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.

BMC Surgery
Peter SchemmerMarkus W Büchler

Abstract

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. 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. 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 melaton...Continue Reading

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Citations

Jul 14, 2012·HPB Surgery : a World Journal of Hepatic, Pancreatic and Biliary Surgery·Arash NickkholghPeter Schemmer
Dec 25, 2010·World Journal of Gastroenterology : WJG·Alexander M Mathes
May 25, 2010·HPB : the Official Journal of the International Hepato Pancreato Biliary Association·Mahmoud Abu-AmaraBrian R Davidson
Apr 13, 2011·Journal of Pineal Research·Arash NickkholghPeter Schemmer
May 20, 2011·Molecular Nutrition & Food Research·Rui LiangPeter Schemmer
Jun 1, 2012·The Journal of Surgical Research·Roman A KireevJesus A F Tresguerres
Oct 13, 2009·The Cochrane Database of Systematic Reviews·Mahmoud Abu-AmaraBrian R Davidson
Jun 21, 2017·BioMed Research International·Cezary ChojnackiJan Chojnacki
Aug 1, 2020·Therapeutic Advances in Medical Oncology·Mindaugas KvietkauskasPeter Schemmer
Dec 16, 2020·The Cochrane Database of Systematic Reviews·Bennedikte K MadsenJacob Rosenberg

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