Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery

NCT ID: NCT00512213

Last Updated: 2012-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-12-31

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].

Conditions

Major Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Immunonutrition containing RNA, omega-3-FAs, arginine

Group Type: ACTIVE_COMPARATOR

Immunonutrition for 5 days preoperative

Intervention Type: DIETARY_SUPPLEMENT

Impact vs Meritene

2

Standard enteral nutrition: isocaloric and isonitrogeneous but w/o active ingredients

Group Type: ACTIVE_COMPARATOR

Standard enteral nutrition for 5 days preoperative

Intervention Type: DIETARY_SUPPLEMENT

Impact vs Meritene

Interventions

Immunonutrition for 5 days preoperative

Impact vs Meritene

Intervention Type: DIETARY_SUPPLEMENT

Standard enteral nutrition for 5 days preoperative

Impact vs Meritene

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Impact, Meritene; Impact vs Meritene

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Nicolas DEMARTINES

professor of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicolas Demartines, MD

Role: STUDY_CHAIR

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

Locations

Department of Visceral Surgery, University Hospital Center

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

P00/07 CHV

Identifier Type: -

Identifier Source: org_study_id