NCT00512213

Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: University of Lausanne Hospitals · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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 \[5, 10\].

Conditions

• Major Abdominal Surgery

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Immunonutrition for 5 days preoperative	Impact vs Meritene
DIETARY_SUPPLEMENT	Standard enteral nutrition for 5 days preoperative	Impact vs Meritene

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-08-07
• Last updated: 2012-04-24

Locations

1 site across 1 country: Switzerland