Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery
Randomized Clinical Trial of Omega-3 Fatty Acid-supplemented Parenteral Nutrition Versus Standard Parenteral Nutrition in Patients Undergoing Major Laparoscopic Abdominal Surgery
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2013
CompletedFirst Posted
Study publicly available on registry
March 28, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMarch 28, 2013
March 1, 2013
6 months
March 20, 2013
March 27, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
infective complications
within the first 30 days after surgery
Secondary Outcomes (2)
length of hospital stay
average of 2 weeks
plasma immunological markers
from 1 day before surgery to 7 days after surgery
Study Arms (2)
MCT/LCT
EXPERIMENTALStructural Fat Emulsion Injection 250ml per day, for 7 days
MCT/LCT and fish oil
EXPERIMENTALStructural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days.
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing an elective major laparoscopic abdominal surgery and required at least 5 days of parenteral nutrition
You may not qualify if:
- Metabolic disease
- Chronic kidney or liver failure
- Shock
- Contraindications for lipid administration
- PN during the 15 days before hospitalisation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wei Zhoulead
Study Sites (1)
Sir Run Run Shaw Hosptial
Hangzhou, Zhejiang, 310016, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yiping Mou, MD
Sir Run Run Shaw Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Attending
Study Record Dates
First Submitted
March 20, 2013
First Posted
March 28, 2013
Study Start
April 1, 2013
Primary Completion
October 1, 2013
Study Completion
December 1, 2013
Last Updated
March 28, 2013
Record last verified: 2013-03