Implementation of a new robotic system: challenges for the surgical team and ethical concerns about patient safety, a longitudinal questionnaire study

Abstract

Introduction

The da Vinci robot continues to be the leading robotic system used in surgery. Following the expiry of its patent, many manufacturers started to develop other systems. We accompanied this sensitive initial phase of implementing a new surgical system in a clinic at which the previously established robotic system has completed its learning curve. Is it ethically justifiable to implement a new robotic system although an established, reliable and low-risk procedure is available?

Research design and methods

We conducted a longitudinal and interdisciplinary questionnaire study from November 2022 to April 2023. Specific questionnaires – answered on a visual analog scale from 1 to 100 - were created for four target groups: surgeons, anesthesiologists, residents, and operating-room (OR) nurses.

Results

A total of 63 participants filled the questionnaire and answered the tailored questions. While the surgeons, along with the OR nurses, initially had the greatest reservations about the Dexter robot and patient safety, their reservations lessened as the number of Dexter procedures performed increased. In contrast, the OR nurses were critical of the new robot and their ratings did not change as the number of Dexter procedures increased. Of all four groups, the residents rated the Dexter robot most positively.

Conclusions

The establishment of a new surgical system that has been approved, yet not established so far, constitutes a major challenge with regard to ethical issues concerning patient safety. A standardized, mandatory curriculum for the entire surgical team would be desirable in order to achieve a similar level of technical expertise as that existing for the established robot system. In addition, we need comprehensible and transparent information for patients. To date, we lack regulations concerning these aspects, which are handled differently in the individual hospitals.

WHAT IS ALREADY KNOWN ON THIS TOPIC

• The implementation of a new surgical system, such as a new robot, is a challenge for the entire surgical team.

WHAT THIS STUDY ADDS

• We accompanied the members of a surgical team (surgeons, anaesthesiologists, residents, operating room nurses) during the initiation phase of a new robotic system and used questionnaires to work out the requirements/problems that the new robot brings with it. Ethical and moral concerns regarding patient safety were at the focus of this process.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

• A standardised mandatory curriculum for the entire surgical team would be desirable in order to achieve a similar level of technical expertise as that existing for the established robot system. In addition, we need comprehensible and transparent information for patients. To date, we lack regulations concerning these aspects, which are handled differently in the individual hospitals.

Introduction

Minimally invasive surgery has become increasingly important in recent years, particularly in gynaecology, urology and general surgery. The da Vinci robot still is the leading robotic system. Following its market launch in 2000 by Intuitive Surgical, Sunnyvale, California, USA, it has been the most frequently used robotic system throughout the world.¹ The expiry of the da Vinci patent gave rise to the introduction of other robotic systems in the market.² These include the Dexter Robotic System (Distalmotion SA, Epalinges, Switzerland), which was introduced in 2020. The Dexter consists of an open sterile surgical console, two patient carts, surgical units containing the robotic arms and a separate endoscopic arm for imaging. The current research situation is limited to studies focused on the new robotic system (Dexter) and comparative studies of new robotic systems, specifically addressing clinical outcome parameters.^{3 4} Some authors have evaluated the da Vinci robot or its competitors (Senhance, Avatera, Hintori), describing their design, pros and cons in handling and clinical outcome parameters.^{2 5} These analyses are important before widespread use of a device can be recommended. A careful comparative evaluation must precede the purchase, use and any statement about the equivalence or superiority of a new device compared with existing procedures.

In Kiel, Germany, a study group performed several studies focused on feasibility, safety and patient outcomes.^{3 4 6 7} The da Vinci robotic system, which has been successfully established at our clinic, has been in use for several years and is considered to be on par with conventional laparoscopy. It has become an inseparable part of clinical routine and is no longer regarded as a major challenge for the surgical team. The learning curve has been completed and surgical procedures can be performed just as swiftly, with as few complications as in conventional laparoscopy.8,10 In addition to the well-established da Vinci system, another robotic system known as Dexter is now to be implemented in clinical routine. Handling and working with the Dexter robot are in the initial stage. The entire surgical team is embarking on the learning curve.

The transparency and clarification of a new surgical challenge for the clinic and the surgical team will be addressed and discussed in the present study. This situation poses major ethical challenges for the treating physicians: the statutory approval of a system does legally entitle a clinician to use a device unconditionally, but from an ethical and moral point of view it does not justify immediate application of the device. This is especially true when a functioning alternative system is available. To what extent should the patient be informed? How can a sensible and ethically acceptable decision be made in this sensitive phase? This ethical aspect has rarely been addressed in the published literature. All ethical issues that arise from the patient’s point of view when implementing and using a new surgical technique, despite the availability of an established method, have not been addressed so far.

Beauchamp and Childress described four principles of medical ethics in 1979.¹¹ Although this was several decades ago, it is more relevant than ever today. The four principles are: (1) Respect for the patient’s autonomy. The patient’s informed consent is paramount. It is given when the patient has been sufficiently informed, has understood the explanation, decides voluntarily, is capable of making a decision and actively gives his consent. (2) The principle of non-maleficence. This principle dates back to antiquity and constitutes the core of the Hippocratic Oath. Possible complications and risks should be compared with the benefits and discussed with the patient. (3) The principle of beneficence means preventing and eliminating harm to the patient, and supporting his or her well-being. (4) The principle of justice refers to a fair distribution of benefits and burdens in the health system, for example, the income-based financing of the public health system.^{11 12}

Unlike other fields such as aviation, where realistic training can be conducted on a simulator, we lack a developed method of true-to-life training in robot-assisted surgery. Even though a Dexter simulator is available for learning to handle the new robot and despite the fact that the manufacturer has implemented a stepwise training concept,¹³ we lack any legal requirements or guidelines that prioritise patient safety. A significant portion of the learning curve is traversed during the treatment of patients and this raises ethical concerns because a new technique signifies a new learning curve and raises the questions: does a new technique need ethical approval and how would this be achieved^{12 14}?

We accompanied the preliminary phase and addressed ethical concerns in implementing a new robotic system that is basically established but still completely new to the surgical team.

Methods

The Dexter robot was provided free of charge by the manufacturer as part of an extended approval study. Before performing the initial surgical procedures with the Dexter robot, the surgeons completed the competency-based training programme provided by the manufacturer. It included an online course, extensive practice on a simulator console with various digital procedures and a mix of dry-lab and wet-lab hands-on sessions. After acquiring the manufacturer’s certification, the surgeons performed their first procedure. The surgical team consisted of a specialist surgeon at the console, an assistant surgeon at the patient’s bedside, two operating room (OR) nurses, an anaesthesiologist and a nurse anaesthetist. In addition to the surgical team, a clinical specialist from Distalmotion was on site during all procedures to assist with any potential technical difficulties with the robot.

We conducted a longitudinal questionnaire study from November 2022 to April 2023. Specific questionnaires were created for four target groups: surgeons, anaesthetists, residents and OR nurses. The residents using the Dexter robot were primarily bedside assisting because operating the console was mainly reserved for senior physicians and chief physicians. The residents were reviewing the patients postoperatively.

The questionnaires were designed to cover the following topics: (1) Self-assessment of surgical skills, perception of competence and learning progress; (2) Simulation and training experience, correlation between practice volume and safety; (3) Assessment of acceptance and technology preference; (4) Safety and changeover aspects, evaluation of stress and patient safety perception. The questions are based on the theoretical, scientific concepts of OSATS (Objective Structured Assessment of Technical Skill) and GEARS (Global Evaluative Assessment of Robotic Skills), but were then individually modified and adapted to the present study.^{15 16}

The questions were to be answered on a Visual Analogue Scale (VAS) from 1 to 100 (0: very low; 100: very high). Five surgeons, 15 anaesthetists, 21 residents and 22 OR nurses were included in the study. The response rate was 88%.

Details of the individual questionnaires are described in the following, based on the questionnaire used for surgeons. Those designed and used for the other three groups are summarised.

The surgeons were first asked to assess their skills in conventional laparoscopy. This was followed by questions about their self-assessment of surgical skills on the da Vinci robot and on simulator training. These basic questions were followed by six further questions, which were answered repeatedly by the surgeons, that is, before each procedure conducted on the Dexter robot, in order to evaluate their learning success and improvement in handling and dealing with the new system (a maximum of 23 Dexter procedures were conducted by an individual surgeon). The surgeons were asked about technical difficulties in performing the respective procedure (question 6), the surgical options offered by the Dexter robot and not available on the da Vinci (question 7), whether a switch to the Dexter robot would mean a major change (question 8), whether the surgeon himself felt confident about using the Dexter robot after the respective operation (question 9), whether the surgeon had concerns regarding patient safety when using the Dexter robot in general and in comparison to the da Vinci system (questions 10 and 11) and whether the respective surgeon would operate a familiar person with the Dexter or the da Vinci robot (question 12).

The anaesthesiologists answered a total of six questions before each Dexter procedure. They were asked about changes and challenges related to the induction, maintenance and emergence of anaesthesia, as well as concerns about patient safety. The residents answered a total of six questions concerning the advantages of the Dexter over the da Vinci robot, whether they had prepared for the change and their views on patient safety. The OR nurses answered a total of eight questions and were asked about the set-up for the Dexter compared with the da Vinci robot, challenges in switching to a different system, personal opinions and—like the other three groups—the same three questions regarding patient safety as detailed below.

All four questionnaires were approved by a medical statistician (www.medistat.de). The questionnaires are available as an online supplemental file 1 at the end of the manuscript.

Statistical analysis

Quantitative values (age, professional experience and the answered questions of the questionnaire) were presented as means and SD, minimum, maximum and quartiles. Ordinally and nominally scaled values (gender, title, handedness and position at the clinic) were shown in absolute and percentage frequencies. The ratings from the questionnaires were presented in scatterplots, depending on the sequence of the Dexter intervention, in order to determine changes over time. SPSS Statistics V.30 (SPSS, an IBM Company, Chicago, Illinois, USA) was used for statistical calculation.

Results

A total of 63 individuals filled the questionnaires. These were 5 surgeons, 15 anaesthetists, 21 residents and 22 OR nurses. The mean ages (SD) in the respective groups were 47.0 years (SD 2.5), 30.1 years (SD 2.8), 38.9 years (SD 6.2) and 29.8 years (SD 8.8), respectively. The male to female ratio was as follows: surgeons 4:1, anaesthetists 6:9, residents 8:13, OR nurses 1:21. The following parameters were also recorded: professional experience, academic titles, handedness, specialisation (of the surgeons and residents), medical function in the clinic (physicians) and the number of training hours on the simulator (surgeons). Table 1 provides a summary of sociodemographic data.

Table 1. Participants’ characteristics.

	Surgeons (n=5)	Anaesthetists (n=15)	Residents (n=21)	Operating room nurses (n=22)
Age (years)
Mean (SD)	47 (2.45)	30.09 (2.84)	38.86 (6.23)	29.82 (8.84)
Professional experience (years)
Mean (SD)	21.4 (2.51)	4.82 (2.99)	13.86 (6.67)	8.5 (7.02)
Gender (total)
Men	4	6	8	1
Women	1	9	13	21
Academic title (total)
No title	X	11	2	22
Doctor	1	4	14	X
Assistant professor	1	X	2	X
Professor	3	X	3	X
Handedness (total)
Left	1	2	2	3
Right	4	13	19	19
Specialisation (total)
Gynaecology	3		17	X
General surgery	1		3	X
Urology	1		1	X
Anaesthesiologist	X	15	X	X
Medical function at the clinic (total)
Resident	X	12	7	X
Specialist	X	3	4	X
Senior physician	2	X	7	X
Chief physician	3	X	3	X
Hours of training on the simulator (total)
da Vinci simulator
10	2	X	X	X
≥20	3	X	X	X
Dexter simulator
<5	2	X	X	X
10	2	X	X	X
≥20	1	X	X	X

In this case, ‘resident’ refers to the assistant at the operating table who assists the surgeon. Accordingly, the assistant can also hold any position in the clinic—from assistant physician to chief physician.

20 general surgical procedures, 16 gynaecological procedures and 2 urological procedures were performed. Online supplemental table 1 provides an overview of the individual operations.

The surgeons rated their surgical skills in conventional laparoscopy as being very high (93.1, SD 8.7) on the VAS and a little lower for the da Vinci robot (83.2, SD 13.4). All surgeons had completed training sessions on the da Vinci simulator (93.8, SD 11.7) and rated their performance on a VAS scale, whereas the benefits of these training sessions on the da Vinci for operations with the Dexter (in the real OR setting) were given a rating of 43.6, SD 31.9, on the VAS. The surgeons compared the da Vinci robot with the Dexter and, depending on the number of procedures performed with the Dexter, assessed whether the Dexter offered advantages that the da Vinci did not. The results are shown in figure 1a. The surgeons stated whether switching to the Dexter would signify a major change (figure 1b) and whether they would feel confident using the Dexter after the respective operation (figure 1c).

Figure 1. (a–c) Advantages, challenges and surgeon satisfaction when switching from the da Vinci to the Dexter robot.

For anaesthesiologists, the switch from the da Vinci robot to the Dexter did not pose any major changes or challenges in terms of induction, anaesthesia or discharge. Although it made no difference to the anaesthesiologists whether the da Vinci or Dexter robot was used on the patient, they did express ethical concerns about patient safety and would prefer to have a friend operated on with the da Vinci rather than the Dexter robot (the corresponding figure is shown in the paragraph below, under figure 3a–c).

Residents cited the following advantages for the surgeon when using the Dexter robot instead of the da Vinci: greater flexibility with regard to the patient, a quick change to laparoscopy if necessary and faster docking after a certain number of operations. With regard to themselves, some residents mentioned advantages such as the possibility to see the image in 3D or a quick changeover between surgeon and resident if necessary. However, the frequency of this statement did not increase with a rising number of Dexter interventions.

The OR nurses stated that the preparation time before the start of surgery (in terms of set-up) was longer with the Dexter robot than with the da Vinci system. However, this statement was modified later: preparation times became shorter as the number of Dexter procedures increased (figure 2a). Many OR nurses found it difficult to handle the Dexter, especially at the beginning. This also improved with increasing numbers of Dexter procedures (figure 2b). Switching from the familiar da Vinci to the new Dexter robot was described as a major challenge. Some OR nurses reported an improvement with increasing numbers of completed procedures (figure 2c).

Figure 2. (a–c) Challenges and handling of the new Dexter robot described by the OR nurses. OR, operation room.

With regard to patient safety, all four groups answered the same three questions:

1. I have concerns about using the Dexter robot on a patient who would otherwise have been operated on with the da Vinci (figure 3a).

2. I see problems regarding patient safety when using the Dexter robot (figure 3b).

3. I would rather operate a friend of mine with the Dexter than with the da Vinci (figure 3c).

Figure 3. (a–c) Assessment of patient safety from the perspective of all four groups (surgeons, anaesthetists, residents and OR nurses). OR, operation room.

While surgeons, along with OR nurses, initially had the greatest reservations about the Dexter robot and patient safety, their reservations reduced as the number of Dexter procedures increased. In contrast, the OR nurses were critical of the new Dexter robot and their view did not change as the number of Dexter procedures increased. The anaesthetists also had reservations about ethical aspects and patient safety, but not as markedly as surgeons and OR nurses. The residents rated the Dexter robot most positively of all four groups, especially when asked whether they would prefer a familiar person to be operated on with the Dexter.

Finally, all members of the surgical team had the opportunity to evaluate the advantages and disadvantages of the Dexter in the form of free text comments. These comments can be used to evaluate a potential risk to patient safety. In detail, there is uncertainty in handling the new robot system, longer operating times with a consequent increased risk regarding anaesthesia and surgical errors. The different arrangement of the foot pedals may increase the risk of incorrect application, for example, during coagulation. In addition, there were frequent system crashes before an update was installed, but these were resolved as the process continued. A selection of the quotes is shown in online supplemental table 2.

Discussion

The longitudinal study design made it possible to evaluate specific developments over a period of time as well as the participants’ personal experience with the new robotic system. The robot operating team is characterised by a certain consistency and constancy in its composition, which makes it easy to assess developments over time. While the changeover to the new system had no relevant influence on the anaesthetist’s work, a preference for the established system was registered among surgeons and OR nurses. With increasing user experience, handling the Dexter improved in both groups. Especially surgeons felt more confident and practised in using the new system and had fewer reservations after performing several operations. Nevertheless, given a choice between the new and the established system, the majority would opt for the established robot. In view of the absence of fixed rules, we need regulations in this regard. Patients undergoing surgery are entitled to transparency and crucial information should not be withheld from them.

The introduction of a new surgical system presents opportunities and challenges. Robot-assisted surgery is still a relatively new surgical method. All we can do at the present time is acquire sensitive data on its preliminary application. These data could give rise to ethical discussions or health policy issues. Once a procedure has been established, the fragile phase is concluded and the uncertainty of the new belongs to the past. The very early phase of new implementation of an existing, yet not established surgical procedure, from the perspective of all those involved in its implementation, has not been extensively addressed so far in the published literature. The Dexter robot is one of many robotic systems that have been launched on the market since the da Vinci patent expired. A systematic review by Leang et al examined the clinical outcomes of six new robotic systems in comparison to conventional laparoscopy and the established da Vinci robot.¹⁷ In detail, Micro Hand S, Senhance, Revo-i MSR-5000, KangDuo, Versius and Hugo RAS were evaluated. The authors concluded that clinical outcomes of these novel robotic platforms were comparable to the established da Vinci platforms. When compared against conventional laparoscopic approaches, the robotic platforms demonstrated lower volume of blood loss, shorter length of stay but longer operative time. The clinical outcomes achieved by these new robotic systems are comparable to the established da Vinci robotic system in simple to moderate case complexities.¹⁷ In contrast to our study, the clinical outcome was analysed here after the robot systems had been established; so, the focus was not on the fragile phase of the new implementation of a robot system, which was presented with the help of a longitudinal questionnaire study.

In surgery, we lack an established procedure for the implementation of a new surgical procedure. We lack a standardised approach for both surgeons and patients. Approval of a new surgical system merely means that a legal hurdle has been overcome. Its subsequent use, how the surgical team is trained, whether there should be examinations and curricula, and whether patients should be informed about the new system, are all handled diversely.

Depending on the respective issue, the classic learning curve is initially marked by a long, flat and often frustrating phase, followed by a steep phase tending towards an asymptote as time goes on. This can be explained by the experience gained over time and improved skills. In surgery, a learning curve effect is defined as the improvement of surgical performance over time.¹⁸ After the introduction of a new surgical method, it is natural to expect improvements in its technical execution. The measurement of acquiring surgical skills is fundamentally difficult. Either surgical progression measures (eg, operation duration or blood loss) or patient-related success measures (eg, the occurrence of complications or patient survival) can be used as a benchmark. However, both aspects only describe parts of surgical learning.¹⁹ It is also of decisive importance for the speed of learning whether the surgeon alone learns the new skills and is supported and supervised by an experienced surgical team, or whether the entire surgical team learns the new technique jointly.¹⁸ The latter was true of the situation described in the present study: surgeons, residents, OR nurses and anaesthetists were all unfamiliar with the new robotic system, so that a general uncertainty and a longer or flatter learning curve could be assumed. Even the manufacturer’s representatives, being young in age, lacked a significant body of experience they might have acquired elsewhere.

The above mentioned learning curve effect was seen in the present study: as the number of Dexter procedures performed increased, the surgeons felt increasingly confident during operations and in handling the Dexter itself, and had fewer ethical reservations in regard to patient safety. The OR nurses also became more confident and faster in the preparation and set-up phase prior to each Dexter operation. Notably, the fact that the surgical team achieved greater confidence in using the new system may well be viewed as a reverse learning curve. Specifically, the so-called worry curve decreased with an increasing number of procedures. Quite simply, the surgeons became better. The reverse learning curve could also be referred to as the ‘concern curve’. These results are consistent with the statements made by the surgical team that they were becoming more familiar with the Dexter robot as the number of procedures increased. The assistants were the most positive about Dexter from the outset. This could be explained by the fact that their area of responsibility was considered to be rather small, as they can rely completely on the surgeon at the console. Our results concerning the learning and concern curve are in line with several published reports. One study comprising a small number of cases, but based on a similar design as ours, analysed the early learning curve in robotic-assisted total knee arthroplasty (RA TKA). Three senior arthroplasty surgeons were surveyed, each performing 15 RA TKA procedures using the new robotic system.²⁰ Data on preparation, cut-to-suture and breakdown times were collected. Surgeon anxiety levels were measured preoperatively using the State-Trait Anxiety Inventory-6 scale, while postoperative satisfaction and confidence were assessed through a questionnaire. Comparing the first five surgeries to the last five surgeries, the cut-to-suture time and the general instrument preparation time decreased significantly. Surgeon anxiety levels dropped, indicating increased comfort with the system, while postoperative surveys showed higher levels of satisfaction and confidence.²⁰

Another study evaluated the learning curve when performing inguinal hernia repair with a da Vinci single-port robotic system instead of a multiport platform.²¹ The operation time (divided into docking time; prerobot time, from skin incision to side cart placement; flap closure time; console time and overall time) of 122 surgical procedures was measured retrospectively in order to analyse the learning curve of the surgical team. A cumulative sum analysis was used to analyse learning curves. The authors registered a rapid learning curve for single-port hernia repair with decreased operating times in prerobot time and overall time/cumulative sum analysis; in other words, the technical skills could be fairly easily transferred from the multiport platform to the da Vinci single-port robotic system by an experienced surgeon.²¹

As regards ethical concerns, Zorn et al addressed a specific problem concerning the safe initiation of robotic urological surgery.²² The authors mention the absence of a standardised credentialing system to assess a doctor’s surgical skills at the commencement of his/her work in robotic surgery.²² This is in strong contrast to other areas such as driving schools: the trainee is permitted to actively participate in road traffic only after he/she has passed the driving test. In aviation the pilot in training must undergo innumerable hours of training on the simulator before he/she is permitted to fly as a copilot.^{14 18} In contrast to medicine or surgery, in aviation it is routine practice to correct and coach a pilot even after several years of professional experience. These routine practices apply to pilots as well as their crew members. A similar set-up would be most desirable in medicine: simulator training before operating on the patient, regular coaching, supervision and being corrected for the purpose of improving one’s skills.¹⁴ This recommendation should not only apply to the implementation of a new surgical procedure, but also—as in our case—to the establishment of a surgical procedure that is evaluated and proven, but still new for the surgical team. As our survey showed, there were uncertainties regarding the general handling of the Dexter robot, which may have a negative impact on patient safety. If we go more into detail regarding patient safety, the following aspects were mentioned, which could fundamentally increase the risk to patient safety: uncertainty in handling the new robot system, longer operating times with a consequent increased risk regarding anaesthesia and surgical errors. The different arrangement of the foot pedals may increase the risk of incorrect application, for example, during coagulation. What does not seem to have any impact on patient safety is the different docking, ergonomic differences and team communication with an open console. With regard to the comments as a whole, it should be emphasised once again that the Dexter robot is not intended to be portrayed negatively here. If the Dexter were the established robot and the da Vinci were the new model, the negative comments would be exactly the opposite. The risks of the new implementation in general should be shown.

In the introduction, the four principles of medical ethics by Beauchamp and Childress were already mentioned and should be applied to the safety considerations in the following.¹¹ The ethical principle of non-maleficence (avoiding harm to patients) must be considered to be at risk because the learning curve for new technology temporarily increases the risk until the learning curve is completed. The examples given above could result in harm to the patient, which could be attributed to the robot system being new to the surgeon. On the other hand, all surgeons in the present study unanimously denied that patient safety had been compromised at any point. Concerning beneficence, it can be said that patients will benefit in the long term from the establishment of new robotic systems and thus from medical progress.²³ The switch from laparotomy to laparoscopy, for example, has also brought enormous advantages for patients. New robot systems represent a significant investment for the respective hospital, which not every hospital can afford. In some situations, it is possible to negotiate with the manufacturer for free provision, for example, as part of an approval study. However, this is only a temporary arrangement. In poorer countries with poor medical care, robotic systems are far from reality. In this respect, the use of robotic systems seems to depend on the availability of sufficient financial resources at the respective clinic.²⁴ Consequently, equal access to excellent patient care is extremely limited—not only when comparing countries, but also within a single area.

We advocate a structured curriculum for all surgeons who are new to the field of robotic surgery, and also for those who are experienced in the field but lacking any experience with the new robotic system. Such curricula would be useful not only as a means of protecting doctors, but also serve the interests of patients.²² Standardised simulator training with a specified training time and corresponding training modules should be mandatory for all surgeons. However, this would require the availability of a simulator at every clinic, which is de facto not the case. Simulator training would constitute an enormous economic factor in the acquisition of a new operative system. Furthermore, the subject of risk for patients would also need to be addressed. One solution to the problem would be several clinics joining forces and purchasing a shared simulator.

The training procedure should be based on a feedback programme. Surgeons should receive feedback from a proctor, both before and after the operations, in order to improve their skills after each operation or after a series of operations.^{14 25 26} Pai et al mention similar views in their report concerning medicolegal considerations in robotic surgery. First, the authors address the absence of a standardised training programme and credentialing for the surgeon’s competence on the one hand, and the patient’s safety on the other. Second, Pai et al draw attention to the patients’ awareness of robotic options and their potential risks (with reference to our work: are patients informed that they are being operated on by a surgeon who has limited experience with the robotic system being used?); and third, the problem of legal liability due to the involvement of multiple stakeholders in the functioning of robotic systems. The authors emphasise the need for structured guidelines, regulations and training programmes to regulate the medicolegal aspects of robotic surgery effectively.²⁷

Figure 4 summarises, in a flowchart, the steps from purchasing a new robot system to its safe and independent operation.

Figure 4. Flowchart showing the essential steps from the purchase of a new robot system to its independent operation.

Strengths and limitations

The study has several notable strengths. It provides real-world data collected during the implementation of the Dexter robot, offering valuable insights into outcomes that can be expected with broader adoption. In addition, the entire surgical team involved in the implementation of the Dexter robot was included in the study. That is what makes this study unique.

Despite these strengths, the study has limitations: it is a single centre study with a small sample size for surgeons and small sample size of nurses, residents and anaesthetists that have more than five cases. Furthermore, no patient perspective was evaluated and no validated questionnaire was used. The free-text comments quoted were not listed chronologically, so it is not possible to trace in detail the extent to which the frequency of positive and negative comments changed. Including a higher number of surgeons, residents, nurses and anaesthetists in the study, as well as presenting the patient’s perspective, could be important points that would strengthen the study in a possible follow-up study.

Conclusions

We have addressed the implementation of the Dexter robotic system as an additive to the existing da Vinci robotic system. The establishment of a new surgical system that has been approved, yet not established, constitutes a major challenge for the entire surgical team, especially for surgeons and OR nurses. Intraoperative safety and personal satisfaction were achieved with an increasing number of procedures, a corresponding learning curve and improved handling. Ethical concerns relating to patient safety and transparency pose a yet unresolved challenge. We are convinced that a standardised mandatory curriculum for the entire surgical team, introduced at the very start of training on a new system and continued during the entire period of training, will close the ethical gap.

Data availability statement

Data are available upon reasonable request.