanced Recovery After Surgery (ERAS) Program on Postoperative Results of Patients Operated for Open Heart Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kocaeli Derince Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kocaeli University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kocaeli Derince Education 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>
      Investigation of the effect of Enhanced Recovery After Surgery (ERAS) program on&#xD;
      postoperative results of patients operated for open heart surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ERAS protocol, also known as evidence based &quot;fast-track surgery&quot; (FTS), is an evidence&#xD;
      based combination of findings regarding suggestions for patient care on various levels of the&#xD;
      perioperative period, which work in synergy for accelerating the postoperative recovery&#xD;
      period. It has been used sucessfully for many surgical disciplines, primarily colorectal&#xD;
      surgery, since it was first reported in 1997. However, there is a significant insufficiency&#xD;
      of this patient oriented rehabilitation program regarding cardiovascular surgeries. This&#xD;
      study is to compare the postoperative follow up periods of patients with ERAS protocol and&#xD;
      patients with standard protocol who were both operated for cardiac surgery.&#xD;
&#xD;
      Following approval of the local ethics committee, 210 patients who are operated for elective&#xD;
      cardiac surgery are enrolled in this prospective randomized clinical trial. The patients who&#xD;
      are not applied the ERAS protocol are evaluated in the control group (n=51). The findings&#xD;
      regarding the patients under ERAS protocol are evaluated based on evidence. Our primary is to&#xD;
      compare the durations of stay in the intensive care unit and in hospital; our secondary is to&#xD;
      compare the incidences of complications of the groups. The demographic data, operative&#xD;
      measurements, complication rates, the amounts of perioperative bleeding and drainage and the&#xD;
      duration of stay in the intensive care unit and hospital are recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>durations of stay</measure>
    <time_frame>24 hours</time_frame>
    <description>compare the durations of stay in the intensive care unit and in hospital</description>
  </primary_outcome>
  <primary_outcome>
    <measure>complications</measure>
    <time_frame>24 hours</time_frame>
    <description>compare the incidences of complications</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">210</enrollment>
  <condition>Enhanced Recovery After Surgery</condition>
  <condition>Open Heart Surgery</condition>
  <arm_group>
    <arm_group_label>ERAS protocol are evaluated</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>It is to compare the durations of stay in the intensive care unit and in hospital&#xD;
It is to compare the incidences of complications of the groups</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERAS protocol are not evaluated</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>It is to compare the durations of stay in the intensive care unit and in hospital&#xD;
It is to compare the incidences of complications of the groups</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ERAS (Enhanced Recovery After Surgery ) are evaluated</intervention_name>
    <description>In this arm ERAS( Enhanced Recovery After Surgery) protocol will be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence.</description>
    <arm_group_label>ERAS protocol are evaluated</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ERAS are not evaluated</intervention_name>
    <description>In this arm ERAS( Enhanced Recovery After Surgery) protocol will not be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence.</description>
    <arm_group_label>ERAS protocol are not evaluated</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over 18 years old;&#xD;
&#xD;
          -  Patients undergoing elective open heart surgery (cardiopulmonarybiasis, aortic and&#xD;
             mitral valve replacement);&#xD;
&#xD;
          -  ASA III ;&#xD;
&#xD;
          -  Patients with informed consent for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse to participate in the study;&#xD;
&#xD;
          -  Patients under emergency conditions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ipek Y duzyol, doctor</last_name>
    <phone>+905067922217</phone>
    <email>ipekyd@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>emine yurt, doctor</last_name>
    <phone>+905054782609</phone>
    <email>dremine@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Emine yurt</name>
      <address>
        <city>Kocaeli</city>
        <state>Derince</state>
        <zip>41400</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ipek y duzyol, doctor</last_name>
      <phone>+905067922217</phone>
      <email>ipekyd@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>emine yurt, doctor</last_name>
      <phone>+905054782609</phone>
      <email>dremine@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kocaeli Derince Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ipek Yakin Duzyol</investigator_full_name>
    <investigator_title>specialist doctor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03799965
org study id: KUGOKAEK 2017/369
nct id: NCT03799965
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigation of the effect of Enhanced Recovery After Surgery (ERAS) program on
      postoperative results of patients operated for open heart surgery.
The ERAS protocol, also known as evidence based "fast-track surgery" (FTS), is an evidence
      based combination of findings regarding suggestions for patient care on various levels of the
      perioperative period, which work in synergy for accelerating the postoperative recovery
      period. It has been used sucessfully for many surgical disciplines, primarily colorectal
      surgery, since it was first reported in 1997. However, there is a significant insufficiency
      of this patient oriented rehabilitation program regarding cardiovascular surgeries. This
      study is to compare the postoperative follow up periods of patients with ERAS protocol and
      patients with standard protocol who were both operated for cardiac surgery.

      Following approval of the local ethics committee, 210 patients who are operated for elective
      cardiac surgery are enrolled in this prospective randomized clinical trial. The patients who
      are not applied the ERAS protocol are evaluated in the control group (n=51). The findings
      regarding the patients under ERAS protocol are evaluated based on evidence. Our primary is to
      compare the durations of stay in the intensive care unit and in hospital; our secondary is to
      compare the incidences of complications of the groups. The demographic data, operative
      measurements, complication rates, the amounts of perioperative bleeding and drainage and the
      duration of stay in the intensive care unit and hospital are recorded.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: durations of stay
time frame: 24 hours
description: compare the durations of stay in the intensive care unit and in hospital
measure: complications
time frame: 24 hours
description: compare the incidences of complications
arm group label: ERAS protocol are evaluated
arm group type: Active Comparator
description: It is to compare the durations of stay in the intensive care unit and in hospital
It is to compare the incidences of complications of the groups
arm group label: ERAS protocol are not evaluated
arm group type: Active Comparator
description: It is to compare the durations of stay in the intensive care unit and in hospital
It is to compare the incidences of complications of the groups
intervention type: Other
intervention name: ERAS (Enhanced Recovery After Surgery ) are evaluated
description: In this arm ERAS( Enhanced Recovery After Surgery) protocol will be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence.
arm group label: ERAS protocol are evaluated
intervention type: Other
intervention name: ERAS are not evaluated
description: In this arm ERAS( Enhanced Recovery After Surgery) protocol will not be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence.
arm group label: ERAS protocol are not evaluated
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ipek Y duzyol, doctor
phone: +905067922217
email: ipekyd@hotmail.com
last name: emine yurt, doctor
phone: +905054782609
email: dremine@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kocaeli Derince Education and Research Hospital
investigator full name: Ipek Yakin Duzyol
investigator title: specialist doctor
sharing ipd: Undecided