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I am involved in a study grant exploring the definition and governance of innovative surgery.  One response to the governance issues is to propose that all surgical innovations be subjected to randomized clinical trials – the ‘gold standard” for determining efficacy and safety.  However, this raises the question: on what conditions can there be effective and ethically acceptable trials of innovative surgery? 
 
These are some of the difficulties:
·      For a trial to be effective, it would need to eliminate as many variables as possible so as to compare the innovation with standard treatment.  Unlike clinical drug trials, the intervention variable is each surgeon.  Does this mean that there can only be a series of trials by the same surgeon for meaningful comparison? [1]
·      Trials of surgical innovations take time to recruit sufficient participants with the appropriate condition on which the innovation can be applied.  Often, but the time there are sufficient numbers for a meaningful outcome, the innovation has been superseded by new developments.
·      Can there be a placebo control group in a surgery trial? Is sham surgery ethically acceptable?[2]
·      Can there be a meaningful clinical trial when a surgical innovation involves an implantable device?[3]
 
For these and other reasons, would it be preferable, ethically, to rely on case series research projects instead of randomize clinical trials – or will this mean that there is an inadequate evidence base for surgical innovations to be adopted as standard practice?[4]
 
Colin Thomson
 

[1]Anyanwu,A., Treasure, T. Surgical research revisited: clinical trials in the cardiothoracic surgical literature, European Journal of Cardio-thoracic Surgery 25 (2004) 299–303

[2]Ridgway, Paul F;Darzi, Ara W, Placebos and standardising new surgical techniques
British Medical Journal; Sep 14, 2002; 325, 7364;

[3]   Freemantle, N Commentary: Evaluating and regulating device therapy, BMJ 2011;342:d2839 doi: 10.1136/bmj.d2839

[4]Demange, M.K., Fregni, F. Limits to clinical trials in surgical areas, CLINICS 2011;66(1):159-161