[Antibiotic prophylaxis for high risk patients undergoing cholecystectomy]

An open, randomised clinical trial was performed on 435 high risk patients who underwent open cholecystectomy between 1 = January 1993. and 31. December 1995. The patients were divided into three groups. Group 1 (AMOX/CLAV, N = 179) was treated with 1.2 g i.v. amoxicillin/clavulanic acid, the patients in Group 2 (COMPARATOR, N = 164) were given other antibiotics commonly used for prophylaxis in biliary surgery (cefamandole, cefuroxime, cefotaxim). Group 3 (CONTROL, N = 92) contained patients without any risk factors for infectious complication. In this group we did not use antibiotic prophylaxis. The results were analysed with Student t, and x2 methods. The wound infection rate in Group 1 was 2.76% versus 5.48% in Group 2. The difference was significant if the patients were older than 65 years or the preoperative hospitalisation was longer than 5 days. The concentration of amoxycillin/calavulanic acid was measured in the serum, in the wall of the gall bladder, in the bile obtained both from the gall bladder and the major bile duct. The observed levels were higher than the therapeutic concentration in the serum and in the bile gained from the major bile duct, whereas lower in the gall bladder wall, and in the bile gained from the gall bladder. Systemic antibiotic prophylaxis is required for open cholecystectomy in high risk patients.