專題討論4:機器人手術的適應症與規範
Indications and regulations of robotic surgery

程 序 表

S4-7
機器人手術的認證與規範
梁金銅
台大醫院大腸直腸外科

  The company designed a marketing strategy that led to a very large diffusion of the Da Vinci technology, even in the absence of good clinical evidence of its efficacy. Although in clinical use for almost 20 years, with thousands of published articles, there are no randomized controlled trials (RCTs) demonstrating the superiority of robotic surgery over standard laparoscopy.
  The way robotic technology is conceived overlaps the characteristics of standard laparoscopy, so that any advantage could be limited to a reduced need for training or an increased comfort of the operator, both difficult to translate into a real clinical benefit for the patients. Difference it would be if robotic technology were used to overcome the current limitations of laparoscopy or to allow to perform surgery through flexible endoscopy taking advantage from automation, miniaturization, and flexibility to access upper or lower GI pathologies through natural orifices.
  Remarkably, the retrospective study from Alemzadeh H et al. on the Adverse Events in Robotic Surgery based on 14 Years of FDA Data (PLOS ONE | DOI:10.1371/journal.pone.0151470 April 20, 2016) showed that.
  144 deaths (1.4% of the 10,624 reports), 1,391 patient injuries (13.1%), and 8,061 device malfunctions (75.9%) were reported. The numbers of injury and death events per procedure have stayed relatively constant (mean = 83.4, 95% confidence interval (CI), 74.2–92.7 per 100,000 procedures) over the years. Surgical specialties for which robots are extensively used, such as gynecology and urology, had lower numbers of injuries, deaths, and conversions per procedure than more complex surgeries, such as cardiothoracic and head and neck (106.3 vs. 232.9 per 100,000 procedures, Risk Ratio = 2.2, 95% CI, 1.9–2.6). Device and instrument malfunctions, such as falling of burnt/broken pieces of instruments into the patient (14.7%), electrical arcing of instruments (10.5%), unintended operation of instruments (8.6%), system errors (5%), and video/imaging problems (2.6%), constituted a major part of the reports. Device malfunctions impacted patients in terms of injuries or procedure interruptions. In 1,104 (10.4%) of all the events, the procedure was interrupted to restart the system (3.1%), to convert the procedure to non-robotic techniques (7.3%), or to reschedule it (2.5%).
  However, in the field of colorectal surgery, we found that the robotic surgical industry is actually similar to the aviation industry. The early flight pioneers were like robotic surgical pioneers, unafraid to try new and bold maneuvers. Both industries has 4 main players: the airlines (hospitals) themselves, the pilots/crew (surgical team), the passengers (patients), and the government (insurance payers…). And, accidents may be due to human or mechanical error. Fortunately, the literature review showed that: (1) The surgical complication in colorectal surgery is fewer in robotic approach, as compared to laparoscopic or traditional open surgery; (2) A better operation assisted by the current robotic system can be extrapolated to a better surgical outcome, even without randomized prospective clinical trials; (3) Precision medicine is a current trend for cancer therapy; and the indication for robotic surgery should also be individualized in the context of disease and anatomic patterns; (4) With emergence of high technology and artificial intelligence, the colorectal surgeons have stood in an enviable leading position for the treatment of cancers; (5) Robotic colorectal surgery is therefore the correct direction that minimally invasive surgery is moving towards.
  In conclusion, despite widespread adoption of robotic systems for minimally invasive surgery in the world, a non-negligible number of technical difficulties and complications are still being experienced during procedures. Adoption of advanced techniques in design and operation of robotic surgical systems and enhanced mechanisms for adverse event reporting may reduce these preventable incidents in the future.