<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/NCT03043183</url>
  </required_header>
  <id_info>
    <org_study_id>ERAS AND Nutritional Status</org_study_id>
    <nct_id>NCT03043183</nct_id>
  </id_info>
  <brief_title>Enhanced Recovery After Surgery(ERAS) for Gastric Cancer and Perioperative Nutritional Status</brief_title>
  <official_title>The Effect of Perioperative Nutritional Status on Enhanced Recovery After Surgery for Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Hospital of Jilin 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>
      This study is a prospective, single-center, randomized controlled trial. The study protocol&#xD;
      was approved by the Ethics Committee at the First Hospital of Jilin University.The&#xD;
      perioperation nutritional status will be assessed in gastric cancer patients within ERAS&#xD;
      protocols.The ERAS patients were randomly divided into perioperational nutrition support&#xD;
      group and conventional pathway group . Inter-group differences were evaluated for nutritional&#xD;
      index,clinical recovery index, complications etc.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>complication</measure>
    <time_frame>30 days after operation</time_frame>
    <description>fever；wound infection；post-operation bleeding；ileus；stenosis；leakage</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1400</enrollment>
  <condition>Nutrition Disorders</condition>
  <arm_group>
    <arm_group_label>Preoperational nutrition support group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Scored patient-generated subjective global assessment(PG-SGA) ≥2，&lt;9 Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>PG-SGA ≥2，&lt;9</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>perioperational nutrition surpport</intervention_name>
    <description>Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation</description>
    <arm_group_label>Preoperational nutrition support group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction&#xD;
             confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy;&#xD;
&#xD;
          -  age 18-75 years;&#xD;
&#xD;
          -  pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy;&#xD;
&#xD;
          -  normal hematological, renal, hepatic, and cardiac parameters,American Society of&#xD;
             Anesthesiology (ASA) score &lt; III without severe systemic disease;&#xD;
&#xD;
          -  no history of treatment with neoadjuvant chemotherapy and/or radiotherapy&#xD;
&#xD;
          -  PG-SGA score ≥2，&lt;9&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients requiring conversion to open gastrectomy&#xD;
&#xD;
          -  excessive bleeding (˃ 500 mL);and patients opting out of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 3, 2017</last_update_submitted>
  <last_update_submitted_qc>February 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Hospital of Jilin University</investigator_affiliation>
    <investigator_full_name>Quan Wang</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>gastric cancer</keyword>
  <keyword>Enhanced recovery after surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Nutrition Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT03043183
org study id: ERAS AND Nutritional Status
nct id: NCT03043183
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, single-center, randomized controlled trial. The study protocol
      was approved by the Ethics Committee at the First Hospital of Jilin University.The
      perioperation nutritional status will be assessed in gastric cancer patients within ERAS
      protocols.The ERAS patients were randomly divided into perioperational nutrition support
      group and conventional pathway group . Inter-group differences were evaluated for nutritional
      index,clinical recovery index, complications etc.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: complication
time frame: 30 days after operation
description: fever；wound infection；post-operation bleeding；ileus；stenosis；leakage
arm group label: Preoperational nutrition support group
arm group type: Experimental
description: Scored patient-generated subjective global assessment(PG-SGA) ≥2，<9 Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation
arm group label: Conventional group
arm group type: No Intervention
description: PG-SGA ≥2，<9
intervention type: Procedure
intervention name: perioperational nutrition surpport
description: Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation
arm group label: Preoperational nutrition support group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: The First Hospital of Jilin University
investigator full name: Quan Wang
investigator title: Director
mesh term: Stomach Neoplasms
mesh term: Nutrition Disorders