Issues in surgical randomized controlled trials.

As technology expands and health care resources become more limited, there is increasing pressure on surgeons to evaluate surgical procedures and technology to ensure they are effective. No longer is evidence from case series acceptable, and treatments must be evaluated in randomized controlled trials. The power of the randomized controlled trial is that because of its rigorous design the risk of random or systematic (bias) error is minimized and thus the risk of making an incorrect conclusion about the efficacy of a treatment is minimized. The randomized controlled trial has been widely accepted for evaluating the efficacy of medical treatments but less so for surgical procedures. Many cite methodologic issues related to surgical issues as the reason for this, including concerns related to standardization of the surgical procedure, timing of surgical trials, difficulties with blinding of subjects and investigators, ethics of surgical trials, and patient and surgeon acceptance of surgical trials. These issues are discussed in this paper as are possible strategies to minimize their effect.