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Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy (KSWEET-03)

Primary Purpose

Gastric Cancer, Complication of Surgical Procedure

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
No use of antimicrobial prophylaxis
Use of 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 Gastric Cancer focused on measuring Gastric cancer, Laparoscopic gastrectomy, Prophylactic antibiotics, Infectious complications

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A patient undergoing totally laparoscopic distal gastrectomy for the gastric cancer located in the low or middle part of the stomach
  • A patient who underwent limited lymphadenectomy (D1 or D1+) with clinical T1-2N0M0 stage based on 8th edition of the International Union Against Cancer (UICC) tumor node metastasis (TNM) classification
  • From 18 to 75 years old
  • Eastern Cooperative Oncology Group (ECOG) status 0-1
  • American Society of Anesthesiologists (ASA) score I-II
  • A patient with appropriate bone marrow function, renal function, lung function, and liver function
  • Before the surgery, decide to participate in this study and agree with the written informed consent

Exclusion Criteria:

  • A patient who underwent previous abdominal surgery
  • Combined other abdominal organ cancer
  • A patient who received chemotherapy and radiotherapy within the last 6 months
  • Combined organ resection other than cholecystectomy
  • A patient undergoing emergency surgery due to perforation or bleeding
  • A patient who have received antibiotic treatment for other infectious diseases within one month of operation
  • Severely malnourished patient

Sites / Locations

  • Chonnam National University Hwasun Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A group (treatment group)

B group (control group)

Arm Description

No use of antimicrobial prophylaxis

Use of antimicrobial prophylaxis

Outcomes

Primary Outcome Measures

Incidence of surgical site infections within 30 days
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.

Secondary Outcome Measures

Length of hospital stay
From date of operation until the date of hospital discharge
Incidence of remote non-surgical site infections
Any postoperative infectious complications other than surgical site infections

Full Information

First Posted
January 7, 2019
Last Updated
March 28, 2022
Sponsor
Korean South West East Gastric Surgery Group
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1. Study Identification

Unique Protocol Identification Number
NCT03802097
Brief Title
Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy
Acronym
KSWEET-03
Official Title
Multicenter Randomized Controlled Trial About no Antimicrobial Prophylaxis for Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Carcinoma (KSWEET-03)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 27, 2018 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
March 25, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Complication of Surgical Procedure
Keywords
Gastric cancer, Laparoscopic gastrectomy, Prophylactic antibiotics, Infectious complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A group (treatment group)
Arm Type
Experimental
Arm Description
No use of antimicrobial prophylaxis
Arm Title
B group (control group)
Arm Type
Experimental
Arm Description
Use of antimicrobial prophylaxis
Intervention Type
Procedure
Intervention Name(s)
No use of antimicrobial prophylaxis
Other Intervention Name(s)
No AMP
Intervention 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
Intervention Type
Procedure
Intervention Name(s)
Use of antimicrobial prophylaxis
Other Intervention Name(s)
AMP
Intervention Description
Use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer
Primary Outcome Measure Information:
Title
Incidence of surgical site infections within 30 days
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.
Time Frame
within 30 days after operation
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
From date of operation until the date of hospital discharge
Time Frame
up to 6 months
Title
Incidence of remote non-surgical site infections
Description
Any postoperative infectious complications other than surgical site infections
Time Frame
within 30 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A patient undergoing totally laparoscopic distal gastrectomy for the gastric cancer located in the low or middle part of the stomach A patient who underwent limited lymphadenectomy (D1 or D1+) with clinical T1-2N0M0 stage based on 8th edition of the International Union Against Cancer (UICC) tumor node metastasis (TNM) classification From 18 to 75 years old Eastern Cooperative Oncology Group (ECOG) status 0-1 American Society of Anesthesiologists (ASA) score I-II A patient with appropriate bone marrow function, renal function, lung function, and liver function Before the surgery, decide to participate in this study and agree with the written informed consent Exclusion Criteria: A patient who underwent previous abdominal surgery Combined other abdominal organ cancer A patient who received chemotherapy and radiotherapy within the last 6 months Combined organ resection other than cholecystectomy A patient undergoing emergency surgery due to perforation or bleeding A patient who have received antibiotic treatment for other infectious diseases within one month of operation Severely malnourished patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oh Jeong, M.D.,Ph.D.
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jellanamdo
ZIP/Postal Code
58128
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy

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