The results of a randomized, multi-center clinical trial of immunoprophylaxis of post-operative infections with intravenous immunoglobulins (IVIG) (Sandoglobulin®) in "septic risk" patients undergoing surgery for gastrointestinal cancer are presented. "Septic risk" patients were selected by an original multiparametric test based on delayed hypersensitivity skin testing and serum protein electrophoretic subfractions. This screening test had shown 76% positive predictivity in a previous validation assessment. In the present study, 159 "septic risk" patients were selected prospectively from 369 patients undergoing colo-rectal (Colon) and other kinds of gastrointestinal (Non-colon) oncologic surgery; 80 "septic risk" patients were included in the Colon and 79 in the Non-colon group. Immunoprophylaxis with IVIG (15 g on the day prior to operation, and on the 1st and 5th post-operative days) was randomly associated to antibiotic prophylaxis (cefoxitin: 2 g 1 h prior to, followed by 2 g at the end of operation plus 2 g every 6 h for 24 h) in Colon surgery while the prophylactic schedule in Non-colon surgery was only based on random administration of IVIG, at the same dosage as in the Colon group. There was a clear-cut reduction of post-operative infections both in Colon and Non-colon "septic risk" patients who had IVIG prophylaxis; in the Colon group, 37 and 21 infections (P ≤ 0.004) in the antibiotic (A) versus IVIG plus antibiotic (IVIG+A) subsets, respectively; in the Non-colon group there were 33 and 19 infections (P <0.01) in the control (C) versus (IVIG) subsets, respectively. Moreover, the serum IgG levels correlated with post-operative infective out-come both in the Colon and Non-colon groups, with a significant decrease of post-operative serum IgG levels in patients who did not have IVIG prophylaxis compared to the significant post-operative increase of serum IgG levels in patients undergoing IVIG prophylaxis.
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