Introduction Among the clinical manifestations of sympto- matic cholelithiasis, biliary colic is by far the most fre- quent. This is caused by chronic inflammation of the gallbladder, associated with and caused by the pres- ence of gallstones. Surgery represents the elective treatment of cholecystitis due to gallstones. In recent years, this is performed through laparoscopic or mini- laparotomic techniques whenever possible, although surgeons may still need to choose open cholecystecto- my for patients with complicated gallstone disease, such as cases of delayed treatment of acute cholecysti- tis or chronic recurrent cholecystitis (1-5). A substantial reduction of morbidity and mortal- ity associated with surgical treatment of gallstone dis- ease is routinely obtained through the use of elective antibiotic prophylaxis of surgical infections (6). Pro- phylaxis also contributes to reduce costs related to the length of hospitalisation. Appropriate regimens of an- tibiotic prophylaxis should offer a good protection against the most common pathogens causing surgical wound infections, while preserving the resident bowel flora. Drugs of choice should therefore be able to reach active concentration at the site of surgery for a sufficient length of time. Ceftriaxone has been long considered the drug of reference for prophylaxis of in- fections in biliary surgery, because of its wide antibac- terial spectrum, its long half-life (8 hours), its favourable tissue distribution and its biliary metabo- lism (7-9). Cefepime is a fourth generation cephalo- sporin, with a modified zwitterionic structure which allows for a more favourable penetration in the bacte- rial wall, a higher affinity for its molecular target (PBP3), and a reduced susceptibility to beta-lacta- mases. Previous studies compared its efficacy with that of gentamicin and mezlocillin in the treatment of acute cholecystitis associated with gallstones; the Cefepime for prophylaxis of infections in the surgery of cholelithiasis. Results of a multicentric comparative trial Paolo Del Rio 1 , Maria Vellone 2 , Paolo Fragapane 3 , Marcello di Millo 4 , Riccardo Mazzitelli 5 , Carlo Allegri 6 , Gennaro Nuzzo 2 , Mario Sianesi 1 1 Department of Surgical Sciences, Unit of General Surgery and Organ Transplantation, University of Parma, Parma; 2 De- partment of Surgery (Hepatobiliary Unit), Catholic University Medical School, Rome; 3 Second General Surgery Division, Hospital “Mauriziano Umberto I”, Turin; 4 Second General Surgery, Hospital Riuniti, University of Foggia; 5 Department of General Surgery, Hospital Riuniti, Reggio Calabria; 6 General Surgery Unit, Hospital “Cristo Re”, Rome, Italy Abstract. A multicenter, open labelled, randomized study was carried out to compare the prophylactic effica- cy of Cefepime and Ceftriaxone in patients undergoing biliary tract surgery. Two hundred and nine patients were included in the study and randomized to receive preoperative infusion of 2 g Cefepime (n=107) or 2 g Ceftriaxone (n=102) both in a single i.v. administration. Antimicrobial prophylaxis was successful in prevent- ing infections in 98.9% of patients in the Cefepime group and 97.7% in the Ceftriaxone group (p=0.3871). Both regimens were well tolerated without any adverse drug-related reactions. A single dose of Cefepime seems to be a very useful alternative to other regimens for antibiotic prophylaxis of postoperative infectious complications in the elective surgical treatment of cholelithiasis. (www.actabiomedica.it) Key words: Antimicrobial prophylaxis, biliary tract surgery, cholecystectomy, Cefepime, Ceftriaxone O R I G I N A L A R T I C L E ACTA BIOMED 2008; 79: 23-27 © Mattioli 1885