[Placebo procedures in the operating room: necessary or an unnecessary risk for the patient?]

Sham surgeries, surgical procedures without actually carrying out the intended surgical intervention, are rarely used in research concerning a new surgical or invasive technique. The conflicting needs of minimizing operational risks and maximizing simulation present challenges in designing placebo-controlled surgical trials. It is important to thoroughly consider ethical considerations in the design of studies involving sham surgeries, including the importance of a transparent research design, objective reporting of results, challenges related to the informed consent procedure, and the inherent risks associated with surgical procedures. Furthermore, there exists a societal need to offer patients the most cost-effective intervention. Responsible sham surgeries are therefore crucial for understanding the potential and cost-effectiveness of surgical interventions compared to less invasive placebo conditions. Clinically high-quality studies involving placebo-based interventions can provide clarity regarding the balance between doing good and avoiding harm through surgical interventions.