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

Primary Purpose

Stomach Neoplasms

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
No Antimicrobial prophylaxis
Sponsored by
Korean South West East Gastric Surgery Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Stomach neoplasms, Surgical site infection, Laparoscopic gastrectomy, Antimicrobial prophylaxis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonnam National University Hwasun Hospital
  • Dong-A University Hospital
  • Kyemyung University Dongsan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

No Antimicrobial prophylaxis

Arm Description

No use of antimicrobial prophylaxis during surgery

Outcomes

Primary Outcome Measures

Postoperative surgical site infection
Incidence of surgical site infection, including superficial incisional, deep incisional, and organ/space infection, until postoperative 1 month

Secondary Outcome Measures

Postoperative morbidity and mortality
Occurence of postoperative complications or deaths until postoperative 1 months or during hospitalization. Postoperative complications will be assessed with respect to types and severity.
Hospital stay
The duration of hospital stay from the operation to hospital discharge

Full Information

First Posted
July 21, 2014
Last Updated
February 1, 2016
Sponsor
Korean South West East Gastric Surgery Group
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1. Study Identification

Unique Protocol Identification Number
NCT02200315
Brief Title
No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy
Acronym
KSWEET-01
Official Title
Phase II Study of the Efficacy of no Antimicrobial Prophylaxis Use for Laparoscopic Distal Gastrectomy for Gastric Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korean South West East Gastric Surgery Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Stomach neoplasms, Surgical site infection, Laparoscopic gastrectomy, Antimicrobial prophylaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Antimicrobial prophylaxis
Arm Type
Experimental
Arm Description
No use of antimicrobial prophylaxis during surgery
Intervention Type
Other
Intervention Name(s)
No Antimicrobial prophylaxis
Intervention Description
Antimicrobial prophylaxis are not administered during an operation
Primary Outcome Measure Information:
Title
Postoperative surgical site infection
Description
Incidence of surgical site infection, including superficial incisional, deep incisional, and organ/space infection, until postoperative 1 month
Time Frame
Within postoperative 1 month
Secondary Outcome Measure Information:
Title
Postoperative morbidity and mortality
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.
Time Frame
Within postoperative 1 month or during hospitalization
Title
Hospital stay
Description
The duration of hospital stay from the operation to hospital discharge
Time Frame
Up to 1month after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oh Jeong, MD, PhD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Young Kyu Park, MD, PhD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun-eup
State/Province
Jeollanam-do
ZIP/Postal Code
519-809
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
State/Province
Kyungsang-do
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Kyemyung University Dongsan Medical Center
City
Daegu
State/Province
Kyungsang-do
ZIP/Postal Code
700-712
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12584377
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
9623456
Citation
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Results Reference
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Citation
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No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy

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