V8 Reporting of governance and ethical considerations in innovative surgical procedures – a systematic review

Abstract

IntroductionThe process of innovation in the field of surgery has largely resulted in improved patient outcomes. However, the uncertainty around the potential benefits and harms of innovative procedures mean that both research governance and ethics are important considerations for those who innovate. Though the need for ethical approval is standardised, other patient safeguards are surgeon and procedure dependent, such as the information provided during the consent procedure. It is currently unknown how ethical considerations in innovative surgery have been reported. This systematic review aims to evaluate the reporting of governance arrangements and ethical safeguards applied to innovative surgical procedures, using a case study of robotic upper gastrointestinal surgery.MethodsThe RoboSurg collaboration is conducting a set of systematic reviews to evaluate reports of innovative robotic surgical procedures including: pancreatectomies, gastrectomies, Roux-en-Y gastric bypasses, oesophagectomies, liver resections, cholecystectomies and anti-reflux operations. Databases were searched in April 2020 using relevant search terms including ‘oesophagectomy’ and ‘robotics’. Data extracted include details of approvals from Institutional Review Boards, ethics committees and clinical effectiveness groups, a priori study registration, and patient consent.ResultsInterim results for the reporting of governance arrangements and ethical safeguards from studies detailing robotic oesophagectomies will be presented. The search yielded 1908 abstracts for screening, of which 101 were included. The proportion of studies reporting on each ethical safeguard for patients undergoing this innovative procedure will be described and summarised.ConclusionThis review will evaluate how governance and ethical safeguards in studies of innovative surgical procedures have been reported.