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      ESTUDIOS CLíNICOS CONTROLADOS EN TÉCNICA QUIRURGICA

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          Abstract

          Los estudios clínicos controlados prospectivo aleatorizados en cirugía deben modificar sustancialmente su metodología, adoptándolas a las evidencias actuales. Por otra parte, este tipo de ensayo no es la única fuente válida, y en muchos casos son innecesarios. El propósito de esta investigación es el de revisar crítica y objetivamente la literatura, y darle un enfoque personal respecto a la materia que constituye su contenido, para ayudar a encontrar la verdad, y establecer la polémica con las distintas corrientes y ámbitos de la investigación, en relación con los ensayos clínicos controlados en pacientes con patología quirúrgica. Evaluar las estrategias que permitan solventar las dificultades y limitaciones.

          Translated abstract

          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.

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          Most cited references40

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          Randomised trials in surgery: problems and possible solutions.

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            Surgical research or comic opera: questions, but few answers

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              The historical development of clinical therapeutic trials.

              J.P. Bull (1959)
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                Author and article information

                Journal
                rfm
                Revista de la Facultad de Medicina
                RFM
                Universidad Central de Venezuela. Facultad de Medicina. Comisión de Publicaciones de la Facultad de Medicina (Caracas, Distrito Capital, Venezuela )
                0798-0469
                June 2005
                : 28
                : 2
                : 146-154
                Affiliations
                [01] orgnameUniversidad Central de Venezuela
                Article
                S0798-04692005000200008 S0798-0469(05)02800208
                02b8dc41-54f7-4c2a-9a97-da9a3b3b6376

                http://creativecommons.org/licenses/by/4.0/

                History
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 33, Pages: 9
                Product

                SciELO Venezuela

                Categories
                Trabajos Originales

                Randomized trial,Clinical trial,Cirugía,Epidemiología,Ensayo aleatorizado,Estudio clínico controlado,Surgery

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