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

Sponsor

Korean South West East Gastric Surgery Group (Other)

Overall Status

Completed

CT.gov ID

NCT03802097

Collaborator

(none)

260

Enrollment

Location

Arms

38.9

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Complication of Surgical Procedure	Procedure: No use of antimicrobial prophylaxis Procedure: Use of antimicrobial prophylaxis	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multicenter Randomized Controlled Trial About no Antimicrobial Prophylaxis for Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Carcinoma (KSWEET-03)

Actual Study Start Date :

Dec 27, 2018

Actual Primary Completion Date :

Jan 31, 2022

Actual Study Completion Date :

Mar 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A group (treatment group) No use of antimicrobial prophylaxis	Procedure: No use of antimicrobial prophylaxis Do not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer Other Names: No AMP
Experimental: B group (control group) Use of antimicrobial prophylaxis	Procedure: Use of antimicrobial prophylaxis Use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer Other Names: AMP

Arm

Intervention/Treatment

Experimental: A group (treatment group)

No use of antimicrobial prophylaxis

Procedure: No use of antimicrobial prophylaxis

Do not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer

Other Names:

No AMP

Experimental: B group (control group)

Use of antimicrobial prophylaxis

Procedure: Use of antimicrobial prophylaxis

Use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer

Other Names:

AMP

Outcome Measures

Primary Outcome Measures

Incidence of surgical site infections within 30 days [within 30 days after operation]
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 [up to 6 months]
From date of operation until the date of hospital discharge
Incidence of remote non-surgical site infections [within 30 days after operation]
Any postoperative infectious complications other than surgical site infections

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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