Perioperative Omega-3 fatty Acids Fails to Confer Protection in Liver Surgery. Results of a multicentric, double-blind, randomized controlled trial
Abstract
OBJECTIVE
To investigate the perioperative use of Omega-3 polyunsaturated fatty acids (Ω3-FA) to reduce post-operative complications after liver surgery.
SUMMARY BACKGROUND DATA
In a variety of animal models, Ω3-FA disclosed strong protective effects in alleviating hepatic ischemia/reperfusion injury and steatosis with enhancement of regeneration after major tissue loss. Given these benefits along with its safety profile, we hypothesized that perioperative administration of Ω3-FA in patients undergoing liver surgery may ameliorate the post-operative course.
METHODS
A multi-centric, double-blind, randomized, placebo-controlled trial was designed to test whether two single intravenous infusions of OmegavenTM (Ω3-FA) vs. placebo may decrease morbidity. The primary endpoints were postoperative complications by severity (Clavien-Dindo classification) integrated in the Comprehensive Complication Index (CCI).
RESULTS
Between July 2013 and July 2018, 261 patients (132 in the Omegaven and 129 in the placebo groups) were included in the trial from three centers. Most cases (87%, n=227) underwent open liver surgery and 56% (n=105) were major resections (≥3 segments). In an intention-to-treat analysis including the drop out cases, the mortality rate was 4% and 2% in the OmegavenTM and placebo groups (P=0.447; OR: 95%CI: 0.04-2.51), respectively. Any complications and major complications (Clavien-Dindo ≥3b) occurred in 46% vs. 43% (P=0.709) and 12% vs. 10% (P=0.69) in the Omegaven and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 227 participants or records.
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