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Omega-3 Fatty Acids and Postoperative Complications After Colorectal Surgery

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase IV Supportive care Active Not specified Other 123omega
VN2005/35, NCT00488904

Trial Description

Summary

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.

Further Study Information

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)

Eligibility Criteria

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 acides

patients operated for 2 different cancers in 1 operation

Trial Contact Information

Trial Lead Organizations/Sponsors

Aalborg Hospital

Erik be schmidt, professor

Study Director

Lone sc Sørensen, consultant		Ph: 45-8695-4145
		Email: lss@mail.dk

Karen lindorfflarsen, consultant		Ph: 45-9932-1111
		Email: kgll@rn.dk

Trial Sites

Denmark

Aalborg

Lone Sc Sørensen, registra Principal Investigator

Karen lindorff-larsen, consultant Ph: 45-9932-1111

Email: kgl@rn.dk

Aalborg Hospital

Lone Sc Sørensen, registra Ph: 45-8695-4145

Email: lss@mail.dk

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00488904
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.