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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
Sponsor:
Information provided by (Responsible Party):
Wei Zhou, Sir Run Run Shaw Hospital

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.

Condition or disease Intervention/treatment Phase
Gastric Tumor Pancreatic Tumor Liver Tumor Drug: MCT/LCT and fish oil Drug: MCT/LCT Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Experimental: MCT/LCT
Structural Fat Emulsion Injection 250ml per day, for 7 days
Drug: MCT/LCT
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)




Primary Outcome Measures :
  1. infective complications [ Time Frame: within the first 30 days after surgery ]

Secondary Outcome Measures :
  1. length of hospital stay [ Time Frame: average of 2 weeks ]
  2. plasma immunological markers [ Time Frame: from 1 day before surgery to 7 days after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Wei Zhou, MD, PhD +86-13588706479 nuzwlvran@yahoo.com.cn

Locations
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China, Zhejiang
Sir Run Run Shaw Hosptial Not yet recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Wei Zhou    +86-13588706479    nuzwlvran@yahoo.com.cn   
Sponsors and Collaborators
Wei Zhou
Investigators
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Study Director: Yiping Mou, MD Sir Run Run Shaw Hospital

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Responsible Party: Wei Zhou, Attending, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT01819961     History of Changes
Other Study ID Numbers: Fo-Lap
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Stomach Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions