Working… Menu

Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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.

Layout table for study information
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
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

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 identifier (NCT number): NCT01819961

Layout table for location contacts
Contact: Wei Zhou, MD, PhD +86-13588706479

Layout table for location information
China, Zhejiang
Sir Run Run Shaw Hosptial Not yet recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Wei Zhou    +86-13588706479   
Sponsors and Collaborators
Wei Zhou
Layout table for investigator information
Study Director: Yiping Mou, MD Sir Run Run Shaw Hospital

Layout table for additonal information
Responsible Party: Wei Zhou, Attending, Sir Run Run Shaw Hospital 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:
Layout table for MeSH terms
Pancreatic Neoplasms
Stomach 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