Surgical clinical studies and their practical realization

The employment of the optimal therapeutic option according to the best curr ent knowledge is called evidence-based medicine (EBM). Moreover, considerin g the cost explosion in public health systems, EBM should contribute toward s economical and targeted use of the restricted resources and towards quali ty assurance in medicine. Obviously, this is applicable to the operative sp ecialties and can be termed as evidence-based surgery. Surgeons have to do their "homework" about this subject and to perform randomized controlled tr ials (the gold standard with the greatest evidence) on a large scale, in or der to come up to this expectation in future. Evidence-based therapy is ess ential for the preservation and especially for the further development and evolution of high-quality surgery with, at the same time, quality assurance in the new millenium. This article presents the definition of EBM and its implication in the operative fields. Fundamental principles for the practic al conduct of clinical randomized controlled trials are defined and the spe cific problems in surgery are discussed.