Omega-3 Fatty Acids and Postoperative Complications After Colorectal Surgery (omega3)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
supportan
supportan placebo
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring infection, colorectalcancer, omega-3 fedtsyre, complications
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 acids
- patients operated for 2 different cancers in 1 operation
Sites / Locations
- Aalborg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
a
b
Arm Description
Outcomes
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%).
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
incorporation of fatty acids in cell membranes
laboratory test on blood sample (leucocytes
development in interleukins after surgery
analysis of blood sample
lenght of stay in hospital
Full Information
NCT ID
NCT00488904
First Posted
June 19, 2007
Last Updated
April 9, 2010
Sponsor
Aalborg University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00488904
Brief Title
Omega-3 Fatty Acids and Postoperative Complications After Colorectal Surgery
Acronym
omega3
Official Title
Omega-3 Fatty Acids and Postoperative Complication After Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aalborg University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
infection, colorectalcancer, omega-3 fedtsyre, complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
a
Arm Type
Experimental
Arm Title
b
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
supportan
Intervention Description
2 sip feed pr. day
Intervention Type
Dietary Supplement
Intervention Name(s)
supportan placebo
Intervention Description
2 sip feed pr. day
Primary Outcome Measure Information:
Title
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%).
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Title
incorporation of fatty acids in cell membranes
Description
laboratory test on blood sample (leucocytes
Time Frame
after 7 days of intervention
Title
development in interleukins after surgery
Description
analysis of blood sample
Time Frame
day 1-4 after surgery
Title
lenght of stay in hospital
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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 acids
patients operated for 2 different cancers in 1 operation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik be schmidt, professor
Organizational Affiliation
Aalborg Hospital the lipid clinic
Official's Role
Study Director
Facility Information:
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9000 Aalborg
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
9428539
Citation
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. doi: 10.1097/00003246-199801000-00012.
Results Reference
background
PubMed Identifier
11822956
Citation
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. doi: 10.1001/archsurg.137.2.174.
Results Reference
background
PubMed Identifier
9366716
Citation
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. doi: 10.1001/archsurg.1997.01430350072012.
Results Reference
background
PubMed Identifier
8875537
Citation
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. doi: 10.1016/s0899-9007(96)00096-2.
Results Reference
background
PubMed Identifier
9295822
Citation
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. doi: 10.1097/00003246-199709000-00015.
Results Reference
background
PubMed Identifier
15158295
Citation
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. doi: 10.1016/j.clnu.2003.07.008. Erratum In: Clin Nutr. 2004 Aug;23(4):755-6.
Results Reference
background
PubMed Identifier
11895158
Citation
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. doi: 10.1079/bjn2001461.
Results Reference
background
PubMed Identifier
9042869
Citation
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. doi: 10.1097/00005373-199702000-00004.
Results Reference
background
PubMed Identifier
8924741
Citation
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. doi: 10.1159/000223143.
Results Reference
background
PubMed Identifier
10449977
Citation
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. doi: 10.1159/000018742.
Results Reference
background
PubMed Identifier
9351723
Citation
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. doi: 10.1097/00000658-199710000-00016.
Results Reference
background
PubMed Identifier
9661120
Citation
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. doi: 10.1177/0148607198022004206.
Results Reference
background
PubMed Identifier
9038665
Citation
Beier-Holgersen R, Boesby S. Influence of postoperative enteral nutrition on postsurgical infections. Gut. 1996 Dec;39(6):833-5. doi: 10.1136/gut.39.6.833.
Results Reference
background
PubMed Identifier
10048740
Citation
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. doi: 10.1080/00365529950172907.
Results Reference
background
PubMed Identifier
8850212
Citation
Meydani SN. Effect of (n-3) polyunsaturated fatty acids on cytokine production and their biologic function. Nutrition. 1996 Jan;12(1 Suppl):S8-14.
Results Reference
background
PubMed Identifier
14578723
Citation
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. doi: 10.1097/01.sla.0000094387.50865.23.
Results Reference
background
PubMed Identifier
15956633
Citation
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. doi: 10.1001/jama.293.23.2884.
Results Reference
background
PubMed Identifier
10096109
Citation
Wu D, Meydani SN. n-3 polyunsaturated fatty acids and immune function. Proc Nutr Soc. 1998 Nov;57(4):503-9. doi: 10.1079/pns19980074.
Results Reference
background
PubMed Identifier
24281905
Citation
Sorensen LS, Thorlacius-Ussing O, Schmidt EB, Rasmussen HH, Lundbye-Christensen S, Calder PC, Lindorff-Larsen K. Randomized clinical trial of perioperative omega-3 fatty acid supplements in elective colorectal cancer surgery. Br J Surg. 2014 Jan;101(2):33-42. doi: 10.1002/bjs.9361. Epub 2013 Nov 26.
Results Reference
derived
PubMed Identifier
23788002
Citation
Sorensen LS, Rasmussen HH, Aardestrup IV, Thorlacius-Ussing O, Lindorff-Larsen K, Schmidt EB, Calder PC. Rapid incorporation of omega-3 fatty acids into colonic tissue after oral supplementation in patients with colorectal cancer: a randomized, placebo-controlled intervention trial. JPEN J Parenter Enteral Nutr. 2014 Jul;38(5):617-24. doi: 10.1177/0148607113491782. Epub 2013 Jun 20.
Results Reference
derived
Learn more about this trial
Omega-3 Fatty Acids and Postoperative Complications After Colorectal Surgery
We'll reach out to this number within 24 hrs