Infections after laparoscopic and open cholecystectomy: ceftriaxone versus placebo; a double blind randomized clinical trial

Background: Gallstone disease is one of the most common gastrointestinal diseases requiring surgery with probable postoperative infection. The role of prophylactic antibiotics (AB) in prevention of infection is controversial. This study aimed to compare the manifestations, complications and outcomes of two groups of patients, those receiving prophylactic AB versus placebo, in order to determine whether antibiotic therapy is required. Patients and methods: In this double blind randomized clinical trial, we studied 130 patients with symptomatic cholelithiasis or polyps of gallbladder admitted in Shohada-e-Tajrish Hospital, Tehran, Iran for cholecystectomy between 2006 and 2008. Patients were randomly assigned in two subgroups: the first group received 1gr ceftriaxone during induction of anesthesia and the second group received 10mL of isotonic sodium chlorides solution as placebo. All patients were followed for 4 weeks after surgery. Results: The study population included 61 males and 69 females with the mean age of 49.3±9.6 and 51.8±9.9 years in treatment and placebo group, respectively. Of 130 bile culture results, 83 were negative. Escherichia coli, Klebsiella and Staphylococcus aureus were the most common cultured bacteria. There was no statistically significant difference in culture results between the patients received AB and placebo (NS). The surgical technique (open versus laparoscopic) did not influence the culture results. Conclusion: It can be concluded that prophylactic antibiotics do not have any preventive effect on wound infection in a double blind setting. According to our findings, routine antibiotic prophylaxis as recommended for biliary surgery (open or laparoscopic cholecystectomy) is now questionable.