Dossier n. 167/2008 [Abstract] Robot-assisted surgery: the da Vinci robot

Robot-assisted surgery is being proposed and used as a minimally invasive surgical technique for surgeries requiring a very high degree of precision due to the smallness of the surgical site as well as the relevance of the reconstruction phase. Although this technology is fairly widely diffused, research is still at an early stage and to date published clinical studies - mainly case series aimed at assessing feasibility and safety - do not provide conclusive information on its clinical effectiveness. Nonetheless it has been judged necessary to carry out a Health Technology Assessment on this costly and innovative technology.

The present report - produced by the Emilia-Romagna Regional Health and Social Agency with the contribution of surgeons of the Regional Health Service - evaluates the da Vinci robot and includes the following six chapters.

Chapter 1. Technical description and evaluation
The main technical characteristics of the da Vinci robot are outlined as well as the certification status and the pattern of geographical diffusion. This trend shows a decisive increment during the year 2007, especially in the United States of America. Italy is holding a fairly relevant share of the European market with its 27 robots installed (19% of the EU distribution). The most important future developments of the technology are also briefly discussed, in particular those relating to further clinical application (neurosurgery, urology, heart surgery etc.) and new technological evolution, such as the haptics function, techniques for the fusion of images and systems for the networking of information.

Chapter 2. Review of the scientific literature
The methodology and main results of a systematic review of the scientific literature are reported. The literature search has been carried out on tertiary (health technology assessment reports) and secondary (systematic reviews) literature published since 2004. A search of primary studies has also been carried out for surgical interventions judged as most promising by the panel’s members. The methodological quality of the systematic reviews and primary studies is generally poor. Trials are mainly aimed at assessing feasibility and safety and there are very few comparative studies. Main conclusions from this literature review are that the da Vinci robot is to be considered an emerging technology for which there are no sufficient data to assess its superiority versus conventional or laparoscopic surgery for any type of surgery. Further randomised controlled clinical trials and cost-effectiveness evaluation are recommended.

Chapter 3. Selection of clinical applications
The methodological process for the identification and selection of the most promising clinical applications of the da Vinci robot in the Regional Health Service is described. Based on the analysis of the literature review, a mapping of the current stage of research and knowledge has been developed and research results have been classified according to an increasing degree of uncertainty into the following four categories: consolidated, plausible, uncertain and unknown. This charting exercise - by defining the relevant primary and secondary clinical outcomes that need to be assessed for each surgical intervention - represents a useful starting point for the set up of future clinical trials as well as for the surveillance and update of the scientific literature. This mapping was also used to draw up a first list of surgical interventions for which a plausibility of the da Vinci’s superior clinical effectiveness can be hypothesized. This initial list was further cut-down using as selection criteria our Region’s availability of high-level professional expertise in non-invasive surgery and regional patients’ volumes. Through this process, a plausible positive outcome in health care was presumed for the following types of surgery: radical prostatectomy, colo-rectal surgery, bariatric surgery and surgery for gastroesophageal diseases.

Chapter 4. Economic analysis
The costs of the technology (set up, use and maintenance) are outlined. Using the Break Even Analysis approach some hypothetical ratios between suitable fees and necessary volumes are put forward to investigate the economic sustainability of this very costly health technology. The analysis, carried out using data referring to the intervention for radical prostatectomy, shows the need for a revision of the robotic surgery’s current fees in order to ensure a point of break-even between the service’s costs and the expected volumes.

Chapter 5. Impact on the Health Regional System
A brief discussion is offered on the methodological and theoretical terms of reference used to study the introduction and implementation of complex interventions in the health organizations. Using the Normalization Process Model approach as a theoretical framework for the identification of necessary requirements and foreseeable bearings on the health service, the following issues have been highlighted and discussed:

• appropriate introduction of the new service in target patients’ current clinical pathway;
• expected impact of the technology on the relationship between professionals and their network and content and format of necessary dedicated professional training programmes;
• necessary system for the recognition of skills, allocation of tasks and evaluation of performance;
• required plans for the allocation of resources and responsibilities needed for the control and implementation of the technology.

Measuring tools and indicators are also suggested to monitor the process of introduction and integration of the new technology into the Regional Health System.

Chapter 6. Adoption of the da Vinci robot in the Regional Health System
In line with the da Vinci robot’s status of emerging technology, knowledge on its clinical effectiveness and potential health impact is limited and does not allow to forward firm conclusions or indications for future adoption programmes. Nonetheless, applying the criteria used for establishing plausible clinical effectiveness (Chapter 3), economic sustainability (Chapter 4) and necessary requirements for introduction and integration of the technology in the health service (Chapter 5), some hypothetical scenarios for the adoption and support to the development of robotic surgery are proposed:

• experimental use of the da Vinci robot in local Health Trusts (mono-center clinical trials);
• experimental use in the Regional Health System (multi-center clinical trials);
• use of the technology for training purposes and set-up of a regional school for robotic surgery;
• acquisition of a da Vinci robot;
• demission of a robotic surgery’s service.

Each scenario is discussed on the basis of the main issues considered in the preceding chapters (clinical use, research questions, organizational requirements and economic impact).

Appendix: full version of the systematic review of scientific literature and tables of evidence.