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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00488904
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : April 12, 2010
Information provided by:
Aalborg University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Dietary Supplement: supportan Dietary Supplement: supportan placebo Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Omega-3 Fatty Acids and Postoperative Complication After Colorectal Surgery
Study Start Date : June 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

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

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00488904

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Aalborg Hospital
Aalborg, Denmark, 9000 Aalborg
Sponsors and Collaborators
Aalborg University Hospital
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Study Director: Erik be schmidt, professor Aalborg Hospital the lipid clinic

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lone Schmidt Sørensen, Fresenius Kabi Identifier: NCT00488904    
Other Study ID Numbers: 123omega
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: April 12, 2010
Last Verified: April 2010
Keywords provided by Aalborg University Hospital:
omega-3 fedtsyre
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes