Robotic surgery: getting the evidence right

Abstract

Obtaining high quality evidence relating to adoption of robotic surgery presents challenges Surgery performed using a robotic platform has led to a step change in how some procedures, largely urological, are delivered. Robotic systems are perceived to be advantageous over laparoscopic and open surgery by providing stereoscopic 3D vision with magnification of the surgical field and precise controlled instrument movement to allow dissection in confined spaces and complex manoeuvres such as suturing. That said, the global adoption of robotic surgery in other specialities has not been at pace, despite what seem to be clear benefits for patients undergoing some complex pelvic and abdominal procedures. Approximately 1.2 million robotic procedures had been performed worldwide as of December 2020, most of which were robotic-assisted radical prostatectomies (RARPs).1 By contrast, many colorectal and gynaecological procedures remain within the remit of laparoscopic or traditional open surgery. In this article, we discuss the evidence and controversy relating to adoption of robotic surgery, challenges in obtaining high quality evidence, and future prospects in implementing new surgical technologies. Opponents of robotic surgery often cite the lack of evidence to support its use and highlight the high health care cost. In Australia, the cost of the da Vinci Xi (Intuitive Surgical, Inc.) platform is an estimated $3.9 million in addition to consumable costs of $1848 per operation and a service cost of $621 245 for a 3-year contract.2 Intuitive has enjoyed a monopoly, although the introduction of new robotic systems into the market has the potential to alter the health economic landscape.3 As competition from newer robotic systems drives cost down, it is conceivable that robust evidence will be important in overcoming barriers to adoption. Gathering high quality evidence for surgical technology is challenging, and perceived benefits, despite little or no evidence of benefit, are often enough for both patients and surgeons to select a new technology.4, 5 This is a world-wide challenge affecting surgical trials more so than non-surgical trials.6, 7 Qualitative analysis of the BOLERO trial, a randomised controlled trial (RCT) of open versus minimally invasive cystectomy, reported that most patients declined trial participation because they had a preference for a particular treatment arm, typically the novel treatment.7 Similarly, an analysis of patients undergoing radical prostatectomy in England between 2010 and 2014 suggested that men were attracted to centres offering RARP and would bypass centres without a robotic service.8 Often, key opinion leaders are early adopters and become advocates for new technologies, which drives expansion and influences decisions before attainment of safety and efficacy data. However, in a catch-22 position, having gained this new expertise, the momentum to pursue clinical trials is often lacking and lags behind clinical expansion. RARP, first described in 2002, is now the standard of care in most developed countries despite little evidence for benefit.9 It was not until 2016, that the first well designed RCT reported outcomes.10 An Australian RCT compared RARP to open radical prostatectomy with a primary endpoint of urinary and sexual function at 6 weeks, 12 weeks and 24 months, suggesting they were comparable.11 However, analysis of secondary endpoints suggests that RARP affords shorter hospital length of stay (1.6 days v 3.3 days), less operative blood loss (443 mL v 1338 mL), less intraoperative adverse events (2% v 8%), as well as shorter operating time (202 minutes v 234 minutes).11 While no observed benefit was reported in the primary endpoint of the trial, it did highlight benefits of RARP in terms of earlier patient recovery. In the LAP-1 trial, a phase 3 RCT, patients with localised prostate cancer were randomised to either RARP or laparoscopic radical prostatectomy.12 In 2021, the trial reported that