Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512213
Status:
COMPLETED
Last Update Posted:
2012-04-24
First Post:
2007-08-06
Brief Title:
Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery
Sponsor:
University of Lausanne Hospitals
Organization:
University of Lausanne Hospitals
Study Overview
Official Title:
Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery A Single-center Double-blinded Controlled Randomized Superiority Trial
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None