Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00512213|
Recruitment Status : Completed
First Posted : August 7, 2007
Last Update Posted : April 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Abdominal Surgery||Dietary Supplement: Immunonutrition for 5 days preoperative Dietary Supplement: Standard enteral nutrition for 5 days preoperative||Not Applicable|
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)  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 .
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 . However, it remains controversial whether standard enteral nutrition (SEN) or immunonutrition (IN) is preferable .
IN, containing arginine, ribonucleic acid and omega-3 polyunsaturated fatty acids aims to improve the nutritional status, immunological function and clinical outcome [5, 10].
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery: A Single-center Double-blinded Controlled Randomized Superiority Trial|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Active Comparator: 1
Immunonutrition containing RNA, omega-3-FAs, arginine
Dietary Supplement: Immunonutrition for 5 days preoperative
Impact vs Meritene
Other Name: Impact, Meritene
Active Comparator: 2
Standard enteral nutrition: isocaloric and isonitrogeneous but w/o active ingredients
Dietary Supplement: Standard enteral nutrition for 5 days preoperative
Impact vs Meritene
Other Name: Impact vs Meritene
- complications after surgery [ Time Frame: 30 days ]
- hospital stay, patient compliance, Interleukin-6 and 10 plasma level [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512213
|Department of Visceral Surgery, University Hospital Center|
|Lausanne, Switzerland, 1011|
|Study Chair:||Nicolas Demartines, MD||Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland|