Abstract
Background
A prophylactic antibiotic is recommended in open cholecystectomy surgeries, but in laparoscopic cholecystectomies such prophylaxis is controversial. Recent reviews have not found conclusive evidence that routine prophylaxis, especially in low risk patients, is effective. This clinical trial was undertaken to evaluate the efficacy of cefazolin in reducing surgical site infection SSI in laparoscopic cholecystectomies in a sample not screened for high or low risk patients.
Methods
A randomized double-blind controlled trial was conducted in a single university hospital. Scheduled cholecystectomy patients without selection for patient risk factors were randomized into two groups. Pre-operatively, group A patients received a placebo of 10 ml isotonic sodium chloride, and group B patients received 1 g of cefazolin as a prophylactic antibiotic. All patients underwent a standard laparoscopic cholecystectomy, and were followed up for at least 30 days.
Results
Two hundred ninety-nine patients were randomized (149 in group A and 150 in group B). SSI occurred in seven patients (2.34 %), five (1.67 %) in the placebo group, and two (0.67 %) in the prophylactic antibiotic group. The difference was not statistically significant (p value = 0.512), and no specific risk factors for post-operative infection were identified.
Conclusions
A single dose of preoperative prophylactic cefazolin has no significant benefit in reducing the incidence of SSI in laparoscopic cholecystectomy. Whether or not to use a prophylactic depends on the individual patient, and the consideration of the attending surgeon.
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Acknowledgments
We would like to give our great thanks to our supporting team: Assistant Professor Thunchanok Wanasuwannakul, MD, Kanjana Nuanjun, RN, Praisuda Bualoy, RN, Miss Jureerat Seangthong (statistical analysis), Mr. Dave Patterson (English editing), and Associate Professor Vicha Jaroonrach, MD (internal reviewer).
Disclosures
Sakchai Ruangsin, Supparerk Laohawiriyakamol, Somkiat Sunpaweravong, Somrit Mahattanobon, have no conflicts of interest or financial ties to disclose. The Faculty of Medicine, Prince of Songkla University provided the funding for the clinical trial without other external sources. They had no role in study design, data collection, analysis, and report to submission paper. The corresponding author had complete access to all data and responsibility for submission for publication.
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Ruangsin, S., Laohawiriyakamol, S., Sunpaweravong, S. et al. The efficacy of cefazolin in reducing surgical site infection in laparoscopic cholecystectomy: a prospective randomized double-blind controlled trial. Surg Endosc 29, 874–881 (2015). https://doi.org/10.1007/s00464-014-3745-x
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DOI: https://doi.org/10.1007/s00464-014-3745-x