Limitations of clinical trials in surgery.

One of the key elements of improving the health care system in the world is to respect the recommendations resulting from the socalled evidence-based medicine (EBM). Improvement considering clinical decision-making in medicine, including surgery may be attained when best evidence based medicine (EBM) will be combined with the following: – clinical experience, – medical knowledge in the field of surgery supplemented by constant access to medical databases, – communication skills in order to engage the patient and his social environment, – proper assessment of the clinical situation in surgery. According to Rothenberger, such understanding of the functioning of the health care system based on the above-mentioned principles forms the basis for the application of evidence based surgery in everyday clinical practice (1). Defining the problem of surgery, followed by systematic exploration and evaluation of the level of the investigated surgical problem, possibility of applying individual medical solutions based on EBM and evidence-based surgery (EBS) in a patient and in accordance with the highest level of evidence, and finally systematic evaluation of therapeutic results are essential stages of creating surgery fulfilling the highest criteria of quality (2). This problem seems to be simple and obvious in assumption, but in practice, it is difficult to achieve by the surgeon. In comparison to other non-interventional medical specialties, surgical disciplines including surgery, create special conditions that clearly define and limit the ability to conduct and apply evidence based medicine. The above-mentioned is influenced by many objective conditions and numerous problems resulting from the specificity of being a surgeon. In order to follow progress in medicine one should read 19 articles everyday, 362 days a year. Every year one may observe the doubling of the number of medical publications (3). It is wellknown that in 40% of patients evidence based medicine is not applied. Additionally, the surgeons personality (self-confidence, impatience, need to take fast and responsible decisions) is not conducive to adopting all medical facts. What’s more, only approximately 60% of surgeons are aware of the functioning of EBM principles: the above-mentioned percentage is higher amongst surgeons practicing in university reference centers, and conducting research. Considering the aspect of age, young surgeons, resident and specialty surgeons are more willing to introduce EBM principles into surgery (3). Therefore, for the surgeon a major challenge is to find the best documented medical data associated with his clinical practice. Thus was born the need to create understandable, easyaccessible, and easy-to-analyze databases. Such databases would be, or already are, the basis for the novel pursuit of education, identifying research problems, or establishing surgical guidelines at the highest level of evidence (2). Another problem is the ability to use these databases. In Western countries the applica-