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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00512213
Enrollment
154
Registered
2007-08-07
Start date
2007-09-30
Completion date
2010-12-31
Last updated
2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Abdominal Surgery

Keywords

preoperative Immunonutrition, major abdominal surgery, complication

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 \[5, 10\].

Interventions

DIETARY_SUPPLEMENTImmunonutrition for 5 days preoperative

Impact vs Meritene

DIETARY_SUPPLEMENTStandard enteral nutrition for 5 days preoperative

Impact vs Meritene

Sponsors

Novartis
CollaboratorINDUSTRY
University of Lausanne Hospitals
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
complications after surgery30 days

Secondary

MeasureTime frame
hospital stay, patient compliance, Interleukin-6 and 10 plasma level30 days

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026