Randomised clinical trials in surgery: a look at the ethical and practical issues.

An ethically conducted randomised controlled trial (RCT) is the backbone of evidence based medicine. In surgical practice however, RCTs have taken a backseat, drawing much adverse comment. There are several reasons to explain surgeons' disinclination to conduct RCTs. These include many practical difficulties such as the problem of blinding surgical procedures, design and funding issues. There are also many ethical issues which need to be considered including the concept of equipoise as well as the ethical issues associated with sham surgery as a control. While there is no doubt that RCTs are essential and in fact have helped to weed out several unnecessary surgical procedures, it is important not to lose sight of the fact that they may not be always necessary in order to obtain evidence in favour of a procedure. Possible solutions could be to follow guidelines that have been issued by learned bodies and a strict adherence to all ethical norms that have been recommended in the conduct of trials.