Introduction

What counts as progress in surgery? And how are the advances measured? In exploring innovation in surgery, it is necessary to ask how innovations are judged, and about the mechanisms for evaluation. This paper will consider the changing methods of evaluating surgical procedures in the later twentieth century by following the fortunes of one alternative and especially contentious method, the placebo-controlled clinical trial. On first consideration, the idea of a surgical placebo may seem odd, or even unsettling. A surgical placebo trial involves fooling some patients into thinking that they received a surgical procedure, with the goal to compare their outcomes to patients who did receive the procedure. The technique entered the modern experimental repertoire as an exciting, if controversial, method in the late 1950s. It subsequently dropped from sight and was considered for a time to be perhaps fundamentally unethical. In the 1980s, however, the placebocontrolled surgical trial reentered use. The surgical placebo—or the sham surgery—is now in the early 2000s an accepted part of the experimentalist's toolbox, if still controversial.

The fraught history of placebo surgery is interesting for what it reveals about the introduction in the late twentieth century of new methods for judging the effects of surgical procedures. In a conventional version of this story, surgery over the last few decades has witnessed a competition between two basic methods for building evidence of effect—the case series and the randomized clinical trial (RCT). For centuries surgeons measured the success of a new procedure in the accumulated experience of use and gradually formalized this process in the mechanism of the case series. Results from a single patient's case, if promising, led to further cases until a convincing series materialized, providing evidence of therapeutic effect or its absence. Accumulating experience could lead to a registry of cases, creating a larger body of evidence. To generate a traditional case series, the surgeon had only to operate and collect results in a systematic, attentive way. The case series proved both practical and influential and remains, with subsequent refinements, a mainstay of the surgical scientific literature.