Prophylaxis of infection with intravenous immunoglobulins plus antibiotic for patients at risk for sepsis undergoing surgery for colorectal cancer: results of a randomized, multicenter clinical trial.
BACKGROUND
The results of a randomized, multicenter clinical trial with perioperative short-term antibiotic plus intravenous immunoglobulins (IVIG + A) versus antibiotic alone (A) for prevention of postoperative infections in patients at risk for sepsis undergoing surgery for colorectal cancer are presented.


METHODS
The patients at risk for sepsis were selected by an original multiparametric test based on delayed-hypersensitivity skin testing and serum protein electrophoretic subfractions. This screening had shown 76% positive predictability in a previous validation assessment. Eighty patients at risk for sepsis were selected prospectively from 210 patients undergoing surgery for colorectal cancer; 43 patients were randomly assigned to the IVIG + A group and 37 to the A group. IVIG was administered on the day before operation, on the first and fifth postoperative days.


RESULTS
There was a clear-cut reduction of postoperative infections in the IVIG + A group: 21 infections in 20 patients versus 37 infections in 29 patients in the A group (p less than 0.004). With regard to serum immunoglobulin (Ig) G monitoring, basal IgG levels were significantly lower in patients given IVIG + A who had postsurgical infections (p less than 0.005) compared with patients with a regular outcome, whereas the same was not true in the A group of patients.


CONCLUSIONS
A significant decrease (p less than 0.001) of postoperative IgG was evidenced in the A group of patients who had infections as opposed to a significant increase (p less than 0.001) of postoperative IgG in IVIG + A patients with a normal outcome.
Cafiero
F
F
Divisione di Oncologia Chirurgica, Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
Gipponi
M
M
Bonalumi
U
U
Piccardo
A
A
Sguotti
C
C
Corbetta
G
G
D000368:Aged; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D003110:Colonic Neoplasms / Q000601:surgery*; D005260:Female; D006801:Humans; D007116:Immunization, Passive / Q000009:adverse effects; D007070:Immunoglobulin A / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood*; D007075:Immunoglobulin M / Q000097:blood; D008297:Male; D012004:Rectal Neoplasms / Q000601:surgery*; D012307:Risk Factors; D018805:Sepsis / Q000209:etiology / Q000517:prevention & control*; D012727:Sex Characteristics; D013530:Surgical Wound Infection / Q000517:prevention & control*
D000900:Anti-Bacterial Agents; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D007075:Immunoglobulin M