IMMUNOPROFILASSI IN PAZIENTI A 'RISCHIO SETTICO' SOTTOPOSTI AD INTERVENTO CHIRURGICO PER NEOPLASIA DELL'APPARATO DIGERENTE. RISULTATI PRELIMINARI DI UN TRIAL CLINICO MULTICENTRICO

Herein reported are the preliminary results of an ongoing randomized, controlled, multicentric clinical trial of ummunoprophylaxis of postoperative infections with intravenous Immunoglobulins (IVIG) (Sandoglobulin) in 'septic risk' patients undergoing surgery for gastrointestinal cancer. Immunoprophylaxis (IVIG, 15 g on the day prior to operation, on the 1st and 5 th postoperative day) is randomly associated to parenteral short-term antibiotic prophylaxis with cefoxitin (2g 1 hr prior to operation, at the end of operation and every 6 hrs for the following 24 hrs) in patients undergoing colo-rectal (colon) surgery while in the other types of gastrointestinal (non colon) surgery prophylaxis is based only on random administrationn of IVIG. Up to now 120 'septic risk' patients have been included (colon n=77; non-colon n=43); this preliminary assessment shows a significant reduction of septic complications in IVIG prophylaxis versus control subset both in colon (20 and 35 infections, respectively; p<0.005) and in non-colon group of patients (10 and 21 infections, respectively; p<0.04), with a significant trend of serum IgG levels correlated with postoperative infection outcome and prophylactic schedule.