Ethical issues in innovative colorectal surgery.

When physicians and surgeons investigate new drugs or devices, they must adhere to stringent regulatory standards governing human experimentation. Although these standards and regulations are not perfect, they serve to protect the interests of patients and research subjects. By contrast, few standards or regulations exist for innovative procedures, including new surgical techniques. Surgeons apply the term "innovative surgery" to describe practices ranging from minor technical modifications in standard procedures to non-validated investigational approaches indistinguishable from human research. By focusing on recent innovations in surgery, including colorectal surgery, this article proposes an ethical model of surgical innovation that protects patients while maintaining professional self-regulation of surgical advances.