Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery
Conditions
Gastric Tumor - Pancreatic Tumor - Liver Tumor
Conditions: official terms
Pancreatic Neoplasms - Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: MCT/LCT and fish oil Type: Drug
Name: MCT/LCT Type: Drug
Overall Status
Not yet recruiting
Summary
The aim of this study is to assess the effect of postoperative parenteral fish oil on clinical outcome and immune function after major laparoscopic abdominal surgery.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 15 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients undergoing an elective major laparoscopic abdominal surgery and required at least 5 days of parenteral nutrition

Exclusion Criteria:

- Metabolic disease

- Chronic kidney or liver failure

- Shock

- Contraindications for lipid administration

- PN during the 15 days before hospitalisation
Location
Sir Run Run Shaw Hosptial
Hangzhou, Zhejiang, China
Status: Not yet recruiting
Contact: Wei Zhou - +86-13588706479 - nuzwlvran@yahoo.com.cn
Start Date
April 2013
Completion Date
December 2013
Sponsors
Wei Zhou
Source
Sir Run Run Shaw Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page