No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy (KSWEET-01)

February 1, 2016 updated by: Oh Jeong, Korean South West East Gastric Surgery Group

Phase II Study of the Efficacy of no Antimicrobial Prophylaxis Use for Laparoscopic Distal Gastrectomy for Gastric Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollanam-do
      • Hwasun-eup, Jeollanam-do, Korea, Republic of, 519-809
        • Chonnam National University Hwasun Hospital
    • Kyungsang-do
      • Busan, Kyungsang-do, Korea, Republic of, 602-715
        • Dong-A University Hospital
      • Daegu, Kyungsang-do, Korea, Republic of, 700-712
        • Kyemyung University Dongsan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven gastric adenocarcinoma clinical stage T1-2N0M0 patients who underwent laparoscopic distal gastrectomy
  • Age between 18 and 65 years
  • American Society of Anaesthesiologists (ASA) status >2
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Normal blood, liver, pulmonary, cardiac, and renal function
  • Informed consent

Exclusion Criteria:

  • Administration of antibiotics within 1 month before surgery
  • Active infection at the time of surgery
  • Combined resection during operation (i.e., spleen, liver, colon, etc.)
  • History of upper abdominal surgery
  • Previous chemotherapy or radiotherapy within 6 months before surgery
  • Uncontrolled underlying comorbidities
  • Malnutrition with BMI less than 18.5 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No Antimicrobial prophylaxis
No use of antimicrobial prophylaxis during surgery
Other: No Antimicrobial prophylaxis
Antimicrobial prophylaxis are not administered during an operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative surgical site infection
Time Frame: Within postoperative 1 month
Incidence of surgical site infection, including superficial incisional, deep incisional, and organ/space infection, until postoperative 1 month
Within postoperative 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morbidity and mortality
Time Frame: Within postoperative 1 month or during hospitalization
Occurence of postoperative complications or deaths until postoperative 1 months or during hospitalization. Postoperative complications will be assessed with respect to types and severity.
Within postoperative 1 month or during hospitalization
Hospital stay
Time Frame: Up to 1month after operation
The duration of hospital stay from the operation to hospital discharge
Up to 1month after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean South West East Gastric Surgery Group

Investigators

  • Study Director: Oh Jeong, MD, PhD, Chonnam National University Hospital
  • Study Chair: Young Kyu Park, MD, PhD, Chonnam National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 1, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSWEET-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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