Resumo

OLAVARRIETA, JR Lucena. ESTUDIOS CLíNICOS CONTROLADOS EN TÉCNICA QUIRURGICA. RFM [online]. 2005, vol.28, n.2, pp.146-154. ISSN 0798-0469.

The number of prospective randomized clinical trials performed in surgery is much lower than the number performed in nonsurgical settings. The design of this type of trial in surgical patients carries an additional set of difficulties on top of those predictable in any clinical trial. Opportunity and validity of the methodology for patient randomization, techniques and, most importantly, surgeons is still highly controversial. The classical methodology for the design of prospective randomized clinical trials must be substantially modified to adapt to the special requirements of clinical research in surgery. On the other hand, the randomized prospective clinical trial is by no means the only source of clinical evidence and in many instances is either unnecessary or plainly harmful. The aim of this article is to review the unique features of prospective randomized clinical trials in surgery and to suggest some strategies to overcome their difficulties and limitations.

Palavras-chave : Clinical trial; Randomized trial; Surgery.