Impact case study database

The ROLARR study was undertaken during a period of great uncertainty about the benefits of robotic surgery and whether it offered value for money and should be more widely adopted. The work was presented at the world’s foremost surgical congresses, including the American Society of Colon and Rectal Surgeons (ASCRS; USA, 2015), the European Society of Coloproctology (Hungary, 2015), the Asian Robotic Camp for Colorectal Surgeons (S Korea, 2018), and the Association of Coloproctology of Great Britain and Ireland (UK, 2016), and is regarded as an exemplar study by the IDEAL (Idea, Development, Exploration, Assessment, Long-term Follow-up, Improving the Quality of Research in Surgery) Collaboration (UK, 2018).

ROLARR galvanised the robotic surgical community, clarified international opinion and put robotic surgery in the public spotlight through national media coverage. The JAMA manuscript [ 2] was named “Paper of the month” by the European Society of Coloproctology in January 2018 [ A] and to date has been cited 324 times on Web of Science, indicating its importance to the surgical community.

Patient and healthcare provider impact

The most important beneficiaries of robotic surgery are patients. Demonstration that robotic rectal cancer surgery was safe, with good oncological and functional outcomes [ 2], and evidence of factors enabling safe technology adoption [ 5, 6], provided reassurance to clinicians and patients. Although robotic surgery was more expensive than laparoscopic surgery, the differential costs were less than previously reported [ 3], providing encouragement to healthcare providers to invest in the technology and widening access for patients to benefit from minimally invasive surgery [ B].

The adoption and utilisation of robotic surgery for rectal cancer has increased markedly since the ROLARR presentations and publications [ 2- 6]. In the National Bowel Cancer Audit 2020, 30 NHS Trusts were regularly performing robotic colorectal cancer surgery with the number of cases more than doubling over the previous 4 years [ B]. Importantly, almost two-thirds of robotic surgery was performed in males and for low rectal cancer – the technically difficult sub-groups identified in ROLARR [ 2]. Similar patterns of robotic adoption have been seen in the US with rates of laparoscopic rectal cancer surgery plateauing at 19%, whilst robotic surgery has increased from 1% to 13% [ C].

Previous single institution studies have suggested that the learning curve for robotic rectal cancer surgery was ~30 patients. ROLARR showed this to be an underestimate, with the true learning curve, even in experienced laparoscopic surgeons, not plateauing until ~90 patients [ 4]. This has had major implications for robotic training programmes, surgeon accreditation, patient safety, and the future design of surgical technology evaluations. It informed the design of further research exploring the subgroups (males, obese patients, low rectal cancers) identified within ROLARR where there was likely to be maximal benefit, including the European RESET trial aiming to recruit 1300 patients with low rectal cancers [ D].

Policy and implementation impact

The importance of ROLARR in determining future healthcare policy is illustrated by its inclusion in an NIHR Signal Report [ E]. NICE guidance on the treatment of colorectal cancer published in 2014 failed to mention robotic surgery. Updated guidance published in 2020 supported the use of robotic rectal cancer surgery within established robotic programmes that have appropriate audited outcomes, affirming the learning curve [ 4] and human factors findings [ 5, 6] of ROLARR [ F]. The potential benefits highlighted by ROLARR for increasing patient access to minimally invasive surgery were formalised within the Royal College of Surgeons of England “Future Surgery” report [ G]. Building on the success of ROLARR, RCS England set up a national research initiative to undertake further research to demonstrate the benefits of robotic surgery.

Commercial impact

Presentation of the ROLARR results at the ASCRS meeting in 2015 had an immediate impact on the commercial robotics sector. US financial markets showed particular interest with investor speculation on Intuitive Surgical Inc., the manufacturer of the da Vinci system. The markets reacted favourably, reassured by the safety and high quality of robotic surgery [ H].

Confidence in robotic surgery was reassured, paving the way for the development and commercialisation of other robotic systems. Manufacturers have taken on board the health economic lessons from ROLARR, in particular the need to reduce capital and instrument costs to make the technology more affordable. Companies, such as CMR Surgical (UK) and Distalmotion (Switzerland), have been consulting with the ROLARR team to better understand the implications of ROLARR and how to develop the next generation of more versatile, affordable systems [ I, J]. Specific influences of ROLARR cited by manufacturers include a focus on colorectal surgery as a strategic market, increased investor confidence, use of health economics data to guide market positioning, and the importance of independent clinical evaluation to facilitate EU and US regulatory approvals.