Where is the evidence for novel surgical devices?

This question was recently addressed and the findings published in the British Journal of Surgery

Two of the authors describe what they did and what they found;

 

Stephen J Chapman, Leeds Institute of Biomedical and Clinical Sciences, University of Leeds, Leeds, UK

 

 

 

Aneel Bhangu, Dept of ColorectalSurgery, University of Birmingham, Birmingham, UK

 

Innovation in surgery is important to ensure the treatment of surgical disease continues to advance. The role of industry is paramount in driving this forward, but must be matched by robust clinical evidence and dedicated regulation.

Whilst regulatory bodies in the U.K. work to ensure safe introduction of surgical devices, many are supported by minimal or no evidence of safety or effectiveness. We are acutely aware of this problem; new surgical devices are introduced every day yet these may be unfamiliar or unproven. Whilst regulatory bodies are often satisfied with evidence of “equivalence”, the true clinical impacts of these are unclear.

Our study, published in the British Journal of Surgery, demonstrated the extent of this problem (1). We systematically compiled a list of implantable devices used in gastrointestinal surgery and set out to find evidence to support their use. Alarmingly, only 1 in 10 of these devices was supported by evidence from high quality randomised controlled trials (RCT).

Whilst RCTs are perceived to slow the rate of innovation, dedicated networks of surgeons have proven their ability to evaluate surgical interventions quickly and effectively (2). Additionally, whilst RCTs are not always the most appropriate design to test novel interventions, they provide high quality evidence when undertaken by dedicated clinical and academic networks.

In line with proposals from the IDEAL Collaboration, we encourage a standardised, step-wise approach to the assessment of novel surgical technology. This should begin with first in man studies, progress through stages of randomised assessment, and culminate in long term surveillance in dedicated devices registries.

References:

  1. Chapman SJ. Shelton B. Maruthappu M. Singh P. McCulloch P. Bhangu A. Cross-sectional observational study of the availability of evidence supporting novel implantable devices used in gastrointestinal surgery. Br J Surg 2017 [Epub ahead of print]. doi: 10.1002/bjs.10485
  2. Bhangu A. Kolias AG. Pinkney T. Hall NJ. Fitzgerald JE. Surgical research collaboratives in the UK. Lancet 2013;382:1091-2.

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