Why the study?
Clinical trials are required in surgery to evaluate procedures and assess new techniques, but specific ethical difficulties exist when conducting randomised controlled trials.
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Design
Review
Ethical difficulties in surgical RCTs require tailored consent and equipoise protocols; extends RCT methodology guidance for procedural specialties.
Clinical trials are required in surgery to evaluate existing procedures and to assess the value of new techniques. Except for observational studies which are considered useful only to propose a hypothesis, all study designs require a comparator group. The randomised controlled trial (RCT) is recognised as the most robust study design. There are specific ethical difficulties in conducting RCTs.
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George Thomas (2020) studied this question.
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