Pitfalls in surgical trials

Emiel Rutgers1

1The Netherlands Cancer Institute, Amsterdam, The Netherlands


Since the polemic editorial "Surgical research a comic opera: questions but few answers" by R. Horton (Lancet  1996), the debate on what good and "relevant" surgical research constitutes, is fierce and ever ongoing. I prefer to see it from another -more positive- angle: how to learn from the past and to design optimal surgical trials leading to practice changing outcomes? Because the only way to advance cancer surgery is by careful and thoughtful implementation of innovations. Are these innovations really worthwhile? What is the clinical benefit? Is the outcome of the patients really improved by these innovations?

First, what are the most relevant possible outcome measures?

Survival and local-regional control are the only real objective outcome measures. Side effects, quality of life and costs are subject to interpretation biases and may in general only serve as secondary endpoints. Small or even a real differences in these subjective outcomes will rarely be strong enough to be practice changing.

What are to me the most important pitfalls or difficulties in executing surgical trials?

Surgical trials: a comic opera? Now, twenty years later, we have learned a lot. It is still a challenge to perform a clinical trial but it is possible and in the end it is for the well being of our patients.