Antibiotic prophylaxis in elective laparoscopic cholecystectomy - Lack of need or lack of evidence?

Background: The need to administer antibiotic prophylaxis (ABP) during laparoscopic cholecystectomy (LC) is still a matter of significant controversy. The purpose of this study was to resolve this issue by performing a meta-analysis of the available randomized controlled trials (RCT) on this topic. Methods: Papers identified via a systematic literature search were evaluated according to standard criteria. Data regarding the patient sample, study methods, and outcomes were abstracted and summarized across studies. The outcome measures were the rates of all perioperative infections, the rates of surgical site infections, and the rates of infections at other sites. Results were examined for 974 patients randomized to ABP or placebo prior to LC in six RCT published from 1997 to 2001. Results: The cumulative rates of all infections were 2.8% in the ABP group and 4.4% in the placebo group. The pooled odds ratio (OR) (95% confidence interval [CI]) was 0.69 (0.34-1.43; p=0.32). The cumulative rates of surgical site infections were 2.1% in the ABP group and 2.9% in the placebo group. The pooled OR (95% CI) was 0.82 (0.36-1.86; p=0.63). The cumulative rates of infections at other sites were 0.7% in the ABP group and 1.5% in the placebo group. Pooled OR (95% CI) was 0.82 (0.18-1.90; p=0.37). No significant heterogeneity was found in any data pooling. Conclusions: Based on the available evidence, there appears to be no need to administer routine ABP to low-risk patients during LC. However, the number of patients enrolled to date into RCT is insufficient to avoid a type 11 error. A large and well-designed trial is urgently needed to find a conclusive answer to this question.