The need for antibiotic prophylaxis in elective laparoscopic cholecystectomy - A prospective randomized study

Hypothesis: The need for antibiotic treatment when performing elective lapa roscopic cholecystectomy may not be as important as it is thought. This stu dy assesses the real efficacy of antibiotic prophylaxis in elective laparos copic cholecystectomy with respect to the postoperative infection rate. Design: A prospective randomized study on the routine use of antibiotic pro phylaxis in laparoscopic cholecystectomy. Setting: University teaching hospital, La Sapienza, Italy. Patients: Eighty-four patients randomly placed into 2 groups (A [n = 44] an d B [n = 40]) immediately before undergoing laparoscopic cholecystectomy. Methods: Before anesthesia was administered, group A received intravenously 2 g of cefotaxime sodium diluted in 100 mL of isotonic sodium chloride sol ution; group B, 10 mL of isotonic sodium chloride solution in 100 mL of sal ine. A gallbladder bile sample for culture was withdrawn intraoperatively f rom all patients. In both groups, age, sex, weight, duration of surgery, pr esence of diabetes, American Society of Anesthesiologists patient classific ation score, preoperative autologous blood donation, antibiotic administrat ion, intraoperative gall-bladder rupture, findings from bile culture positi ve for bacteria, episodes of colic within 30 days before surgery, length of postoperative hospital stay, and number of septic complications were recor ded. All data were correlated by univariate and multivariate analyses with the onset of septic phenomena. Results: In group A, 3 cases of wound infection, 1 case of subhepatic absce ss from bile leakage, and 1 case of urinary tract infection were observed; group B, 4 cases of wound infection, 1 case of bronchopneumonia, and 2 case s of urinary tract infection. Comparison of data showed no statistically si gnificant difference between the groups. Findings from bile examination in patients with sepsis complications were positive in 5 patients in group A a nd in 6 in group B (P = .91). Multivariate analysis showed diabetes mellitu s and colic episodes within 30 days before surgery as independent factors s ignificantly associated to the onset of infectious complications. Conclusions: In elective laparoscopic cholecystectomy, antibiotic treatment did not seem to affect the incidence and severity of infections or the deg ree of bile contamination.