Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery

Lausanne University Hospital (CHUV)

Status: Completed

Conditions: Major Abdominal Surgery

Treatments: Dietary Supplement: Standard enteral nutrition for 5 days preoperative; Dietary Supplement: Immunonutrition for 5 days preoperative

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00512213

P00/07 CHV

Details and patient eligibility

About

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.

Full 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].

Enrollment: 154 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 2 patient groups

1

Active Comparator group

Description:

Immunonutrition containing RNA, omega-3-FAs, arginine

Treatment:

Dietary Supplement: Immunonutrition for 5 days preoperative

2

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Standard enteral nutrition for 5 days preoperative