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To study the efficacy and safety of intravenous Omegavenâ„¢ (vs. Placebo) in reducing postoperative morbidity and mortality after major liver resection.
With two single doses of Omegaven (pre- and postoperatively) we aim to reduce postoperative complications measured by the CCI (Comprehensive Complication Index) and the Clavien Dindo classification of surgical complications. The study will include adults (more than 18 years) patients requiring liver resection of at least 1 segment or multiple wedge resections (≥3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omegavenâ„¢ | Active Comparator | Omegavenâ„¢ (approval number:54750 Swissmedic)- 100ml intravenously. The first dose (Omegavenâ„¢ or placebo) is administered in the evening before surgery, the second dose at the beginning of anesthesia. The maximum infusion rate must be adjusted to bodyweight (0.5 ml Omegavenâ„¢/kg/hour). |
|
| NaCl 0.9% | Placebo Comparator | 100ml of saline is used as a placebo comparator and administered as described above. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omegavenâ„¢ | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Complications will be assessed using the Comprehensive Complication Index (CCI) and the Clavien-Dindo complication classification. | 1 month after hospital discharge |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Linecker, MD | Contact | 0041 442553300 | Michael.Linecker@usz.ch | |
| Pierre Alain Clavien, MD PhD | Contact | 0041 442553300 | clavien@access.uzh.ch |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Alain Clavien, MD PhD | University Hospital Zurich, Visceral and Transplantation Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Visceral and Transplantation Surgery | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31626819 | Derived | Linecker M, Botea F, Aristotele Raptis D, Nicolaescu D, Limani P, Alikhanov R, Kim P, Wirsching A, Kron P, Schneider MA, Tschuor C, Kambakamba P, Oberkofler C, De Oliveira ML, Bonvini J, Efanov M, Graf R, Petrowsky H, Khatkov I, Clavien PA, Popescu I. Perioperative omega-3 fatty acids fail to confer protection in liver surgery: Results of a multicentric, double-blind, randomized controlled trial. J Hepatol. 2020 Mar;72(3):498-505. doi: 10.1016/j.jhep.2019.10.004. Epub 2019 Oct 15. | |
| 26268565 |
| Label | URL |
|---|---|
| Omegaven | View source |
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| ID | Term |
|---|---|
| C568345 | fish oil triglycerides |
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| Derived |
| Linecker M, Limani P, Botea F, Popescu I, Alikhanov R, Efanov M, Kim P, Khatkov I, Raptis DA, Tschuor C, Beck-Schimmer B, Bonvini J, Wirsching A, Kron P, Slankamenac K, Humar B, Graf R, Petrowsky H, Clavien PA. "A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven) on outcome after major liver resection". BMC Gastroenterol. 2015 Aug 14;15:102. doi: 10.1186/s12876-015-0331-1. |