Immersive Virtual Reality (VR) laparoscopy simulation is emerging to enhance the attractiveness and realism of surgical procedural training. This study analyses the usability and presence of a Virtual Operating Room (VOR) setup via user evaluation and sets out the key elements for an immersive environment during a laparoscopic procedural training.In the VOR setup, a VR headset displayed a 360-degree computer-generated Operating Room (OR) around a VR laparoscopic simulator during laparoscopy procedures. Thirty-seven surgeons and surgical trainees performed the complete cholecystectomy task in the VOR. Questionnaires (i.e., Localized Postural Discomfort scale, Questionnaire for Intuitive Use, NASA-Task Load Index, and Presence Questionnaire) followed by a semi-structured interview were used to collect the data.The participants could intuitively adapt to the VOR and were satisfied when performing their tasks (M=3.90, IQR=0.70). The participants, particularly surgical trainees, were highly engaged to accomplish the task. Despite the higher mental workload on four subscales (p < 0.05), the surgical trainees had a lower effort of learning (4 vs 3.33, p < 0.05) compared to surgeons. The participants experienced very slight discomfort in seven body segments (0.59-1.16). In addition, they expected improvements for team interaction and personalized experience within the setup.The VOR showed potential to become a useful tool in providing immersive training during laparoscopy procedure simulation based on the usability and presence noted in the study. Future developments of user interfaces, VOR environment, team interaction and personalization should result in improvements of the system.

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Virtual reality (VR) training is widely used in several minimal invasive surgery (MIS) training curricula for procedural training. However, VR training in its current state lack immersive training environments, such as using head-mounted displays that is implemented in military or aviation training and even entertainment. The virtual operating room simulation setup (VORSS) is explored in this study to determine the effectiveness of immersive training in MIS. Twenty-eight surgeons and surgical trainees performed a laparoscopic cholecystectomy on the VORSS comprising of a head-mounted 360-degree realistic OR surrounding on a VR laparoscopic simulator. The VORSS replicated a full setup of instruments and surgical team-members as well as some of the distractions occurring during surgical procedures. Questionnaires were followed by semi-structured interviews to collect the data. Experts and novices found the VORSS to be intuitive and easy to use (p = 0.001). The outcome of the usability test, applying QUESI and NASA-TLX, reflected the usability of the VORSS (p < 0.05), at the cognitive level, which indicates a good sense of immersion and satisfaction, when performing the procedure within VORSS. The need for personalized experience within the setup was strongly noted from most of the participants. The VORSS for procedural training has the potential to become a useful tool to provide immersive training in MIS surgery. Further optimizing of the VORSS realism and introduction of distractors in the OR should result in an improvement of the system.

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Motion tracking software for assessing laparoscopic surgical proficiency has been proven to be effective in differentiating between expert and novice performances. However, with several indices that can be generated from the software, there is no set threshold that can be used to benchmark performances. The aim of this study was to identify the best possible algorithm that can be used to benchmark expert, intermediate and novice performances for objective evaluation of psychomotor skills. 12 video recordings of various surgeons were collected in a blinded fashion. Data from our previous study of 6 experts and 23 novices was also included in the analysis to determine thresholds for performance. Video recording were analyzed both by the Kinovea 0.8.15 software and a blinded expert observer using the CAT form. Multiple algorithms were tested to accurately identify expert and novice performances. ½ L + 13 A + 16 J scoring of path length, average movement and jerk index respectively resulted in identifying 23/24 performances. Comparing the algorithm to CAT assessment yielded in a linear regression coefficient R² of 0.844. The value of motion tracking software in providing objective clinical evaluation and retrospective analysis is evident. Given the prospective use of this tool the algorithm developed in this study proves to be effective in benchmarking performances for psychomotor skills evaluation.

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Background: The eoSim^® laparoscopic augmented reality (AR) simulator has instrument tracking capabilities that may be suitable for implementation in laparoscopic training. The objective is to assess face, content, and construct validity of this simulator for basic laparoscopic skills training. Methods: Participants were divided into three groups: novices (no training), intermediates (<50 laparoscopic procedures), and experts (>50 laparoscopic procedures). Three basic tasks were completed on the simulator: thread transfer (1), cyst dissection (2), and tube ligation (3). A questionnaire was completed on realism, didactic value, and usability of the simulator. Measured outcome parameters were as follows: time, distance, time off screen, average speed, acceleration, and smoothness. Results: Mean ± standard deviation scores on realism were positive (Task 1 or T1; 3.9 ± 0.7, P = .13, T2; 3.7 ± 0.7, P = .07, T3; 3.7 ± 0.07), as well as didactic value (T1; 3.9 ± 0.8, P = .71, T2; 3.9 ± 0.8, P = .31, T3; 4.0 ± 0.8, P = .40). Usability was valued the highest, with mean scores between 3.9 and 4.3 (T1; P = .71, T2; P = .80, T3; P = .85). Scores did not differ significantly between groups. Experts were significantly faster (Task 1; P < .001, Task 2; P = .042, Task 3: P < .001) with higher handling speed for tasks 2 and 3 (Task 1; P = .20, task 2; P = .034, task 3; P = .049). Results for other outcome parameters also indicated experts had better instrument control and efficiency than novices, although these differences did not reach statistical significance. Conclusions: The eoSim laparoscopic AR simulator is regarded as a realistic, accessible, and useful tool for the training of basic laparoscopic skills, with good face validity. Construct validity of the eoSim AR simulator was demonstrated on several core variables, but not all.

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Background: The purpose of this study was to validate the eoSim, an affordable and mobile inanimate laparoscopic simulator with instrument tracking capabilities, regarding face, content and construct validity on complex suturing tasks. Methods: Participants recruited for this study were novices (no laparoscopic experience), target group for this training (surgical/gynaecologic/urologic residents, > 10 basic and < 20 advanced laparoscopic procedures) and experts (> 20 advanced laparoscopic procedures). Each participant performed the intracorporeal suturing exercise (Task 1), an upside down needle transfer (Task 2, developed for this study) and an anastomosis needle transfer (Task 3). Following, the participants completed a questionnaire regarding their demographics and opinion on the eoSim in terms of realism, didactic value and usability. Measured outcome parameters were time, distance, percentage of instrument tip off-screen, working area, speed, acceleration and smoothness. Results: In total, 104 participants completed the study, of which 60 novices, 31 residents and 13 experts. Face and content validity results showed a mean positive opinion on realism (3.9 Task 1, 3.6 Task 2 and 3.7 Task 3), didactic value (4.0, 3.4 and 3.7, respectively) and usability (4.2. 3.7 and 4.0, respectively). There were no significant differences in these outcomes between the specified expertise groups. Construct validity results showed significant differences between experts, target group or novices for Task 1 in terms of time (means 339, 607 and 1224 s, respectively, p < 0.001) and distance (means 8.1, 15.6 and 21.7 m, respectively, p < 0.001). Task 2 showed significant differences between groups regarding time (p < 0.001), distance (p 0.003), off-screen (p < 0.001) and working area (p < 0.001). Task 3 showed significant differences between groups, after subanalyses, on total number of stitches (p < 0.001), time per stitch (p < 0.001) and distance per stitch (p < 0.001). Conclusions: The results of this study indicate that the eoSim is a potential meaningful and valuable simulator in the training of suturing tasks.

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Introduction: There has been a wide uptake in the use of Minimal Invasive Surgery (MIS) globally across different surgical specialties. Whilst evidence exists for a structured training curriculum for basic laparoscopic surgery, there is little agreement on a complete framework for an advanced MIS training curriculum, defining the essential elements of the curriculum including the optimal assessment methods. The aim of this study is to obtain a consensus on the essential elements of a training curriculum for advanced MIS. Materials and Methods: A Delphi study was carried out involving 57 international experts in advanced MIS across different surgical specialties. A three round survey was conducted to reach consensus on the essential domains of a curriculum. This included defining the learners, trainers and training centres; curriculum content and competency based assessment. Results: Unanimous agreement was reached for the completion of basic laparoscopic training before entry into advanced training. A trainer should have reached competency in advanced MIS and attended a ‘Train the trainer’ course. The curriculum should be delivered as modular training, including a multi-modal approach with a structured clinical proctorship programme. Formative assessment was considered as an integral part of learning and should be performed using objective work based assessment tools such as global assessment scale (GAS) forms. Accreditation in advanced MIS can be achieved by objective assessment of technical performance of unedited videos in addition to key clinical performance outcomes. Conclusion: A consensus on the framework of an advanced MIS training curriculum has been achieved defining the essential elements of entry criteria, selection of trainers and training units and curriculum content. Multimodal learning, clinical proctorship programme and competency based assessment are integral parts of the curriculum.@en

Background: The use of motion tracking has been proved to provide an objective assessment in surgical skills training. Current systems, however, require the use of additional equipment or specialised laparoscopic instruments and cameras to extract the data. The aim of this study was to determine the possibility of using a software-based solution to extract the data. Methods: 6 expert and 23 novice participants performed a basic laparoscopic cholecystectomy procedure in the operating room. The recorded videos were analysed using Kinovea 0.8.15 and the following parameters calculated the path length, average instrument movement and number of sudden or extreme movements. Results: The analysed data showed that experts had significantly shorter path length (median 127 cm vs. 187 cm, p = 0.01), smaller average movements (median 0.40 cm vs. 0.32 cm, p = 0.002) and fewer sudden movements (median 14.00 vs. 21.61, p = 0.001) than their novice counterparts. Conclusion: The use of software-based video motion tracking of laparoscopic cholecystectomy is a simple and viable method enabling objective assessment of surgical performance. It provides clear discrimination between expert and novice performance.

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Objective: To establish whether a systematized approach to self-assessment in a laparoscopic surgical skills course improves accordance between expert- and self-assessment.

Design: A systematic training course in self-assessment using Competency Assessment Tool was introduced into the normal course of evaluation within a Laparoscopic Surgical Skills training course for the test group (n = 30). Differences between these and a control group (n = 30) who did not receive the additional training were assessed.

Setting: Catharina Hospital, Eindhoven, The Netherlands (n = 27), and GSL Medical College, Rajahmundry, India (n = 33).

Participants: Sixty postgraduate year 2 and 3 surgical residents who attended the 2-day Laparoscopic Surgical Skills grade 1 level 1 curriculum were invited to participate.

Results: The test group (n = 30) showed better accordance between expert- and self-assessment (difference of 1.5, standard deviation [SD] = 0.2 versus 3.83, SD = 0.6, p = 0.009) as well as half the number (7 versus 14) of cases of overreporting. Furthermore, the test group also showed higher overall mean performance (mean = 38.1, SD = 0.7 versus mean = 31.8, SD = 1.0, p < 0.001) than the control group (n = 30). The systematic approach to self-assessment can be viewed as responsible for this and can be seen as "reflection-before-practice" within the framework of reflective practice as defined by Donald Schon.

Conclusion: Our results suggest that "reflection-before-practice" in implementing self-assessment is an important step in the development of surgical skills, yielding both better understanding of one's strengths and weaknesses and also improving overall performance.

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Background: The sleeve gastrectomy is an example of minimally invasive surgery. It is important to determine the critical steps of the procedure in order to reduce complications and increase safety and efficiency. Objective: The aim of this study was to detect the key elements of the sleeve gastrectomy and find the potential hazard zones of the procedure. Setting: Bariatric department of a large teaching hospital in the Netherlands. Methods: A prospective clinical observation study was performed including 60 sleeve gastrectomy procedures. An expert panel determined the key steps, and two experts assessed the procedures systematically for technical errors according to the principles of Observational Clinical Human Reliability Assessment (OCHRA). Results: A total of 213 technical errors have been made, and the majority were made during mobilization of the greater curvature and during stapling of the stomach. In 44.6 %, errors had consequences and 96 additional actions were performed. There was a significant correlation between errors during opening of the lesser sac and postoperative complications, and between repositioning of the stapler and postoperative complications. Conclusions: In this study, the 13 key steps of the SG were defined, and OCHRA was considered a valuable assessment tool for surgical performance and potential hazard zones. Most consequential errors are made during dissection of the greater curvature and during stapling of the stomach. Errors during the start of mobilization of the greater curvature and repositioning of the stapler lead to longer duration of the procedure and are associated with a higher risk of postoperative complications.

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Background: The concept of self-assessment has been widely acclaimed for its role in the professional development cycle and self-regulation. In the field of medical education, self-assessment has been most used to evaluate the cognitive knowledge of students. The complexity of training and evaluation in laparoscopic surgery has previously acted as a barrier in determining the benefits self-assessment has to offer in comparison with other fields of medical education. Methods: Thirty-five surgical residents who attended the 2-day Laparoscopic Surgical Skills Grade 1 Level 1 curriculum were invited to participate from The Netherlands, India and Romania. The competency assessment tool (CAT) for laparoscopic cholecystectomy was used for self- and expert-assessment and the resulting distributions assessed. Results: A comparison between the expert- and self-assessed aggregates of scores from the CAT agreed with previous studies. Uniquely to this study, the aggregates of individual sub-categories—‘use of instruments’; ‘tissue handling’; and errors ‘within the component tasks’ and the ‘end product’ from both self- and expert-assessments—were investigated. There was strong positive correlation (r_s > 0.5; p < 0.001) between the expert- and self-assessment in all categories with only the ‘tissue handling’ having a weaker correlation (r_s = 0.3; p = 0.04). The distribution of the mean of the differences between self-assessment and expert-assessment suggested no significant difference between the scores of experts and the residents in all categories except the ‘end product’ evaluation where the difference was significant (W = 119, p = 0.03). Conclusion: Self-assessment using the CAT form gives results that are consistently not different from expert-assessment when assessing one’s proficiency in surgical skills. Areas where there was less agreement could be explained by variations in the level of training and understanding of the assessment criteria.

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BACKGROUND: The sleeve gastrectomy is being performed increasingly as a primary procedure for the treatment of morbid obesity. A minimally invasive approach is currently applied to the procedure. The two major steps are dissection and stapling. For dissection, several tools have been developed. The goal of this study was to compare the efficiency and the ergonomics of two ultrasonic devices during the sleeve gastrectomy.MATERIALS AND METHODS: Thirty patients were randomised for the use of a cordless Sonicision™ (Covidien, Mansfield, MA) or a cord-containing HARMONIC ACE®+ (Ethicon Endo-Surgery Inc., Cincinnati, OH) during dissection. Both devices were assessed for objective and subjective measures.RESULTS: There was no significant difference in duration of the procedures. The assembly and installation time of the Sonicision™ were significantly shorter; however, the dismantle time was not. No difference in plume formation or dissection failures was found between the devices. Scrub nurses scored the Sonicision™ significantly clearer and easier in use and more reliable. The surgeons, however, did not find one of the devices easier in use, more reliable or precise, but they did report better manoeuvrability of the Sonicision™.CONCLUSION: In comparison to the wired HARMONIC ACE®+, during sleeve gastrectomy, the cordless Sonicision™ was considered easier to use, faster during assembling and installation, and more reliable with better manoeuvrability. Surgeons scored both devices equally effective. Both ultrasonic devices can be used easily and safely for a sleeve gastrectomy.@en

Background: Laparoscopic surgery for colon cancer is associated with improved recovery and similar cancer outcomes at 3 and 5 years in comparison with open surgery. However, long-term survival rates have rarely been reported. Here, we present survival and recurrence rates of the Dutch patients included in the COlon cancer Laparoscopic or Open Resection (COLOR) trial at 10-year follow-up. Methods: Between March 1997 and March 2003, patients with non-metastatic colon cancer were recruited by 29 hospitals in eight countries and randomised to either laparoscopic or open surgery. Main inclusion criterion for the COLOR trial was solitary adenocarcinoma of the left or right colon. The primary outcome was disease-free survival at 3 years, and secondary outcomes included overall survival and recurrence. The 10-year follow-up data of all Dutch patients were collected. Analysis was by intention-to-treat. The trial was registered at ClinicalTrials.gov (NCT00387842). Results: In total, 1248 patients were randomised, of which 329 were Dutch. Fifty-eight Dutch patients were excluded and 15 were lost to follow-up, leaving 256 patients for 10-year analysis. Median follow-up was 112 months. Disease-free survival rates were 45.2 % in the laparoscopic group and 43.2 % in the open group (difference 2.0 %; 95 % confidence interval (CI) −10.3 to 14.3; p = 0.96). Overall survival rates were 48.4 and 46.7 %, respectively (difference 1.7 %; 95 % CI −10.6 to 14.0; p = 0.83). Stage-specific analysis revealed similar survival rates for both groups. Sixty-two patients were diagnosed with recurrent disease, accounting for 29.4 % in the laparoscopic group and 28.2 % in the open group (difference 1.2 %; 95 % CI −11.1 to 13.5; p = 0.73). Seven patients had port- or wound-site recurrences (laparoscopic n = 3 vs. open n = 4). Conclusions: Laparoscopic surgery for non-metastatic colon cancer is associated with similar rates of disease-free survival, overall survival and recurrences as open surgery at 10-year follow-up.

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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.@en

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.

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Background. Surgery for locally advanced and recurrent rectal carcinoma can be associated with major blood loss. Objective. We developed a promising technique using a hemostatic balloon to stop uncontrollable bleeding. Design. Models were developed using pelvic magnetic resonance imaging scans, and these models were tested in a cadaveric study. Eventually a model was tested in a clinical setting. The Hemostatic Balloon Device was placed in patients in whom during surgery uncontrollable bleeding from the venous presacral plexus occurred. Settings. A tertiary referral hospital for locally advanced and recurrent rectal cancer. Patients. Patients receiving multimodality treatment for primary or recurrent locally advanced rectal carcinomas. Main Outcome Measures. First the developed prototypes were tested in a cadaveric study where the developing pressure on the pelvic wall was measured. Second, the Hemostatic Balloon Device was placed in patients in whom during surgery uncontrollable bleeding from the venous presacral plexus occurred. Results. The balloon was used in 9 patients. Median volume of blood loss was 7500 mL. In 8 patients treatment with the hemostatic balloon was successful. In 1 patient the balloon was dislocated cranially and the pelvis was packed with surgical gauzes. Limitations. These first results are promising but further research is needed to evaluate how effective the balloon is in controlling massive bleeding during rectal cancer surgery. Future perspectives include a possibly thinner silicon rubber that can be stretched more easily with a lower inflated volume. Discussion. The hemostatic balloon is a new and promising technique for accomplishing hemostasis with controllable pressure on the pelvic cavity wall and can be removed without the need for a second laparotomy.

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Objective: The cost of laparoscopic simulators restricts the wide use of simulation for training of basic psychomotor skills. This paper describes the scientifically-based development of an inexpensive and portable Ergonomic Laparoscopic Skills (Ergo-Lap) simulator with multiple tasks. Material and methods: The design of this Ergo-Lap simulator and related training task panel was based on scientific research regarding the representative skills and the ergonomic guidelines for laparoscopic surgery. A user-centred design approach was followed. Fifty-three surgical participants with variable laparoscopic experience (14 medical students, 27 surgeons in training, and 12 experienced laparoscopic surgeons) performed several tasks on the prototype and gave their feedback by filling out a 5-point scale Likert scale questionnaire. Results: The results of the usability evaluation showed that the participants regarded the Ergo-Lap simulator as a useful device to practice the basic and advanced skills effectively. Forty-three of the 53 participants indicated they would like to purchase this simulator since it is easy to use and challenges their laparoscopic skills. Conclusions: For laparoscopic skills training, this inexpensive Ergo-Lap simulator with diverse task choices offers a simple training opportunity for trainees who want to practice laparoscopic skills at home or at the office.

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