HYPOTHESIS: Perioperatively administered enteral immunonutrition will improve early postoperative morbidity and cost-effectiveness after gastrointestinal tract surgery. DESIGN: A prospective, randomized, double-blind, multicenter clinical trial. SETTING:Surgical departments in German university and teaching hospitals. PATIENTS: One hundred fifty-four patients with upper gastrointestinal tract malignant neoplasms who were eligible for analysis. INTERVENTION: Preoperatively, patients received 5 days of oral immunonutrition (an arginine-, RNA-, and omega3 fatty acid-supplemented diet) or an isoenergetic control diet (1 L/d). Early postoperative enteral feeding with immunonutrition or an isoenergetic, isonitrogenous control diet using a catheter jejunostomy was performed for 10 days. MAIN OUTCOME MEASURES: Postoperative infectious complications, their treatment costs, and cost-effectiveness of immunonutrition were analyzed. Plasma levels of the fatty acids eicosapentaenoic acid and docosahexaenoic acid were measured. RESULTS: In the immunonutrition group, significantly fewer infectious complication events occurred (14 vs 27; P = .05). The number of patients with complications was significantly lower in the supplemented diet group after postoperative day 3 (7 vs 16; P = .04). The treatment costs of complications in the supplemented diet group were suggestively lower than in the control diet group (DM 75172 vs DM 204273). Cost-effectiveness was DM 1503 in the experimental group vs DM 3587 in the control group, where DM denotes deutsche mark (German currency). CONCLUSION: The perioperative administration of an enteral immunonutrition significantly (P = .05) decreased the early occurrence of postoperative infections and reduced substantially the treatment costs of the complications after major upper gastrointestinal tract surgery.
RCT Entities:
HYPOTHESIS: Perioperatively administered enteral immunonutrition will improve early postoperative morbidity and cost-effectiveness after gastrointestinal tract surgery. DESIGN: A prospective, randomized, double-blind, multicenter clinical trial. SETTING: Surgical departments in German university and teaching hospitals. PATIENTS: One hundred fifty-four patients with upper gastrointestinal tract malignant neoplasms who were eligible for analysis. INTERVENTION: Preoperatively, patients received 5 days of oral immunonutrition (an arginine-, RNA-, and omega3 fatty acid-supplemented diet) or an isoenergetic control diet (1 L/d). Early postoperative enteral feeding with immunonutrition or an isoenergetic, isonitrogenous control diet using a catheter jejunostomy was performed for 10 days. MAIN OUTCOME MEASURES: Postoperative infectious complications, their treatment costs, and cost-effectiveness of immunonutrition were analyzed. Plasma levels of the fatty acidseicosapentaenoic acid and docosahexaenoic acid were measured. RESULTS: In the immunonutrition group, significantly fewer infectious complication events occurred (14 vs 27; P = .05). The number of patients with complications was significantly lower in the supplemented diet group after postoperative day 3 (7 vs 16; P = .04). The treatment costs of complications in the supplemented diet group were suggestively lower than in the control diet group (DM 75172 vs DM 204273). Cost-effectiveness was DM 1503 in the experimental group vs DM 3587 in the control group, where DM denotes deutsche mark (German currency). CONCLUSION: The perioperative administration of an enteral immunonutrition significantly (P = .05) decreased the early occurrence of postoperative infections and reduced substantially the treatment costs of the complications after major upper gastrointestinal tract surgery.
Authors: Dan L Waitzberg; Hideaki Saito; Lindsay D Plank; Glyn G Jamieson; Palepu Jagannath; Tsann-Long Hwang; Juan M Mijares; David Bihari Journal: World J Surg Date: 2006-08 Impact factor: 3.352