Metabolic optimized fast track concept in general surgery - MOFA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004814-33-DE

Enrollment

100

Registered

2006-02-10

Start date

2006-03-23

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma of the colon or the liver scheduled for surgical resection

Interventions

Trade Name: Omegaven-Fresenius Product Name: Omegaven-Fresenius Product Code: Omegaven-Fresenius Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: Icosapent CAS Number: 10417-94-4 Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient scheduled for surgical resection of carcinoma of the colon or the liver age 18-85 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Contraindications against fish oil emulsions Contraindications against hydroxy ethyl starch solutions Decompensated diabetes mellitus Chemotherapy within one year before inclusion Therapy with cyclooxygenase inhibitors within the last week before inclusion Patient living further than 20km out of the city of Dresden (follow up examination)

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess the effects of perioperative metabolic optimization with fish oil (Omegaven) on the recovery of gastrointestinal function;Secondary Objective: assessment of: Duration and amount of volume and vasopressor support Markers of inflammation, antibiotic demand Occurrence of complications General condition assessed by SAPS II score Expenditures for therapy (TISS 28 score) Mortality ;Primary end point(s): recovery of gastrointestinal function	—

Measure

Time frame

Main Objective: to assess the effects of perioperative metabolic optimization with fish oil (Omegaven) on the recovery of gastrointestinal function;Secondary Objective: assessment of: Duration and amount of volume and vasopressor support Markers of inflammation, antibiotic demand Occurrence of complications General condition assessed by SAPS II score Expenditures for therapy (TISS 28 score) Mortality ;Primary end point(s): recovery of gastrointestinal function

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 2, 2026