A Proposed Road Map for the Ethical Evaluation of Sham (Placebo) Surgery

Objective: The study proposes a possible roadmap for the ethical assessment\r\nof sham surgery clinical trials (CTs), focusing on methodological aspects, as a\r\nresult of the lack of this type of practical tool in the literature/practice.\r\nBackground: Surgical procedures are frequently conducted without closely\r\ncontrolled studies. For this reason, these procedures are less rigorous than\r\nthose for drug/device clinical trials. The aim of a sham (placebo) surgery CTis\r\nto carry out a surgical CT with a legitimate control group. The use of sham\r\nsurgery is controversial from an ethical point of view.\r\nMethods: This evaluation system is set up according to ICH/GCP, World\r\nMedical Association Declaration of Helsinki, CONSORT 2010 standards.\r\nThe proposed roadmap is based on the following 4 steps/levels: safety/clinical\r\nindications; adequacy of trial methodology/design adopted for a sham surgery\r\nCT; specific informed consent, and economic issues.\r\nResults: A flowchart is proposed which can be used at two levels: as a basic\r\nguideline for the design of a surgical protocol representing a benchmark level\r\nof care; and a multiaxial assessment considering the first two sources of\r\nmorality of human acts according to Aristotelian ethics: the object of the act\r\n(step 1) and some of its circumstances (steps 2–4).\r\nConclusions: The use of a placebo and of double-blind control groups in\r\nsurgery CTs would improves the quality of results, providing that an accurate\r\nethical assessment procedure is in place, firstly to ensure patient safety and\r\nsecondly to prevent abuses/procedural biases. Future testing of the proposed\r\nflowchart is outlined.