Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery | NCT01819961

Studies
Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery

NCT01819961

Sponsor

Wei Zhou

Status

Unknown status

Last Update Posted

Mar 28, 2013Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Gastric Tumor
Pancreatic Tumor
Liver Tumor

Interventions

MCT/LCT and fish oil
MCT/LCT

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Oct 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Mar 20, 2013

First Submission Date that Met QC Criteria

Mar 27, 2013

First Posted Date

Mar 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2013

Last Update Posted Date

Mar 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MCT/LCT	Experimental	Structural Fat Emulsion Injection 250ml per day, for 7 days	Drug: MCT/LCT
MCT/LCT and fish oil	Experimental	Structural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days.	Drug: MCT/LCT and fish oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MCT/LCT and fish oil	Drug		MCT/LCT and fish oil	Structural Fat Emulsion Injection (Fresenius-Kabi, Germany) and fish oil (Omegaven,Fresenius-Kabi, Germany)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
infective complications		within the first 30 days after surgery

Secondary Outcomes

Measure	Description	Time Frame
length of hospital stay		average of 2 weeks
plasma immunological markers		from 1 day before surgery to 7 days after surgery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wei Zhou, MD, PhD	Contact	+86-13588706479		nuzwlvran@yahoo.com.cn

Overall Officials

Name	Affiliation	Role
Yiping Mou, MD	Sir Run Run Shaw Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sir Run Run Shaw Hosptial		Hangzhou	Zhejiang	310016	China

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D010190	Pancreatic Neoplasms
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005395	Fish Oils
C568345	fish oil triglycerides

Ancestor Terms

ID	Term
D009821	Oils
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided