Know Cancer

or
forgot password

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


Phase 4
15 Years
85 Years
Not Enrolling
Both
Gastric Tumor, Pancreatic Tumor, Liver Tumor

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

infective complications

Outcome Time Frame:

within the first 30 days after surgery

Safety Issue:

Yes

Principal Investigator

Yiping Mou, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sir Run Run Shaw Hospital

Authority:

China: Ministry of Health

Study ID:

Fo-Lap

NCT ID:

NCT01819961

Start Date:

April 2013

Completion Date:

December 2013

Related Keywords:

  • Gastric Tumor
  • Pancreatic Tumor
  • Liver Tumor
  • Liver Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms

Name

Location