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Completed

NCT Number: NCT00488904

Omega-3 Fatty Acids and Postoperative Complications 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.

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

supportan

Dietary Supplement

2 sip feed pr. day

supportan placebo

Dietary Supplement

2 sip feed pr. day

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. incorporation of fatty acids in cell membranes

    Time frame: after 7 days of intervention

    laboratory test on blood sample (leucocytes

  3. development in interleukins after surgery

    Time frame: day 1-4 after surgery

    analysis of blood sample

  4. lenght of stay in hospital

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

Omega-3 Fatty Acids and Postoperative Complication After Colorectal Surgery

Acronym: omega3

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 20, 2007
Registry last updated
Apr 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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