Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery

Liver Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01819961
• Other study ID #: Fo-Lap
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 20, 2013
• Last updated: March 27, 2013
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2013
• Source: Sir Run Run Shaw Hospital
• Contact: Wei Zhou, MD, PhD
• Phone: +86-13588706479
• Email: nuzwlvran[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• MCT/LCT and fish oil

• MCT/LCT

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hosptial	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wei Zhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infective complications		within the first 30 days after surgery	Yes
Secondary	length of hospital stay		average of 2 weeks	Yes
Secondary	plasma immunological markers		from 1 day before surgery to 7 days after surgery	Yes