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2013-04
2013-10
2013-12
50
NCT01819961
Sir Run Run Shaw Hospital
Sir Run Run Shaw Hospital
INTERVENTIONAL
Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2013-03-20 | N/A | 2013-03-27 |
2013-03-27 | N/A | 2013-03-28 |
2013-03-28 | N/A | 2013-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: MCT/LCT Structural Fat Emulsion Injection 250ml per day, for 7 days | DRUG: MCT/LCT and fish oil DRUG: MCT/LCT |
| EXPERIMENTAL: MCT/LCT and fish oil Structural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days. | DRUG: MCT/LCT and fish oil |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| infective complications | within the first 30 days after surgery |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| length of hospital stay | average of 2 weeks | |
| plasma immunological markers | from 1 day before surgery to 7 days after surgery |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Wei Zhou, MD, PhD Phone Number: +86-13588706479 Email: nuzwlvran@yahoo.com.cn |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
15 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
