Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery

Not Applicable

Completed

• Conditions: Major Abdominal Surgery
• Interventions: Dietary Supplement: Immunonutrition for 5 days preoperative; Dietary Supplement: Standard enteral nutrition for 5 days preoperative

• Registration Number: NCT00512213
• Lead Sponsor: University of Lausanne Hospitals

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.

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 \[5, 10\].

Study Timeline

• Study First Submitted: 2007-08-06
• Study First Submitted QC: 2007-08-06
• Study First Posted: 2007-08-07
• Study Start: 2007-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-21
• Last Update Posted: 2012-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Immunonutrition for 5 days preoperative	Immunonutrition containing RNA, omega-3-FAs, arginine
2	Standard enteral nutrition for 5 days preoperative	Standard enteral nutrition: isocaloric and isonitrogeneous but w/o active ingredients

Primary Outcome Measures

Name	Time	Method
complications after surgery	30 days

Secondary Outcome Measures

Name	Time	Method
hospital stay, patient compliance, Interleukin-6 and 10 plasma level	30 days

Trial Locations

Locations (1)

Department of Visceral Surgery, University Hospital Center; 🇨🇭 Lausanne, Switzerland