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Open Access Study protocol

PORTAL: Pilot study on the safety and tolerance of preoperative melatonin application in patients undergoing major liver resection: a double-blind randomized placebo-controlled trial

Peter Schemmer1*, Arash Nickkholgh1, Heinz Schneider3, Michael Sobirey4, Markus Weigand2, Moritz Koch1, Jürgen Weitz1 and Markus W Büchler1

Author Affiliations

1 Department of General Surgery, Ruprecht-Karls University, Heidelberg, Germany

2 Department of Anesthesiology, Ruprecht-Karls University, Heidelberg, Germany

3 HealthEcon AG, Basel, Switzerland

4 Nutri~fit GmbH & Co KG, Mühlen, Germany

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BMC Surgery 2008, 8:2  doi:10.1186/1471-2482-8-2

Published: 23 January 2008

Abstract

Background

Major surgical procedures facilitate systemic endotoxinemia and formation of free radicals with subsequent inflammatory changes that can influence the postoperative course. Experimental data suggest that preoperative supraphysiological doses of melatonin, a potent immuno-modulator and antioxidant, would decrease postoperative infectious and non-infectious complications induced by major abdominal surgery.

Methods/Design

A randomized controlled double blind single center clinical trial with two study arms comprising a total of 40 patients has been designed to assess the effects of a single preoperative dose of melatonin before major liver resection. Primary endpoints include the determination of safety and tolerance of the regimen as well as clinical parameters reflecting pathophysiological functions of the liver. Furthermore, data on clinical outcome (infectious and non-infectious complications) will be collected as secondary endpoints to allow a power calculation for a randomized clinical trial aiming at clinical efficacy.

Discussion

Based on experimental data, this ongoing clinical trial represents an advanced element of the research chain from bench to bedside in order to reach the highest level of evidence-based clinical facts to determine if melatonin can improve the general outcome after liver resection.

Trial Registration

EudraCT200600530815