<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/NCT04451473</url>
  </required_header>
  <id_info>
    <org_study_id>ERAS ZYP</org_study_id>
    <nct_id>NCT04451473</nct_id>
  </id_info>
  <brief_title>Lung Surgery With Enhanced Recovery VS. Lung Surgery Without Enhanced Recovery</brief_title>
  <official_title>The Short Term and Long Term Comparison of Lung Surgery With or Without Enhanced Recovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Hospital of Shandong University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: The adoption of Enhanced Recovery Surgery programs in lung resection is relatively&#xD;
      recent with limited outcome data. This study aimed to determine the impact of an Enhanced&#xD;
      Recovery Surgery pathway on short- term and long- term results in patients undergoing lung&#xD;
      resection for primary lung cancer.&#xD;
&#xD;
      Methods: A Randomized Controlled Trial was designed to collect the perioperative data on&#xD;
      consecutive patients undergoing lung resection for primary lung cancer. Patients will be&#xD;
      randomizely assigned to the ERAS- Group and Control- Group. Short-term and long- term effect&#xD;
      will be compared between the two groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 8, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2027</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intensive care unit utilization</measure>
    <time_frame>within 4 days after surgery</time_frame>
    <description>the time in intensive care unit utilization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the degree of pain</measure>
    <time_frame>within 4 days after surgery</time_frame>
    <description>Visual Analogue Scale/Score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the time of ambulation</measure>
    <time_frame>within 48 hours after surgery</time_frame>
    <description>the time after surgery that patients could leave the bed and walk</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the time for oral feed</measure>
    <time_frame>within 48 hours after surgery</time_frame>
    <description>the time for oral feed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the time of hospitalization</measure>
    <time_frame>within 5 days after surgery</time_frame>
    <description>the time of hospitalization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>complications</measure>
    <time_frame>within 7 days after surgery</time_frame>
    <description>the rate of complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>disease- free survival</measure>
    <time_frame>within 5 years after surgery</time_frame>
    <description>disease- free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>within 10 years after surgery</time_frame>
    <description>overall survival</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Surgery</condition>
  <condition>ERAS</condition>
  <arm_group>
    <arm_group_label>ERAS- Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients underwent surgery for lung cancer accepted the enhanced recovery after surgery (ERAS).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control- Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients underwent surgery for lung cancer without enhanced recovery after surgery (ERAS).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Enhanced Recovery After Surgery (ERAS )</intervention_name>
    <description>the treatment of procedure according to Guidelines for enhanced recovery after lung surgery: recommendations of the ERAS Society and the ESTS</description>
    <arm_group_label>ERAS- Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Traditional perioperative management without Enhanced Recovery After Surgery (ERAS )</intervention_name>
    <description>the treatment of procedure not abiding Guidelines for enhanced recovery after lung surgery</description>
    <arm_group_label>Control- Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: patients with stage I-IIIa Non-small-cell Lung Cancer underwent radical&#xD;
        resection or other benign lung lesions need VATS surgery.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: cardio-pulmonary function couldn't tolerate surgery&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaogang Zhao, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>The Second Hospital of Shandong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yunpeng Zhao, Doctor</last_name>
    <phone>17660081916</phone>
    <phone_ext>17660081916</phone_ext>
    <email>zhaoyunpengsddx@sdu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yunpeng Zhao</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250033</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yunpeng Zhao, Doc.</last_name>
      <phone>17660081916</phone>
      <phone_ext>17660081916</phone_ext>
      <email>zhaoyunpengsddx@sdu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>November 14, 2022</last_update_submitted>
  <last_update_submitted_qc>November 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04451473
org study id: ERAS ZYP
nct id: NCT04451473
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Objective: The adoption of Enhanced Recovery Surgery programs in lung resection is relatively
      recent with limited outcome data. This study aimed to determine the impact of an Enhanced
      Recovery Surgery pathway on short- term and long- term results in patients undergoing lung
      resection for primary lung cancer.

      Methods: A Randomized Controlled Trial was designed to collect the perioperative data on
      consecutive patients undergoing lung resection for primary lung cancer. Patients will be
      randomizely assigned to the ERAS- Group and Control- Group. Short-term and long- term effect
      will be compared between the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: intensive care unit utilization
time frame: within 4 days after surgery
description: the time in intensive care unit utilization
measure: the degree of pain
time frame: within 4 days after surgery
description: Visual Analogue Scale/Score
measure: the time of ambulation
time frame: within 48 hours after surgery
description: the time after surgery that patients could leave the bed and walk
measure: the time for oral feed
time frame: within 48 hours after surgery
description: the time for oral feed
measure: the time of hospitalization
time frame: within 5 days after surgery
description: the time of hospitalization
measure: complications
time frame: within 7 days after surgery
description: the rate of complications
measure: disease- free survival
time frame: within 5 years after surgery
description: disease- free survival
measure: overall survival
time frame: within 10 years after surgery
description: overall survival
arm group label: ERAS- Group
arm group type: Experimental
description: Patients underwent surgery for lung cancer accepted the enhanced recovery after surgery (ERAS).
arm group label: Control- Group
arm group type: Other
description: Patients underwent surgery for lung cancer without enhanced recovery after surgery (ERAS).
intervention type: Procedure
intervention name: Enhanced Recovery After Surgery (ERAS )
description: the treatment of procedure according to Guidelines for enhanced recovery after lung surgery: recommendations of the ERAS Society and the ESTS
arm group label: ERAS- Group
intervention type: Procedure
intervention name: Traditional perioperative management without Enhanced Recovery After Surgery (ERAS )
description: the treatment of procedure not abiding Guidelines for enhanced recovery after lung surgery
arm group label: Control- Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Xiaogang Zhao, Doctor
role: Study Director
affiliation: The Second Hospital of Shandong University
last name: Yunpeng Zhao, Doctor
phone: 17660081916
phone ext: 17660081916
email: zhaoyunpengsddx@sdu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor