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Phase III study: Intrao-perative versus extended antimicrobial prophylaxis after gastric cancer surgery

Reference: The Lancet Infectious Diseases, Early Online Publication, 31 January 2012

Source: Lancet Infectious Diseases

Date published: 31/01/2012 17:08

Summary
by: Sheetal Ladva

In this open-label phase III study, the researchers compared the incidence of surgical-site infections with intra-operative antimicrobial prophylaxis alone versus intra-operative plus postoperative administration in Japanese patients with gastric cancer that was potentially curable with a distal gastrectomy.

 

A total of 355 patients were randomised to either intraoperative antimicrobial prophylaxis alone (cefazolin 1 g before the surgical incision and every 3 hours as intraoperative supplements; n=176) or extended antimicrobial prophylaxis (intraoperative administration plus cefazolin 1 g once after closure and twice daily for 2 postoperative days; n=179). The primary endpoint was the incidence of surgical-site infections.

 

Eight patients (5%, 95% CI 2—9%) had surgical-site infections in the intraoperative group compared with 16 (9%, 5—14) in the extended group. The relative risk of surgical-site infections with intraoperative antimicrobial prophylaxis was 0•51 (0.22—1.16), which revealed statistically significant non-inferiority (p<0.0001).

 

The researchers concluded that based on their findings, they do not recommend antimicrobial prophylaxis after gastric cancer surgery.

 

An accompanying editorial discusses the findings from this study.

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