ABSTRACT
While there is an ethical obligation to improve clinical outcomes by developing better therapies, surgical innovation has largely progressed without the strict regulations required of novel pharmaceutical products. We explore the reasons why new surgical techniques are frequently introduced without the benefit of randomised controlled trials, and present an approach to the ethical evaluation of novel surgical procedures.
Innovative surgery is perhaps best defined as “a novel procedure, a significant modification of a standard technique, a new application of or a new indication for an established technique, or an alternative combination of an established technique with another therapeutic modality that is developed and tested for the first time.” Unlike the clear policies regulating the human testing of new drugs and medical devices, there is currently no established protocol for the introduction of new surgical therapy. Often, modifications to established techniques are instituted in an ad hoc manner by a surgeon or a group of surgeons either due to the immediacy of need, or as a planned attempt to achieve a more efficient or effective surgical outcome. In other instances, surgeons proficient in a technique may extend its use for new indications. As most of such modifications are the natural evolution of the practice of surgery and have marginal or incremental impact on outcomes, it is debatable if all such innovations need to be governed by the same standards mandatory for novel pharmaceutical products. Is it practical for a surgeon to always require formal approval from an Institution Review Board (IRB) before performing an improvisation of an established surgical technique? Should all new surgical techniques be subject to the rigours of a randomised trial for validation of safety and efficacy prior to implementation and dissemination? Given the large numbers of new and alternative surgical techniques, their potential demands on healthcare resources and for harm, adequate regulation would seem necessary. We explore the reasons why many surgical techniques have been adopted without supporting prospective randomised trials, and propose a practical and ethically sound approach to the evaluation of novel surgical procedures.
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