<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/NCT02200315</url>
  </required_header>
  <id_info>
    <org_study_id>KSWEET-01</org_study_id>
    <nct_id>NCT02200315</nct_id>
  </id_info>
  <brief_title>No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy</brief_title>
  <acronym>KSWEET-01</acronym>
  <official_title>Phase II Study of the Efficacy of no Antimicrobial Prophylaxis Use for Laparoscopic Distal Gastrectomy for Gastric Carcinoma</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>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the feasibility and safety of no use of antimicrobial&#xD;
      prophylaxis during laparoscopic distal gastrectomy for gastric carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase II clinical trial investigating the postoperative surgical site infection&#xD;
      (SSI) rates after no antimicrobial prophylaxis use during laparoscopic distal gastrectomy.&#xD;
      Target ranges of SSI rates after laparoscopic distal gastrectomy were determined based on the&#xD;
      previous reports and our data. If SSI rates are within the target range, the investigators&#xD;
      will proceed to a randomized controlled trial investigating the efficacy of no antimicrobial&#xD;
      use for laparoscopic gastrectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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 surgical site infection</measure>
    <time_frame>Within postoperative 1 month</time_frame>
    <description>Incidence of surgical site infection, including superficial incisional, deep incisional, and organ/space infection, until postoperative 1 month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative morbidity and mortality</measure>
    <time_frame>Within postoperative 1 month or during hospitalization</time_frame>
    <description>Occurence of postoperative complications or deaths until postoperative 1 months or during hospitalization. Postoperative complications will be assessed with respect to types and severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>Up to 1month after operation</time_frame>
    <description>The duration of hospital stay from the operation to hospital discharge</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Stomach Neoplasms</condition>
  <arm_group>
    <arm_group_label>No Antimicrobial prophylaxis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No use of antimicrobial prophylaxis during surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Antimicrobial prophylaxis</intervention_name>
    <description>Antimicrobial prophylaxis are not administered during an operation</description>
    <arm_group_label>No Antimicrobial prophylaxis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven gastric adenocarcinoma clinical stage T1-2N0M0 patients who&#xD;
             underwent laparoscopic distal gastrectomy&#xD;
&#xD;
          -  Age between 18 and 65 years&#xD;
&#xD;
          -  American Society of Anaesthesiologists (ASA) status &gt;2&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1&#xD;
&#xD;
          -  Normal blood, liver, pulmonary, cardiac, and renal function&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Administration of antibiotics within 1 month before surgery&#xD;
&#xD;
          -  Active infection at the time of surgery&#xD;
&#xD;
          -  Combined resection during operation (i.e., spleen, liver, colon, etc.)&#xD;
&#xD;
          -  History of upper abdominal surgery&#xD;
&#xD;
          -  Previous chemotherapy or radiotherapy within 6 months before surgery&#xD;
&#xD;
          -  Uncontrolled underlying comorbidities&#xD;
&#xD;
          -  Malnutrition with BMI less than 18.5 kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oh Jeong, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Chonnam National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Young Kyu Park, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Chonnam National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Hwasun-eup</city>
        <state>Jeollanam-do</state>
        <zip>519-809</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A University Hospital</name>
      <address>
        <city>Busan</city>
        <state>Kyungsang-do</state>
        <zip>602-715</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyemyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <state>Kyungsang-do</state>
        <zip>700-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Burke JP. Infection control - a problem for patient safety. N Engl J Med. 2003 Feb 13;348(7):651-6. doi: 10.1056/NEJMhpr020557. No abstract available.</citation>
    <PMID>12584377</PMID>
  </reference>
  <reference>
    <citation>Choudhary A, Bechtold ML, Puli SR, Othman MO, Roy PK. Role of prophylactic antibiotics in laparoscopic cholecystectomy: a meta-analysis. J Gastrointest Surg. 2008 Nov;12(11):1847-53; discussion 1853. doi: 10.1007/s11605-008-0681-x. Epub 2008 Sep 9.</citation>
    <PMID>18780131</PMID>
  </reference>
  <reference>
    <citation>McDonald M, Grabsch E, Marshall C, Forbes A. Single- versus multiple-dose antimicrobial prophylaxis for major surgery: a systematic review. Aust N Z J Surg. 1998 Jun;68(6):388-96. doi: 10.1111/j.1445-2197.1998.tb04785.x.</citation>
    <PMID>9623456</PMID>
  </reference>
  <reference>
    <citation>Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568. No abstract available.</citation>
    <PMID>23327981</PMID>
  </reference>
  <reference>
    <citation>Imai E, Ueda M, Kanao K, Miyaki K, Kubota T, Kitajima M. Surgical site infection surveillance after open gastrectomy and risk factors for surgical site infection. J Infect Chemother. 2005 Jun;11(3):141-5. doi: 10.1007/s10156-005-0379-x. Erratum In: J Infect Chemother. 2006 Feb;12(1):51.</citation>
    <PMID>15990978</PMID>
  </reference>
  <reference>
    <citation>Imamura H, Furukawa H, Iijima S, Sugihara S, Tsujinaka T, Tsukuma H, Shimokawa T. Multicenter phase II study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer. Gastric Cancer. 2006;9(1):32-5. doi: 10.1007/s10120-005-0354-3.</citation>
    <PMID>16557434</PMID>
  </reference>
  <reference>
    <citation>Migita K, Takayama T, Matsumoto S, Wakatsuki K, Enomoto K, Tanaka T, Ito M, Nakajima Y. Risk factors for surgical site infections after elective gastrectomy. J Gastrointest Surg. 2012 Jun;16(6):1107-15. doi: 10.1007/s11605-012-1838-1. Epub 2012 Feb 15.</citation>
    <PMID>22350727</PMID>
  </reference>
  <reference>
    <citation>Memon MA, Khan S, Yunus RM, Barr R, Memon B. Meta-analysis of laparoscopic and open distal gastrectomy for gastric carcinoma. Surg Endosc. 2008 Aug;22(8):1781-9. doi: 10.1007/s00464-008-9925-9. Epub 2008 Apr 25.</citation>
    <PMID>18437472</PMID>
  </reference>
  <reference>
    <citation>Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.</citation>
    <PMID>20160637</PMID>
  </reference>
  <reference>
    <citation>Ammori BJ. A prospective randomized study of prophylactic antibiotics in elective laparoscopic cholecystectomy. Surg Endosc. 2004 Mar;18(3):565; author reply 566. doi: 10.1007/s00464-003-9141-6. Epub 2004 Feb 2. No abstract available.</citation>
    <PMID>14973693</PMID>
  </reference>
  <reference>
    <citation>Catarci M, Mancini S, Gentileschi P, Camplone C, Sileri P, Grassi GB. Antibiotic prophylaxis in elective laparoscopic cholecystectomy. Lack of need or lack of evidence? Surg Endosc. 2004 Apr;18(4):638-41. doi: 10.1007/s00464-003-9090-0. Epub 2004 Feb 2.</citation>
    <PMID>14752639</PMID>
  </reference>
  <reference>
    <citation>Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):152S-157S. doi: 10.1016/0002-9343(91)90361-z.</citation>
    <PMID>1656747</PMID>
  </reference>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>February 1, 2016</last_update_submitted>
  <last_update_submitted_qc>February 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2016</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>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Stomach neoplasms</keyword>
  <keyword>Surgical site infection</keyword>
  <keyword>Laparoscopic gastrectomy</keyword>
  <keyword>Antimicrobial prophylaxis</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/NCT02200315
org study id: KSWEET-01
nct id: NCT02200315
lead sponsor: 
has dmc: Yes
The aim of this study is to evaluate the feasibility and safety of no use of antimicrobial
      prophylaxis during laparoscopic distal gastrectomy for gastric carcinoma.
This is a phase II clinical trial investigating the postoperative surgical site infection
      (SSI) rates after no antimicrobial prophylaxis use during laparoscopic distal gastrectomy.
      Target ranges of SSI rates after laparoscopic distal gastrectomy were determined based on the
      previous reports and our data. If SSI rates are within the target range, the investigators
      will proceed to a randomized controlled trial investigating the efficacy of no antimicrobial
      use for laparoscopic gastrectomy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative surgical site infection
time frame: Within postoperative 1 month
description: Incidence of surgical site infection, including superficial incisional, deep incisional, and organ/space infection, until postoperative 1 month
measure: Postoperative morbidity and mortality
time frame: Within postoperative 1 month or during hospitalization
description: Occurence of postoperative complications or deaths until postoperative 1 months or during hospitalization. Postoperative complications will be assessed with respect to types and severity.
measure: Hospital stay
time frame: Up to 1month after operation
description: The duration of hospital stay from the operation to hospital discharge
arm group label: No Antimicrobial prophylaxis
arm group type: Experimental
description: No use of antimicrobial prophylaxis during surgery
intervention type: Other
intervention name: No Antimicrobial prophylaxis
description: Antimicrobial prophylaxis are not administered during an operation
arm group label: No Antimicrobial prophylaxis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Oh Jeong, MD, PhD
role: Study Director
affiliation: Chonnam National University Hospital
last name: Young Kyu Park, MD, PhD
role: Study Chair
affiliation: Chonnam National University Hospital
facility: 
facility: 
facility: 
country: Korea, Republic of
citation: Burke JP. Infection control - a problem for patient safety. N Engl J Med. 2003 Feb 13;348(7):651-6. doi: 10.1056/NEJMhpr020557. No abstract available.
PMID: 12584377
citation: Choudhary A, Bechtold ML, Puli SR, Othman MO, Roy PK. Role of prophylactic antibiotics in laparoscopic cholecystectomy: a meta-analysis. J Gastrointest Surg. 2008 Nov;12(11):1847-53; discussion 1853. doi: 10.1007/s11605-008-0681-x. Epub 2008 Sep 9.
PMID: 18780131
citation: McDonald M, Grabsch E, Marshall C, Forbes A. Single- versus multiple-dose antimicrobial prophylaxis for major surgery: a systematic review. Aust N Z J Surg. 1998 Jun;68(6):388-96. doi: 10.1111/j.1445-2197.1998.tb04785.x.
PMID: 9623456
citation: Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568. No abstract available.
PMID: 23327981
citation: Imai E, Ueda M, Kanao K, Miyaki K, Kubota T, Kitajima M. Surgical site infection surveillance after open gastrectomy and risk factors for surgical site infection. J Infect Chemother. 2005 Jun;11(3):141-5. doi: 10.1007/s10156-005-0379-x. Erratum In: J Infect Chemother. 2006 Feb;12(1):51.
PMID: 15990978
citation: Imamura H, Furukawa H, Iijima S, Sugihara S, Tsujinaka T, Tsukuma H, Shimokawa T. Multicenter phase II study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer. Gastric Cancer. 2006;9(1):32-5. doi: 10.1007/s10120-005-0354-3.
PMID: 16557434
citation: Migita K, Takayama T, Matsumoto S, Wakatsuki K, Enomoto K, Tanaka T, Ito M, Nakajima Y. Risk factors for surgical site infections after elective gastrectomy. J Gastrointest Surg. 2012 Jun;16(6):1107-15. doi: 10.1007/s11605-012-1838-1. Epub 2012 Feb 15.
PMID: 22350727
citation: Memon MA, Khan S, Yunus RM, Barr R, Memon B. Meta-analysis of laparoscopic and open distal gastrectomy for gastric carcinoma. Surg Endosc. 2008 Aug;22(8):1781-9. doi: 10.1007/s00464-008-9925-9. Epub 2008 Apr 25.
PMID: 18437472
citation: Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.
PMID: 20160637
citation: Ammori BJ. A prospective randomized study of prophylactic antibiotics in elective laparoscopic cholecystectomy. Surg Endosc. 2004 Mar;18(3):565; author reply 566. doi: 10.1007/s00464-003-9141-6. Epub 2004 Feb 2. No abstract available.
PMID: 14973693
citation: Catarci M, Mancini S, Gentileschi P, Camplone C, Sileri P, Grassi GB. Antibiotic prophylaxis in elective laparoscopic cholecystectomy. Lack of need or lack of evidence? Surg Endosc. 2004 Apr;18(4):638-41. doi: 10.1007/s00464-003-9090-0. Epub 2004 Feb 2.
PMID: 14752639
citation: Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):152S-157S. doi: 10.1016/0002-9343(91)90361-z.
PMID: 1656747
responsible party type: Principal Investigator
investigator affiliation: Korean South West East Gastric Surgery Group
investigator full name: Oh Jeong
investigator title: Associate Professor
mesh term: Stomach Neoplasms
mesh term: Anti-Infective Agents
mesh term: Anti-Bacterial Agents
sharing ipd: No