Clinical trial · Interventional
Omega-3 Fatty Acids and Postoperative Complications After Colorectal Surgery
Omega-3 Fatty Acids and Postoperative Complication After Colorectal Surgery
NCT00488904CI-TRIAL-00003354omega3completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| supportan | Dietary Supplement | — | UNRESOLVED |
| supportan placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- a
- interventionNames
- Dietary Supplement: supportan
- type
- PLACEBO_COMPARATOR
- label
- b
- interventionNames
- Dietary Supplement: supportan placebo
Primary outcomes (1)
- measure
- 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%).
- timeFrame
- 1 year
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (20)
- BACKGROUNDBraga 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. PMID 9428539
- BACKGROUNDBraga 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. PMID 11822956
- BACKGROUNDGianotti 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. PMID 9366716
- BACKGROUNDSchilling 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. PMID 8875537
- BACKGROUNDSenkal 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. PMID 9295822
- BACKGROUNDTsekos 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. PMID 15158295
- 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.