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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
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring infection, colorectalcancer, omega-3 fedtsyre, complications

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 19, 2007
Last Updated
April 9, 2010
Sponsor
Aalborg University Hospital
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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:
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9428539
Citation
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Citation
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Citation
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Omega-3 Fatty Acids and Postoperative Complications After Colorectal Surgery

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