The Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery

Study Overview
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Brief Summary
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The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients following elective upper GI surgery

Detailed Description
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All patients qualified between June 2002 and December 2007 to total and distal subtotal gastrectomy or pancreaticoduodenectomy were screened for eligibility to participate in the study. Malnutrition was defined by the Nutritional Risk Index (NRI), calculated according to the formula used in the Veterans Administration Cooperative Group trial.{, 1991 #70} Additional eligibility criteria included: age between 18 and 80 years, Karnofsky performance status score of 80 or more, and adequate organ function measured by routine blood tests. Patients without features of malnutrition, as well as those with disseminated tumors, serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5), and renal or liver failure were excluded. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients following elective upper GI surgery. Therefore, patients were randomly assigned in a 2×2 factorial design to four groups receiving immunostimulating versus normal diets, and enteral versus intravenous nutritional support. The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay.

Official Title
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The Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial.

Conditions
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Gastrointestinal Surgery

Intervention / Treatment
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* Drug: Reconvan, Dipeptiven, Omegaven


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 80 years, Karnofsky performance status score of 80 or more, adequate organ function measured by routine blood tests Exclusion Criteria: patients <18 or > 80 Karnofsky performance < 50
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Standard Enteral Nutrition - Peptisorb, Nutricia Ltd. | Drug: Reconvan, Dipeptiven, Omegaven<br>* Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.<br>|
| No Intervention: 2<br>Standard Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes | Drug: Reconvan, Dipeptiven, Omegaven<br>* Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.<br>|
| Experimental: 3<br>Immunomodulating Enteral Nutrition: Reconvan, Fresenius Kabi Poland | Drug: Reconvan, Dipeptiven, Omegaven<br>* Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.<br>|
| Experimental: 4<br>Immunomodulating Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes + Omegaven (Fresenius Kabi), Dipepitven (Fresenius Kabi) | Drug: Reconvan, Dipeptiven, Omegaven<br>* Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients |  | Immunonutrition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay |  | morbidity | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunonutrition, surgical patients, postoperative period