Clinical Evaluation LLC
The da Vinci Surgical Robot
Abstract:
The term “robotic surgery” comprises devices that function as
navigation systems, positioning robots, machine tool robots used for
implanting various prosthetic devices, or telemanipulator systems
which maneuver surgical implements under the control of a human
operator (e.g., the da Vinci™ surgical robot). In March of 2001 FDA,
via the 510(k) process, approved the da Vinci device for assistance in
the control of various surgical instruments, and the following month
sent a Warning Letter to the manufacturer that material on the company’
s web site made “misleading claims” for the device and promoted
off-label uses.
We reviewed reports of robotic surgery published between 2000 - 2004. Databases searched included MEDLINE, Current Contents, EMBASE, BIOSIS, and the Cochrane Library. Search terms of robotics, telerobotics, telemanipulation, telepresence, remote control, and video-assisted, combined with surgery and surgeon were employed, together with the various brand names of current products. The search retrieved 465 unique references. From that number were selected studies that met the following criteria: reports of primary data and outcomes using FDA-approved devices; abstract or full text in English; and sample size of at least 12 human subjects. Only the most recent or largest study published by the same investigators for the same purpose was included. In addition, high quality systematic reviews were evaluated. Prior to this assessment, a number of technology evaluation groups prepared and published systematic reviews of the da Vinci™ robotic surgery system, including the University Health Consortium and public agencies in France (2), the United Kingdom, Canada (2), and Australia. The large majority of published data consisted of relatively small retrospective case series. No randomized controlled trials were published.
The data indicated that the da Vinci robotic telemanipulator holds promise for improvements in minimally invasive surgery, particularly with respect to three-dimensional vision, magnification, precision of movement, reduction of tremor, and use in limited or confined spaces. However, thus far there are no data confirming improved outcomes versus traditional surgery or standard laparoscopic surgery in any specific operative interventions. The time required in surgery and needed OR staff seemed to be greater than in other approaches. The cost of the equipment, maintenance, training, replacements, etc. is high. While few cost-effectiveness analyses have been completed, one study completed in Belgium concluded that even over a ten year span of 200 operations per year, the average cost per procedure was considerably higher than would be the case with standard laparoscopic techniques.
Thomas V. Holohan M.D., FACP
Associate Chief Medical Director (Clinical Programs)
Veterans Health Administration
Elizabeth Adams M.P.H.
VA Technology Assessment Program