Robotic Enhancement in prostate cancer Surgery: from clinical and cosTanalysis of patient Recovery to Environmental and social assessment. (the RESTORE project).
Progetto Modern hospital environment is highly connected to robotics. Robotic
surgery allows optimizing the level of offered health care improving patient
recovery thanks to the inherent technical advantages of this technology. The
use of robotics in surgery, therefore, needs to be evaluated in a multifaceted
scenario, where economic and organizational aspects interplay with
technical features to better define the benefits that this technology can
provide to the community. The purpose of the RESTORE study is to assess
the impact of robotic surgery in the clinical, socio-economical, and legal
field in a standardized set of patients and in a heterogeneous geographical
context, characterized and influenced by different socio-economic and
environmental factors. Specifically, it has been developed in three specific
directions: 1) Clinical milestone: To evaluate the short-term functional and
clinical outcomes using validated questionnaires for patient reported
outcomes measures (PROMS) in patients treated with robot-assisted radical
prostatectomy for prostate cancer. 2) Economic milestone: To assess the
financial sustainability of the robotic surgical procedure, intended as the
ability to produce outcomes at population level greater than the cost. 3) Legal
milestone: To define the appropriateness of the robotic system, both from a
clinical and organizational point of view, in the context of the definition of
the essential levels of assistance (LEA) in the health sector. The study
implies the inclusion of five Clinical Research Units that are hub referral
centers for their regional area with homogeneous characteristics: high annual
volume of robotic-assisted surgical procedures and a management system
following the current norms of clinical good practice. The two Economic
Research units include researchers belonging to the Italian Academy of
Business Economics (AIDEA), with specific skills to the project in the fields
of public and health management, cost accounting and performance
management. Legal Research Unit members are specialized in constitutional
and public law, labor law and urology. Clinical and treatment-related data
will be prospectively recorded by specialized medical personnel in an online
platform. Socio-economic and demographic data, quality of life, activities of
daily living (ADLs) will be recorded through a smartphone app. The final
deliverable of the project will be a unique set of FAIR (findable, accessible,
interoperable, reusable) data (prospective, consecutive, multicentric but
uniform) safely stored in a repository with associated multidisciplinary
clinical, cost-analysis and legal reports. This will represent a benchmark
useful to make comparisons with other series of data in the future, for
planning expenses and organization of healthcare, in a clinical scenario
characterized by the evolution of the market secondary to the introduction of
new technological devices increasing the competition rate between robotic
industries.