<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/NCT03016026</url>
  </required_header>
  <id_info>
    <org_study_id>ERAS-LAG-01</org_study_id>
    <nct_id>NCT03016026</nct_id>
  </id_info>
  <brief_title>Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Gastrectomy</brief_title>
  <official_title>Effect of Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Subtotal Gastrectomy: A Single Arm Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the safety and effectiveness of enhanced recovery after surgery(ERAS) on&#xD;
      laparoscopic distal gastrectomy for gastric cancer.All of participants received an ERAS&#xD;
      program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preoperative education about ERAS program is administered in the ward after admission by a&#xD;
      specific team. Breathing training and atomizing during the time of preoperative preparation&#xD;
      is performed during hospitalization (5-7 days). Patients are allowed to eat a normal diet and&#xD;
      intake of 1000 ml 10% carbohydrate drink 10 hours before surgery and oral 500ml 10%&#xD;
      carbohydrate drink 2 hours before the induction of anesthesia. Mechanical bowel preparation&#xD;
      is not recommended as routine procedure.&#xD;
&#xD;
      The intravenous fluid therapy is restricted. Urinary catheters are routinely placed after&#xD;
      anesthesia. In principle, drainage and nasogastric tube are not placed (except the concerns&#xD;
      of surgical safety). Surgical site infiltration is implemented.All patients undergo&#xD;
      laparoscopic distal gastrectomy.&#xD;
&#xD;
      Urinary catheters are routinely removed within 24 hours after operation. An optimal&#xD;
      management of acute postoperative pain is multimodal analgesia consists of surgical site&#xD;
      infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and&#xD;
      epidural analgesia. Adjunctive analgesia with acetaminophen is used after the resumption of&#xD;
      oral intake until adequate pain relief. Patients were encouraged to move from POD 1. The&#xD;
      patients are encouraged to a full fluid diet on POD 2. Adhere to the premise of eating little&#xD;
      and often daily increase, then to semi-fluids to soft diet. A normal diet is often started on&#xD;
      POD 4. Abdominal drains are routinely removed within 72 hours after operation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative hospital stays</measure>
    <time_frame>1 month</time_frame>
    <description>Days from surgery to discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rehabilitative rate</measure>
    <time_frame>4 days</time_frame>
    <description>Postoperative 4 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medical cost</measure>
    <time_frame>1 month</time_frame>
    <description>From surgery to discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain score</measure>
    <time_frame>4 days</time_frame>
    <description>Postoperative 4 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative recovery index</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative inflammatory immune response</measure>
    <time_frame>4 days</time_frame>
    <description>Postoperative 4 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity rates</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rates</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">98</enrollment>
  <condition>Stomach Neoplasms</condition>
  <arm_group>
    <arm_group_label>ERAS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preoperative education,breathing training and atomizing during the time of preoperative preparation.Shorten fasting time and carbohydrate load.The intravenous fluid therapy is restricted.Drainage and nasogastric tube are not placed (except the concerns of surgical safety).All patients undergo laparoscopic distal gastrectomy.An optimal management of acute postoperative pain is multimodal analgesia consists of surgical site infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and epidural analgesia.Early oral take and move.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ERAS</intervention_name>
    <description>Undergo an ERAS program</description>
    <arm_group_label>ERAS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age from over 18 to under 75 years&#xD;
&#xD;
          -  Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or&#xD;
             poorly differentiated) confirmed pathologically by endoscopic biopsy&#xD;
&#xD;
          -  cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging&#xD;
             Manual Seventh Edition&#xD;
&#xD;
          -  Expected curative resection through distal subtotal gastrectomy with D2&#xD;
             lymphadenectomy&#xD;
&#xD;
          -  no severe organ dysfunction&#xD;
&#xD;
          -  Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale&#xD;
&#xD;
          -  ASA (American Society of Anesthesiology) score class I or II&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women during pregnancy or breast-feeding&#xD;
&#xD;
          -  Severe mental disorder&#xD;
&#xD;
          -  History of previous upper abdominal surgery (except laparoscopic cholecystectomy)&#xD;
&#xD;
          -  History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal&#xD;
             dissection&#xD;
&#xD;
          -  Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging&#xD;
&#xD;
          -  History of other malignant disease within past five years&#xD;
&#xD;
          -  History of previous neoadjuvant chemotherapy or radiotherapy&#xD;
&#xD;
          -  History of unstable angina or myocardial infarction within past six months&#xD;
&#xD;
          -  History of cerebrovascular accident within past six months&#xD;
&#xD;
          -  History of continuous systematic administration of corticosteroids within one month&#xD;
&#xD;
          -  Requirement of simultaneous surgery for other disease&#xD;
&#xD;
          -  Emergency surgery due to complication (bleeding, obstruction or perforation) caused by&#xD;
             gastric cancer&#xD;
&#xD;
          -  FEV1&lt;50% of predicted values&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guoxin Li, MD.,Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southern Medical University, Guangzhou,China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kexuan Liu, MD.,Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southern Medical University, Guangzhou,China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hao Liu, MD.,Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Southern Medical University, Guangzhou,China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Li Zhen, MD.,Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Southern Medical University, Guangzhou,China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaomin Hou, MD.,Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Southern Medical University, Guangzhou,China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jiang Yu, MD.,Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Southern Medical University, Guangzhou,China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yu Zhu, MD.</last_name>
    <role>Study Director</role>
    <affiliation>MD.,Ph.D</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guoxin Li, MD.,Ph.D</last_name>
    <phone>+86-138-0277-1450</phone>
    <email>gzliguoxin@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hao Liu, MD.,Ph.D</last_name>
    <phone>+86-138-2215-8578</phone>
    <email>283934099@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nanfang Hospital, Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510-515</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guoxin Li, M.D., Ph.D.</last_name>
      <phone>+86-138-0277-1450</phone>
      <email>gzliguoxin@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Yu Zhu, M.D.</last_name>
      <phone>+86-135-6022-0055</phone>
      <email>283934099@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanfang Hospital, Southern Medical University</investigator_affiliation>
    <investigator_full_name>Guoxin Li</investigator_full_name>
    <investigator_title>M.D.,Ph.D.</investigator_title>
  </responsible_party>
  <keyword>ERAS,Laparoscopy,Distal Gastrectomy,Safety,Effectiveness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03016026
org study id: ERAS-LAG-01
nct id: NCT03016026
lead sponsor: 
has dmc: Yes
This study evaluates the safety and effectiveness of enhanced recovery after surgery(ERAS) on
      laparoscopic distal gastrectomy for gastric cancer.All of participants received an ERAS
      program.
Preoperative education about ERAS program is administered in the ward after admission by a
      specific team. Breathing training and atomizing during the time of preoperative preparation
      is performed during hospitalization (5-7 days). Patients are allowed to eat a normal diet and
      intake of 1000 ml 10% carbohydrate drink 10 hours before surgery and oral 500ml 10%
      carbohydrate drink 2 hours before the induction of anesthesia. Mechanical bowel preparation
      is not recommended as routine procedure.

      The intravenous fluid therapy is restricted. Urinary catheters are routinely placed after
      anesthesia. In principle, drainage and nasogastric tube are not placed (except the concerns
      of surgical safety). Surgical site infiltration is implemented.All patients undergo
      laparoscopic distal gastrectomy.

      Urinary catheters are routinely removed within 24 hours after operation. An optimal
      management of acute postoperative pain is multimodal analgesia consists of surgical site
      infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and
      epidural analgesia. Adjunctive analgesia with acetaminophen is used after the resumption of
      oral intake until adequate pain relief. Patients were encouraged to move from POD 1. The
      patients are encouraged to a full fluid diet on POD 2. Adhere to the premise of eating little
      and often daily increase, then to semi-fluids to soft diet. A normal diet is often started on
      POD 4. Abdominal drains are routinely removed within 72 hours after operation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative hospital stays
time frame: 1 month
description: Days from surgery to discharge
measure: Rehabilitative rate
time frame: 4 days
description: Postoperative 4 days
measure: Medical cost
time frame: 1 month
description: From surgery to discharge
measure: Postoperative pain score
time frame: 4 days
description: Postoperative 4 days
measure: Postoperative recovery index
time frame: 1 month
measure: Postoperative inflammatory immune response
time frame: 4 days
description: Postoperative 4 days
measure: Morbidity rates
time frame: 30 days
measure: Mortality rates
time frame: 30 days
arm group label: ERAS
arm group type: Experimental
description: Preoperative education,breathing training and atomizing during the time of preoperative preparation.Shorten fasting time and carbohydrate load.The intravenous fluid therapy is restricted.Drainage and nasogastric tube are not placed (except the concerns of surgical safety).All patients undergo laparoscopic distal gastrectomy.An optimal management of acute postoperative pain is multimodal analgesia consists of surgical site infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and epidural analgesia.Early oral take and move.
intervention type: Procedure
intervention name: ERAS
description: Undergo an ERAS program
arm group label: ERAS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Guoxin Li, MD.,Ph.D
role: Principal Investigator
affiliation: Southern Medical University, Guangzhou,China
last name: Kexuan Liu, MD.,Ph.D
role: Principal Investigator
affiliation: Southern Medical University, Guangzhou,China
last name: Hao Liu, MD.,Ph.D
role: Study Director
affiliation: Southern Medical University, Guangzhou,China
last name: Li Zhen, MD.,Ph.D
role: Study Director
affiliation: Southern Medical University, Guangzhou,China
last name: Xiaomin Hou, MD.,Ph.D
role: Study Director
affiliation: Southern Medical University, Guangzhou,China
last name: Jiang Yu, MD.,Ph.D
role: Study Director
affiliation: Southern Medical University, Guangzhou,China
last name: Yu Zhu, MD.
role: Study Director
affiliation: MD.,Ph.D
last name: Guoxin Li, MD.,Ph.D
phone: +86-138-0277-1450
email: gzliguoxin@163.com
last name: Hao Liu, MD.,Ph.D
phone: +86-138-2215-8578
email: 283934099@qq.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanfang Hospital, Southern Medical University
investigator full name: Guoxin Li
investigator title: M.D.,Ph.D.
mesh term: Stomach Neoplasms
sharing ipd: No