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

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.

Study Overview

• Status: Completed
• Conditions: Major Abdominal Surgery
• Intervention / Treatment: Dietary supplement: Immunonutrition for 5 days preoperative; Dietary supplement: Standard enteral nutrition for 5 days preoperative

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 Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Department of Visceral Surgery, University Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Immunonutrition containing RNA, omega-3-FAs, arginine	Dietary supplement: Immunonutrition for 5 days preoperative; Impact vs Meritene; Other Names: 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 Names: Impact vs Meritene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
complications after surgery	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
hospital stay, patient compliance, Interleukin-6 and 10 plasma level	30 days

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Collaborators: Novartis
• Investigators: Study Chair: Nicolas Demartines, MD, Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: August 6, 2007
• First Submitted That Met QC Criteria: August 6, 2007
• First Posted (Estimate): August 7, 2007

Study Record Updates

• Last Update Posted (Estimate): April 24, 2012
• Last Update Submitted That Met QC Criteria: April 21, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: major abdominal surgery; complication; preoperative Immunonutrition
• Other Study ID Numbers: P00/07 CHV