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Randomized Controlled Trial Comparative Study Clinical Trial
Outcome and cost-effectiveness of perioperative enteral immunonutrition in patients undergoing elective upper gastrointestinal tract surgery: a prospective randomized study.
- M Senkal, V Zumtobel, K H Bauer, B Marpe, G Wolfram, A Frei, U Eickhoff, and M Kemen.
- Department of Surgery, Ruhr-University Bochum, St Josef Hospital, Germany.
- Arch Surg Chicago. 1999 Dec 1;134(12):1309-16.
HypothesisPerioperatively administered enteral immunonutrition will improve early postoperative morbidity and cost-effectiveness after gastrointestinal tract surgery.DesignA prospective, randomized, double-blind, multicenter clinical trial.SettingSurgical departments in German university and teaching hospitals.PatientsOne hundred fifty-four patients with upper gastrointestinal tract malignant neoplasms who were eligible for analysis.InterventionPreoperatively, 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 MeasuresPostoperative 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.ResultsIn 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).ConclusionThe 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.
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