Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery

NCT ID: NCT01819961

Last Updated: 2013-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Tumor Pancreatic Tumor Liver Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MCT/LCT

Structural Fat Emulsion Injection 250ml per day, for 7 days

Group Type EXPERIMENTAL

MCT/LCT

Intervention Type DRUG

MCT/LCT and fish oil

Structural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days.

Group Type EXPERIMENTAL

MCT/LCT and fish oil

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MCT/LCT and fish oil

Intervention Type DRUG

MCT/LCT

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Structural Fat Emulsion Injection (Fresenius-Kabi, Germany) and fish oil (Omegaven,Fresenius-Kabi, Germany) Structural Fat Emulsion Injection (Fresenius-Kabi, Germany)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wei Zhou

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wei Zhou

Attending

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yiping Mou, MD

Role: STUDY_DIRECTOR

Sir Run Run Shaw Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sir Run Run Shaw Hosptial

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wei Zhou, MD, PhD

Role: CONTACT

+86-13588706479

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wei Zhou

Role: primary

+86-13588706479

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Fo-Lap

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

An Evaluation of Omega-3 Fatty Acid
NCT03017651 COMPLETED PHASE1