Clinical trial NCT00512213: Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery
Official title: Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery: A Single-center Double-blinded Controlled Randomized Superiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Abdominal Surgery
Keywords: preoperative Immunonutrition
major abdominal surgery
complication
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2007-08-07
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[5, 10\].

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.

Primary outcomes:
measure: complications after surgery
timeFrame: 30 days
Secondary outcomes:
measure: hospital stay, patient compliance, Interleukin-6 and 10 plasma level
timeFrame: 30 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Visceral Surgery, University Hospital Center
Study officials:
affiliation: Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
name: Nicolas Demartines, MD
role: STUDY_CHAIR
References: