Randomized Clinical Trial of Omega-3 Fatty Acid-supplemented Parenteral Nutrition Versus Standard Parenteral Nutrition in Patients Undergoing Major Laparoscopic Abdominal Surgery
Postoperative patients are randomized by a sealed envelope to receive either a 50:50
(vol/vol) mixture of an oil rich in medium-chain fatty acids and soybean oil (termed
MCT/LCT) or a mixture of MCT/LCT and fish oil Omegaven for 7 days. Full blood count,
biochemistry and coagulation are routinely assessed. Fresh blood samples are centrifuged
into plasma, red blood cells and lymphocytes then stored at −80°C pending analysis.
The primary endpoint was numbers of infective complications.Secondary endpoints were other
clinical outcomes, length of hospital stay, and in-hospital mortality, along with plasma
immunological markers.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
infective complications
within the first 30 days after surgery
Yes
Yiping Mou, MD
Study Director
Sir Run Run Shaw Hospital
China: Ministry of Health
Fo-Lap
NCT01819961
April 2013
December 2013
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