Omega-3 Fatty Acids and Postoperative Complications After Colorectal Surgery (omega3)

April 9, 2010 updated by: Aalborg University Hospital

Omega-3 Fatty Acids and Postoperative Complication After Colorectal Surgery

To discover whether an Omega-3 fatty acid (eicosapentaenoic acid/EPA and docosahexaensyre/DHA) enriched nutritional supplement given 7 days preoperatively and 7 days postoperatively may reduce the frequency of postoperative infectious complications defined as: pneumonia, wound infection, urinary tract infection, peritonitis (including anastomotic leakage) and septic conditions of any cause in patients who undergo elective operations for colorectal cancer compared with a nutritional preparation that is identical apart from the EPA content.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several earlier studies indicate that perioperative supplements of Omega-3 fatty acids can reduce the risk of postoperative complications after major surgery through an immune modulating effect in the form of a downward adjustment of the inflammatory response. (1-7) The interpretation of these studies is made more difficult by differences in their method of administration (parentally/enterally), differences in the time of the intervention (preoperative/postoperative) and differences in the selection of patients (malnourished cancer patients / upper GI cancer patients/mixed surgical patients) and finally because many of the studies deal with a so-called immune modulating preparation containing a mixture of arginine, Omega-3 fatty acids and ribonucleic acid.

The biological effects of fish oils are related to their content of such things as Omega-3 fatty acids that can be incorporated in cell membranes where they influence receptor function, enzyme activity and the production of lipid mediators. The cells from the immune system perform their functions through membrane-associated activities like secretion of cytokines, antibodies, lymphocyte transformation and contact lysine. These functions can be affected by changes in the membrane structure. (7;8) Besides the effect parameter of postoperative septic complications, many of these studies use pseudoparameters such as length of stay, need for respirator treatment, time in intensive care as well as a wide range of biochemical changes whose relevance to the clinic process can be difficult to assess. (1-7;9-13;). It is well-known that early enteral nutrition reduces the risk of postoperative complications (14; 15). Many of the aforementioned studies similarly point to a benefit from using Omega-3 fatty acid enriched nutritional preparations preoperatively. There is now a commercially manufactured nutritional preparation for peroral consumption containing Omega-3 fatty acids - Supportan (Fresenius-Kabi). The preparation is more energy intensive than similar drink preparations, but does not otherwise differ in composition from standard preparations. It is approved by the Danish Veterinary and Food Administration for this study.

In 2 x 200ml of Supportan 3 g EPA and DHA are given daily. In other studies up to 10 g have been given daily without side effects. (6; 16)

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000 Aalborg
        • Aalborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients for elective colorectal resection for cancer, ASA group 1-3 (see annex)

Exclusion Criteria:

  • Diabetes Mellitus
  • Alcohol consumption > 5 drinks per day
  • Acute operation
  • Non Danish speakers
  • Patients with untreated psychiatric conditions
  • Pregnant or breast-feeding women
  • Patients with ICD-pacemaker
  • Patients with reduces kidney function and immunosuppressed patients
  • patients that eat or drink omega-3 fatty acids
  • patients operated for 2 different cancers in 1 operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: a
Dietary supplement: supportan
2 sip feed pr. day
Placebo Comparator: b
Dietary supplement: supportan placebo
2 sip feed pr. day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In previous studies a complication frequency (infectious complications) of at least 30% was found for this type of operation (14; 17) This figure has to be reduced to 10% (MIREDIF = 20%).
Time Frame: 1 year

Primary outcome measures are infectious complications after surgery for colorectal cancer defined as: pneumonia, cystitis, wound infection, intraabdominal abscess, peritonitis, septicemia, other infections.

30 day mortality and other complications such as bleeding, wound dehiscence, anastomotic leakage will also be registered
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary outcome variable is hospitalisation time and mortality. Given the material's size, it is not expected to be possible to demonstrate a significant reduction in mortality
Time Frame: 1 year
1 year
incorporation of fatty acids in cell membranes
Time Frame: after 7 days of intervention
laboratory test on blood sample (leucocytes
after 7 days of intervention
development in interleukins after surgery
Time Frame: day 1-4 after surgery
analysis of blood sample
day 1-4 after surgery
lenght of stay in hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Investigators

  • Study Director: Erik be schmidt, professor, Aalborg Hospital the lipid clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Estimate)

April 12, 2010

Last Update Submitted That Met QC Criteria

April 9, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123omega
  • VN2005/35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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