Surg Endosc (2013) 27:364–377 DOI 10.1007/s00464-012-2503-1
and Other Interventional Techniques
Procedural virtual reality simulation in minimally invasive surgery Cecilie Va˚penstad • Sonja N. Buzink
Received: 12 July 2012 / Accepted: 19 July 2012 / Published online: 7 September 2012 Ó Springer Science+Business Media, LLC 2012
Abstract 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 Electronic supplementary material The online version of this article (doi:10.1007/s00464-012-2503-1) contains supplementary material, which is available to authorized users. C. Va˚penstad Department of Medical Technology, SINTEF Technology and Society, PB 4760 Sluppen, 7465 Trondheim, Norway e-mail:
[email protected] S. N. Buzink (&) Faculty of Industrial Design Engineering, Delft University of Technology, Landbergstraat 15, 2628 CE Delft, The Netherlands e-mail:
[email protected]
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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. Keywords Virtual reality Procedural simulation Training Laparoscopy Endoscopy Endovascular
Any surgical intervention consists of a complex series of actions. To safely perform a procedure, the surgeon needs technical, theoretical, and interpersonal skills. The increase of minimally invasive surgery, medicolegal issues, new working time directives, and the increased focus on surgical production with increased time pressure and costs makes the operating room (OR) not the ideal learning environment [1–5]. Therefore, new ways of training outside of the OR have been developed. Most image-based minimally invasive surgical (MIS) techniques are amenable to virtual reality (VR) simulation [6]. Surgeons insert instruments through small incisions or natural orifices and use the images from the scope or the c-arm, presented on a monitor, to guide the intervention. In the virtual world, the surgical environment is mimicked by interacting hardware interfaces and software components (Fig. A, available online) [6]. The fidelity resources of the simulator consist of software components simulating the surgical scene in addition to pathophysiological behavior, as well as hardware interfaces, being the physical link
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between the trainer and the virtual world [7]. In addition, a simulator might have teaching resources, such as educational software tools with evaluation metrics, and management resources to set up training programs, manage trainees, and organize groups. An important aspect of VR simulation is the reproduction of the actual challenges, technical and nontechnical, that a surgeon perceives during real surgery. It involves all senses, but especially visual and haptic input [6]. Complex procedural VR simulation demands high-end computational power, elaborate graphics programing, and realistic physical interfaces, including haptic devices [6, 7]. VR procedural simulators can be very expensive [3, 8, 9]. However, these costs need to be weighted in comparison to the decrease of direct and indirect costs of training in a clinical setting, e.g., shortening of operating time per procedure and reduction of adverse events and complication rates [10, 11]. The advantages of training on and assessment of basic skills for image-based surgery outside of the OR using VR simulators are widely accepted already, through studies that established the level of face, content, construct, concurrent, and predictive validity [5, 9, 10, 12– 20]. However, the step from training on isolated basic skills to the performance of complex surgical procedures in the OR needs improvement [19, 21]. Procedural VR simulation has the potential to bridge this gap. The advancement of simulation technology is dependent on the use of and demand for it by the surgical community in conjunction with research and development by simulator companies and academia. The purpose of this review is to provide an overview of available VR procedural training and assessment for MIS. By means of a literature review and a company survey, we established the current state of art on procedural VR simulation for three common fields of MIS that allow treatment or surgical interventions: laparoscopy (LS), flexible gastrointestinal endoscopy (FGE), and endovascular surgery (EVS). A procedural task is defined as a simulator exercise that offers training in the performance of a complete or part of a surgical procedure, simulating the anatomical landscape in which the specific procedure takes place (the surgical scene), pathophysiological behavior, and interaction characteristics of the instruments used to perform the procedure in real life.
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Survey An online survey was sent to companies and research groups selling and/or developing VR simulation systems for LS, FGE, or EVS. The questionnaire was developed together with surgical experts. It contained questions regarding procedural training on the VR simulators, and the simulators teaching, management, and fidelity resources. Depending on the options and number of simulators each company or research group had, the survey contained 109 questions in total (LS: 40, FGE: 33, and EVS: 32 questions). The questionnaire consisted of dichotomous, closed format and open format questions and was developed using software by Conforimit (Oslo, Norway). The companies and research groups were found through a search on the internet and in scientific publications. Companies with simulators that are no longer available on the market, such as Olympus with the EndoTS-1 simulator for FGE, were not contacted and neither were research groups with nonsufficient contact details, such as the developer of the Sung 2003 system [22–24]. Literature review A systematic search in the PUBMED and SCOPUS databases was performed on February 9, 2012 for articles published since 1985 in English using the following query: (virtual or (computer based) or (computer-based)) and (simulator OR simulation OR simulate) and (surgery or surgical or procedure or procedural or intervention or interventional) and (laparoscopic or laparoscopy or endoscopic or endoscopy or endovascular or gastrointestinal or (minimal and invasive) or (minimally invasive)). After removal of duplicates and publications in other languages, the title and abstract of the remaining publications were analyzed by the two authors independently. For inclusion, the article or conference proceeding needed to present a VR simulation system or application of the system to train or assess procedural skills for LS, FGE, or EVS. Review articles, editorials, letters, and articles focussing solely on diagnostics, basic skills, open procedures, or non-VR simulation systems were excluded. After comparison of the independent analyses, differences among the results were discussed and resolved. The selection process was completed with a full-text scan of the remaining publications. The included papers were reviewed and classified according to the categories listed in Table 1.
Methods Results The review is composed of two parts: a survey among manufacturers of VR simulators for MIS and a literature review. We investigated to what level the simulated procedures have been the subject of validation studies and what the technical specifications of the available simulation platforms are.
Survey The survey was sent to 13 companies and research groups. Six companies completed the survey, of which one
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Table 1 Categories used to classify the retrieved publications according to study type Label
Description of study type
1
Presentation of a VR simulation system (simulation software and hardware); demonstrating feasibility for procedural training.
2a
Rating of the realism of the simulator system and its appropriateness as a teaching modality judged by experts in the field and proposed trainees; face or content validation.
2b
Assessment of the degree to which the simulator system can discriminate between subjects from different experience levels; construct validation.
2c
Evaluation of the degree to which the performance of the trainees improves by repetitive training on the simulator system; training and assessment are both done on the simulator itself.
2d
Comparison of performance improvement by training on the simulator system and training using alternative training methods/tools.
2e
Evaluation of the degree to which the performance of trainees improves by training on the simulator system, using alternative tools for performance assessment (including transfer to the clinical setting).
3a
Assessment of performance tested on procedural task(s) on the simulator after basic skills training.
3b
Embedding of VR procedural simulation in a surgical curriculum.
4
Other study types involving procedural task(s) on a VR simulator system (e.g., to study the impact of specific setups in simulator training, such as the use of haptic feedback or expert tutoring).
company did not have LS, FGE, or EVS simulators and was thus excluded. The included companies were: CAE Healthcare Inc., with headquarters in Montreal, Canada, has been trading VR simulators since 2010 after they took over VIMEDIX, Immersion Medical, Haptica Ltd. and METI Inc. in 2010 and 2011. They offer simulators called LaparoscopyVR (LapVR) and ProMIS for LS, EndoscopyVR for FGE, and CathLabVR for EVS. The ProMIS simulator is an augmented reality simulator that has, at a time, simulated VR tasks and tasks with real tools and physical models, in both cases with tracking of instruments and objective feedback. In the further presentation, the results are related to the LapVR simulator, except when mentioned otherwise. Mentice AB with headquarters in Gothenburg, Sweden, has been trading VR simulators since 1999. They acquired Xitact SA in 2005. They currently offer simulators called MIST VR Nephrectomy for LS, and for EVS Mentice VIST, Mentice VIST-C, and Mentice VIST-Lab. Simbionix LTD has been trading VR simulators since 2000 and offers VR simulators called LAP Mentor and LAP Mentor Express for LS, GI BRONCH Mentor for
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FGE, and ANGIO Mentor and PROcedure Rehearsal Studio (PRS) for EVS. Their headquarters are in Cleveland, Ohio. SimSurgery AS with headquarters in Oslo, Norway, has since 2003 been trading a VR simulator for LS called SEP. Surgical Science AB has been trading VR simulators since 2001 and has their headquarters in Gothenburg, Sweden. They offer a VR simulator for LS called LapSim and have a simulator for FGE under development. The FGE simulator under development was not further elaborated in the survey and is therefore not included in the results. Laparoscopy All of the five companies that were included in the survey offer VR simulators for LS: in total 33 procedures (Table 2). Some of the procedural tasks can be run as parttasks; dividing the procedure in different sub tasks, e.g., dissection of Calot’s triangle in a cholecystectomy (Table 2). The LapVR and the LapSim offer different anatomies for all the procedural tasks. On the Lap Mentor the procedural tasks for cholecystectomy, ectopic pregnancy, and hernia can be run with different anatomies. In the near future, the companies stated to expect that also simulations for fundoplication, cystectomy, pyeloplastics, liver resection, and colorectal surgery would become available. Both MIST VR Nephrectomy and SEP state to offer the possibility to train on single-port surgery. The SEP simulator also can be configured for generic robotic surgery training. None of the VR simulators states that they have dedicated modules to train on natural orifice transluminal endoscopic surgery (NOTES) or laparoscopic ultrasound. In all of the simulated procedural tasks, the simulator has already created the pneumoperitoneum and the training begins with the insertion of instruments and usually ends with the final resection of the organ (Table 2). On the ProMIS, the SEP, and the MIST VR Nephrectomy simulators, the candidate can train on port placement by physically moving the ports and instruments, whereas on the Lap Mentor it is possible to train on port placement virtually. Flexible Gastrointestinal Endoscopy CAE Healthcare and Simbionix offer VR simulators with procedural tasks to train on FGE (Table 3). All of the simulated procedural tasks, in total 12, can be run with different anatomies. The procedures usually start by scope introduction and ends by scope removal. If the companies would add new procedural tasks, they stated that they would add endoscopic submucosal dissection and resection.
Surg Endosc (2013) 27:364–377 Table 2 Overview of VR simulated LS procedures available on the market
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Simulator company, VR simulator name
Procedural exercises (starting point–end point)
CAE Healthcare, Laparoscopy VR/ProMIS
GI: Cholecystectomy (exploration-removal of gallbladder), Colectomy (exploration-removal of colon portion), Nissen fundoplication (exploration-completion of fundoplication step), Appendectomy (exploration-resection of appendix), GYN: Ectopic pregnancy (exploration-removal of ectopic pregnancy), Salpingo-oophorectomy (exploration-removal of ovaries)
Mentice, MIST VR Nephrectomy Simbionix, LAP Mentor
URO: Nephrectomy (dissection-clipping and removal)
SimSurgery, SEP
GI: Cholecystectomy (dissection of Calot’s triangle-complete dissection of gallbladder from liver bed), GYN: Salpingectomy (insert instrumentsfinal inspection), Salpingostomy (insert instruments-final inspection), Ovarian cystectomy (insert instruments-final inspection) URO: Nephrectomy (bowel mobilization-hilar dissection)
Surgical Science, LapSim
GI: Cholecystectomy in two steps (step one: entry in cavity-cutting of artery and duct, step two: after artery and duct cut-gallbladder removal), appendectomy (infected appendix–appendix removal) GYN: Tubal occlusion (entry in-exit from cavity), salpingectomy (entry in-exit from cavity), salpingostomy (entry in-exit from cavity), myoma suturing (after removal of myoma-suturing complete), hysterectomy (in cavity approaching uterine vessels-uterine vessels cut and divided), vaginal cuff opening (ready to cuff opening-uterus separated from other tissues), vaginal cuff suturing (uterus removed-suturing complete without leakage).
The listed procedural tasks are the results of a survey answered by the manufacturer themselves. These were the companies that answered the survey. The authors do not guarantee for the completeness or the exactness of the table
GI: Cholecystectomy (exploration-removal of gallbladder: as full procedure and in several steps), Hernia procedures (free the hernia adhesions-mesh is placed), Gastric bypass (creating the gastric pouch, measuring and dividing the jejunum into duodenojejunal limb, gastrojejunal anastomosis, enteroenterostomy Anastomosis), Sigmoidectomy (peritoneal incision-distal division), Sigmoidectomy anastomosis, GYN: Tubal sterilization, salpingo-oophorectomy, ectopic pregnancies: salpingostomy, salpingectomy, Hysterectomy (superior pedicle division and bladder mobilization, uterine artery divisioncomplete the colpotomy) URO: Nephrectomy (colon mobilizationexposure and division of the renal vessels completed, freeing of the kidney)
Table 3 Overview of VR simulated FGE procedures available on the market Simulator company, VR simulator name
Procedural exercisesa
CAE Healthcare, EndoscopyVR
Colonoscopy, sigmoidoscopy, biopsy, polypectomy, upper GI bleeding, ERCP, including intubation and cannulation of confluence and optional treatment
Simbionix, GI-BRONCH Mentor
Colonoscopy, gastroscopy, sigmoidoscopy, gastric bleeding, ERCP including cannulation and optional stenting. EBUS including patient sedation and sampling.b Diagnostic bronchoscopy including samplingb
The listed procedural tasks are the results of a survey answered by the manufacturer themselves. These were the companies that answered the survey and have simulators for FGE. The authors do not guarantee for the completeness or the exactness of the table. All simulated procedures can be run with different anatomies ERCP endoscopic retrograde cholangiopancreatography; EBUS endobronchial ultrasound; TBNA transbronchial needle aspiration a
All procedures start with scope introduction and end with scope removal
b
Not FGE procedures but included in the overview because they are part of the VR simulator
Endovascular Surgery CAE Healthcare, Mentice, and Simbionix offer VR simulators for EVS, in total 33 procedures (Table 4). All of the simulated procedural tasks can be run with different
anatomies. The simulated procedures start after surgical puncture. New procedural tasks the companies would add in the future are electrophysiological procedures, closure of atrial septal defect, and transcatheter aortic valve implantation.
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Table 4 Overview of VR simulated EVS procedures available on the market Simulator company, VR simulator name
Procedural exercises
Starting point-end point
CAE Healthcare, CathLabVR
Neuro: Carotid stenting. Cardiac: PCI, cardiac surgery, femoral/retrograde, transapical placement of stent/valve. CRM including pacemaker placement and threshold testing
Guidewire insertion-completion of procedure
Mentice, VIST/VIST-C and VIST-Lab
Neuro: Neuro coil stenting, stroke management with thrombus removal, carotid stenting including EPD. Cardiac: PCI, CRM including coronary sinus lead placement and impedance and threshold capture, transeptal puncture. Peripheral: Angiography, microvascular decompression, chronic total occlusion, acute mesenteric ischemia, EVAR, renal ballooning/stenting, iliac/ superficial femoral arteries, below the knee lesions including advanced treatment decisions, uterine artery embolization
Measurement and procedural planning (EVAR), Choice of puncture sitea/after surgical puncture—end of procedure
Simbionix, Angio Mentor and PROcedure Rehearsal Studio (PRS)
Neuro: Carotid stenting, cerebral thrombus removal. Cardiac: PCI, CRM lead placement, transseptal puncture, aortic valve replacement. Peripheral: Superficial femoral arteries and Iliac stenting, EVAR, thoracic endovascular aortic aneurysm repair, peripheral thrombus removal, renal angioplasty and stenting
After surgical puncture—all instruments out, short sheath still inside
The listed procedural tasks are the results of a survey answered by the manufacturer themselves. These were the companies that answered the survey and have simulators for EVS. The authors do not guarantee for the completeness or the exactness of the table. All simulated procedures can be run with different anatomies PCI percutaneous coronary intervention; CRM cardiac rhythm management; EPD embolic protection device; EVAR endovascular aortic aneurysm repair a
For some procedures, the candidate is asked to choose puncture site and then the simulator performs the surgical puncture
Fidelity resources Most VR simulators simulate shadows, the effects of collision, and topological changes due to tearing, grasping, cutting, and bleeding (Table 5). Seven of ten simulators have haptic feedback either as standard or as an option. Eight of ten simulators come with specialized tools that mimic standard tools used in the clinic. Some simulators permit the use of standard tools as is, modified, or together with an adaptor. The ProMIS simulator (the augmented reality simulator from CAE Healthcare) uses real laparoscopic tools (Table 5).
of the simulators present a total score and half of the simulators have the possibility to set pass–fail criteria (Table 6). Literature review In total, 2,869 publications were retrieved. After removal of duplicates and non-English publications, the title and abstract of the remaining 1,873 publications were analyzed by the two authors independently. Based on the title and abstract analysis, 284 articles were included for a full-text scan, of which 116 articles were selected for a full review: 45 articles on LS, 43 on FGE, and 28 on EVS.
Teaching resources Laparoscopy Most VR simulators have guiding features, such as instructional aids, visual aids, tactile aids, and interaction indicators (Table 6). The simulated procedures for eight of ten simulators can be performed with different levels of guidance, where faculty might choose to (partly) turn on the teaching aids. The simulators track the instruments by mechanical, optical, magnetic, or electromagnetic tracking, which permits motion analysis and presentation of movements’ metrics. In addition, the simulator companies state that they measure safety metrics and errors, metrics related to quality of performance, and time-related metrics. Half
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Thirty-five articles were identified that evaluated or applied a VR simulation system for procedural training for LS (Table 7; Table A, available online) [20, 24–57]. Most publications involved procedural training for cholecystectomy [20, 25–47], others involved gynecologic LS [24, 48– 53], colorectal surgery [54], nephrectomy [55, 56], and gastric band placement [57]. Ten articles were found that aimed solely to present a VR simulation system (study type 1) for training on: cholecystectomy [58–62] (among others GerTiSS [58], Xitact LS500 [59], VSOne [60],
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Table 5 Fidelity resources on VR simulators for LS, FGE, and EVS available on the market Fidelity Resources
Laparoscopy Lap VR
Surgical scene
Hardware interface
Endovascular CathLabVR
MIST VR
Lap Mentora
SEP
LapSim
Endoscopy VR
GIBRONCH Mentor d
VISTa
Angio Mentorb
Shadowsc,d
d
»
d
m
d
d
Effects of collision
d
d
d
d
d
d
d
d
d
d
Topological changese
d
»
d
d
d
d
d
d
d
d
d
d
d
»
d
Bleeding
d
»
d
d
d
Removal of blood or other liquidsc
d
m
d
d
d
Body movementsf Injection of contrast agentsg
m
m
d
m
d
»
d
d d
d d
m d
Simulated instruments (number)
8
7
14
14
13
6
15
4
10
6
Haptic feedback Standard tools/ scopes
m m
dh m
dh m
m m
dh d
d m
m m
d m
d d
d d
Tools mimicking standard tools
d
d
d
d
d
d
d
d
m
m
Pistol grip, scissor handlesc Needle holderc
d
d
d
d
d
d
m
d
d
d
Camera holderc
m
d
d
d
d
d
d
d
d
d d
d
m
d
m
m
m
Drug administrationd,g
m
d
d
d
d
Vital signs (i.e., heart rate, ECG) Other
d
d
d
d
d
Foot pedal
c
Biopsy channeld Physiological features
Flexible GI Endoscopy
Gas insufflationc
d
m
d
m
d
d
d
d
d
d
Anatomical variations
»
m
»
m
d
d
d
d
d
d
Patient-specific rehearsal
m
m
m
m
m
m
m
m
d
d
d = yes, » = partly, m = no, blank = not applicable or not answered The listed resources are the results of a survey answered by the manufacturer themselves. The authors do not guarantee for the completeness or the exactness of the table a
The answers are related to the high-end version of the simulator in the LapMentor or the VIST family
b
Including the PROcedure Rehearsal Studio Only LS VR simulators
c d
Only FGE VR simulators
e
Topological changes due to tearing, cutting, pushing, pulling, etc
f
Body movements due to respiration, peristalsis, etc
g
Only EVS VR simulators
h
Optional
VESTA [61]), colorectal surgery [63–65] (among others CAE Healthcare ProMIS [63]), tubal occlusion (VSOne [60]), nephrectomy [66], and common bile duct exploration [67].
Flexible Gastrointestinal Endoscopy Forty-one publications were identified that evaluate or apply a VR procedural simulation system for procedural
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123 m
d M&O d d d d d m
d O d d d d m d
Tracking of the instruments Safety metrics, errors Movements metrics Time metrics Performance metrics Total score Passed–fail
Tracking technology
Evaluation metrics
m
d d m
m m d
Comparatively to performances of peers
Comparatively to an expert level
m
d m
d
d
Comparatively to previous performances of the trainee
m
d
d
d
M
d
Per performance of the trainee
Presentation of results:
d
m
m
Real-time remote instructions
m
d
d
m
m
d
d
Monitoring of physiological stressf
Audible discomforte
m
Release of instrument by overstretchd d
d
d
d
Forces restricting/guiding movements d
d
d
Force feedback function m
d
d d
d d
Virtual point of view Written dialog boxes
Change of color at collision
d
d
m
Indicated path d
d
d
d
m
d
d
d
d
d
d
d
d
E
d
m
m
d
d
m
m
d
d
d
d
d
d
d
m d
Targets Arrows
d
d
d
d
d
d
d
d
d
d
M, O, etc.
d
m
d
d
d
m
d
d
m
m
d
d
d
m
mc
m
m
Voice instructions
d
d
m
m
m
Animation of 3D anatomy
d d
d d
d d
d d
d m
Written task description Instruction video
Different levels of guidance
Interaction indicators
Tactile aids
Visual aids
Instructional aids
Lap Sim
d
m
m
d
d
m
d
d
d
d
M&O
d
m
d
d
d
m
m
d
d
m
m
m
m
d
m
d
Endoscopy VR
SEP
MIST VR
LapVR
Lap Mentora
FGE
LS
m
m
m
d
m
m
d
d
d
d
MA
d
m
d
d
m
d
d
d
d
d
m
d
m
d
d
d
GI BRONCH Mentor
d
m
m
d
d
m
d
d
d
d
m
m
d
m
m
m
m
d
m
m
m
m
m
d
m
m
CathLabVR
EVS
m
m
d
d
m
d
d
d
d
d
M&O
m
m
m
d
m
d
d
d
d
d
O
d
m d
m d
d
d
m
d
d
d
m
d
d
d
d
d
d
Angio Mentorb
d
d
d
d
d
d
d
d
m
d
d
d
m
d
VISTa
f
e
d
c
b
a
Only EVS VR simulators
Only FGE VR simulators
Only LS VR simulators
A virtual instructor can be turned on
Including the PROcedure Rehearsal Studio
The answers are related to the high-end version of the simulator in the LapMentor or the VIST family
E electromagnetic; MA magnetic; M mechanical; O optical
The listed resources are the results of a survey answered by the manufacturer themselves. The authors do not guarantee for the completeness or the exactness of the table. d = yes, m = no, blank = not applicable or not answered
Evaluation metrics and feedback system
Guiding features
Teaching resources
Table 6 Teaching resources on VR simulators for LS, FGE, and EVS available on the market
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Table 7 Summary of study types and conclusions presented within the 115 publications retrieved in the literature review (several publications present results of multiple studies) Study type
LS (c–pc–nc)
EFG (c–pc–nc)
EVS (c–pc–nc)
1
10
2
9
2a
8 (7–0–1)
11 (7–1–3)
9 (6–3–0)
2b 2c
13 (12–0–1) 13 (13–0–0)
19 (12–6–1) 8 (8–0–0)
6 (2–2–2) 9 (9–0–0)
2d
2 (1–0–1)
4 (2–0–2)
2 (2–0–0)
2e
4 (3–0–1)
10 (9–0–1)
2 (2–0–0)
3a
8 (6–0–2)
2 (2–0–0)
0
3b
0
0
3 (3–0–0)
4
5 (1–0–4)
7 (4–1–2)
3 (2–1–0)
Total
63
63
43
Research question—c confirmed, pc partly confirmed, nc not confirmed
training for FGE (Table 7; Table B, available online) [22, 23, 68–106]. Most articles deal with one specific type of lower or upper gastrointestinal endoscopy: gastroscopy [68–74], sigmoidoscopy [75–81], colonoscopy [22, 23, 82– 101], or ERCP [102–104]. Two articles discussed both gastroscopy and colonoscopy [105, 106]. Two articles were found that aimed solely to present a VR simulation system (study type 1) for training of FGE: the CIT/MCG system [107] and the Simbionix GI BRONCH Mentor [108].
60
P-EO P-PE LA-EO AM-EO AM-MT SM-EO VR-SC VR-EO VR-SA
50
40
30
20
10
0 LS
FGE
EVS
Fig. 1 Overview of outcome types used for procedural performance assessment in the retrieved publications for LS (n = 32), FGE (n = 39), and EVS (n = 17). P-EO patient (expert observer); P-PE patient (patient experience); LA-EO living animal (expert observer); AM-EO animal cadaver model (expert observer); AM-MT animal cadaver model (motion tracking); SM-EO synthetic model (expert observer); VR-SC VR task (simulator generated score); VR-EO VR task (expert observer); VR-SA VR task (self-assessment)
other training methods (n = 8), or the transfer of skills to other settings allowing performance assessment (n = 16). The outcome types used for procedural performance assessment differ for the articles retrieved for LS, FGE, and EVS (Fig. 1).
Endovascular Surgery Discussion Nineteen publications were identified that evaluate or apply a VR simulation system for training of procedural skills for EVS (Table 7; Table C, available online) [109–127]. Some cover the use of procedural simulation for a specific type of procedure (carotid [109–112], renal [113–118], or iliac [119–121] artery stenting); others covered several types of procedures [122–124] or focused on patient-specific cases [125–127]. Nine publications were identified that aimed solely to present a VR simulation system (study type 1) for procedural EVS training [128–136] (among others the ICTS [128, 129], Simbionix PROcedure Rehearsal Studio [130, 131], HERMES [132], CathL [133]). Approximately half of the retrieved publications that evaluate or apply a VR simulation system for procedural training (study type 2–4) investigated multiple research questions, resulting in a total of 169 studies comprised in 95 publications (Table 7). The majority of the studies (n = 66) focus on verification of validity of the procedural simulation. Approximately a third of the studies (n = 54) investigated the acquisition of skills by training on procedural VR simulators by looking at; the performance curve on the simulation system itself (n = 30), compared with
Basic skills training on VR simulators has been shown to be of considerable added value on the quality of performance of novice surgeons during their first clinical procedures [10, 15]. With technological and educational advances, complex procedural VR simulation has entered surgical training curriculums. Although the general construct and added value of preclinical simulation training is widely acknowledged, the validity and added value of procedural simulation still needs to be established before widespread implementation of these tools will occur [19, 21, 137]. In this review, we provide an overview of the state of art on the available VR simulation systems for procedural training and assessment, through a literature review and a company survey. Five simulator companies were included in the survey. In the literature review, the results related to simulators from nine companies and 16 research groups are represented. In total, 78 different VR simulated procedural tasks (33 LS, 12 FGE, 33 EVS) are listed in the survey results (Tables 2, 3, 4), of which 17 also were retrieved in the literature review. A large number of procedures found in this study (n = 61)
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have to our knowledge not yet been scientifically investigated. For the VR simulated procedures that are investigated (n = 17), the majority of the publications (68/115) present results that confirm the validity and/or application of VR simulation for procedural training (study types 2A– 2E; Table 7). Approximately 25 % of the studies of type 2A–2E presented in the retrieved publications for FGE and EVS did not find sufficiently convincing evidence, whereas for LS this was the case in only approximately 10 %. It was expected to find some discrepancy between the results of the survey and the literature review, because some literature refers to systems not commercially available anymore and companies have taken over other companies. Caution must be taken that procedures found in the literature might be of different versions, both software and hardware, than what is commercially available today. Simulator companies continuously keep improving the performance of their hardware and software [137], and even though they still have the same simulator name, important characteristics might have been changed, making validity studies potentially inapplicable for the currently available simulator set-ups. The interaction with the system during a simulated procedural task is highly dependent on the software version and hardware, because it can directly influence the training experience for the trainee (e.g., haptic feedback, speed of onscreen action following user input, and so on). The outcome of a validation study is therefore dependent on not only the type of simulator but also software versions, hardware options, and study set-up [138]. Complete description of the simulator set-up and training context is not always described in scientific publications. Only 12 of the 116 retrieved articles specified which specific hardwaresoftware combination and software version were used to conduct the experiments they described [39, 50–52, 80, 82, 86–88, 92, 98, 106]. It was in only three articles on EVS for example stated that the surgical protocol was available on paper for the trainees as support while performing the procedural training on the simulator [115, 122, 123]. This makes it difficult for the surgical community to judge and compare the presented results and to reproduce the settings of a given study. Patient-specific rehearsal, also known as mission rehearsal, has developed the training potential further, i.e., for EVS, where the Angio Mentor and VIST offer patientspecific simulation. None of the VR simulators for LS or FGE do so (Table 5). In the literature review, five publications were found that established the feasibility of patient specific simulation for EVS [125–127, 130, 131]. Previous research has indicated that basic skills acquired by VR simulator training transfer to the clinical setting and is better than no preclinical training [10]. In the retrieved literature, some transfer studies (study type 2E) support this finding for VR procedural training for LS [33, 47, 51], FGE
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[22, 68, 70, 73, 81, 82, 86, 93, 101], and EVS [119, 120], whereas others could not find sufficient evidence that VR procedural training is beneficial to improve clinical performance for LS [37] and FGE [72]. For FGE, approximately one-third of the publications involved performance assessment on patients subsequent to procedural VR training (Fig. 1) [22, 68, 70, 72, 73, 76, 80–82, 86, 88, 93, 101], for LS three publications (9 %) involved clinical performance assessment [29, 47, 51] and for EVS no publications were retrieved that studied the transfer of skills from procedural VR simulator training to the clinical setting. The studies for FGE and LS that investigated the transfer of skills from simulator training to the clinical setting did so by comparing with either no simulator training or with other training methods. None of these publications evaluated predictive validity in the sense that the extent to which good performance on the simulator predicts good performance on real patients. To provide a proper educational experience, just having a VR simulator at the trainees’ disposal does not suffice. The way the simulator is implemented, such as the distribution of training, the use of objective assessment, and the degree and type of feedback, influences the effectiveness of simulator-based training [1, 12, 84]. Criterion-based training has the potential to better assure the quality of surgical skills than time-based training, because criterionbased training addresses the fact that trainees have different learning styles [1, 139, 140]. VR simulators offer the possibility to set up criterion-based training by setting up objective assessment criteria and presenting the results to the trainee (summative feedback) (Table 6). In the articles retrieved in the literature review ten publications (five on LS and FGE each, none on EVS) describe to have used benchmarks to facilitate criterion-based training [20, 25, 36, 38, 51, 82, 89–91, 101]. Most of these studies based the benchmarks on expert performance scores (proficiencybased training) [20, 25, 36, 38, 82, 89, 101]; others retrieved the benchmarks from previously published performance scores [51, 90, 91]. Feedback is an important aspect to strengthen the learning process [1, 12], both intrinsic (e.g., visual or haptic cues during task performance) and extrinsic, in the form of formative feedback (tips during task performance) or summative feedback (post-task performance scores). Most simulators in this study have the possibility to provide both (Table 6). However, expert coaching can still be beneficial. In the literature review, publications were found that presented a positive effect of proctored training [84, 115] as well as studies that did not [89, 91]. VR procedural simulation might be used to ascertain that surgeons in training are sufficiently skilled to continue their training in the clinical setting or to accredit surgeons to operate independently. However, the validity
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of the simulator metrics diverge considerably. More than one-third of the studies did not use the performance scores provided by the simulator, indicating that there is room for improvement of the simulator output on summative performance. Simulation is a way of creating safe and riskless substitutes for the real surgical environment. The concept of simulation comprises diverse ways of experiential learning. This review has dealt with the use of VR simulators—devices—that mimic the patient, the hardware interfaces with which the trainee interacts, and the surgical scene (Fig. A, available online). The simulation is immersive in its nature by evoking and replicating substantial aspects of the real surgical setting in an interactive manner. A simulator is, in a clinical view, not interesting per se, but can be a valuable tool in training and assessment. Achieving very high simulation fidelity (visual realism and feedback, tool interaction, and haptic feedback) is technologically challenging and costly. The needed level of simulation fidelity [7] depends on what aspects the trainee need to immerse into acquire skills that can be transferred to the clinical setting. An important aspect is the influence of haptic feedback [30, 34, 141– 145], which among others can impact interpretation of performance scores, effectiveness of skills acquisition, and transfer to other training modalities and the OR. Furthermore, embedding the VR procedural simulation in a more comprehensive training environment also adds to increase the simulation fidelity. Such immersive simulation can be applied to train not only technical skills, but also to train how to deal with anatomic variations and complications, professionalism, communication skills, teamwork, leadership skills, and dealing with equipment failures [3, 12, 21, 146, 147]. The literature review includes publications for all three surgical fields that incorporated research in more immersive simulation environments where procedural simulation was combined with for example training or assessment of teamwork [26, 77, 126, 131]. Another way of preparing for surgical performance in the clinic is to train on technical and cognitive skills separately [147], where cognitive simulators can be purely software-based, allowing virtual procedural training without the emphasis on the hardware interface and the training of technical skills. Such cognitive simulators have not been dealt with in this review. In summary, procedural VR simulation is an important educational tool to limit patient risk and to increase training efficiency, both in early phase and throughout surgical training and extended career. Procedural VR simulation is largely available on the market; some simulated procedures have been subject to validation, whereas the majority still needs validation. There is still a need in the surgical community for evidence on how to optimally embed simulator training in surgical education and to determine its
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role in (re)accreditation of surgeons. In the future, it will be important to delineate the necessary similarities between simulated and real-world environments to create successful transfer of technical and cognitive skills learnt on simulators to the clinical setting. Acknowledgments The authors thank Professor Jack Jakimowicz, Professor Ronald Ma˚rvik, and Edmund Søvik for clinical expert advices. The authors equally thank the companies that have contributed to the survey: CAE Healthcare (www.cae.com/en/healthcare/home.asp), Mentice AB (www.mentice.com), Simbionix Ltd (www.simbionix.com), SimSurgery AS (www.simsurgery.com), and Surgical Science AB (www.surgicalscience.com). Disclosures Cecilie Va˚penstad and Sonja Buzink have no conflicts of interest or financial ties to disclose. The work of Cecilie Va˚penstad was supported by the Centre for ultrasound- and image-guided therapy, the National Centre for Advanced Laparoscopic Surgery, and SINTEF (all Trondheim, Norway). The work of Sonja Buzink was supported by a TU Delft Fellowship Grant provided by the Executive Board of Delft University of Technology, The Netherlands.
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