"Evidence-based medicine: open and laparoscopic bariatric surgery" by Gentileschi et al., published in Surgical Endoscopy (2002) 16: 736-744.

Gentileschi et al. [1], in the article entitled ‘‘Evidence based medicine: open and laparoscopic bariatric surgery,’’ state that the only procedures proved to be highly effective on a long-term basis are open Roux-en-Y grastric bypass (RYGB) for morbidly obese and open longlimb RYGB (L-L RYGB) for superobese patients. RCTs are essential when comparing two procedures whose outcome is predicted to be so similar that only randomization can show the differences. Bariatric operations (malabsorptive versus gastric restrictive) have substantial differences in outcome, acknowledged by their authors. In particular, there is a general consensus that biliopancreatic diversion (BPD) is the most effective procedure. We see no rationale in performing an RCT comparing BPD with another procedure knowing in advance which one will yield the best results. To assess worthiness in aerial combat of the latest stealth fighter, you don’t need to compare it with a World War I biplane. Furthermore, the level of standardization in obesity surgery is too low to perform a proper RCT. With different surgeons performing the same operation differently and the number of other variables influencing the outcome in this particular surgery, the meaning of a single-institution RCT is that that specific operation, in the way it is performed by that specific surgeon, yields better results than another operation performed by the same surgeon in his specific patient population. We see no reason in questioning the use of a procedure that has earned its establishment in over 25 years of clinical practice only because of the existence of other procedures with different or unknown mechanisms of action and wellknown inferior results. Not always is an RCT needed to determine what is the ‘‘current best evidence’’ in making decisions about the care of individual patients.