European Society of Coloproctology guideline on training in robotic colorectal surgery (2024)

Robotic surgery has been utilized increasingly, including in colorectal surgery. Newer robotic platforms are coming onto the market, and more emphasis is being placed on the safety and adequate training of surgeons and theatre teams. Training in robotic colorectal surgery has not been standardized, and there are no agreed structured training and assessment methods. Some studies in minimally invasive surgery across specialities have shown that training curricula shortened the learning curve in minimally invasive surgery and, therefore, there is a greater need for guidance on training in robotic colorectal surgery based on up-to-date available evidence on the subject. The European Society of Coloproctology (ESCP) Guidelines Committee aimed to conduct a comprehensive literature review, assess currently available evidence and collate expert opinion on training in robotic colorectal surgery. Evidence was graded, and the recommendation was based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. When evidence is lacking expert opinion is considered, and the research gap is highlighted. The robotic guideline group addressed six topics with 15 research questions in the PICO format (patient/population, intervention, comparison and outcomes) and developed 11 recommendations. Most of the recommendations are based on a low or very low quality of evidence. Where the case benefits could be seen by indirect evidence or strong recommendations are unwarranted but made as good practice statements, they are made explicit by stating 'expert opinion only' without a GRADE level. The use of robotic surgery has steadily increased over the last years in both general surgery and colorectal surgery [1]. Approximately 1000 robotic-assisted procedures were performed worldwide in 2000; by 2018 this had increased to more than a million [2]. The advantages of robotic surgery were thought to be its suitability for confined spaces and complex operations such as rectal cancer surgery. The application and volume of practice continue to expand, and more robotic platforms are coming to the market [1, 3]. The projected global surgical robot market by 2025 is 275 billion USD. This is driven by innovation, growth in procedure volume and access to emerging markets [4]. It is crucial when introducing surgical techniques that patients should not come to harm, and surgical societies should have a leading role in appraising evidence and implementing surgical procedures [5, 6]. Evidence has suggested that training curricula shortened the learning curve in laparoscopic surgery and robotic surgery [7, 8]. However, there are variations in training components and assessments in different curricula [9]. It is therefore crucial to appraise the evidence on some key training components when implementing a structured training programme. This guideline is written and intended for surgeons, theatre teams, trainees, purchasers, local, regional and national policymakers, hospital leaderships, scientific societies, professional bodies for training and accreditation, and industry partners. The ESCP guidelines committee appointed project leads (ST, YM, DC) to curate this guideline. A steering group was formed with experts in robotic surgery, training and education, and guideline development with a common interest in improving training in robotic colorectal surgery. ESCP e-newsletters and social media announced a call for other working group members to participate in the guideline. The selection of final working group members was assessed based on the following set of criteria, and also keeping to the principle of equality, diversity and inclusion (EDI): 1. Appropriate and relevant clinical experience.2. A proven track record of scientific knowledge and research skills.3. International expertise and recognition or willingness to collaborate with diverse professionals and patients.4. Geographical distribution. The working group comprises colorectal surgeons, trainees, educators, expert robotic surgeons, surgical assist/allied health professionals familiar with robotic training, a patient representative and GRADE methodologist. A professor in systematic reviews and expert guideline methodologist helped with the methodological aspects of this guideline (Table 1). The group worked closely with the methodologist (JK) to devise a strategy to perform a single set of searches to address all statements and questions relating to training in robotic colorectal surgery. The searches were not limited by date, language or publication status. The group assessed the evidence with robust analysis using GRADE. The current guidance analysed all available data through GRADE so that the strengths and limitations are transparent, and the grade of recommendation is based on these analyses. This guideline development followed the ESCP guideline recommendations and the AGREE II tool [10]. This guideline focuses on the common training components, assessments and quality controls used in robotic colorectal training. Therefore it does not cover robotic surgery in other specialities nor other minimally invasive techniques in colorectal surgery. This guideline aims to address the PICO (Patient/Population/Problem, Intervention, Comparison, Outcome) questions detailed in the following subsections. What are the effects of robotic platform training (for learners) versus no robotic platform training on patient safety in robotic colorectal surgery? *What are the effects of procedural anatomy training (for learners) versus no procedural anatomy training on patient safety in colorectal robotic surgery training? *What are the effects of the modular approach on procedural training (for learners) versus not using the modular approach on the learning curve of colorectal robotic surgery training? Is eLearning more effective than traditional learning for health professional trainees in colorectal robotic surgery training? *Note: During the Working Group discussions, these two research questions were initially proposed but dropped: please see the Results section. What are the effects of having prior laparoscopic experience (for learners) versus no prior laparoscopic experience on the learning curve for robotic colorectal surgery? What are the effects of having prior experience of one robotic platform (for learners) versus no such prior experience on the learning curve for learning another robotic platform? What are the effects of simulation training (for learners) versus no simulation training on operative performance in colorectal robotic surgery? What are the effects of simulation training (for learners) versus no simulation training on patient outcomes in colorectal robotic surgery? What are the effects of using mentoring (for learners) versus no mentoring on clinical outcomes in training colorectal robotic surgery? What are the effects of telementoring versus onsite mentoring (for learners) on clinical outcomes in colorectal robotic surgery? What are the effects of the modular approach on procedural training in the operating room (for learners) versus not using the modular approach on the learning curve of colorectal robotic surgery training? What are the effects of attending a structured TTT course for robotic surgery (for trainer) versus not attending such a course on the operative performance (trainee) of colorectal robotic surgery training? What are the effects of nontechnical skills training (for learners) versus no nontechnical skills training on patient safety in colorectal robotic surgery? What are the effects of competency-, proficiency-based supervised training (for learners) versus noncompetency-, nonproficiency-based supervised training during colorectal robotic surgery training on operative performance? What are the effects of competency-, proficiency-based supervised training (for learners) versus noncompetency-, nonproficiency-based supervised training during colorectal robotic surgery training on patient clinical outcomes? What are the effects of credentialing (for the practitioner) versus no credentialing in colorectal robotic surgery on patient clinical outcomes? What are the effects of registering clinical outcome data (for the practitioner) versus no registering in colorectal robotic surgery on patient clinical outcomes? A list of outcome measurements was suggested by members of the working group relevant to the PICO questions. Some outcomes are more important in certain PICOs than others. As there are many PICO questions, these outcomes were grouped into the following categories. intraoperative postoperative◦ Clinical◦ Oncological◦ Functional◦ Quality of life operative skills surrogate markers◦ Time◦ Complication rates◦ Oncological outcomes health professionals' behaviour, skills or knowledge time to complete a task complications errors procedural steps completed validated scores◦ Global Assessment Score (GAS), Global Rating Scale (GRS)◦ Global Evaluative Assessment of Robotic Skills (GEARS)◦ objective performance metrics such as proficiency-based progression (PBP) metrics According to the GRADE recommendations [11], outcomes were ranked according to their relative importance into three groups by panel members: (1) critical for decision-making; (2) important, but not critical for decision-making; (3) of low importance. The number next to the outcomes is on an importance scale (e.g. 1 is least important and 9 is most important). Outcomes in the first two categories, i.e. (1) and (2), will be included in the evidence profile. Literature searches were conducted on 4 May 2022 to identify relevant references on training for robotic colorectal surgery. The search strategy was supported by an expert methodologist (JK) in systematic reviews and guidelines and his team. A single set of searches was devised which aimed to address all statements and questions raised in this topic area. The search strategies were developed specifically for each database and the keywords adapted according to the configuration of each database. Searches were not limited by date, language or publication status. A further up-to-date search was performed on 1 September 2023. Full details of all search strategies are presented in Appendix 0. References identified from the searches were downloaded into EndNote bibliographic management software for further assessment and handling. Two guideline authors (ST, KR) reviewed all the abstracts generated from the searches stored in the database and retrieved the full papers for the potential studies. The two guideline authors independently identified studies, resolving disagreements through discussion with the guideline group. References in the included studies were assessed for any suitable articles for inclusion and any additional studies identified by the working group. For each predefined review question, we included study(ies) with the best available evidence, and these include randomized controlled studies, comparative studies, case series, reviews and expert opinions. Guideline authors were not blind to authors' names, institutions or journals. For each included study, data extraction was based on predefined outcomes. If the data were available, we aimed to compare the differences in effect between the baseline and after treatment in the treatment group and the difference in baseline and after treatment in the control group. We intended to present the results using confidence interval (CI) with the use of Review Manager (RevMan) 5 (Version 5.4, Copenhagen, The Cochrane Collaboration). Individual study quality was assessed using the GRADE score. Additionally, the quality of the evidence for each question was evaluated with the use of the GRADE system, which assigns one of four levels of evidence: very low (⊕∘∘∘), low (⊕ ⊕ ∘∘), moderate (⊕ ⊕ ⊕∘) or high (⊕ ⊕ ⊕⊕). Within the GRADE system, randomized controlled trials (RCTs) were generally rated as high quality but may have been downgraded on the basis of specific design flaws. Observational studies were generally assigned a low quality but may have been upgraded based on the strength of the association demonstrated and the absence of bias. The outcomes of study assessment are presented using the GradePro Guideline Development Tool (https://gdt.gradepro.org/app/). In some instances where there was no evidence or a low level of evidence we upgraded the statement after discussion within the guideline group. When there was no clear evidence in the literature, yet practice or concept was established with consensus among clinicians, recommendations were made as 'Expert opinion only' and distinguished as 'Upgraded recommendation'. All statements and the initial supporting text were presented via a virtual working group meeting. The content and the strength of each statement and recommendation were further reviewed at a dedicated Guideline Session at the ESCP Annual Conference in Dublin in September 2022. All statements were then revised to meet the changes recommended. Following this meeting, a final working group virtual meeting was convened to finalize all statements. All statements and the supporting text were subsequently edited by ST, YM and KM before the paper was sent for final revision and approval by all the authors combined. The searches retrieved a total of 1831 records. After removing the duplicates, 1298 records remained and were screened by two guideline authors. Fifty-eight articles were included in this review (Figure 1). During the discussion among the working group, the question on procedural anatomy training was dropped as this question was best incorporated into eLearning. The modular approach of knowledge learning would be under eLearning/procedural training. However, we may have to reassess these research questions in the future guidance. In the end, the working group generated the following recommendation statements for these research questions. Question 1: What are the effects of robotic platform training (for learners) versus no robotic platform training on patient safety in robotic colorectal surgery? Robotic platform training is essential to patient safety and therefore should be used in a structured colorectal robotic training curriculum. [Expert opinion only] Very little evidence has addressed this question, as platform training has been accepted as a fundamental element and requirement of robotic surgery training from its inception. Few recent articles have focused on investigating it, including this literature summary. In 2015, Tsuda et al. published a literature review to summarize the clinical evidence of the safety and effectiveness of the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA) [12]. The authors summarized peer-reviewed publications up to 2014 and specifically supported individual platform training. It is considered best practice that all users undergo individual robotic platform training (basic technology training/basic device training/'buttonology') before performing live robotic surgery [13]. Furthermore, it is recommended that training should be completed on each different platform before use. This concept is translated from the aviation industry, where training is required on each aeroplane model before flying and is generally accepted. There is a paucity of research evidence on the benefits of specific device/console training in robotic surgery. This is gaining increasing importance with the clinical introduction of multiple robotic platforms. The transferability of skills from one platform to another should also be addressed, whether there are benefits of being trained in one platform previously and how it may impact the learning curve. Patient safety, in terms of complications, should be measured according to the type of platform training. Question 2: Is eLearning more effective than traditional learning for health professionals in colorectal robotic surgery training? eLearning could be used to deliver content in colorectal robotic surgery training. [Expert opinion only] One abstract described a dedicated website to promote surgical learning and training – the Advance in Surgery (AIS) Channel [14]. It was created to provide a learning experience for colorectal and robotic surgery. The teaching is self-administered without formal feedback. This website is online-based, delivered by experts and focuses on surgical techniques, anatomy, live surgery and debates. Two studies [15, 16] examined the educational value of videos of robotic right hemicolectomy posted on YouTube (San Bruno, CA, US). Uzunoglu and colleagues evaluated the educational value of the videos by three experienced oncological surgeons using a Likert scale. They classified these videos into good, moderate or poor according to how many predefined steps these videos contain. Sixty-eight videos were assessed, and the authors observed that the educational value of these videos was variable. Bal and colleagues conducted a similar study on a YouTube channel assessing robotic right hemicolectomy (with or without complete mesocolic excision). Various methods were used to evaluate the quality and educational value of these videos, including a modified LAP-VEGaS criterion [17, 18]. Seventy-two videos were assessed, and most were deemed to have insufficient educational value. Herrando et al. 2023 [19] published robotic colorectal procedural surgical techniques on the Colorectal Disease (the official Journal for the Association of Coloproctology of Great Britain & Ireland and ESCP) YouTube channel. The videos posted via this route have gone through the peer-reviewed process to enhance their educational value. There are widely available teaching materials for robotic surgery on the web, some are from individual surgeons and others are from organizations. There is no online quality assurance mechanism for materials, and the industry funds some of these teaching materials. It is crucial to have independent bodies provide objective assessments of the training materials to ensure there is no conflict of interest. These training materials should be developed with clear aims, objectives and assessment components for educational purposes and to assess learners' proficiency in the content. Studies should examine the effectiveness of this eLearning educational content, surgeons or trainees' acceptability and accessibility. Question 3: What are the effects of having prior laparoscopic experience (for learners) versus no prior laparoscopic experience on the learning curve for robotic colorectal surgery? Prior laparoscopic experience is not essential for training in robotic colorectal surgery. [Very low quality of evidence; conditional recommendation] Nine articles were considered relevant to this statement. Three of the nine articles had numerical data comparing the learning curve of trainees with prior laparoscopic colorectal experience with trainees with no such prior experience. Two studies [20, 21] had data on the learning curve of robotic colorectal surgery measured in terms of clinical outcomes. In this guideline, the clinical outcomes of these two studies have been pooled to facilitate comparison. Noh et al. (2020) was a retrospective observational study on 662 patients who underwent robotic low anterior resection for low rectal cancer [20]. They were stratified into five groups according to operating surgeons with varying laparoscopic experience (from a previous 403 laparoscopic cases to no cases) and their clinical outcomes were analysed. Sian et al. (2018) was an observational study on the clinical outcomes of the first 30 robotic colorectal procedures (including high anterior resection, low anterior resection, abdominoperineal resection, right hemicolectomy and abdominal suture rectopexy) performed by two surgeons, one who was a minimally invasive colorectal trained surgeon (T) and the other was a nonminimally invasive colorectal trained surgeon (nT) [21]. There were no statistical comparisons performed between the two comparators. Both studies have data on conversion rate and the results are summarized in Figure 2. There was no statistically significant difference in conversion between surgeons with prior laparoscopic experience and those without (p = 0.24). Both studies have data on postoperative complications and the results are summarized in Figure 3. There was no statistically significant difference in postoperative complications between surgeons with prior laparoscopic experience and those without (p = 0.33). However, it should be noted that while Sian et al. (2018) [21] had provided a description of postoperative complications included in their study, namely wound infection, pelvic collection, wound dehiscence and postoperative bleeding, Noh et al. (2020) [20] had not provided a breakdown of the postoperative complications observed. GRADE quality assessment for Noh et al. (2020) [20] and Sian et al. (2018) [21] on conversion and postoperative complications are summarized in Table 2. Both outcomes are graded very low in certainty due to risk of selection bias, confounding bias, inconsistency and imprecision. ⨁◯◯◯ Very low ⨁◯◯◯ Very low Noh et al. (2020) [20] provided the mean operating time while Sian et al. (2018) [21] provided the median operating time, therefore their results cannot be pooled together. In Noh et al, the average operating time for surgeons with previous laparoscopic experience was 303.09 min and that of the surgeon with no prior laparoscopic experience was 305.1 min. In Sian et al., the median operating times of T and nT were respectively 5 h and 5.5 h for high anterior resection, 7 and 5.5 h for low anterior resection and 8 and 4 h for abdominoperineal resection. The learning curve in terms of operating time was analysed in Noh et al. [20] using the cumulative sum technique. Surgeon A with the greatest experience of laparoscopic rectal surgery showed a learning curve period of 110 cases. Surgeons B and C, who had less laparoscopic experience, had learning curves of 39 and 114 cases, respectively, while surgeons D and E, with limited laparoscopic surgery experience, had learning curves of 55 and 23 cases, respectively. One potential confounding factor could be the different timing in initiating robotic surgery, with Surgeons A and C being early adopters. Surgeons B, D and E were later adopters and had a shorter learning curve. This might be because they had benefited from observing A's and C's experience and might have been offered more tips and training programmes before initiation. The results from the two studies could not be directly pooled. Noh et al. [20] reported 60 (9.6%) anastomosis-related complications among the surgeon group with prior laparoscopic experience and one (2.9%) in the surgeon group with no prior laparoscopic experience. This might not be due to the difference in complexity of cases in the two groups as there was no significant difference in the tumour locations. However, this could potentially be because of the discrepancy in the total number of cases performed in the two groups (n = 628 in prior laparoscopic experience group versus n = 34 in the no prior laparoscopic experience group). In Sian et al. [21], there were no anastomotic leaks in either group. Only one study [22] contained data on the learning curve measured in terms of robotic simulator performance. This was an observational study that compared the performance of a novice in laparoscopic surgery with that of an intermediate operator (≤100 laparoscopic cases) and expert operator (>100 laparoscopic cases). It concluded that there was no significant difference in the overall simulation score among the three groups in three of the four simulation tasks. The laparoscopic novice outperformed experts in one of the tasks (p = 0.004). Laparoscopic intermediates did not significantly differ from the other two groups in overall simulation score. There was no pattern or difference between groups in terms of parameters of specific simulator tasks. This study was not specific to colorectal procedures and assessed whether laparoscopic skills were transferable to robotics in general. It was hindered by a small sample size and differences in size between the experience groups (novice 41, intermediate 8, expert 11), limiting the generalizability of the findings. Furthermore, the study was observational with no randomization, blinding or allocation concealment. Another shortcoming of the study was that the intermediate and expert laparoscopic groups were potentially rather heterogeneous as they were defined by the previous number of laparoscopic procedures performed not considering the complexity of previously performed procedures. The current literature seems to suggest that prior laparoscopic experience may not have an effect on the learning curve of robotic colorectal surgery measured in terms of clinical outcomes. However, the literature on the topic specific to robotic colorectal surgery is scarce and of very low quality. Future research in the field is required to define prior experience and establish a learning curve by measuring performance for homogeneous case loads in comparative studies. Question 4: What are the effects of having prior experience of one robotic platform (for learners) versus no such prior experience on the learning curve for learning another robotic platform? No recommendation could be provided regarding the effects of having prior experience of one robotic platform versus no such prior experience on the learning curve for learning another robotic platform. Question 5: What are the effects of simulation training (for learners) versus no simulation training on operative performance in colorectal robotic surgery? Question 6: What are the effects of simulation training (for learners) versus no simulation training on patient outcomes in colorectal robotic surgery? Simulation should be used as part of the colorectal robotic training curriculum. [Very low level of evidence and expert opinion, upgraded by the guideline working group; strong recommendation] Although there is very little evidence on these topics, the guideline group felt that simulation should be offered as part of the robotic training curriculum based on the balance of benefits versus harm, as most robotic users have access to simulation and these include skill exercises and some procedural exercises. There is a scarcity of data on the effect of simulation training in colorectal robotic surgery with regard to operative performance and patient outcomes. Simulation training could potentially increase trainees' confidence and familiarity with the robotic platform. The most important reason to adopt effective simulation training is to ensure patient safety, in particular to avoid an increased rate of adverse clinical outcomes at the beginning of a surgeon's learning curve. Simulation training can potentially ensure that a trainee surgeon develops a certain level of competence in robotic skills and familiarity with the robotic platform in a safe environment before starting his or her first robotic case. Apart from simulation in basic surgical skills, a few simulation models designed specifically for robotic rectal dissection have been developed [23, 24]. A recent study has shown that although 63% of US residents indicated that they had participated in robotic cases, only 18% had experience using the robotic console and 60% received no prior education or training before their first robotic case [25]. Indeed, integrating surgical trainees into robotic procedures is challenging, especially in the initial phase of launching a new robotic service in a centre. One contributing factor is the lack of formal and mandatory robotic simulation curricula. Formal robotic platform training and simulation may allow increased trainee participation and skill acquisition in robotic procedures. This section explores the effect of simulation training on operative performance and patient outcomes in colorectal robotic surgery. Eight articles were considered relevant to this statement [23-30]. Three of the eight articles have data on operative performance and one of the eight articles has data on patient outcome. The three studies that had data on operative performance were Schlottman et al. (2019), Thomas et al. (2023) and Cho et al. (2013) [26-28]. The data from these studies cannot be synthesized as the specific operative performances they measured were different. We felt that the three studies were not suitable for quality assessment through GRADE because GRADE is an outcome-based assessment and the three studies did not have a common outcome measure. Specifically, Schlottman et al. [26] did not have an outcome measure of critical importance, Thomas et al. [27] is a conference abstract with limited data. The outcomes of Cho et al. [28] were specific to that study and did not conform to known outcome measures. Schlottman et al. [26] was an observational study comparing the confidence level of 20 senior surgical residents in using the robotic platform before and after simulation training with porcine tissue blocks to perform various operations including Heller myotomy, sleeve gastrectomy, colectomy and lobectomy. It showed a significant increase in confidence level in port placement (5.36 vs. 7.05, p = 0.007), docking (5.59 vs. 7.18, p = 0.01), suturing (5.05 vs. 7.50, p < 0.001), using an energy device (5.36 vs. 7.36, p < 0.001) and using staples (4.91 vs. 7.41, p < 0.001) after 3 days of simulation training. The highest increases in confidence level were seen in skills often less readily developed in theatre without prior practice, such as suturing and using energy devices or staples. The limitation is that the sample size was small and that the study was not limited to colorectal robotic procedures. Thomas et al. [27] is a conference abstract; 19 surgical residents practised during a training session using a live porcine model consist