Imamura, H., Kurokawa, Y., Tsujinaka, T., Inoue, K., Kimura, Y., Iijima, S., . . . Furukawa, H. (2012). Intraoperative versus extended antimicrobial prophylaxis after gastric cancer surgery: A phase 3, open-label, randomised controlled, non-inferiority trial. Lancet Infectious Diseases, 12, 381–387.

The purpose of the study was compare surgical site infection rates between intraoperative antibiotic therapy alone versus intraoperative and postoperative antibiotic administration in patients undergoing distal gastrectomy surgery for potentially curable gastric cancer.

Participants were randomly assigned to receive either intraoperative antimicrobial prophylaxis alone or intraoperative antimicrobial prophylaxis plus extended use of prophylactic antibiotic administration for two days postoperatively. Patients were monitored for surgical site infections for 30 days postoperatively.

• The total sample size was 355 with an average age of 65.5 years (range = 35–84)
• Males made up 68% of the sample; females made up 32%
• A key disease characteristic was gastric adenocarcinoma considered curable with distal gastrectomy.

Multiple inpatient settings in Japan

Active antitumor treatment

Randomized, controlled trial (non-blinded)

The Centers for Disease Control and Prevention's National Nosocomial Infection Surveillance System

The group that received intraoperative antibiotics only had a lower rate of surgical site infections (5%) than the group that received intraoperative and extended antibiotic prophylaxis (9%). This indicates statistically significant non-inferiority (p < 0.0001). The authors also studied subgroups of patient characteristics, including length of surgery, body mass index, and prognostic nutritional index. None of these subgroups showed benefit from extended antimicrobial administration.

Interestingly, those patients who got more doses of antibiotic had nearly double the rate of surgical site infection as those who received intraoperative antibiotic prophylaxis only. Additional study is warranted to determine if limited antimicrobial prophylaxis is superior in preventing infection.

Risk of bias (no blinding)

Because elimination of postoperative antibiotic prophylaxis did not negatively affect surgical wound infection rates, this intervention is not recommended. Elimination of the unnecessary treatment will reduce expense, free up pharmacy and nursing time (further reducing expense), and reduce the potential for antibiotic resistance.