Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery

Wei Zhou

Status and phase: Unknown; Phase 4

Conditions: Liver Tumor; Pancreatic Tumor; Gastric Tumor

Treatments: Drug: MCT/LCT and fish oil; Drug: MCT/LCT

Study type: Interventional

Funder types: Other

Identifiers

NCT01819961

Fo-Lap

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

MCT/LCT

Experimental group

Description:

Structural Fat Emulsion Injection 250ml per day, for 7 days

Treatment:

Drug: MCT/LCT

MCT/LCT and fish oil

Experimental group

Description:

Structural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days.

Treatment:

Drug: MCT/LCT and fish oil