Immunoprophylaxis in "septic risk" patients undergoing surgery for gastrointestinal cancer. Results of a randomized, multicenter clinical trial

The results of a randomized, multicenter 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 sub‐fractions. 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, on the 1st and 5th postoperative days) was randomly associated with antibiotic prophylaxis (cefoxitin: 2 g one hour prior to, followed by 2 g at the end of operation plus 2 g every six hours for 24 hours) 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 antibiotic (A) versus IVIG plus antibiotic (IVIG + A) subset, respectively; in the non‐colon group, 33 and 19 infections (P < 0.01) in control (C) versus (IVIG) subset, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)