Randomized clinical trial of single- versus multiple-dose antimicrobial prophylaxis in gastric cancer surgery

Abstract

Abstract Background The optimum duration of antimicrobial prophylaxis in elective gastric cancer surgery is still open to question. This multicentre randomized clinical trial compared a single-dose with a multiple-dose regimen of antimicrobial prophylaxis for prevention of surgical-site infection. Methods Between May 2001 and December 2004, 501 patients undergoing elective surgery for gastric cancer in ten centres were allocated randomly to single- or multiple-dose antimicrobial prophylaxis. The primary outcome measure was the incidence of surgical-site infection, analysed by intention to treat. Results Some 243 patients who received a single dose and 243 who received multiple doses of antibiotics were included in the final analysis. The surgical-site infection rate was 9·5 per cent (23 of 243) and 8·6 per cent (21 of 243) respectively (difference 0·9 (95 per cent confidence interval − 4·3 to 5·9) per cent). Antimicrobial prophylaxis had no major adverse effects. Conclusion The incidence of surgical-site infection in elective gastric cancer surgery was similar with both antibiotic prophylaxis regimens.