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

This study has been completed.
Sponsor:
Information provided by:
Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT00488904
First received: June 19, 2007
Last updated: April 9, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Colorectal Cancer
Dietary Supplement: supportan
Dietary Supplement: supportan placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Omega-3 Fatty Acids and Postoperative Complication After Colorectal Surgery

Resource links provided by NLM:


Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: No ]
  • incorporation of fatty acids in cell membranes [ Time Frame: after 7 days of intervention ] [ Designated as safety issue: No ]
    laboratory test on blood sample (leucocytes

  • development in interleukins after surgery [ Time Frame: day 1-4 after surgery ] [ Designated as safety issue: No ]
    analysis of blood sample

  • lenght of stay in hospital [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: June 2007
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: a Dietary Supplement: supportan
2 sip feed pr. day
Placebo Comparator: b Dietary Supplement: supportan placebo
2 sip feed pr. day

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)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 acids
  • patients operated for 2 different cancers in 1 operation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488904

Locations
Denmark
Aalborg Hospital
Aalborg, Denmark, 9000 Aalborg
Sponsors and Collaborators
Aalborg Universityhospital
Investigators
Study Director: Erik be schmidt, professor Aalborg Hospital the lipid clinic
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lone Schmidt Sørensen, Fresenius Kabi
ClinicalTrials.gov Identifier: NCT00488904     History of Changes
Other Study ID Numbers: 123omega, VN2005/35
Study First Received: June 19, 2007
Last Updated: April 9, 2010
Health Authority: Denmark: National Board of Health
Denmark: Danish Dataprotection Agency

Keywords provided by Aalborg Universityhospital:
infection
colorectalcancer
omega-3 fedtsyre
complications

Additional relevant MeSH terms:
Colorectal Neoplasms
Postoperative Complications
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014