Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery

Phase 4

• Conditions: Gastric Tumor; Pancreatic Tumor; Liver Tumor
• Interventions: Drug: MCT/LCT; Drug: MCT/LCT and fish oil

• Registration Number: NCT01819961
• Lead Sponsor: Wei Zhou

Brief 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.

Study Timeline

• Status Verified: 2013-03
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-27
• Last Update Submitted: 2013-03-27
• Study First Posted: 2013-03-28
• Last Update Posted: 2013-03-28
• Study Start: 2013-04
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCT/LCT	MCT/LCT	Structural Fat Emulsion Injection 250ml per day, for 7 days
MCT/LCT and fish oil	MCT/LCT and fish oil	Structural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days.

Primary Outcome Measures

Name	Time	Method
infective complications	within the first 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
length of hospital stay	average of 2 weeks
plasma immunological markers	from 1 day before surgery to 7 days after surgery

Trial Locations

Locations (1)

Sir Run Run Shaw Hosptial; 🇨🇳 Hangzhou, Zhejiang, China