The impact of immunostimulating nutrition on infectious complications after upper gastrointestinal surgery: a prospective, randomized, clinical trial.
OBJECTIVE
Immunomodulating nutrition is supposed to reduce the number of complications and lengthen of hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.


METHODS
Between June 1, 2001, and December 31, 2005, a group of 214 well-nourished patients was initially assessed (150 men, 64 women, mean age 61.2 years) to participate in the study. Nine patients were subsequently excluded and the remaining 205 subjects were randomly assigned in a 2 x 2 factorial design into 4 study groups, ie, standard enteral nutrition (n = 53), immunomodulating enteral nutrition (n = 52), standard parenteral nutrition (n = 49), and immunomodulating enteral nutrition (n = 51). The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay. The study was registered in the Clinical Trials Database-number NCT 00558155.


RESULTS
The overall morbidity rate was 33% and the incidence of individual complications was comparable between all groups. Infectious complications occurred in 26 of 102 patients given standard diets and in 22 of 103 patients receiving immunomodulatory formulas (odds ratio 0.81; 95% CI, 0.43-1.50). There were no significant differences between infectious complications in patients using parenteral nutrition (22 of 100 patients) and parenteral formulas (26 of 105, odds ratio 1.14; 95% CI, 0.61-2.14). Neither immunostimulating formulas nor enteral feeding significantly affected secondary outcome measures, including overall morbidity and mortality rates, and hospital stay.


CONCLUSIONS
Our study failed to demonstrate any clear advantage of routine postoperative immunonutrition in patients undergoing elective upper gastrointestinal surgery. Both enteral and parenteral treatment options showed similar efficacy, tolerance, and effects on protein synthesis. Parenteral nutrition composed according to contemporary rules showed similar efficiency to enteral nutrition. However, because of its cost-efficiency, enteral therapy should be considered as the treatment of choice in all patients requiring nutritional therapy.
Klek
Stanislaw
S
Department of Surgery, Jagiellonian University Medical College, Krakow, Poland. klek@poczta.onet.pl
Kulig
Jan
J
Sierzega
Marek
M
Szybinski
Piotr
P
Szczepanek
Kinga
K
Kubisz
Aldona
A
Kowalczyk
Tomasz
T
Gach
Tomasz
T
Pach
Radoslaw
R
Szczepanik
Antoni M
AM
D000328:Adult; D000368:Aged; D013505:Digestive System Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D017558:Elective Surgical Procedures; D004750:Enteral Nutrition / Q000379:methods* / Q000592:standards; D005260:Female; D005500:Follow-Up Studies; D005526:Food, Formulated; D005770:Gastrointestinal Neoplasms / Q000276:immunology / Q000601:surgery / Q000628:therapy; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009751:Nutritional Requirements; D010288:Parenteral Nutrition / Q000379:methods / Q000592:standards; D011182:Postoperative Care; D011446:Prospective Studies; D012016:Reference Values; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000276:immunology*; D016896:Treatment Outcome
D007155:Immunologic Factors