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Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery

Randomized Clinical Trial of Omega-3 Fatty Acid-supplemented Parenteral Nutrition Versus Standard Parenteral Nutrition in Patients Undergoing Major Laparoscopic Abdominal Surgery

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01819961
Enrollment
50
Registered
2013-03-28
Start date
2013-04-30
Completion date
2013-12-31
Last updated
2013-03-28

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

Conditions

Gastric Tumor, Liver Tumor, Pancreatic Tumor

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.

Interventions

DRUGMCT/LCT and fish oil

Sponsors

Wei Zhou
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
15 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
infective complicationswithin the first 30 days after surgery

Secondary

MeasureTime frame
length of hospital stayaverage of 2 weeks
plasma immunological markersfrom 1 day before surgery to 7 days after surgery

Countries

China

Contacts

Primary ContactWei Zhou, MD, PhD
nuzwlvran@yahoo.com.cn+86-13588706479

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026