Face validation of a portable ergonomic laparoscopy skills simulator for single-incision laparoscopic surgery training.

In recent years, many efforts have been made to reduce the trauma of surgical access further by the use of single-incision laparoscopic surgery (SILS). The Ergo-Lap (ergonomic laparoscopic) simulator was taken to the 20th International Congress of the European Association for Endoscopic Surgery (EAES) in 2012 in Brussels, Belgium. During the congress, the simulator was assessed by 13 general surgeons with different SILS experience using a standardized questionnaire to determine the usability of the Ergo-Lap simulator training for basic SILS skills. Eleven of the 13 participants rated the simulator as an attractive simulator (attractive here means arousing interest of the trainees). For the aspects of training in an ergonomic way, 12 of 13 participants rated it as good to excellent because the work space and task panel location can be adjusted according to the length of instruments. Also, 92% (12 of 13) thought the Ergo-Lap simulator was useful for practicing basic SPLS skills. And 85% (11 of 13) thought it was very easy to use. For SILS skills training, this in~xpensive and portable Ergo-Lap simulator offers a feasible training opportunity to help trainees practice their SILS skills under ergonomic conditions.

Face, content, and construct validity of a novel portable ergonomic simulator for basic laparoscopic skills.

OBJECTIVE: Laparoscopic skills can be improved effectively through laparoscopic simulation. The purpose of this study was to verify the face and content validity of a new portable Ergonomic Laparoscopic Skills simulator (Ergo-Lap simulator) and assess the construct validity of the Ergo-Lap simulator in 4 basic skills tasks. DESIGN: Four tasks were evaluated: 2 different translocation exercises (a basic bimanual exercise and a challenging single-handed exercise), an exercise involving tissue manipulation under tension, and a needle-handling exercise. Task performance was analyzed according to speed and accuracy. The participants rated the usability and didactic value of each task and the Ergo-Lap simulator along a 5-point Likert scale. SETTING: Institutional academic medical center with its affiliated general surgery residency. PARTICIPANTS: Forty-six participants were allotted into 2 groups: a Novice group (n = 26, <10 clinical laparoscopic procedures) and an Experienced group (n = 20, >50 clinical laparoscopic procedures). RESULTS: The Experienced group completed all tasks in less time than the Novice group did (p < 0.001, Mann-Whitney U test). The Experienced group also completed tasks 1, 2, and 4 with fewer errors than the Novice group did (p < 0.05). Of the Novice participants, 96% considered that the present Ergo-Lap simulator could encourage more frequent practice of laparoscopic skills. In addition, 92% would like to purchase this simulator. All of the experienced participants confirmed that the Ergo-Lap simulator was easy to use and useful for practicing basic laparoscopic skills in an ergonomic manner. Most (95%) of these respondents would recommend this simulator to other surgical trainees. CONCLUSIONS: This Ergo-Lap simulator with multiple tasks was rated as a useful training tool that can distinguish between various levels of laparoscopic expertise. The Ergo-Lap simulator is also an inexpensive alternative, which surgical trainees could use to update their skills in the skills laboratory, at home, or in the office.

Assessment of basic laparoscopic skills on virtual reality simulator or box trainer.

INTRODUCTION: We investigated whether the peg transfer task is interchangeable between a VR simulator and a box trainer. Our research questions: (1) Are scores of the box trainer interchangeable with the virtual equivalent of the exercise; (2) does training on the box affect performance on the VR simulator and vice versa; and (3) which system is preferred? METHODS: Experienced laparoscopists and medical interns were randomly assigned to one of two groups (V or B). They performed eight repetitions of the peg transfer task (4 on each simulator system) following a crossover study design. Group B started on the box trainer and group V started on the VR simulator. Opinion of participants was evaluated by a questionnaire. RESULTS: A significant correlation was found between time to complete the task on the box and the VR simulator. The comparison of the performances per system showed that group B (N = 14) performed the peg transfer task on the VR simulator in significantly less time than group V (N = 14; p = 0.014). Overall, the box was preferred over the VR simulator. CONCLUSIONS: Although performances on the box trainer and VR simulator were correlated, they were not interchangeable. The results also imply that assessment on the VR simulator after pretraining on the box is acceptable, whereas VR simulator training alone might not suffice to pass an assessment on a box trainer. More research is needed to validate the use of the VR simulator as a FLS and PLUS assessment instrument.

Procedural virtual reality simulation in minimally invasive surgery.

BACKGROUND: Simulation of procedural tasks has the potential to bridge the gap between basic skills training outside the operating room (OR) and performance of complex surgical tasks in the OR. This paper provides an overview of procedural virtual reality (VR) simulation currently available on the market and presented in scientific literature for laparoscopy (LS), flexible gastrointestinal endoscopy (FGE), and endovascular surgery (EVS). METHODS: An online survey was sent to companies and research groups selling or developing procedural VR simulators, and a systematic search was done for scientific publications presenting or applying VR simulators to train or assess procedural skills in the PUBMED and SCOPUS databases. RESULTS: The results of five simulator companies were included in the survey. In the literature review, 116 articles were analyzed (45 on LS, 43 on FGE, 28 on EVS), presenting a total of 23 simulator systems. The companies stated to altogether offer 78 procedural tasks (33 for LS, 12 for FGE, 33 for EVS), of which 17 also were found in the literature review. Although study type and used outcomes vary between the three different fields, approximately 90 % of the studies presented in the retrieved publications for LS found convincing evidence to confirm the validity or added value of procedural VR simulation. This was the case in approximately 75 % for FGE and EVS. CONCLUSIONS: Procedural training using VR simulators has been found to improve clinical performance. There is nevertheless a large amount of simulated procedural tasks that have not been validated. Future research should focus on the optimal use of procedural simulators in the most effective training setups and further investigate the benefits of procedural VR simulation to improve clinical outcome.

Single versus multimodality training basic laparoscopic skills.

INTRODUCTION: Even though literature provides compelling evidence of the value of simulators for training of basic laparoscopic skills, the best way to incorporate them into a surgical curriculum is unclear. This study compares the training outcome of single modality training with multimodality training of basic laparoscopic skills. METHODS: Thirty-six medical students without laparoscopic experience performed six training sessions of 45 min each, one per day, in which four different basic tasks were trained. Participants in the single-modality group (S) (n = 18) practiced solely on a virtual reality (VR) simulator. Participants in the multimodality group (M) (n = 18) practiced on the same VR simulator (2x), a box trainer (2x), and an augmented reality simulator (2x). All participants performed a pre-test and post-test on the VR simulator (the four basic tasks + one additional basic task). Halfway through the training protocol, both groups performed a salpingectomy on the VR simulator as interim test. RESULTS: Both groups improved their performance significantly (Wilcoxon signed-rank, P < 0.05). The performances of group S and group M in the additional basic task and the salpingectomy did not differ significantly (Mann-Whitney U test, P > 0.05). Group S performed the four basic tasks in the post-test on the VR faster than group M (P ≤ 0.05), which can be explained by the fact that they were much more familiar with these tasks. CONCLUSIONS: Training of basic laparoscopic tasks on single or multiple modalities does not result in different training outcome. Both training methods seem appropriate for the attainment of basic laparoscopic skills in future curricula.

Criterion-based laparoscopic training reduces total training time.

INTRODUCTION: The benefits of criterion-based laparoscopic training over time-oriented training are unclear. The purpose of this study is to compare these types of training based on training outcome and time efficiency. METHODS: During four training sessions within 1 week (one session per day) 34 medical interns (no laparoscopic experience) practiced on two basic tasks on the Simbionix LAP Mentor virtual-reality (VR) simulator: 'clipping and grasping' and 'cutting'. Group C (criterion-based) (N = 17) trained to reach predefined criteria and stopped training in each session when these criteria were met, with a maximum training time of 1 h. Group T (time-based) (N = 17) trained for a fixed time of 1 h each session. Retention of skills was assessed 1 week after training. In addition, transferability of skills was established using the Haptica ProMIS augmented-reality simulator. RESULTS: Both groups improved their performance significantly over the course of the training sessions (Wilcoxon signed ranks, P < 0.05). Both groups showed skill transferability and skill retention. When comparing the performance parameters of group C and group T, their performances in the first, the last and the retention training sessions did not differ significantly (Mann-Whitney U test, P > 0.05). The average number of repetitions needed to meet the criteria also did not differ between the groups. Overall, group C spent less time training on the simulator than did group T (74:48 and 120:10 min, respectively; P < 0.001). Group C performed significantly fewer repetitions of each task, overall and in session 2, 3 and 4. CONCLUSIONS: Criterion-based training of basic laparoscopic skills can reduce the overall training time with no impact on training outcome, transferability or retention of skills. Criterion-based should be the training of choice in laparoscopic skills curricula.

Visuo-spatial ability in colonoscopy simulator training.

Visuo-spatial ability is associated with a quality of performance in a variety of surgical and medical skills. However, visuo-spatial ability is typically assessed using Visualization tests only, which led to an incomplete understanding of the involvement of visuo-spatial ability in these skills. To remedy this situation, the current study investigated the role of a broad range of visuo-spatial factors in colonoscopy simulator training. Fifteen medical trainees (no clinical experience in colonoscopy) participated in two psycho-metric test sessions to assess four visuo-spatial ability factors. Next, participants trained flexible endoscope manipulation, and navigation to the cecum on the GI Mentor II simulator, for four sessions within 1 week. Visualization, and to a lesser degree Spatial relations were the only visuo-spatial ability factors to correlate with colonoscopy simulator performance. Visualization additionally covaried with learning rate for time on task on both simulator tasks. High Visualization ability indicated faster exercise completion. Similar to other endoscopic procedures, performance in colonoscopy is positively associated with Visualization, a visuo-spatial ability factor characterized by the ability to mentally manipulate complex visuo-spatial stimuli. The complexity of the visuo-spatial mental transformations required to successfully perform colonoscopy is likely responsible for the challenging nature of this technique, and should inform training- and assessment design. Long term training studies, as well as studies investigating the nature of visuo-spatial complexity in this domain are needed to better understand the role of visuo-spatial ability in colonoscopy, and other endoscopic techniques.

Influence of anatomic landmarks in the virtual environment on simulated angled laparoscope navigation.

BACKGROUND: The aim of this study is to investigate the influence of the presence of anatomic landmarks on the performance of angled laparoscope navigation on the SimSurgery SEP simulator. METHODS: Twenty-eight experienced laparoscopic surgeons (familiar with 30° angled laparoscope, >100 basic laparoscopic procedures, >5 advanced laparoscopic procedures) and 23 novices (no laparoscopy experience) performed the Camera Navigation task in an abstract virtual environment (CN-box) and in a virtual representation of the lower abdomen (CN-abdomen). They also rated the realism and added value of the virtual environments on seven-point scales. RESULTS: Within both groups, the CN-box task was accomplished in less time and with shorter tip trajectory than the CN-abdomen task (Wilcoxon test, p < 0.05). No significant differences were found between the performances of the experienced participants and the novices on the CN tasks (Mann-Whitney U test, p > 0.05). In both groups, the CN tasks were perceived as hard work and more challenging than anticipated. CONCLUSIONS: Performance of the angled laparoscope navigation task is influenced by the virtual environment surrounding the exercise. The task was performed better in an abstract environment than in a virtual environment with anatomic landmarks. More insight is required into the influence and function of different types of intrinsic and extrinsic feedback on the effectiveness of preclinical simulator training.

Risk-sensitive events during laparoscopic cholecystectomy: the influence of the integrated operating room and a preoperative checklist tool.

BACKGROUND: Awareness of the relative high rate of adverse events in laparoscopic surgery created a need to safeguard quality and safety of performance better. Technological innovations, such as integrated operating room (OR) systems and checklists, have the potential to improve patient safety, OR efficiency, and surgical outcomes. This study was designed to investigate the influence of the integrated OR system and Pro/cheQ, a digital checklist tool, on the number and type of equipment- and instrument-related risk-sensitive events (RSE) during laparoscopic cholecystectomies. METHODS: Forty-five laparoscopic cholecystectomies were analyzed on the number and type of RSE; 15 procedures were observed in the cart-based OR setting, 15 in an integrated OR setting, and 15 in the integrated OR setting while using Pro/cheQ. RESULTS: In the cart-based OR setting and the integrated OR setting, at least one event occurred in 87% of the procedures, which was reduced to 47% in the integrated OR setting when using Pro/cheQ. During 45 procedures a total of 57 RSE was observed-most were caused by equipment that was not switched on or with the wrong settings. In the integrated OR while using Pro/cheQ the number of RSE was reduced by 65%. CONCLUSIONS: Using both an integrated OR and Pro/cheQ has a stronger reducing effect on the number of RSE than using an integrated OR alone. The Pro/cheQ tool supported the optimal workflow in a natural way and raised the general safety awareness amongst all members of the surgical team. For tools such as integrated OR systems and checklists to succeed it is pivotal not to underestimate the value of the implementation process. To further improve safety and quality of surgery, a multifaceted approach should be followed, focusing on the performance and competence of the surgical team as a whole.

Do basic psychomotor skills transfer between different image-based procedures?

BACKGROUND: Surgical techniques that draw from multiple types of image-based procedures (IBP) are increasing, such as Natural Orifice Transluminal Endoscopic Surgery, fusing laparoscopy and flexible endoscopy. However, little is known about the relation between psychomotor skills for performing different types of IBP. For example, do basic psychomotor colonoscopy and laparoscopy skills interact? METHODS: Following a cross-over study design, 29 naïve endoscopists were trained on the Simbionix GI Mentor and the SimSurgery SEP simulators. Group C (n = 15) commenced with a laparoscopy session, followed by four colonoscopy sessions and a second laparoscopy session. Group L (n = 14) started with a colonoscopy session, followed by four laparoscopy sessions and a second colonoscopy session. RESULTS: No significant differences were found between the performances of group L and group C in their first training sessions on either technique. With additional colonoscopy training, group C outperformed group L in the second laparoscopy training session on the camera navigation task. CONCLUSIONS: Overall, training in the basic colonoscopy tasks does not affect performance of basic laparoscopy tasks (and vice versa). However, to limited extent, training of basic psychomotor skills for colonoscopy do appear to contribute to the performance of angled laparoscope navigation tasks. Thus, training and assessment of IBP type-specific skills should focus on each type of tasks independently. Future research should further investigate the influence of psychometric abilities on the performance of IBP and the transfer of skills for physicians who are experienced in one IBP type and would like to become proficient in another type of IBP.

Training of basic laparoscopy skills on SimSurgery SEP.

The aim of this study was to assess the performance curve for novices training in bimanual tissue manipulation and angled laparoscope navigation, and compare those performances with the performances of experienced laparoscopic surgeons. The Camera Navigation task with a 30 degrees angled laparoscope and the Place Arrow task of the new SimSurgery SEP virtual reality simulator were used. Fourteen medical trainees (no laparoscopy experience) performed four training sessions within one week, including 15 repetitions of each task in total. The experienced participants (>50 procedures & familiar with angled laparoscope) performed each task twice. The performance on both tasks by the novices improved significantly over the training sessions. The experienced participants performed both tasks significantly better than the novices in repetition 3. After repetition 15, the performances of the novices on both tasks were of the same level as the performances of the experienced participants. By training on SimSurgery SEP, medical trainees can extensively improve their skills in navigation with 30 degrees angled laparoscope and bimanual tissue manipulation. Further research should focus on the transfer of skills acquired on the simulator to the clinical setting. Knowledge on proficiency thresholds and training end-points for pre-clinical criterion-based training of different laparoscopic tasks also needs to be extended.

Do absorption and realistic distraction influence performance of component task surgical procedure?

BACKGROUND: Surgeons perform complex tasks while exposed to multiple distracting sources that may increase stress in the operating room (e.g., music, conversation, and unadapted use of sophisticated technologies). This study aimed to examine whether such realistic social and technological distracting conditions may influence surgical performance. METHODS: Twelve medical interns performed a laparoscopic cholecystectomy task with the Xitact LC 3.0 virtual reality simulator under distracting conditions (exposure to music, conversation, and nonoptimal handling of the laparoscope) versus nondistracting conditions (control condition) as part of a 2 x 2 within-subject experimental design. RESULTS: Under distracting conditions, the medical interns showed a significant decline in task performance (overall task score, task errors, and operating time) and significantly increased levels of irritation toward both the assistant handling the laparoscope in a nonoptimal way and the sources of social distraction. Furthermore, individual differences in cognitive style (i.e., cognitive absorption and need for cognition) significantly influenced the levels of irritation experienced by the medical interns. CONCLUSION: The results suggest careful evaluation of the social and technological sources of distraction in the operation room to reduce irritation for the surgeon and provision of proper preclinical laparoscope navigation training to increase security for the patient.

Camera navigation and tissue manipulation; are these laparoscopic skills related?

BACKGROUND: It is a tacit assumption that clinically based expertise in laparoscopic tissue manipulation entails skilfulness in angled laparoscope navigation. The main objective of this study was to investigate the relation between these skills. To this end, face and construct validity had to be established for the place arrow (PA) and camera navigation (CN) tasks on the SimSurgery SEP. METHODS: Thirty-three novices (no laparoscopy experience) and 33 experienced participants (>50 laparoscopic procedures and familiar with angled laparoscopy) performed both tasks twice, on one of two hardware platforms (SimSurgery SimPack or Xitact/Mentice IHP), and rated the realism and didactic value of SimSurgery SEP on five-point scales. RESULTS: Both tasks were rated by the experienced participants as realistic (CN: 3.7; PA: 4.1) and SimSurgery SEP as a user-friendly environment to train basic skills (4.1). Both tasks were performed in less time by the experienced group, with shorter tip trajectories. For both groups jointly, the time to accomplish each task correlated with the tip trajectory and also with the time and tip trajectories of the opposite task (Spearman's correlation, p

ProMIS augmented reality training of laparoscopic procedures face validity.

BACKGROUND: Conventional video trainers lack the ability to assess the trainee objectively, but offer modalities that are often missing in virtual reality simulation, such as realistic haptic feedback. The ProMIS augmented reality laparoscopic simulator retains the benefit of a traditional box trainer, by using original laparoscopic instruments and tactile tasks, but additionally generates objective measures of performance. METHODS: Fifty-five participants performed a "basic skills" and "suturing and knot-tying" task on ProMIS, after which they filled out a questionnaire regarding realism, haptics, and didactic value of the simulator, on a 5-point-Likert scale. The participants were allotted to 2 experience groups: "experienced" (>50 procedures and >5 sutures; N = 27), and "moderately experienced" (<50 procedures and <5 sutures; N = 28). RESULTS: General consensus among all participants, particularly the experienced, was that ProMIS is a useful tool for training (mean: 4.67, SD: 0.48). It was considered very realistic (mean: 4.44, SD: 0.66), with good haptics (mean: 4.10, SD: 0.97) and didactic value (mean 4.10, SD: 0.65). CONCLUSIONS: This study established the face validity of the ProMIS augmented reality simulator for "basic skills" and "suturing and knot-tying" tasks. ProMIS was considered a good tool for training in laparoscopic skills for surgical residents and surgeons.

The importance of haptic feedback in laparoscopic suturing training and the additive value of virtual reality simulation.

INTRODUCTION: Previous studies on the difference between physical, augmented and virtual reality (VR) simulation state that haptic feedback is an important feature in laparoscopic suturing simulation. Objective assessment is important to improve skills during training. This study focuses on the additive value of VR simulation for laparoscopic suturing training. METHODS: All participants of several European Association for Endoscopic Surgery (EAES)-approved laparoscopic skills courses (N = 45) filled out a questionnaire on their opinion on laparoscopic suturing training. Additionally, participants with little or no laparoscopic suturing experience were allotted to two groups: group A (N = 10), who started training on the box trainer and subsequently the VR simulator (SimSurgery), and group B (N = 10), who began on the VR simulator followed by the box. Finally, suturing and knot-tying skills were assessed by an expert observer, using a standard evaluation form (eight items on five-point-Likert scale). The same was done after the initial training on the box in group A, as a control. Significant differences were calculated with the independent-sample t-test and the paired t-test. RESULTS: The total score of group A was higher than both group B and control (means of 30.80, 27.60, 28.20, respectively), but not significantly. The only tendency to a significant difference between group A and B was found in 'taking proper bites' (mean 4.10 versus 3.60, p = 0.054). All the participants scored the features of the box trainer significantly higher than those of the VR simulator (p < 0.001), 46.7% was of the opinion that the box alone would be sufficient for laparoscopic suturing training. CONCLUSION: From this study we can conclude that VR simulation does not have a significant additional value in laparoscopic suturing training, over traditional box trainers. One should consider that the future development in VR simulation should focus on basic skills and component tasks of procedural training in laparoscopic surgery, rather than laparoscopic suturing.

Expert and construct validity of the Simbionix GI Mentor II endoscopy simulator for colonoscopy.

OBJECTIVES: The main objectives of this study were to establish expert validity (a convincing realistic representation of colonoscopy according to experts) and construct validity (the ability to discriminate between different levels of expertise) of the Simbionix GI Mentor II virtual reality (VR) simulator for colonoscopy tasks, and to assess the didactic value of the simulator, as judged by experts. METHODS: Four groups were selected to perform one hand-eye coordination task (EndoBubble level 1) and two virtual colonoscopy simulations on the simulator; the levels were: novices (no endoscopy experience), intermediate experienced (<200 colonoscopies performed before), experienced (200-1,000 colonoscopies performed before), and experts (>1,000 colonoscopies performed before). All participants filled out a questionnaire about previous experience in flexible endoscopy and appreciation of the realism of the colonoscopy simulations. The average time to reach the cecum was defined as one of the main test parameters as well as the number of times view of the lumen was lost. RESULTS: Novices (N = 35) reached the cecum in an average time of 29:57 (min:sec), intermediate experienced (N = 15) in 5:45, experienced (N = 20) in 4:19 and experts (N = 35) in 4:56. Novices lost view of the lumen significantly more often compared to the other groups, and the EndoBubble task was also completed significantly faster with increasing experience (Kruskal Wallis Test, p < 0.001). The group of expert endoscopists rated the colonoscopy simulation as 2.95 on a four-point scale for overall realism. Expert opinion was that the GI Mentor II simulator should be included in the training of novice endoscopists (3.51). CONCLUSION: In this study we have demonstrated that the GI Mentor II simulator offers a convincing realistic representation of colonoscopy according to experts (expert validity) and that the simulator can discriminate between different levels of expertise (construct validity) in colonoscopy. According to experts the simulator should be implemented in the training programme of novice endoscopists.

Augmented versus virtual reality laparoscopic simulation: what is the difference? A comparison of the ProMIS augmented reality laparoscopic simulator versus LapSim virtual reality laparoscopic simulator.

BACKGROUND: Virtual reality (VR) is an emerging new modality for laparoscopic skills training; however, most simulators lack realistic haptic feedback. Augmented reality (AR) is a new laparoscopic simulation system offering a combination of physical objects and VR simulation. Laparoscopic instruments are used within an hybrid mannequin on tissue or objects while using video tracking. This study was designed to assess the difference in realism, haptic feedback, and didactic value between AR and VR laparoscopic simulation. METHODS: The ProMIS AR and LapSim VR simulators were used in this study. The participants performed a basic skills task and a suturing task on both simulators, after which they filled out a questionnaire about their demographics and their opinion of both simulators scored on a 5-point Likert scale. The participants were allotted to 3 groups depending on their experience: experts, intermediates and novices. Significant differences were calculated with the paired t-test. RESULTS: There was general consensus in all groups that the ProMIS AR laparoscopic simulator is more realistic than the LapSim VR laparoscopic simulator in both the basic skills task (mean 4.22 resp. 2.18, P < 0.000) as well as the suturing task (mean 4.15 resp. 1.85, P < 0.000). The ProMIS is regarded as having better haptic feedback (mean 3.92 resp. 1.92, P < 0.000) and as being more useful for training surgical residents (mean 4.51 resp. 2.94, P < 0.000). CONCLUSIONS: In comparison with the VR simulator, the AR laparoscopic simulator was regarded by all participants as a better simulator for laparoscopic skills training on all tested features.

Hand supports to assist toilet use among the elderly.

Improving the toilet environment holds promises for increasing the quality of life for elderly and disabled persons. This is one of the goals of the Friendly Rest Room (FRR) project. The study described in this article explored the preference and use of supports in the toilet environment during the entire toilet ritual. An adjustable test frame was built with a toilet and three types of supports. Fourteen subjects were asked which positions they favoured for each support. After using all three supports, they were asked which support they found most comfortable. In general, the preferred positions depended on personal preferences more than on dimensions of the body. It was concluded that there is a preference for vertical supports for sitting down and standing up. During toilet use the side supports were equally appreciated.