A proposed road map for the ethical evaluation of sham (placebo) surgery

Objective: The study proposes a possible roadmap for the ethical assessmentof sham surgery clinical trials (CTs), focusing on methodological aspects, as aresult of the lack of this type of practical tool in the literature/practice.Background: Surgical procedures are frequently conducted without closelycontrolled studies. For this reason, these procedures are less rigorous thanthose for drug/device clinical trials. The aim of a sham (placebo) surgery CTisto carry out a surgical CT with a legitimate control group. The use of shamsurgery is controversial from an ethical point of view.Methods: This evaluation system is set up according to ICH/GCP, WorldMedical Association Declaration of Helsinki, CONSORT 2010 standards.The proposed roadmap is based on the following 4 steps/levels: safety/clinicalindications; adequacy of trial methodology/design adopted for a sham surgeryCT; specific informed consent, and economic issues.Results: A flowchart is proposed which can be used at two levels: as a basicguideline for the design of a surgical protocol representing a benchmark levelof care; and a multiaxial assessment considering the first two sources ofmorality of human acts according to Aristotelian ethics: the object of the act(step 1) and some of its circumstances (steps 2–4).Conclusions: The use of a placebo and of double-blind control groups insurgery CTs would improves the quality of results, providing that an accurateethical assessment procedure is in place, firstly to ensure patient safety andsecondly to prevent abuses/procedural biases. Future testing of the proposedflowchart is outlined.