The introduction of laparoscopic cholecystectomy was associated with increased incidences of bile duct injury. The primary cause appears to be misidentification of the biliary anatomy. Routine intra-operative cholangiography has been recommended to reduce accidental duct injury, although in practice it is more often reserved for selected cases. There has been interest in the use of fluorescent agents excreted via the biliary system to enable real-time intra-operative imaging, to aid the laparoscopic surgeon in correctly interpreting the anatomy. The primary aim of this review is to evaluate the ability of fluorescent cholangiography to identify important biliary anatomy intra-operatively. Secondary aims are to investigate its ability to detect important intra-operative pathology such as bile leaks, identify potential alternative fluorophores, and evaluate the evidence regarding patient outcomes.
IntroductionThe development of innovative invasive procedures and devices are essential to improving outcomes in healthcare. However, how these are introduced into practice has not been studied in detail. The Lotus study will follow a wide range of ‘case studies’ of new procedures and/or devices being introduced into NHS trusts to explore what information is communicated to patients, how procedures are modified over time and how outcomes are selected and reported.Methods and analysisThis qualitative study will use ethnographic approaches to investigate how new invasive procedures and/or devices are introduced. Consultations in which the innovation is discussed will be audio-recorded to understand information provision practice. To understand if and how procedures evolve, they will be video recorded and non-participant observations will be conducted. Post-operative interviews will be conducted with the innovating team and patients who are eligible for the intervention. Audio-recordings will be audio-recorded, transcribed verbatim and analysed thematically using constant comparison techniques. Video-recordings will be reviewed to deconstruct procedures into key components and document how the procedure evolves. Comparisons will be made between the different data sources.Ethics and disseminationThe study protocol has Health Research Authority (HRA) and Health and Care Research Wales approval (Ref 18/SW/0277). Results will be disseminated at appropriate conferences and will be published in peer-reviewed journals. The findings of this study will provide a better understanding of how innovative invasive procedures and/or devices are introduced into practice.
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