Alternative methodological approach to randomized trial for surgical procedures routinely used.

BACKGROUND: In medical oncology, changes in practices are almost always based on randomized trials but medical history shows that it is different in surgical oncology. In the past, many surgical procedures were routinely performed without a rigorous evaluation of the risk-benefit. To highlight the complexity of developing randomized surgical trials, disquisitions on methodology presented in the medical literature. This is particularly true when we consider breast reconstruction after surgical treatment for breast cancer. It is illusory to perform and conduct a randomized clinical trial (RCT) when a surgical procedure is routinely used by most surgeons.

METHODS: As a case study, we present the scientific rationale and the design of the MAPAM01 trial which evaluates the security of the nipple sparing mastectomy. Other alternative approaches, such as propensity score and CUSUM, are presented.

RESULTS: In this situation, to design surgical trials using alternative methodological approaches present a particularly important challenge both for surgeons and methodologists. Alternative approach to randomized trials can be useful to evaluate surgical procedures routinely used.

CONCLUSION: Close collaboration between surgeons and methodologists is needed to propose appropriate and well-designed surgical trials.