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Omega-3 Fatty Acids and Postoperative Complications After Colorectal Surgery (omega3)
This study is currently recruiting participants.
Verified by Aalborg Hospital, July 2009
First Received: June 19, 2007   Last Updated: July 31, 2009   History of Changes
Sponsored by: Aalborg Hospital
Information provided by: Aalborg Hospital
ClinicalTrials.gov Identifier: NCT00488904
  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 IV

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Omega-3 Fatty Acids and Postoperative Complication After Colorectal Surgery

Resource links provided by NLM:


Further study details as provided by Aalborg Hospital:

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 ]

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 ]

Estimated Enrollment: 140
Study Start Date: June 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
a: Experimental Dietary Supplement: supportan
2 sip feed pr. day
b: Placebo Comparator 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488904

Contacts
Contact: Lone sc Sørensen, consultant 45-8695-4145 lss@mail.dk
Contact: Karen lindorfflarsen, consultant 45-9932-1111 kgll@rn.dk

Locations
Denmark
Aalborg Hospital Recruiting
Aalborg, Denmark, 9000 Aalborg
Contact: Lone Sc Sørensen, registra     45-8695-4145     lss@mail.dk    
Contact: Karen lindorff-larsen, consultant     45-9932-1111     kgl@rn.dk    
Principal Investigator: Lone Sc Sørensen, registra            
Sponsors and Collaborators
Aalborg Hospital
Investigators
Study Director: Erik be schmidt, professor Aalborg Hospital the lipid clinic
  More Information

Publications:
Braga M, Gianotti L, Vignali A, Cestari A, Bisagni P, Di Carlo V. Artificial nutrition after major abdominal surgery: impact of route of administration and composition of the diet. Crit Care Med. 1998 Jan;26(1):24-30.
Braga M, Gianotti L, Nespoli L, Radaelli G, Di Carlo V. Nutritional approach in malnourished surgical patients: a prospective randomized study. Arch Surg. 2002 Feb;137(2):174-80.
Gianotti L, Braga M, Vignali A, Balzano G, Zerbi A, Bisagni P, Di Carlo V. Effect of route of delivery and formulation of postoperative nutritional support in patients undergoing major operations for malignant neoplasms. Arch Surg. 1997 Nov;132(11):1222-9; discussion 1229-30.
Schilling J, Vranjes N, Fierz W, Joller H, Gyurech D, Ludwig E, Marathias K, Geroulanos S. Clinical outcome and immunology of postoperative arginine, omega-3 fatty acids, and nucleotide-enriched enteral feeding: a randomized prospective comparison with standard enteral and low calorie/low fat i.v. solutions. Nutrition. 1996 Jun;12(6):423-9.
Senkal M, Mumme A, Eickhoff U, Geier B, Spath G, Wulfert D, Joosten U, Frei A, Kemen M. Early postoperative enteral immunonutrition: clinical outcome and cost-comparison analysis in surgical patients. Crit Care Med. 1997 Sep;25(9):1489-96.
Tsekos E, Reuter C, Stehle P, Boeden G. Perioperative administration of parenteral fish oil supplements in a routine clinical setting improves patient outcome after major abdominal surgery. Clin Nutr. 2004 Jun;23(3):325-30. Erratum in: Clin Nutr. 2004 Aug;23(4):755-6.
Weiss G, Meyer F, Matthies B, Pross M, Koenig W, Lippert H. Immunomodulation by perioperative administration of n-3 fatty acids. Br J Nutr. 2002 Jan;87 Suppl 1:S89-94.
Wachtler P, Konig W, Senkal M, Kemen M, Koller M. Influence of a total parenteral nutrition enriched with omega-3 fatty acids on leukotriene synthesis of peripheral leukocytes and systemic cytokine levels in patients with major surgery. J Trauma. 1997 Feb;42(2):191-8.
Braga M, Vignali A, Gianotti L, Cestari A, Profili M, Di Carlo V. Benefits of early postoperative enteral feeding in cancer patients. Infusionsther Transfusionsmed. 1995 Oct;22(5):280-4.
Di Carlo V, Gianotti L, Balzano G, Zerbi A, Braga M. Complications of pancreatic surgery and the role of perioperative nutrition. Dig Surg. 1999;16(4):320-6.
Heslin MJ, Latkany L, Leung D, Brooks AD, Hochwald SN, Pisters PW, Shike M, Brennan MF. A prospective, randomized trial of early enteral feeding after resection of upper gastrointestinal malignancy. Ann Surg. 1997 Oct;226(4):567-77; discussion 577-80.
McCarter MD, Gentilini OD, Gomez ME, Daly JM. Preoperative oral supplement with immunonutrients in cancer patients. JPEN J Parenter Enteral Nutr. 1998 Jul-Aug;22(4):206-11.
Beier-Holgersen R, Boesby S. Influence of postoperative enteral nutrition on postsurgical infections. Gut. 1996 Dec;39(96):833-5.
Beier-Holgersen R, Brandstrup B. Influence of early postoperative enteral nutrition versus placebo on cell-mediated immunity, as measured with the Multitest CMI. Scand J Gastroenterol. 1999 Jan;34(1):98-102.
Meydani SN. Effect of (n-3) polyunsaturated fatty acids on cytokine production and their biologic function. Nutrition. 1996 Jan;12(1 Suppl):S8-14. Review.
Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8.
Raitt MH, Connor WE, Morris C, Kron J, Halperin B, Chugh SS, McClelland J, Cook J, MacMurdy K, Swenson R, Connor SL, Gerhard G, Kraemer DF, Oseran D, Marchant C, Calhoun D, Shnider R, McAnulty J. Fish oil supplementation and risk of ventricular tachycardia and ventricular fibrillation in patients with implantable defibrillators: a randomized controlled trial. JAMA. 2005 Jun 15;293(23):2884-91.
Wu D, Meydani SN. n-3 polyunsaturated fatty acids and immune function. Proc Nutr Soc. 1998 Nov;57(4):503-9. Review.

Responsible Party: Fresenius Kabi ( Lone Schmidt Sørensen )
Study ID Numbers: 123omega, VN2005/35
Study First Received: June 19, 2007
Last Updated: July 31, 2009
ClinicalTrials.gov Identifier: NCT00488904     History of Changes
Health Authority: Denmark: National Board of Health;   Denmark: Danish Dataprotection Agency

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

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Postoperative Complications
Gastrointestinal Diseases
Omega 3 Fatty Acid
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

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

ClinicalTrials.gov processed this record on September 01, 2009