Published online by Cambridge University Press: 10 March 2009
Decision-making in medicine is a very complex process that demands input both from the doctor and from the client. From the doctor's point of view, the most important component for this decision concerns the quality of evidence available that the recommended intervention is the best available in terms of both cost and benefit. Good quality evidence demands good quality science. The randomized controlled trial is the expression of this scientific process at work within medical practice. This article reviews both the rationale and the ethics of randomized controlled trials in the epistemology of surgery. The ethical dilemma is accentuated because surgery by its very nature is invasive and often irreversible. As an illustration of the scientific and ethical dilemmas arising out of randomized controlled trials in surgery, a description of the CEA directed second-look laparotomy trial in the United Kingdom is provided. This trial may be judged essential because of the clash of attitudes between surgeons in the United States and the United Kingdom. It is unlikely that the truth lies entirely with one or other national groupings of surgeons, and this randomized trial will eventually resolve a conflict of ideas to the ultimate benefit of all patients with operable colorectal cancer.