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Omega-3 Fatty Acids and Postoperative Complication After Colorectal Surgery

Phase 4
Not Enrolling
Colorectal Cancer

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Trial Information

Omega-3 Fatty Acids and Postoperative Complication After Colorectal Surgery

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)

Inclusion Criteria:

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

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%).

Outcome Description:

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

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Erik be schmidt, professor

Investigator Role:

Study Director

Investigator Affiliation:

Aalborg Hospital the lipid clinic


Denmark: National Board of Health

Study ID:




Start Date:

June 2007

Completion Date:

February 2010

Related Keywords:

  • Colorectal Cancer
  • infection
  • colorectalcancer
  • omega-3 fedtsyre
  • complications
  • Colorectal Neoplasms
  • Postoperative Complications