Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery

Study Overview
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Brief Summary
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The aim of this trial is to compare preoperative Imunnonutrition with standard enteral nutrition regarding morbidity after major abdominal surgery in patients with NRS greater 3. The primary end point is the complication rate until 30 days after surgery.

Detailed Description
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Malnutrition affects about 20-50% of all patients in hospital [1, 2]. Major surgery further increases postoperative malnutrition and immunity reduction. Therefore, postoperative complication and infection rates after major surgery exceed 30% [3-6]. The nutritional risk score (NRS) [1] is based on the ESPEN (European society of parenteral and enteral nutrition) screening guidelines and identifies patients who are likely to benefit from nutritional support. Patients with a NRS ≥ 3 are considered severely undernourished, or to have a certain degree of severity of disease in combination with certain degree of malnutrition [7]. In a prospective cohort study patients with a NRS ³ 3 had significant more infectious and overall complications after major abdominal surgery [4, 7, 8]. Several studies showed a benefit by nutritional support on complications [3, 5, 6]. International guidelines suggest therefore preoperative oral nutritional support for malnourished patients undergoing major surgery [9]. However, it remains controversial whether standard enteral nutrition (SEN) or immunonutrition (IN) is preferable [9]. IN, containing arginine, ribonucleic acid and omega-3 polyunsaturated fatty acids aims to improve the nutritional status, immunological function and clinical outcome [5, 10].

Official Title
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Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery: A Single-center Double-blinded Controlled Randomized Superiority Trial

Conditions
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Major Abdominal Surgery

Intervention / Treatment
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* Dietary Supplement: Immunonutrition for 5 days preoperative
* Dietary Supplement: Standard enteral nutrition for 5 days preoperative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients admitted for elective major abdominal surgery: Open and laparoscopic esophageal, gastric, hepatic, pancreatic, intestinal and colorectal surgery and with a NRS ≥ 3. Exclusion Criteria: Age < 18 years No informed consent Emergency situation Patients not speaking french or german.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Immunonutrition containing RNA, omega-3-FAs, arginine | Dietary Supplement: Immunonutrition for 5 days preoperative<br>* Impact vs Meritene<br>* Other names: Impact, Meritene;|
| Active Comparator: 2<br>Standard enteral nutrition: isocaloric and isonitrogeneous but w/o active ingredients | Dietary Supplement: Standard enteral nutrition for 5 days preoperative<br>* Impact vs Meritene<br>* Other names: Impact vs Meritene;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications after surgery |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital stay, patient compliance, Interleukin-6 and 10 plasma level |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preoperative Immunonutrition, major abdominal surgery, complication