<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/NCT03802097</url>
  </required_header>
  <id_info>
    <org_study_id>KSWEET-03</org_study_id>
    <nct_id>NCT03802097</nct_id>
  </id_info>
  <brief_title>Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy</brief_title>
  <acronym>KSWEET-03</acronym>
  <official_title>Multicenter Randomized Controlled Trial About no Antimicrobial Prophylaxis for Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Carcinoma (KSWEET-03)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korean South West East Gastric Surgery Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Korean South West East Gastric Surgery Group</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>
      Laparoscopic gastrectomy has fewer infectious complications compared to open surgery.&#xD;
      Recently, the incidence of postoperative infectious complications was greatly reduced due to&#xD;
      the development of surgical techniques and improvement of prevention and control of surgical&#xD;
      infection. Previous multicenter, phase II study (KSWEET-01) revealed that the incidence of&#xD;
      infectious complications of laparoscopic gastrectomy without prophylactic antibiotics was not&#xD;
      significantly higher than previously reported data.&#xD;
&#xD;
      Therefore, this study aim to prove the safety of totally laparoscopic distal gastrectomy&#xD;
      without prophylactic antibiotics, specially reference to the postoperative infectious&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study was to investigate the non-inferiority of incidence of infectious&#xD;
      complications in the experimental group that did not use prophylactic antibiotics compared to&#xD;
      the control group using prophylactic antibiotics.&#xD;
&#xD;
      The primary endpoint is the incidence of surgical site infections within 30 days after&#xD;
      surgery and the difference limit of the non-inferiority of the experimental group is assumed&#xD;
      to be - 0.05 (5%). Assuming that the incidence of postoperative infectious complications in&#xD;
      the control group is 5% and the incidence of infectious complications in the experimental&#xD;
      group is assumed to be about 8%. It is assumed that the significant level is 5% and the power&#xD;
      is at least 80%.&#xD;
&#xD;
      According to the above method, a total of 260 patients (130 patients in each group) are&#xD;
      needed when 117 patients are needed in each group and about 10% of drop rates and protocol&#xD;
      violence are considered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2018</start_date>
  <completion_date type="Actual">March 25, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of surgical site infections within 30 days</measure>
    <time_frame>within 30 days after operation</time_frame>
    <description>The diagnosis of infectious complications is made according to the Centers for Disease Control and Prevention (CDC) surgical site infection diagnosis criteria according to physical or radiological findings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>up to 6 months</time_frame>
    <description>From date of operation until the date of hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of remote non-surgical site infections</measure>
    <time_frame>within 30 days after operation</time_frame>
    <description>Any postoperative infectious complications other than surgical site infections</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Complication of Surgical Procedure</condition>
  <arm_group>
    <arm_group_label>A group (treatment group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No use of antimicrobial prophylaxis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B group (control group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of antimicrobial prophylaxis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No use of antimicrobial prophylaxis</intervention_name>
    <description>Do not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer</description>
    <arm_group_label>A group (treatment group)</arm_group_label>
    <other_name>No AMP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Use of antimicrobial prophylaxis</intervention_name>
    <description>Use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer</description>
    <arm_group_label>B group (control group)</arm_group_label>
    <other_name>AMP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A patient undergoing totally laparoscopic distal gastrectomy for the gastric cancer&#xD;
             located in the low or middle part of the stomach&#xD;
&#xD;
          -  A patient who underwent limited lymphadenectomy (D1 or D1+) with clinical T1-2N0M0&#xD;
             stage based on 8th edition of the International Union Against Cancer (UICC) tumor node&#xD;
             metastasis (TNM) classification&#xD;
&#xD;
          -  From 18 to 75 years old&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) status 0-1&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) score I-II&#xD;
&#xD;
          -  A patient with appropriate bone marrow function, renal function, lung function, and&#xD;
             liver function&#xD;
&#xD;
          -  Before the surgery, decide to participate in this study and agree with the written&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A patient who underwent previous abdominal surgery&#xD;
&#xD;
          -  Combined other abdominal organ cancer&#xD;
&#xD;
          -  A patient who received chemotherapy and radiotherapy within the last 6 months&#xD;
&#xD;
          -  Combined organ resection other than cholecystectomy&#xD;
&#xD;
          -  A patient undergoing emergency surgery due to perforation or bleeding&#xD;
&#xD;
          -  A patient who have received antibiotic treatment for other infectious diseases within&#xD;
             one month of operation&#xD;
&#xD;
          -  Severely malnourished patient&#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>Oh Jeong, M.D.,Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonnam National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Hwasun</city>
        <state>Jellanamdo</state>
        <zip>58128</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Korean South West East Gastric Surgery Group</investigator_affiliation>
    <investigator_full_name>Oh Jeong</investigator_full_name>
    <investigator_title>MD, PhD, FACS</investigator_title>
  </responsible_party>
  <keyword>Gastric cancer</keyword>
  <keyword>Laparoscopic gastrectomy</keyword>
  <keyword>Prophylactic antibiotics</keyword>
  <keyword>Infectious complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Infective Agents</mesh_term>
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_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/NCT03802097
org study id: KSWEET-03
nct id: NCT03802097
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Laparoscopic gastrectomy has fewer infectious complications compared to open surgery.
      Recently, the incidence of postoperative infectious complications was greatly reduced due to
      the development of surgical techniques and improvement of prevention and control of surgical
      infection. Previous multicenter, phase II study (KSWEET-01) revealed that the incidence of
      infectious complications of laparoscopic gastrectomy without prophylactic antibiotics was not
      significantly higher than previously reported data.

      Therefore, this study aim to prove the safety of totally laparoscopic distal gastrectomy
      without prophylactic antibiotics, specially reference to the postoperative infectious
      complications.
The purpose of this study was to investigate the non-inferiority of incidence of infectious
      complications in the experimental group that did not use prophylactic antibiotics compared to
      the control group using prophylactic antibiotics.

      The primary endpoint is the incidence of surgical site infections within 30 days after
      surgery and the difference limit of the non-inferiority of the experimental group is assumed
      to be - 0.05 (5%). Assuming that the incidence of postoperative infectious complications in
      the control group is 5% and the incidence of infectious complications in the experimental
      group is assumed to be about 8%. It is assumed that the significant level is 5% and the power
      is at least 80%.

      According to the above method, a total of 260 patients (130 patients in each group) are
      needed when 117 patients are needed in each group and about 10% of drop rates and protocol
      violence are considered.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of surgical site infections within 30 days
time frame: within 30 days after operation
description: The diagnosis of infectious complications is made according to the Centers for Disease Control and Prevention (CDC) surgical site infection diagnosis criteria according to physical or radiological findings.
measure: Length of hospital stay
time frame: up to 6 months
description: From date of operation until the date of hospital discharge
measure: Incidence of remote non-surgical site infections
time frame: within 30 days after operation
description: Any postoperative infectious complications other than surgical site infections
arm group label: A group (treatment group)
arm group type: Experimental
description: No use of antimicrobial prophylaxis
arm group label: B group (control group)
arm group type: Experimental
description: Use of antimicrobial prophylaxis
intervention type: Procedure
intervention name: No use of antimicrobial prophylaxis
description: Do not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer
arm group label: A group (treatment group)
other name: No AMP
intervention type: Procedure
intervention name: Use of antimicrobial prophylaxis
description: Use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer
arm group label: B group (control group)
other name: AMP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Oh Jeong, M.D.,Ph.D.
role: Principal Investigator
affiliation: Chonnam National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Korean South West East Gastric Surgery Group
investigator full name: Oh Jeong
investigator title: MD, PhD, FACS
mesh term: Stomach Neoplasms
mesh term: Anti-Infective Agents
mesh term: Anti-Bacterial Agents
sharing ipd: No