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ROBOTIC-ASSISTED SURGERY ROBOTIC-ASSISTED SURGERY: A PATHWAY TO THE FUTURE A guide to good practice July 2023 www.rcseng.ac.uk/standardsandguidance Contents 1. The current state of robotics in surgery 4 1.1. Aims of this document 2. The promise and challenge of robotic-assisted surgery 5–6 3. Establishing a training pathway for robotic-assisted surgery 7–9 3.1. Minimum requirements of robotic skills training 3.2. Determining competence and proficiency 4. Developing the surgical team 10 5. Introducing robotic-assisted surgery into surgical services 11–17 5.1. The hospital trust/health board 5.2. The surgeon 5.3. The robotic company 5.4. The proctor 5.5. The GMC 5.6. Other key considerations 6. A pathway to the future 18 7. Bibliography/references 19–22 RCS England Quality Improvement July 2023 2 Acknowledgements This document was written with the contributions of: Professor David Beard Mr Josh Burke Professor Tim Goodacre Professor Deena Harji Mr Omer Karim Mr Richard Kerr Professor Ian Loftus Professor Neil Mortensen Professor Tim Rockall Ms Katerina Sarafidou Professor Naeem Soomro Mr Ralph Tomlinson Ms Nuha Yassin 3 1. The current state of robotics in surgery Robotic-assisted surgery (RAS) was first healthcare system. Despite the centralised introduced in the UK in the late 1990s, approaches in Wales and Scotland, the with robotic systems such as AESOP and lack of a national strategy in England ZEUS, followed by the da Vinci system and Northern Ireland has meant that the in 2000. Since then, over 12 million use of robotics is often based on local operations have been performed across availability, resources and expertise rather 70 countries, with over 1.8 million in 2022 than patient suitability and care. There alone and several newer robotic platforms are currently no consistent standards for emerging in recent years. In 2018, a established surgeons and surgical teams, College-led commission on the future of let alone services wishing to transition from surgery predicted the rapid expansion of open or conventional minimally invasive RAS across the UK and internationally surgery to an independent RAS practice. due to its proposed advantages in There is also limited access to the required ergonomics and operative precision, as training, assessment, feedback and support well as its potential for improving training necessary to perform robotic surgical and service practices. Historically, cardiac procedures competently and safely, and no surgery pioneered RAS with urology clear definition of roles and responsibilities driving adoption in conditions such as for the hospital, trust/health board, surgeon, prostatectomy, where it has been able to robotic company, proctor or the regulators. demonstrate a reduction in intraoperative blood loss, length of hospital admission 1.1 AIMS OF THIS and risk of positive resection margins. For many other surgical specialties, RAS is still DOCUMENT experimental, but it has seen an increase This document discusses some of the in uptake over the last ten years, and it challenges and promises of robotic surgery is currently available in more than 100 hospitals in the UK. and the potential future application of robotics. It makes recommendations for Nevertheless, wide recognition of the sound governance practices that can potential and the adoption of robotics has lead to the safe adoption and expansion not moved as quickly as other surgical of robotic surgery in UK hospitals and innovations, with the level of robotic proposes a structured pathway for adoption varying significantly across established surgeons who want to different surgical specialties. This was transition to RAS. Finally, it aims to identify due partly to the acquisition and running costs of the technology and partly to the the relevant roles and responsibilities of key stakeholders for ensuring safe and difficulty of obtaining complex enough sustainable independent practice in evidence to understand the full impact robotic surgery. of the implementation of RAS in the 4 2. The promise and challenge of RAS The implementation of RAS has been significant advantages of RAS, particularly considered disruptive, in the sense that its when performed by experienced robotic innovation has the potential to bring about surgeons, on appropriately selected radical change in the field. On the one patients and in advanced programmes. hand, it can be seen as another tool for These advantages include increased improving the technical aspects of surgery, patient satisfaction, reduced postoperative with many operations being similar to their pain, more efficient use of anaesthetics, laparoscopic counterpart requiring similar reduced perioperative blood loss, decision making and operative techniques. fewer blood transfusions, improved bed On the other hand, it has the potential utilisation, shorter hospital stays, faster to introduce a complete transformation return to work and family, and lower rates of surgical provision: widespread of return to theatre. To benefit from the implementation of RAS requires new areas potential advantages of RAS, however, any of knowledge and full-service realignment, investment in purchasing robots needs to including reconfiguration of space for be accompanied by proper planning for its larger equipment, workforce training, new introduction into the service. This includes clinical pathways and potentially a different the potentially long learning curve for configuration of the surgical team. As surgeons and theatre teams before such, multiple stakeholders need to be these efficiencies can be observed at a considered: not only patients and surgeons large scale. but also commissioners, regulators, In the area of patient safety, the suggested policymakers, industry and others. The benefits are significant. For example, emergence of new companies providing most platforms provide a magnified, robotic equipment adds to the complexity with differing platforms, consoles and three-dimensional image of the surgical site; tremor elimination; motion scaling delivery systems. and instruments that increase freedom of The multidirectional implications of robotic movement, while newer platforms include technology make the assessment of its even more enhanced technologies such as benefits and downsides very complex. So eye tracking and haptic feedback–all these far, there has yet to be a clear consensus in combination can be argued to increase on how these should be measured, and precision and reduce the likelihood of error. which outcomes or benchmarks should be At a time when there is less exposure of used to determine its clinical and economic trainee surgeons to in-depth procedural value. As such, a number of stakeholders training, RAS could allow for increased remain uncertain, seeing it as slower and safety across the spectrum of case more costly than laparoscopic surgery, complexity and expand the capacity of the certainly in the learning phase. surgical workforce more broadly. Nevertheless, studies across a variety of Despite this evolution of robotic technology surgical procedures seem to demonstrate over the last 10–20 years, there is still 5considerable work to be carried out by all investigation across all specialties that relevant stakeholders to overcome the utilise RAS to demonstrate improved challenges it poses. The elevated cost of instrumentation accuracy, operative commercially available robotic equipment efficiency and patient safety. is often cited as one of the reasons for the In addition, there is currently no national, slower adoption of robotic technology. It multi-stakeholder strategy to support the is difficult to quantify precisely the cost- adoption and growth of RAS, and no robust effectiveness of robotic adoption–a number regulatory framework to delineate the of studies suggest that RAS will always be more costly to the NHS due to the cost responsibilities between the technology and the surgeon and to determine the of acquisition, training and maintenance roles and relationships of the various of the robotic system, including the cost stakeholders. This inevitably results in of disposables and energy use. It is likely variations in governance processes and in that such costs can eventually be reduced by improving clinical outcomes alongside the availability of robotic technology and has an adverse impact on quality control application to a larger volume of patients and equity of access for patients. and by taking account of efficiencies It is essential that national training such as possibly reduced operating time and reduction in length of hospital stay, standards are developed to enhance the both of which can be improved when the readiness of the workforce to meet the rapidly expanding robotic technology. surgical team is experienced and well- National guidelines are needed to trained in RAS. It is possible that the standardise several aspects of RAS costs of purchasing and maintaining the robotic system may also reduce through practice, such as the metrics needed to commercial negotiation, particularly as quantify quality, skills and expertise and to determine competence. This includes the more companies bring systems to market nature of tasks that should be evaluated, One of the main challenges of RAS is minimum volumes of procedures and the lack of consistent and sufficiently comprehensive data to adequately evaluate relevant clinical outcomes. Standardisation can also include a provisional selection robotic technological advancements, such of procedures that are suitable for RAS, as collaborative multicentre cohort studies, although it is important not to be too registries and large datasets that can prescriptive on this as the field is reveal patterns, trends and associations across the spectrum of relevant surgical still evolving. The next sections of this document will procedures (including in relation to human aim to put forward a series of principles behaviours and team interactions). This means that there need to be more ways to and recommendations for establishing a generate evidence for evolving technology, robust training programme on RAS and for including real world evidence as well introducing RAS into service. as randomised trials with a meticulous 6 3. Establishing a training pathway for RAS There are no established protocols or minimum requirements for robotic 3.1 MINIMUM REQUIREMENTS OF training of either established surgeons or ROBOTIC SKILLS surgeons in training, although a number of organisations have developed curricula TRAINING to expose surgeons to basic robotic technology. Such training may vary based We recommend that a minimum training in on the specialty, procedure and the various robotic skills should include the following: tasks involved, but they should entail • Online training. This should be a both technical and non-technical skills, combination of generic and platform- including decision making, troubleshooting agnostic skills to ensure early career and effective communication. Training in surgeons are safe to enter a robotic robotic surgery can generally be divided theatre. Basic training in specific systems, normally specified by the into four sequential stages: e-learning, device training, simulation and hands-on respective robotic system provider, procedure-based training. can introduce learners to the various Although the scope of this document is components of specific robotic limited to established consultant surgeons platforms, common applications and and those in a fellowship programme, troubleshooting tips, and include an given the increasing adoption of robotic assessed component that leads to a surgery and the likely future need for certificate of completion. more proficient robotic surgeons, we Virtual reality training, competency- • recommend the introduction of a structured based and using a console-based and validated curriculum of core, pre- skills simulator and/or wet lab procedural skills in robotic surgery across training (a minimum of nine hours all stages of surgical training. This will and dexterity/accuracy scores support the general competence and early above 90% for all parameters). development of relevant knowledge and Learners here obtain hands-on skills and will allow trainees to be prepared experience with the functionality of the for procedure-based training in robotic robotic platform. Wet lab training enables surgery when the opportunity arises the learner to take particular steps of the (Burke et al 2023). procedure either in a cadaver training centre or on simulated models. Simulation allows for progress through the learning curve and can be transferable to the clinical setting. Most simulators have a variety of exercises dedicated to technical training for camera clutching, instrument manipulation and switching, use of surgical energy and others. 7A dedicated curriculum should include • Observership for an established didactic instructions for: Consultant Surgeon. This includes • robotic systems/basic console observing and/or assisting in robotic orientation surgery performed by a proctor, likely visiting the proctor’s hospital. • cognitive skills training Under supervision, learners should • psychomotor skills training be familiar with all aspects involved • team training/communication skills with proper and optimal set-up to • basic and intermediate provide safe and efficient care, while maximising surgical skills. the utility of robotic technology. • Observership (bedside training). There are currently two ways through This includes instruction on the which surgeons are introduced to following tasks: - operating theatre set up and robotics: through a fellowship or as patient position a consultant already in post. The requirements of observership and - choice of port placement based on the interaction with the trainer will be the case slightly different in each case: - effective communication with • Observership for a Robotic operative staff when docking the Fellow. This includes observing and robot assisting in robotic surgery performed - docking robotic arms to patient by an existing robotics-trained surgeon, ports and instrument insertion probably from the learner’s own - principles of instrument exchange/ hospital. Under supervision, learners camera manipulation should be familiar with all aspects involved with proper and optimal set - assistant port side selection up to provide safe and efficient care, and utilisation while maximising the utility of robotic - emergency undocking technology. This includes instruction - Observing proctor and/or proctor’s on the following tasks: operative videos for a minimum of - operating theatre set-up and ten cases. We recommend that patient position the surgical team (including nurse, - choice of port placement based surgical assistant and on the case anaesthetist) should visit the - effective communication with proctor’s hospital for at least one operative staff when docking the of their operating lists. The nuances of the proctor’s robot - docking robotic arms to patient surgical technique can then be ports and instrument insertion gleaned from more detailed study - principles of instrument exchange/ of the proctor’s own operative camera manipulation videos. - assistant port side selection • Operating at the console for a and utilisation minimum number of procedures - emergency undocking under the guidance of a proctor or robotically trained surgeon. In the - serving as first assistant to the learning phase, and depending on the robotics-trained surgeon for a platform used, it is essential to have minimum of ten cases. 8 a dual console system or equivalent, It is important to note also that competence where the proctor or robotically trained and proficiency may be device- or platform- surgeon can take control at any specific, and further training with additional point, with an approach of graduated robotic cases may be required for a autonomy. Learners should perform a different platform. specified minimum number of cases on An example of metrics to demonstrate dual console (or equivalent, depending competence can be the following: on the platform) before they are signed off for independent practice. • Completion of five core simulator skill exercises with a passing score of 90% • Sign off for platform proficiency every two years. and independent robotic practice to an oversight committee (see • Case logs from recent two years must next section). Upon completion of perform at least 20 procedures per the above stages of training, the year, in these two years. learner graduates with a certificate that • Failure in the above will result in case- proctoring for the next two cases. enables them to apply for accreditation to practise independently. • Surgeons who are inactive for more than 90 days must complete core simulator exercises with a passing 3.2. DETERMINING score above 90%. COMPETENCE AND • Surgeons performing more than 50 PROFICIENCY cases in two years will be exempt from Up until recently, competence was based the above. on case observations by proctors, usually It is important to note that the criteria for qualifying as a proctor need to be based designated by the company. Case volumes on multidimensional assessment that takes alone should not be sufficient to determine competence. Ideally, there would be into account volumes of procedures but evidence of competence based on agreed also goes beyond mere volumes to include metrics and clinical outcomes, which are clinical benchmarks and the demonstrable collected, recorded and monitored through ability to train and educate others. a local oversight committee in charge of maintaining quality. Video recording of cases is often a good way for surgeons to learn from mistakes and become more efficient, so we recommend that surgeons provide evidence of video-recording of cases for review before being signed off as competent and proficient. 9 4. Developing the robotic surgical team Safe and successful surgery always nature of the surgical work, including depends on effective teamwork of the the absence of tactile feedback for the wider surgical team, with every member operating surgeon, who may not be contributing and playing a part in a complex scrubbed and be far away from the bedside division of labour. When it comes to robotic theatre team. Using robots has a significant surgery in particular, several studies (eg, impact on the division of labour in the Jayne et al 2017 and Randell et al 2023) team: as the robotic equipment enables the demonstrate that building effective robotic surgeon to do more, the role of the surgical teams is integral to successful assistant changes and there is a different robotic programmes. distribution of tasks among team members, When planning for the introduction of different professional jurisdictions and RAS, it is important that each hospital a different way of coordinating the surgical workflow, including the need for has a surgical workforce strategy in the assistant surgeon to communicate place that focuses on capacity building and appropriate training for surgical care information to the operating surgeon practitioners, robotic assistants and nurses, who may not have visual contact with so that they are able to work confidently the patient. It is imperative that there is with surgical robots. The Royal College a clear understanding of each member’s of Surgeons of England has developed respective role and responsibilities, and a robotic surgery module in its recently a defined framework for verbal and non- verbal communication between members revised surgical care practitioner curriculum of the surgical team who may not be close that lays out the minimum theoretical, clinical and technical skills for working as to each other. part of a RAS team in a given surgical Hospitals should therefore focus on more specialty and can be used as a basis for than just training surgeons or individual the training of the wider surgical team. members of the surgical team in isolation, but make plans for the training of whole When developing robotic teams, it is teams, including team evaluation processes particularly important to take into account how the introduction of RAS alters the and assessment benchmarks. 10 5. Introducing RAS into surgical services There are currently no national standards • ensuring RAS is conducted in a safe for introducing and maintaining a successful manner by an appropriately trained programme of RAS in hospitals, including surgeon adequate further training, accreditation of skills and ongoing quality improvement. • approving new programmes/ This section outlines individual roles and departments intending to develop RAS • approving proposals for new responsibilities for all key stakeholders procedures to be performed with involved in the successful introduction and RAS before their submission to the governance of the programme, alongside New Interventions and Procedures basic principles for building and maintaining Committee (NIPC) competence and quality. • facilitating less complex cases to be carried out robotically if deemed 5.1 THE HOSPITAL beneficial for training TRUST/HEALTH BOARD • signing off surgeons for platform competence/proficiency and While developing a robotic surgery independent robotic practice programme, a hospital trust or a health board will ensure that it has developed • developing a surgical workforce processes and procedures for safe strategy that builds capacity and and continued training of its workforce ensures appropriate training for the (surgeons and theatre staff), infrastructure wider surgical team, including surgical (sterilisation, theatres) and service care practitioners, robotic assistants agreements with the provider robotic and nurses (see section Developing company for 24/7 technical support. the surgical team) overseeing audit and outcome data of The robotics programme in each individual • hospital trust/health board should be established and new RAS procedures overseen by an oversight committee, eg, • providing recording equipment/facilities a ‘Robotics Surgery Governance Group for all robotic operations for the (RSGG)’ with responsibility for ensuring purposes of audit and/or assessment the safe delivery of robotics surgery for • encouraging innovation and research patients. Once established, this RSGG in the field of RAS in a secure would meet on a quarterly basis and governance framework comprise representatives from the surgical directorates undertaking robotics surgery, • devising a streamlined process of theatres, audit and governance lead. temporary contracts for UK and Recognised International Proctors, Its terms of reference will be defined by which bypasses protracted Human each individual hospital trust/health board. Resources checks. These will include the following: 11Independent practice (sign-off Once all the above requirements had been met, surgeons would submit the and full accreditation) • Surgeons would be granted permission documentary evidence to the RSGG to practise RAS after completing the to apply for structured training on the minimum required number of proctored robotics surgical system (or another cases as outlined above; and after robotics system, as applicable). This would be primarily to ensure that training and submitting completed proctoring forms resources were coordinated and utilised as and a letter of competence from their efficiently as possible. Structured training surgical proctor to the RSGG. would comprise the mandatory elements • Such permission for independent practice should consider the mentioned in the previous section of this document. differences in robotic platforms and, It would be the responsibility of each where appropriate, it should be device- surgeon/hospital trust/health board to or platform-specific. fund and support training as required. All • Full accreditation would be granted to the submitting surgeon after a surgeons would be required to provide satisfactory audit of outcomes of their documentary evidence of completion of all elements of the training. first ten cases had been reviewed and The only permitted exemptions would approved by the RSGG. Where the be in the case of fellowship-trained necessary expertise was not available robotics surgeons and also newly locally, audited outcomes would be submitted to a national or international appointed consultants who were already expert for review, as required. independently performing robotic surgery at other hospital trusts/health boards—they • Where possible, we strongly would not be required to repeat elements of recommend that surgeons start a the training. The hospital trust/health board robotic surgery practice in collaboration may, however, request that the surgeon’s with at least one other surgeon—this first few robotic cases should be proctored can provide valuable peer support and by a recognised proctor as they would be safeguard against isolation. working in a new environment and with a new surgical team. 5.2 THE SURGEON To be considered a fellowship-trained robotics surgeon, an applicant would need Surgeons wishing to incorporate robotics to demonstrate that they had successfully surgery into their scope of practice would first have to demonstrate completion of the completed no less than 6–12 months’ following requirements: training at a nationally and/or internationally recognised centre for robotic surgery and • evidence of an approved, fully training. Required documentation could costed business case for a specific include the following: procedure(s), signed off by the details of the specific robotics training Clinical Director • Fellowship undertaken, including • approval by the ‘New Intervention information regarding the amount of Procedure Committee’ (or similar body time spent on the following elements: with the same function) theoretical training; the number of • a letter of support from the applying simulator sessions; dry-lab training and surgeon’s Clinical Director. operations performed as an assistant and console time undertaken 12• a completed robotics training logbook of RAS proctors (UK and European) with a clear delineation of each • a certificate of completion of robotics proctor’s device- or platform-specific training, or alternatively, a letter area of expertise; of support from a robotics training supervisor confirming satisfactory • it will also keep a register of hand- completion of specific robotics training dominance, to match a left-handed Established robotics surgeons, newly surgeon with a left-handed proctor appointed to a respective hospital trust where this is feasible. and intending to continue offering robotics surgery, would need to submit the following: 5.4 THE PROCTOR • a letter of support from the lead clinician at their previous employing Every attempt should be made to utilise trust, confirming their competence to existing robotics-trained surgeons already perform robotics surgery, and a copy of employed in a department. This would not their most recent appraisal only be the most cost-effective solution for the hospital trust/health board but would • a completed surgical logbook also provide more robust governance demonstrating surgical outcomes from measures than external ‘drop-in’ proctors the last 12 months of robotics surgical who would have no specific allegiance. procedures • accreditation requirements for robotics Where this is not possible—for example, surgical practice as outlined below. where there are no robotically trained surgeons in a specific department or in the UK—mandatory requirements for robotics 5.3 THE ROBOTIC proctors would be as follows: a surgeon already accredited to COMPANY • perform robotics surgery elsewhere It will be the responsibility of the company and who had performed more than 100 supplying a robotic system to ensure that: robotics procedures (platform-specific) • its system is provided with 24/7 • a surgeon with their own library technical support; of prerecorded operative videos • it will develop well-defined training demonstrating the surgical techniques pathways for surgeons and theatre or procedure they plan to teach staff, which are compliant with good • a surgeon on the respective robotics clinical practice and recommended that company’slistofapprovedsurgicalproctors it is accredited by RCS England. This • Once appointed, the same surgeon will include online training modules, would attend all proctored cases for the simulation and technical training on the robotics trainee to ensure appropriate robotic system; safety and progression. For the sake • it will organise for the surgical team to of continuity and consistent oversight, visit the proctor hospital; we recommend avoiding the use of • it will arrange for the proctor to come multiple proctors other than in over to train the surgeon and the exceptional circumstances. surgical team until the surgeon is • A proctor would be required to be a deemed fit for an independent practice surgeon in the same specialty as the by the RSGG; training surgeon and be familiar with both the robotics and non-robotics • it is responsible for keeping a register 13 form of the surgery. Ideally, they would 5.5 THE GENERAL be on hand to assist with specific MEDICAL COUNCIL issues pertaining to positioning, system docking and instrumentation The General Medical Council (GMC) and system troubleshooting. It would, needs to define its role and responsibility in however, be expected that from time developing a safe RAS practice in the UK. to time, the proctor might be required As the number of surgeons and surgical to perform components of the surgery; specialities seeking to develop RAS is for example, to assist in a difficult expected to increase in the UK, there dissection and to ensure that the will invariably be a need to rely on RAS surgery was completed in a timely fashion. proctors from Europe or the US as there will be very few or no proctors available in • All visiting surgical proctors would certain specialities in the UK. require a letter of authority from Human We would welcome a confirmation from Resources, indicating that the GMC that they will offer temporary they were indemnified by the hospital trust/health board to supervise registration to internationally recognised proctors and world-renowned surgeons robotics training. who may agree to come over to train UK • Every effort should be made to avoid surgeons for a short period (3–6 months). the occurrence of adverse events at the hospital trust. As such, all Under current arrangements a European/ US proctor may come over and advise training surgeons would be required to but cannot legally take over part of the undertake a minimum of ten proctored robotic procedure in case of a difficulty. This surgical cases before being considered exposes the patient, surgeon and the trust for independent surgical practice. to great jeopardy. This remains one of the Exceptions would include fellowship- trained robotics surgeons who would major factors for the slow development of be required to undertake a minimum of RAS in the UK when compared with Europe and the US. five proctored cases. A mechanism needs to be developed under • Established robotics surgeons from which a proctor could be given a temporary outside the hospital but recently employed may still require observation registration (3–6 months) by the GMC on the recommendation of the hospital trust’s by an internal trust/health board proctor medical director. for a minimum of three cases. Each There is a need to develop (in concert with proctored case would be signed off by the surgeon, proctor and scrub nurse the surgical royal colleges and surgical or anaesthetist for submission to specialty associations) a national register/ the RSGG. audit of patients undergoing RAS, or to adapt existing audits to incorporate comprehensive new datasets to capture this information. 14Hospital Trust/ Surgeon Proctor Robotic GMC Health Board Company Develop a process Apply for and A surgeon who has Its system is Must devise and procedures undertake structured already performed provided with 24/7 a mechanism for safe and training in RAS more than 100 technical support of temporary continued training robotics procedures registration for of its workforce Online training and is registered as Develop well- a recognised (surgeons and programme (as a robotics proctor defined training proctor on theatre staff), specified by pathways for the advice of respective robotics Attend all surgical surgeons and infrastructure system provider) cases to ensure theatre staff in the medical (sterilisation, director of a theatres), service Undertake a appropriate safety concert with RSGG hospital trust/ agreements with and progression Arrange for the health board robotic company specified number of for 24/7 technical robotic procedures Assist with proctor visits to Develop in support under the guidance all aspects of train the surgeon concert with of a proctor surgery including and the surgical surgical royal Develop a trouble-shooting team until the colleges Sign off from RSGG and performing surgeon is robotic surgery for independent components of the deemed fit for and surgical governance robotic practice speciality group with clearly surgery an independent associations defined TORs Participate in Would advise practice by the a national continuous audit RSGG register/audit Devise a of robotic surgical RSSG on the of patients streamlined sign-off of the Keep a public, undergoing process of outcomes trainee surgeon device-specific temporary register of RAS RAS proctors (UK and contracts for European) proctors 5.6 OTHER KEY tactile feedback. Learners should aim to restrict training cases to those with CONSIDERATIONS a BMI below 35. • Selection of cases: There must be • Consent: The College’s guide careful consideration around which Consent: Supported Decision-Making cases should be selected for the sets out the information that surgeons initial cases of robotic surgery. We should provide to patients as part of recommend learners start with easier the consent process. This includes cases and non-severely comorbid the purpose and expected benefit of patients before gradually stepping up the treatment, what it involves, the to more complex cases. High body likelihood of success, the material risks mass index (BMI) is one of the main of the procedure and the alternative determinants of surgical difficulty in options. Even if a surgeon cannot robotic surgery, as intracorporeal fat offer all alternatives, they should be tends to obscure normal anatomy and familiar enough with the relevant compounds the challenge of lack of literature to refer the patient to the right 15 service/professional. When it comes Conflicts may also arise where the to new technologies such as RAS, it is patient has been referred to, or has essential that the consent discussion specifically asked to see, a particular also includes information about: surgeon because they are known to undertake an innovative procedure, • the innovative nature of the placing pressure on the surgeon to procedure • the surgeon’s learning curve and undertake the procedure even though their specific experience with the an alternative might be more suitable for that particular patient. There may technology be financial incentives for both the • the presence or absence of a surgeon and for healthcare providers surgical proctor for the procedure to offer an innovative procedure, • the risks and benefits of the in terms of the fees paid. In these procedure, including possible situations, conflicts can arise for both unforeseeable or unknown risks the surgeon and the organisation. or outcomes Oversight mechanisms for the surgical innovation must exclude any • alternatives to the innovative procedure. temptation to encourage patients The learning curve refers to the increased to participate in innovation over an established procedure or to overstate risks to patients during the time in which a its benefits. The natural desire to surgeon or surgical team gain competency obtain positive outcomes when in a new procedure. It applies where the original innovator is gaining experience implementing new technologies may in the new technique but also where the lead to bias in patient management decisions, as well as in data technique is performed in different hospitals collection and reporting. At all times, by other surgeons (Soomro, 2019). surgeons must preserve the best Patients and their families must know when interests of their patient and uphold they are participating in innovation, so it is essential that surgeons are transparent ethical standards when making and particularly tell their patients when they decisions about the application and dissemination of new technologies. carry out a procedure for the first time. Lack Registers: For registers to be effective of transparency when it comes to material • information and the availability of other and to adequately support the safe options can result in furthering disparities and consistent expansion of RAS, they in healthcare literacy, which in turn is must be accessible. In this document, we have therefore recommended correlated with lower socioeconomic status. that each company keeps a public • Managing conflicts of interest: Surgeons must be open about any register of RAS proctors with a clear conflict of interest arising for both the description of their experience and expertise in any given device. In surgeon and their organisation. Such due course, we would like to see a conflict can arise from their relationship single, international register across all with the companies that manufacture companies. This should be company- the innovative technology, particularly where this leads to significant financial funded and hosted by an independent or reputational gain. Surgeons organisation such as the Healthcare Quality Improvement Partnership, should disclose to their patients all preferably led by the surgical relationships with companies that royal colleges. manufacture technology used as part of their operation. 16• Mentoring: Other than proctorship, relationship with an experienced which is an essential part of RAS colleague who can guide and support training, the College also recommends another surgeon at any stage of their that surgeons seek a surgical mentor career regarding their personal and throughout their career but particularly professional development. The mentor when taking on a new role and in achieves this by listening and talking the early stages of their independent to the mentee in confidence. The RAS practice. Proctorship includes mentoring relationship can include a hands-on training, feedback and re-examination of the surgeon’s ideas oversight in the clinical setting, or career goals, identifying further as well as an assessment of the learning, skills improvement and wider surgeon’s skills and competence professional development needs, before practising independently. and can provide support in difficult Mentoring, on the other hand, is an situations. informal (albeit structured) supportive 17 6. A pathway to the future The 21st century has brought an increasing could either perform preprogrammed variety of less invasive ways to treat tasks, thereby complementing human disease and to carry out surgery. In addition performance, or learn from its own to being a tool in the surgeon’s toolkit, experience through a feedback sequence robotics and computer-assisted technology of good and poor outcomes. This is in particular have the potential to provide a probably a long way in the future and pathway to the future not just by improving comes with significant additional ethical the technical or mechanical aspects of and systemic considerations. This makes surgery but also by providing enhanced the proper and cautious evaluation and vision around preoperative or intraoperative meticulous comparative effectiveness imaging. Incoming technologies in surgery research of RAS even more important. Any can support intraoperative decision making future developments need to proceed with through rapid pattern recognition and by transparency and sufficient assurances converting data to information in a way of patient privacy and confidentiality of that can support the operating surgeon’s data through high-security platforms and judgement and perception and steer them appropriate regulation. Decisions need away from danger or error. to be based on objective research that Digital surgery can also enhance training considers the full implications of using new through the integration of digital tools technologies, not just at the individual level into the surgical curriculum, including but also at a systemic and societal level. telementoring and teleproctoring. It is also important to establish the right Such technologies can provide more relationship with industry, being clear sophisticated ways of benchmarking and transparent about what constitutes training progress and introduce better and a conflict of interest and establishing an more accessible simulation training. They effective dialogue that will benefit both can also drive improvements in patient patients and surgical education. care by converting large data into valuable information that accurately measures The College is committed to working with surgeons, patients, industry partners, technical performance, identifies poor regulators and commissioners to achieve surgical outcomes and advances equity and maintain a high standard of surgical of access to surgery. As such, they can training and practice so as to realise the offer better value to society at large when benefits of RAS for hospitals, surgeons it comes to understanding and responding and patients. To find out more about the effectively to the population’s surgical needs. College’s work on robotic surgery, please visit our website at www.rcseng.ac.uk. It is possible that robotic surgery will eventually reach an era where a robot 18 7. References Peer-reviewed literature 1. Aradaib M, Neary P, Hafeez A et al. 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Eur Spine J 2016; 25: 947–955. 16. Kayani B, Konan S, Pietrzak JRT et al. Iatrogenic bone and soft tissue trauma in robotic-arm assisted total knee arthroplasty compared with conventional jig-based total knee arthroplasty: a prospective cohort study and validation of a new classification system. J Arthroplasty 2018; 33: 2496–2501. 17. Kayani B, Tahmassebi J, Ayuob A et al. A prospective randomized controlled trial comparing the systemic inflammatory response in conventional jig-based total knee arthroplasty versus robotic-arm assisted total knee arthroplasty. Bone Joint J 2021; 103-B: 113–122. 18. Kayani B, Konan S, Tahmassebi J et al. An assessment of early functional rehabilitation and hospital discharge in conventional versus robotic arm assisted unicompartmental knee arthroplasty. Bone Joint J 2019; 101-B: 24–33. 19. Kayani B, Konan S, Tahmassebi J et al. Robotic-arm assisted total knee arthroplasty is associated with improved early functional recovery and reduced time to hospital discharge compared with conventional jig-based total knee arthroplasty: a prospective cohort study. Bone Joint J 2018; 100-B: 930–937. 20. Kayani B, Konan S, Tahmassebi J et al. A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty. Trials 2020; 21: 194. 21. Khlopas A, Sodhi N, Sultan AA et al. Robotic arm-assisted total knee arthroplasty. J Arthroplasty 2018; 33: 2002–2006. 22. Lawrie L, Gillies K, Davies L et al. 2022. Barriers and enablers to the effective implementation of robotic assisted surgery. PloS One 2022; 17: e0273696. 23. Marchand RC, Sodhi N, Khlopas A et al. Coronal correction for severe deformity using robotic-assisted total knee arthroplasty. J Knee Surg 2018; 31: 2¬–5. 24. Moss EL, Morgan G, Martin AP et al. Surgical trends, outcomes and disparities in minimal invasive surgery for patients with endometrial cancer in England: a retrospective cohort study. BMJ Open 2020; 10: e036222. 25. Naziri Q, Cusson BC, Chaudhri M et al. Making the transition from traditional to robotic-arm assisted TKA: what to expect? A single surgeon comparative-analysis of the first-40 consecutive cases. J Orthop 2019; 16: 364–368. 26. Patel V. Future of robotics in spine surgery. Spine 2018; 43: S28. 27. Ramsay C, Pickard R, Robertson C et al. Systematic review and economic modelling of the relative clinical benefit and cost-effectiveness of laparoscopic surgery and robotic surgery for removal of the prostate in men with localised prostate cancer. Health Technol Assess 2012; 16: 1–313. 28. Randell R, Greenhalgh J, Hindmarsh J et al. 2019. How do team experience and relationships shape new divisions of labour in robot-assisted surgery? A realist investigation. Health (London) 2021; 25: 250–268. 2029. Robertson C, Shaikh S, Hudson J et al., 2022. The RoboCOS Study: development of an international core outcome set for the comprehensive evaluation of patient, surgeon, organisational and population level impacts of robotic assisted surgery. PLoS One 2023; 18: e0283000. 30. Sánchez-Margallo FM, Sánchez-Margallo JA. Analysis of surgeons’ muscle activity during the use of a handheld robotic instrument in laparoendoscopic single- site surgery. In: Duffy VG and Lightner L (eds) Advances in Human Factors and Ergonomics in Healthcare, Advances in Intelligent Systems and Computing. Cham: Springer; 2017: 482. 31. Scholl LY, Hampp E, Alipit V et al. Does the use of robotic technology improve surgeon ergonomic safety during TKA? EPiC Series in Health Sciences 2019; 3: 322–324 https://easychair.org/publications/open/62mV. 32. Shepherd JM, Harilingam MR, Hamade A. Ergonomics in laparoscopic surgery—a survey of symptoms and contributing factors. Surg Laparosc Endosc Percutan Tech 2016; 26: 72–77. 33. Smith R, Patel V, Satava R. Fundamentals of robotic surgery: a course of basic robotic surgery skills based upon a 14-society consensus template of outcomes measures and curriculum development. Int J Med Robot 2014; 10: 379–384. 34. Soomro NA, Hashimoto DA, Porteous AJ et al. Systematic review of learning curves in robot-assisted surgery. Br J Surg 2020; 4: 27–44. 35. Suarez-Ahedo C, Gui C, Martin T et al. 2017. Robotic arm assisted total hip arthroplasty results in smaller acetabular cup size in relation to the femoral head size: a matched-pair controlled study. Hip Int 2017: 27: 147–152. 36. Vigdorchik JM, Sharma AK, Aggarwal VK et al. The use of robotic-assisted total hip arthroplasty in developmental dysplasia of the hip. Arthroplast Today 2020; 6: 770– 776. 37. Wallace DJ, Vardiman AB, Booher GA et al. Navigated robotic assistance improves pedicle screw accuracy in minimally invasive surgery of the lumbosacral spine: 600 pedicle screws in a single institution J Robot Sur 2020; 16: e2054. 38. Warwick Clinical Trials Unit. Robotic arthroplasty: a clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip). June 2021. https://warwick. ac.uk/fac/sci/med/research/ctu/trials/racer-hip/patientsinfo/racer-hip_protocol_ v1.1_22_june_2021.pdf 21Professional organisation and industry documents 1. Association of British HealthTech Industries, 2022. White Paper – Robotic-assisted surgery and new models of surgical care. 2. Association of Surgeons in Training and The Royal College of Surgeons of England, 2022. Future of Surgery: Technology Enhanced Surgical Training: Report of the FOS:TEST Commission, August 2022. DOI: 10.1308/FOS2.2022. 3. CMR Surgical, 2019. Feeling the strain: The physical and mental impact of performing surgery. 4. NHS England, 2015. National Commissioning Policies - RAS procedures for prostate cancer. 5. NHS England, 2018. RAS for early kidney cancers that are unsuitable for conventional laparoscopic surgery. 6. Royal College of Surgeons of Edinburgh, 2023. Development of new robotic surgical services. 7. Royal College of Surgeons of England, 2014. Good Surgical Practice. 8. Royal College of Surgeons of England, 2015. The High Performing Surgical Team. 9. Royal College of Surgeons of England, 2018. Report of the Commission on the Future of Surgery. 10. Royal College of Surgeons of England, 2019. Surgical Innovation, New Techniques and Technologies - A guide to good practice. 11. Royal College of Surgeons of England, 2022. Supported Decision-Making – A guide to good practice. 12. Royal College of Surgeons of England, 2022. Working in the Independent Sector - A Guide to Good Practice. 13. Royal College of Surgeons of England, 2022. The Curriculum Framework for the Surgical Care Practitioner. 14. Royal College of Surgeons of England, 2023 (forthcoming). Mentoring – A Guide to Good Practice. 22The Royal College of Surgeons of England RCS England produces a wide range of standards and guidance to support the surgical profession within the areas of team working and leadership, legal and ethical concerns, personal development and service improvement. To find out more about our work visit www.rcseng.ac.uk/standardsandguidance. The Royal College of Surgeons of England 38–43 Lincoln’s Inn Fields London WC2A 3PE The Royal College of Surgeons of England The Royal College of Surgeons of England @RCSnews @royalcollegeofsurgeons The Royal College of Surgeons of England Registered Charity number 212808 www.rcseng.ac.uk/standardsandguidance