The role of clinical trials in the development of novel surgical techniques.

The new paradigm and standard for medicine and surgery is the evidence-based practice for which the randomized controlled trial is fundamental. Despite the early involvement of surgeons in clinical trials, randomized trials testing novel surgical therapies are not common. Indeed, only 24% of surgical patients are managed based on level 1 evidence. This chapter details how randomized controlled trial methodologies facilitate the development of level 1 evidence in support of minimally invasive colon cancer surgery. 2007 Wiley-Liss, Inc