Surgical experimentation and clinical trials: differences and related ethical problems

Surgical techniques are not introduced into clinical practice as the result of randomised clinical trials (RCT), but usually through the gradual evolution of existing techniques or, more rarely, through audacious departures from the norm that are decided by a surgical team on the basis of experience. Sham surgery is held by some to be not only an ethically acceptable procedure but also a perfectly fit and proper one, as it could endow surgical experiments with the strict methodological and statistical precision typically associated with RCTs. This article first briefly examines some of the methodological aspects of both RCTs and surgical experiments and then offers a few considerations regarding the ethical issues raised by sham surgery.