Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery
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|ClinicalTrials.gov Identifier: NCT01819961|
Recruitment Status : Unknown
Verified March 2013 by Wei Zhou, Sir Run Run Shaw Hospital.
Recruitment status was: Not yet recruiting
First Posted : March 28, 2013
Last Update Posted : March 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Gastric Tumor Pancreatic Tumor Liver Tumor||Drug: MCT/LCT and fish oil Drug: MCT/LCT||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Clinical Trial of Omega-3 Fatty Acid-supplemented Parenteral Nutrition Versus Standard Parenteral Nutrition in Patients Undergoing Major Laparoscopic Abdominal Surgery|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||December 2013|
Structural Fat Emulsion Injection 250ml per day, for 7 days
Other Name: Structural Fat Emulsion Injection (Fresenius-Kabi, Germany)
Experimental: MCT/LCT and fish oil
Structural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days.
Drug: MCT/LCT and fish oil
Other Name: Structural Fat Emulsion Injection (Fresenius-Kabi, Germany) and fish oil (Omegaven,Fresenius-Kabi, Germany)
- infective complications [ Time Frame: within the first 30 days after surgery ]
- length of hospital stay [ Time Frame: average of 2 weeks ]
- plasma immunological markers [ Time Frame: from 1 day before surgery to 7 days after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819961
|Contact: Wei Zhou, MD, PhDfirstname.lastname@example.org|
|Sir Run Run Shaw Hosptial||Not yet recruiting|
|Hangzhou, Zhejiang, China, 310016|
|Contact: Wei Zhou +86-13588706479 email@example.com|
|Study Director:||Yiping Mou, MD||Sir Run Run Shaw Hospital|