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400+ Validation Studies

Evidence-based Simulation Training

Find here a selection of validation studies, the culmination of extensive research and rigorous validation processes providing evidence of the validity and reliability of our simulation technology, which helped pave the way for revolutionizing surgical education and training. Based on some of the studies we have established proficiency-based curricula which are integrated into our simulators.

 

 

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Training simulator efficacy in developing thoracic and general surgical skills in a residency programme: a pilot study Sara Grossi et al., Eur J Cardiothorac Surg .Feb 2024

Objectives: Virtual training simulators have been introduced in several surgical disciplines to improve residents’ abilities. Through the use of the LapSim® virtual training simulator (Surgical Science, Göteborg, Sweden), this study aims to plan an effective learning path in minimally invasive thoracic and general surgery.

Methods: All thoracic and general surgery trainees in their 1st and 2nd year of residency at the University of Insubria were enrolled and randomized into 2 groups: residents undergoing an intensive twice-a-week virtual training programme (group A: n = 8) and those undergoing a once-weekly non-intensive virtual training programme (group B: n = 9). The virtual training programme was divided into 4 modules, each of 12 weeks. In the 1st module, trainees repeated grasping, cutting, clip application, lifting and grasping, and fine dissection exercises during each training session. Seal-and-cut exercise was performed as the initial and final test. Data on surgical manoeuvres (time and on mistakes) were collected; intra- and inter-group comparisons were planned.

Results: No significant differences were observed between groups A and B at the 1st session, confirming that the 2 groups had similar skills at the beginning. After 12 weeks, both groups showed improvements, but comparing data between initial and final test, only Group A registered a significant reduction in total time (P-value = 0.0015), left (P-value = 0.0017) and right (P-value = 0.0186) instrument path lengths, and in left (P-value = 0.0010) and right (P-value = 0.0073) instrument angular path lengths, demonstrating that group A acquired greater precision in surgical manoeuvres.

Conclusions: Virtual simulator training programme performed at least twice a week was effective for implementing basic surgical skills required for the trainee’s professional growth. Additional virtual training modules focused on more complex exercises are planned to confirm these preliminary results.

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Effect of virtual reality training on laparoscopic surgery: randomised controlled trial Christian R Larsen et al, British Medical Journal 2009

Objective: To assess the effect of virtual reality training on an actual laparoscopic operation.

Setting and Participants: Seven gynaecological departments in the Zeeland region of Denmark. 24 first and second year registrars specialising in gynaecology and obstetrics.

Interventions: Proficiency based virtual reality simulator training in laparoscopic salpingectomy and standard clinical education (controls).

Main outcome measure: The main outcome measure was technical performance assessed by two independent observers blinded to trainee and training status using a previously validated general and task specific rating scale. The secondary outcome measure was operation time in minutes.

Results: The simulator trained group (n=11) reached a median total score of 33 points (interquartile range 32-36 points), equivalent to the experience gained after 20-50 laparoscopic procedures, whereas the control group (n=10) reached a median total score of 23 (22-27) points, equivalent to the experience gained from fewer than five procedures (P<0.001). The median total operation time in the simulator trained group was 12 minutes (interquartile range 10-14 minutes) and in the control group was 24 (20-29) minutes (P<0.001). The observers’ inter-rater
agreement was 0.79.

Conclusion: Skills in laparoscopic surgery can be increased in a clinically relevant manner using proficiency based virtual reality simulator training. The performance level of novices was increased to that of intermediately experienced laparoscopists and operation time was halved. Simulator training should be considered before trainees carry out laparoscopic procedures.

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Proficiency-based virtual reality training significantly reduces the error rate for residents during their first 10 laparoscopic cholecystectomies Ahlberg et al, American Journal of Surgery 2007

Background: Virtual reality (VR) training has been shown previously to improve intraoperative performance during part of a laparoscopic cholecystectomy. The aim of this study was to assess the effect of proficiency-based VR training on the outcome of the first 10 entire cholecystectomies performed by novices.

Methods: Thirteen laparoscopically inexperienced residents were randomized to either (1) VR training until a predefined expert level of performance was reached, or (2) the control group.  Videotapes of each resident’s first 10 procedures were reviewed independently in a blinded fashion and scored for predefined errors.

Results: The VR-trained group consistently made significantly fewer errors (P = .0037). On the other hand, residents in the control group made, on average, 3 times as many errors and used 58% longer surgical time. Conclusions: The results of this study show that training on the VR simulator to a level of proficiency significantly improves intraoperative performance during a resident’s first 10 laparoscopic cholecystectomies.

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Predictors of laparoscopic simulation performance among practicing obstetrician gynecologists Shyama Mathews et al, Am J Obstet Gynecol 2017

Background: While simulation training has been established as an effective method for improving laparoscopic surgical performance in surgical residents, few studies have focused on its use for attending surgeons, particularly in obstetrics and gynecology. Surgical simulation may have a role in improving and maintaining proficiency in the operating room for practicing obstetrician gynecologists.

Objective: We sought to determine if parameters of performance for validated laparoscopic virtual simulation tasks correlate with surgical volume and characteristics of practicing obstetricians and gynecologists.

Study Design: All gynecologists with laparoscopic privileges (n ¼ 347) from 5 academic medical centers in New York City were required to complete a laparoscopic surgery simulation assessment. The physicians took a presimulation survey gathering physician self-reported characteristics and then performed 3 basic skills tasks (enforced peg transfer, lifting/grasping, and cutting) on the LapSim virtual reality laparoscopic simulator (Surgical Science Ltd, Gothenburg, Sweden). The association between simulation outcome scores (time, efficiency, and
errors) and self-rated clinical skills measures (self-rated laparoscopic skill score or surgical volume category) were examined with regression models.

Results: The average number of laparoscopic procedures per month was a significant predictor of total time on all 3 tasks (P ¼ .001 for peg transfer; P ¼ .041 for lifting and grasping; P < .001 for cutting). Average monthly laparoscopic surgical volume was a significant predictor of 2 efficiency scores in peg transfer, and all 4 efficiency scores in cutting (P¼ .001 to P ¼ .015). Surgical volume was a significant predictor of errors in lifting/grasping and cutting (P < .001 for both). Self-rated laparoscopic skill level was a significant predictor of total time in all 3 tasks (P < .0001 for peg transfer; P ¼ .009 for lifting and grasping; P < .001 for cutting) and a significant predictor of nearly all efficiency scores and errors scores in all 3 tasks.

Conclusion: In addition to total time, there was at least 1 other objective performance measure that significantly correlated with surgical volume for each of the 3 tasks. Higher-volume physicians and those with fellowship training were more confident in their laparoscopic skills. By determining simulation performance as it correlates to active physician practice, further studies may help assess skill and individualize training to maintain skill levels as case volumes fluctuate.

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Prospective Cohort Study of Haptic Virtual Reality Laparoscopic Appendicectomy Learning Curve Trajectory Chris Brown et al, J LapEndo & Advanced Surg Tech 2019

Background: Simulation training is strongly advocated by 24/7 risk-rich professions because swift learning curve inflection point attainment delivers earlier competence; the left-shift effect. The aim of this study was to determine the value of haptic laparoscopic virtual reality simulation, by iterative benchmark exercise (n = 8), before simulated laparoscopic appendicectomy (SLA); the hypothesis was that favorable benchmark learning curve trajectories would be associated with improved SLA competence when compared with consultant expert performance.

Methods: A 28-trainee cohort completed 1349 Laparoscopic Haptic Virtual Reality Skills (LHVRS) tasks, during which 19 ergonomic variables were assessed by virtual interface, including force feedback (Surgicalscience.com), before 153 SLAs. Primary outcome measure was SLA composite competence score related to six consultant trainer experts.

Results: Of the eight LHVRS tasks, the three with the steepest learning curve trajectories correlated with better median overall SLA competence scores, namely tissue grasping/lifting (rho = 0.362, P = .049), fine dissection (rho = 0.388, P = .028), and camera navigation (rho = 0.518, P = .007); fine dissection was the only haptic laparoscopic virtual reality simulation task that predicted a SLA score within a Youden index defined, 70% of the consultant expert level (area under curve [AUC] = 0.803, P = .028). A significant SLA learning curve emerged, with a learning curve trajectory inflection point at the fourth SLA attempt (first SLA 30.5% versus fourth SLA score 76.0%, gradient 76°, P = .010).

Conclusion: Learning curve trajectory can be measured, influenced, and accelerated significantly; a pronounced left-shift effect, with translational potential for enhanced shorter training time and improved patient safety.

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Effect of virtual reality training to enhance laparoscopic assistance skills Chen X et al., BMC Med. Edu., Jan 4, 2024

Background

While laparoscopic assistance is often entrusted to less experienced individuals, such as residents, medical students, and operating room nurses, it is important to note that they typically receive little to no formal laparoscopic training. This deficiency can lead to poor visibility during minimally invasive surgery, thus increasing the risk of errors. Moreover, operating room nurses and medical students are currently not included as key users in structured laparoscopic training programs.

Objectives

The aim of this study is to evaluate the laparoscopic skills of OR nurses, clinical medical postgraduate students, and residents before and after undergoing virtual reality training. Additionally, it aimed to compare the differences in the laparoscopic skills among different groups (OR nurses/Students/Residents) both before and after virtual reality training.

Methods

Operating room nurses, clinical medical postgraduate students and residents from a tertiary Grade A hospital in China in March 2022 were selected as participants. All participants were required to complete a laparoscopic simulation training course in 6 consecutive weeks. One task from each of the four training modules was selected as an evaluation indicator. A before-and-after self-control study was used to compare the basic laparoscopic skills of participants, and laparoscopic skill competency was compared between the groups of operating room nurses, clinical medical postgraduate students, and residents.

Results

Twenty-seven operating room nurses, 31 clinical medical postgraduate students, and 16 residents were included. The training course scores for the navigation training module, task training module, coordination training module, and surgical skills training module between different groups (operating room nurses/clinical medical postgraduate/residents) before laparoscopic simulation training was statistically significant (p < 0.05). After laparoscopic simulation training, there was no statistically significant difference in the training course scores between the different groups. The surgical level scores before and after the training course were compared between the operating room nurses, clinical medical postgraduate students, and residents and showed significant increases (p < 0.05).

Conclusion

Our findings show a significant improvement in laparoscopic skills following virtual surgery simulation training across all participant groups. The integration of virtual surgery simulation technology in surgical training holds promise for bridging the gap in laparoscopic skill development among health care professionals.

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Curriculum-based solo virtual reality training for laparoscopic intracorporeal knot tying: objective assessment of the transfer of skill from virtual reality to reality Munz Y. et al, Am J Surg . 2007

Background: Very few studies have addressed the transferability of skills from virtual reality (VR) to real life. The aim of this study was to assess the feasibility and effectiveness of teaching intracorporeal knot tying (ICKT) by VR simulation only.

Methods: Twenty novices underwent structured training of basic skills training on the Minimally Invasive Surgical Trainer simulator (Mentice AB, Gothenburg, Sweden) followed by knot tying training on the LapSim simulator (Surgical Science, Gothenburg, Sweden). They were assessed pre- and post-training on a video trainer. Assessment of performance included motion tracking and video-based checklist. Nonparametric statistical analysis was used, and P < .05 was deemed significant.

Results: All participants completed a correct knot as compared with only 25% before VR training. Time to completion was 66% faster and knot quality 45% better after VR training. Significant reduction in number of movements (P = .006) and distance traveled (P < .000) by both hands after VR training.

Conclusions: Teaching ICKT by VR simulators only is feasible and effective. Furthermore, this study highlights the complementary use of different VR simulators within a structured curriculum.

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