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La chirurgia robotica - Agenzia sanitaria e sociale regionale ...

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Abstract<br />

<strong>La</strong> <strong>chirurgia</strong> <strong>robotica</strong>: il robot da Vinci<br />

Robot-assisted surgery: the da Vinci robot<br />

Robot-assisted surgery is being proposed and used as a minimally invasive surgical<br />

technique for surgeries requiring a very high degree of precision due to the smallness<br />

of the surgical site as well as the relevance of the reconstruction phase. Although this<br />

technology is fairly widely diffused, research is still at an early stage and to date<br />

published clinical studies - mainly case series aimed at assessing feasibility and safety -<br />

do not provide conclusive information on its clinical effectiveness. Nonetheless it has<br />

been judged necessary to carry out a Health Technology Assessment on this costly and<br />

innovative technology.<br />

The present report - produced by the Emilia-Romagna Regional Health and Social Agency<br />

with the contribution of surgeons of the Regional Health Service - evaluates the da Vinci<br />

robot and includes the following six chapters.<br />

Chapter 1. Technical description and evaluation<br />

The main technical characteristics of the da Vinci robot are outlined as well as the<br />

certification status and the pattern of geographical diffusion. This trend shows a decisive<br />

increment during the year 2007, especially in the United States of America. Italy<br />

is holding a fairly relevant share of the European market with its 27 robots installed<br />

(19% of the EU distribution). The most important future developments of the technology<br />

are also briefly discussed, in particular those relating to further clinical application<br />

(neurosurgery, urology, heart surgery etc.) and new technological evolution, such as the<br />

haptics function, techniques for the fusion of images and systems for the networking<br />

of information.<br />

Chapter 2. Review of the scientific literature<br />

The methodology and main results of a systematic review of the scientific literature are<br />

reported. The literature search has been carried out on tertiary (health technology<br />

assessment reports) and secondary (systematic reviews) literature published since 2004.<br />

A search of primary studies has also been carried out for surgical interventions judged as<br />

most promising by the panel’s members. The methodological quality of the systematic<br />

reviews and primary studies is generally poor. Trials are mainly aimed at assessing<br />

feasibility and safety and there are very few comparative studies. Main conclusions from<br />

this literature review are that the da Vinci robot is to be considered an emerging<br />

technology for which there are no sufficient data to assess its superiority versus<br />

conventional or laparoscopic surgery for any type of surgery. Further randomised<br />

controlled clinical trials and cost-effectiveness evaluation are recommended.<br />

Dossier 167<br />

10

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