<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/NCT03271606</url>
  </required_header>
  <id_info>
    <org_study_id>zs2017822</org_study_id>
    <nct_id>NCT03271606</nct_id>
  </id_info>
  <brief_title>ERAS in Video-assisted Mediastinal Surgery</brief_title>
  <official_title>The Clinical Study of ERAS Protocol in Video-assisted Mediastinal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center, randomized,single blind study to investigate the effectiveness of&#xD;
      enhanced recovery regimen (ERAS) in patients undergoing Video-assisted Mediastinal Surgery.&#xD;
      And we also going to compare the effectiveness of ERAS with that of traditional regimen in&#xD;
      these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compare to traditional measures, the ERAS protocal mainly includes:Good preoperative visit,&#xD;
      shorten the fast time, minimumal invasive surgery procedures, fewer opioids and early&#xD;
      movements after surgery. These items have been successfully used in colon cancer surgery, and&#xD;
      we thus plan to investigate the effectiveness of these measures in mediastinal surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Anticipated">February 23, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 23, 2018</primary_completion_date>
  <phase>Phase 1</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>15-item quality of recovery scale (QoR-15)</measure>
    <time_frame>At preoperative vist</time_frame>
    <description>This scale mainly reflects the patient's status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>15-item quality of recovery scale (QoR-15)</measure>
    <time_frame>At 24 hours after surgery</time_frame>
    <description>This scale mainly reflects the patient's status</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Enhanced Recovery After Surgery</condition>
  <arm_group>
    <arm_group_label>ERAS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in this group receive enhanced measures perioperatively</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients in this group receive traditional measures perioperatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>ERAS</intervention_name>
    <description>The investigators mainly used enhanced measures perioperatively in mediastinal surgery as these used in other surgery</description>
    <arm_group_label>ERAS group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Traditional measures</intervention_name>
    <description>The investigators mainly used traditional measures perioperatively in mediastinal surgery as these used in other surgery</description>
    <arm_group_label>Traditional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients elective mediastinal surgery;&#xD;
&#xD;
          -  BMI 18-30 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refuse;&#xD;
&#xD;
          -  ASA≥3;&#xD;
&#xD;
          -  Patients allergic to used anesthetics (propofol,rocuronium), patients with liver&#xD;
             and/or kidney and/or mental dysfunction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>chao liang, Ph.D</last_name>
      <phone>15921679955</phone>
      <email>superwm226@aliyun.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03271606
org study id: zs2017822
nct id: NCT03271606
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a single center, randomized,single blind study to investigate the effectiveness of
      enhanced recovery regimen (ERAS) in patients undergoing Video-assisted Mediastinal Surgery.
      And we also going to compare the effectiveness of ERAS with that of traditional regimen in
      these patients.
Compare to traditional measures, the ERAS protocal mainly includes:Good preoperative visit,
      shorten the fast time, minimumal invasive surgery procedures, fewer opioids and early
      movements after surgery. These items have been successfully used in colon cancer surgery, and
      we thus plan to investigate the effectiveness of these measures in mediastinal surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: 15-item quality of recovery scale (QoR-15)
time frame: At preoperative vist
description: This scale mainly reflects the patient's status
measure: 15-item quality of recovery scale (QoR-15)
time frame: At 24 hours after surgery
description: This scale mainly reflects the patient's status
arm group label: ERAS group
arm group type: Experimental
description: The patients in this group receive enhanced measures perioperatively
arm group label: Traditional group
arm group type: Active Comparator
description: The patients in this group receive traditional measures perioperatively
intervention type: Combination Product
intervention name: ERAS
description: The investigators mainly used enhanced measures perioperatively in mediastinal surgery as these used in other surgery
arm group label: ERAS group
intervention type: Combination Product
intervention name: Traditional measures
description: The investigators mainly used traditional measures perioperatively in mediastinal surgery as these used in other surgery
arm group label: Traditional group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
sharing ipd: Undecided