Back to results

Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery

Primary Purpose

Gastric Tumor, Pancreatic Tumor, Liver Tumor

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

MCT/LCT and fish oil

MCT/LCT

About this trial

This is an interventional treatment trial for Gastric Tumor

Eligibility Criteria

15 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sir Run Run Shaw Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

MCT/LCT

MCT/LCT and fish oil

Arm Description

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

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

Outcomes

Primary Outcome Measures

infective complications

Secondary Outcome Measures

length of hospital stay

plasma immunological markers

Full Information

NCT ID

NCT01819961

First Posted

March 20, 2013

Last Updated

March 27, 2013

Sponsor

Wei Zhou

1. Study Identification

Unique Protocol Identification Number

NCT01819961

Brief Title

Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery

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 Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

April 2013 (undefined)

Primary Completion Date

October 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Wei Zhou

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Tumor, Pancreatic Tumor, Liver Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MCT/LCT

Arm Type

Experimental

Arm Description

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

Arm Title

MCT/LCT and fish oil

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

MCT/LCT and fish oil

Other Intervention Name(s)

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

Intervention Type

Drug

Intervention Name(s)

MCT/LCT

Other Intervention Name(s)

Structural Fat Emulsion Injection (Fresenius-Kabi, Germany)

Primary Outcome Measure Information:

Title

infective complications

Time Frame

within the first 30 days after surgery

Secondary Outcome Measure Information:

Title

length of hospital stay

Time Frame

average of 2 weeks

Title

plasma immunological markers

Time Frame

from 1 day before surgery to 7 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Zhou, MD, PhD

Phone

+86-13588706479

nuzwlvran@yahoo.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yiping Mou, MD

Organizational Affiliation

Sir Run Run Shaw Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Sir Run Run Shaw Hosptial

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310016

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei Zhou

Phone

+86-13588706479

nuzwlvran@yahoo.com.cn

12. IPD Sharing Statement

Learn more about this trial

Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery

We'll reach out to this number within 24 hrs