<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/NCT02198898</url>
  </required_header>
  <id_info>
    <org_study_id>CUMCGC1301</org_study_id>
    <secondary_id>GUARDIXGASTRIC</secondary_id>
    <nct_id>NCT02198898</nct_id>
  </id_info>
  <brief_title>Anti-adhesion Effect of GUARDIX-SGⓇ in Gastric Cancer Surgery</brief_title>
  <official_title>Prospective Multicenter Trial for Anti-adhesion Effect of GUARDIX-SGⓇ Following Radical Gastrectomy in Patients With Gastric Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Catholic University of Korea</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate the efficacy of GUARDIX-SGⓇ for patients with gastrectomy in Korea&#xD;
      and the investigators hypothesized applying of adhesive preventing agent would reduce&#xD;
      incidence of adhesive obstruction after gastrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adhesive bowel obstruction is relatively often complication in patients after abdominal&#xD;
      surgery&#xD;
&#xD;
      Gastric cancer is the most frequent cancer in Korea.&#xD;
&#xD;
      The incidence of adhesive bowel obstruction would be increased in patients with gastric&#xD;
      cancer, especially associated radical lymphadenectomy.&#xD;
&#xD;
      The causes of postoperative adhesive obstruction include adhesion of the wound, adhesion of&#xD;
      small intestine to small intestine, adhesion of the small intestine to other abdominal&#xD;
      organs, and internal hernia.&#xD;
&#xD;
      Several studies reported efficacy of adhesive preventing agent after colorectal resection.&#xD;
&#xD;
      Gastrectomy is associated with a high risk (incidence, 11.7%-38.5%) of bowel obstruction.&#xD;
&#xD;
      To date, however, no randomized study has shown that GUARDIX-SGⓇ reduces the rate of small&#xD;
      bowel obstruction after gastrectomy with radical lymphadenectomy for gastric cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 3</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>incidence of adhesive intestinal obstruction</measure>
    <time_frame>up to 1 years after operation (every 3 month)</time_frame>
    <description>the incidence of adhesive bowel obstruction between using GUARDIX-SG group and control group</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">224</enrollment>
  <condition>Adhesive Intestinal Obstruction</condition>
  <arm_group>
    <arm_group_label>GUARDIX</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no guadix</description>
  </arm_group>
  <arm_group>
    <arm_group_label>guadix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>guadix treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GUARDIX-SG</intervention_name>
    <arm_group_label>guadix</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with gastric adenocarcinoma who scheduled to undergo open gastrectomy&#xD;
&#xD;
          -  Informed consents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Ascites&#xD;
&#xD;
          -  Liver dysfunction&#xD;
&#xD;
          -  Renal failure&#xD;
&#xD;
          -  Past history of abdominal operation or small bowel obstruction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyo Young Song, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Catholic University of Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 29, 2013</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Kyo Young Song</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Obstruction</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/NCT02198898
org study id: CUMCGC1301
secondary id: GUARDIXGASTRIC
nct id: NCT02198898
lead sponsor: 
has dmc: Yes
This study is to evaluate the efficacy of GUARDIX-SGⓇ for patients with gastrectomy in Korea
      and the investigators hypothesized applying of adhesive preventing agent would reduce
      incidence of adhesive obstruction after gastrectomy.
Adhesive bowel obstruction is relatively often complication in patients after abdominal
      surgery

      Gastric cancer is the most frequent cancer in Korea.

      The incidence of adhesive bowel obstruction would be increased in patients with gastric
      cancer, especially associated radical lymphadenectomy.

      The causes of postoperative adhesive obstruction include adhesion of the wound, adhesion of
      small intestine to small intestine, adhesion of the small intestine to other abdominal
      organs, and internal hernia.

      Several studies reported efficacy of adhesive preventing agent after colorectal resection.

      Gastrectomy is associated with a high risk (incidence, 11.7%-38.5%) of bowel obstruction.

      To date, however, no randomized study has shown that GUARDIX-SGⓇ reduces the rate of small
      bowel obstruction after gastrectomy with radical lymphadenectomy for gastric cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: incidence of adhesive intestinal obstruction
time frame: up to 1 years after operation (every 3 month)
description: the incidence of adhesive bowel obstruction between using GUARDIX-SG group and control group
arm group label: GUARDIX
arm group type: No Intervention
description: no guadix
arm group label: guadix
arm group type: Experimental
description: guadix treatment
intervention type: Device
intervention name: GUARDIX-SG
arm group label: guadix
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kyo Young Song, M.D.
role: Principal Investigator
affiliation: The Catholic University of Korea
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Kyo Young Song
investigator title: Professor
mesh term: Intestinal Obstruction