Infections

All Conditions

Neoplasms

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Carcinoma

Communicable Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Antibiotics, Antitubercular

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

No 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

Use of antimicrobial prophylaxis

Oh Jeong, M.D.,Ph.D.

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.

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 About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy

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

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.

From date of operation until the date of hospital discharge

Any postoperative infectious complications other than surgical site infections

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy	NCT03802097	Gastric Cancer Complication of...	No use of antim... Use of antimicr...	18 Years - 75 Years	Korean South West East Gastric Surgery Group
Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy	NCT03802097	Gastric Cancer Complication of...	No use of antim... Use of antimicr...	18 Years - 75 Years	Korean South West East Gastric Surgery Group

Spots Global Cancer Trial Database for no use of antimicrobial prophylaxis