Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery

Major Abdominal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512213
• Other study ID #: P00/07 CHV
• Status: Completed
• Phase: N/A
• First received: August 6, 2007
• Last updated: April 21, 2012
• Start date: September 2007
• Est. completion date: December 2010

Study information

• Verified date: April 2012
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Major Abdominal Surgery

Intervention

Dietary Supplement:
• Immunonutrition for 5 days preoperative
Impact vs Meritene
• Standard enteral nutrition for 5 days preoperative
Impact vs Meritene

Locations

Country	Name	City	State
Switzerland	Department of Visceral Surgery, University Hospital Center	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne Hospitals	Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications after surgery		30 days	Yes
Secondary	hospital stay, patient compliance, Interleukin-6 and 10 plasma level		30 days	Yes