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Purpose: To develop and validate a trans oral endoscopic thyroidectomy vestibular approach (TOETVA) simulator., Methods: The first phase of the project consisted of designing and developing a transoral thyroid surgery simulator based on real surgeries. The product has the oral cavity for attaching the three trocars and the cervical part containing the thyroid and adjacent structures. In the second phase, the simulator was validated by specialists who performed an endoscopic thyroidectomy procedure. They all filled a questionnaire about the simulator and the simulation based on the Likert scale., Results: The simulator consists of a console similar to a human bust and a high-resolution camera system connected to a 22-inch monitor. The simulator had excellent results in the visual evaluation (face validity), with 100% of responses between good and excellent for the following characteristics: synthetic structures, design, visibility of the surgery field, resistance, resilience, fulcrum effect, ergonomics, surgical material, and practicality. The last three were rated higher, with more votes for excellent. For content validity, the items that received the best ratings were, precisely, the steps relating to the surgical procedure: opening the intermuscular midline, isthmotomy, and thyroidectomy., Conclusions: The thyroidectomy training box showed great ability to simulate a TOETVA, with satisfactory evaluations concerning its visual and content validation.

Background: A transnasal transsphenoidal (TNTS) approach can be performed through a binostril or mononostril technique. The binostril technique is generally preferred, however the mononostril may be an underutilized approach with significant benefits., Methods: All (n = 521) pituitary adenoma transsphenoidal surgeries performed from March 2008 until July 2017 at a university hospital in Indonesia were isolated. The majority (n = 512) were performed through a mononostril approach with no nasal speculum by a single experienced neurosurgeon. A PubMed literature review researching the differences in indications, techniques, and outcomes for both approaches supplements the case series. The mononostril surgical technique is described in detail., Results: The average mononostril operating time was 105 min. The most prevalent surgical complications were CSF leak (4.1 %), diabetes insipidus (3.7 %) and cacosmia (2.1 %). Visual field deficits noted in 85 %, 89 % improved. Length of stay was less than 2 days for 90 %, with 13 ICU admissions (average one day). Recurrence rate was 8.2 % at follow up (1-10 years)., Conclusions: Based on a literature review, binostril TNTS surgeries have longer operative time and a higher risk of epistaxis. According to our experience, post-operative patient comfort and satisfaction are higher with the monostril approach. Furthermore, this technique is easier to teach, ENT assistance unnecessary, and thus especially advantageous in low resource settings. Our CSF leak and tumor recurrence rates were lower than reported binostril rates in the literature. The mononostril technique is both safe and effective and should be strongly considered for an appropriately pre-selected subset of pituitary adenomas., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objectives: In 2009, the Food and Drug Administration approved the use of the surgical robotic system for removal of benign and malignant conditions of the upper aerodigestive tract. This novel application of robotic-assisted surgery, termed transoral robotic surgery (TORS), places robotic instruments and camera system through the mouth to reach recessed areas of the pharynx and larynx. Over the successive decade, there was a rapid adoption of TORS with a surgical growth rate that continues to increase. Despite the rapid clinical acceptance, the field of TORS has not yet seen substantive changes or advances in the technical shortcomings, the lack of which has restricted objective TORS-specific surgical skills assessment as well as subsequent skills improvement efforts. One of the primary technical challenges of TORS is operating in a confined space, where the robotic system is maneuvered within the restrictive boundaries of the mouth and throat. Due to these confined boundaries of the pharynx, instruments can frequently collide with anatomic structures such as teeth and bone, producing anatomic collisions. Therefore, we hypothesized that anatomic collisions negatively impact TORS surgical performance. Secondarily, we hypothesized that avoidance of unwanted anatomic collisions could improve TORS surgical proficiency., Methods: Design and fidelity testing for a custom TORS training platform with an integrated anatomic collision-sensing system providing real-time tactile feedback is described. Following successful platform assembly and testing, validation study using the platform was carried through prospective surgical training with trial randomization. Twenty otolaryngology-head and neck surgery residents, each trainee performing three discrete mock surgical trials (n = 60), performed the initial system validation. Ten of the 20 residents were randomized to perform the surgical trials utilizing the real-time feedback system. The remaining 10 residents were randomized to perform the surgical trials without the feedback system, although the system still could record collision data. Surgical proficiency was measured by Global Evaluative Assessment of Robotic Skills (GEARS) score, time to completion, and tumor resection scores (categorical scale ranging 0-3, describing the adequacy of resection)., Results: Major anatomic collisions (greater than 5N of force) negatively affected GEARS robotic skills. A mixed model analysis demonstrated that for every additional occurrence of a major collision, GEARS robotic skills assessment score would decrease by 0.29 points (P = .04). Real-time collision awareness created significantly fewer major (> 5 N) anatomic collisions with the tactile feedback system active (n = 30, mean collisions = 2.9 ± 4.2) as compared with trials without tactile feedback (n = 30, mean collisions = 12.53 ± 23.23) (P < .001). The second assessment measure of time to completion was unaffected by the presence of collisions or by the use of tactile feedback system. The third proficiency assessment was measured with tumor resection grading. Tumor resection scores was significantly (P = .02) improved with collision awareness system activated than trials without collision awareness., Conclusion: In order to test our primary hypothesis, a novel TORS training platform was successfully developed that provides collision force measurements including frequency, severity, and duration of anatomic collisions. Additionally, the platform was modulated to provide real-time tactile feedback of the occurrence of out-of-field collisions. Utilizing this custom platform, our hypothesis that anatomic collisions during TORS diminishes surgical performance was supported. Additionally, our secondary hypothesis that subsequent reduction of anatomic collisions improves TORS proficiency was supported by the surgical trial. Dedicated investigation to characterize the effect size and clinical impact is required in order to translate this finding into training curriculums and into clinical utilization., Level of Evidence: II (Randomized trial) Laryngoscope, 130:S1-S17, 2020., (© 2020 American Laryngological, Rhinological and Otological Society Inc, "The Triological Society" and American Laryngological Association (ALA).)

Background: Minimally invasive neurosurgical approaches reduce patient morbidity by providing the surgeon with better visualization and access to complex lesions, with minimal disruption to normal anatomy. The use of rigid or flexible neuroendoscopes, supplemented with a conventional stereoscopic operating microscope, has been integral to the adoption of these techniques. Neurosurgeons commonly use neuroendoscopes to perform the ventricular and endonasal approaches. It is challenging to learn neuroendoscopy skills from the existing apprenticeship model of surgical education. The training methods, which use simulation-based systems, have achieved wide acceptance. Physical simulators provide anatomic orientation and hands-on experience with repeatability. Our aim is to review the existing physical simulators on the basis of the skills training of neuroendoscopic procedures., Methods: We searched Scopus, Google Scholar, PubMed, IEEE Xplore, and dblp. We used the following keywords "neuroendoscopy," "training," "simulators," "physical," and "skills evaluation." A total of 351 articles were screened based on development methods, evaluation criteria, and validation studies on physical simulators for skills training in neuroendoscopy., Results: The screening of the articles resulted in classifying the physical training methods developed for neuroendoscopy surgical skills into synthetic simulators and box trainers. The existing simulators were compared based on their design, fidelity, trainee evaluation methods, and validation studies., Conclusions: The state of simulation systems demands collaborative initiatives among translational research institutes. They need improved fidelity and validation studies for inclusion in the surgical educational curriculum. Learning should be imparted in stages with standardization of performance metrics for skills evaluation., (Copyright © 2020. Published by Elsevier Inc.)

Objective: Endoscopic endonasal approaches (EEAs) to the skull base have evolved over the last 20 years to become an essential component of a comprehensive skull base practice. Many case series show a learning curve from the earliest cases, in which the authors were inexperienced or were not using advanced closure techniques. It is generally accepted that once this learning curve is achieved, a plateau is reached with little incremental improvement. Cases performed during the early steep learning curve were eliminated to examine whether the continued improvement exists over the "tail end" of the curve., Methods: A prospectively acquired database of all EEA cases performed by the senior authors at Weill Cornell Medicine/NewYork-Presbyterian Hospital was reviewed. The first 200 cases were eliminated and the next 1000 consecutive cases were examined to avoid the bias created by the early learning curve., Results: Of the 1000 cases, the most common pathologies included pituitary adenoma (51%), meningoencephalocele or CSF leak repair (8.6%), meningioma (8.4%), craniopharyngioma (7.3%), basilar invagination (3.1%), Rathke's cleft cyst (2.8%), and chordoma (2.4%). Use of lumbar drains decreased from the first half to the second half of our series (p <0.05) as did the authors' use of fat alone (p <0.005) or gasket alone (p <0.005) for dural closure, while the use of a nasoseptal flap increased (p <0.005). Although mean tumor diameter was constant (on average), gross-total resection (GTR) increased from 60% in the first half to 73% in the second half (p <0.005). GTR increased for all pathologies but most significantly for chordoma (56% vs 100%, p <0.05), craniopharyngioma (47% vs 0.71%, p <0.05) and pituitary adenoma (67% vs 75%, p <0.05). Hormonal cure for secreting adenomas also increased from 83% in the first half to 89% in the second half (p <0.05). The rate of any complication was unchanged at 6.4% in the first half and 6.2% in the latter half of cases, and vascular injury occurred in only 0.6% of cases. Postoperative CSF leak occurred in 2% of cases and was unchanged between the first and second half of the series., Conclusions: This study demonstrates that contrary to popular belief, the surgical learning curve does not plateau but can continue for several years depending on the complexity of the endpoints considered. These findings may have implications for clinical trial design, surgical education, and patient safety measures.

Study Objective: This study was designed to evaluate the learning curve of transvaginal natural orifice surgery (NOS) for adnexal tumors based on the type of procedure (adnexectomy or cystectomy)., Design: Retrospective cohort study., Setting: Tertiary-care university hospital., Patients: One hundred thirty-six women with adnexal tumors., Interventions: A series of 136 consecutive transvaginal NOS for adnexal tumor were performed between April 2011 and June 2016. Eighty-five patients (62.5%) had undergone cystectomy, and 51 patients (37.5%) had undergone adnexectomy., Measurements and Main Results: The transvaginal NOS procedures included vaginal, endoscopic, single-port access techniques and were divided into 2 categories: adnexectomy and cystectomy. Operating time was electronically recorded and was defined as the time from the creation of a posterior colpotomy incision until the complete closure of the posterior colpotomy opening. The average operating time for the cystectomy and adnexectomy groups was 42.7 and 37.7 minutes, respectively (p = .015). The learning curve was analyzed using the cumulative summation method and showed that 36 cases were needed to achieve proficiency in transvaginal NOS for ovarian cystectomy. However, there was no significant cut-off point to determine the number of patients who had undergone adnexectomy., Conclusion: A well-trained gynecologic endoscopist can achieve surgical proficiency in transvaginal NOS cystectomy after 36 cases. It is suggested that the surgical transvaginal NOS procedure should begin with adnexectomy rather than with cystectomy to avoid initial technical challenges., (Copyright © 2019. Published by Elsevier Inc.)

Backgound: Functional endoscopic sinus surgery (FESS) can be challenging as novices become accustomed to handling endoscopes and instruments while navigating complex sinonasal anatomy. Experts demonstrate fluid and efficient motions when addressing pathology. The training process from novice to expert relies on hands-on experience in cadaveric laboratories and preceptorship models that require significant time and expense. This study aims to validate the use of a virtual coach to guide users step-by-step through a basic FESS., Methods: Seventeen surgeons were grouped into novice (n = 10) and expert (n = 7) based on self-reported levels of surgical experience. Users were trained using the maxillary antrostomy module in the Neurorhinological Surgery (NRS) simulator combining the physical craniofacial model with virtual reality (VR)-tracked surgical instruments in the VR operating room. The virtual coach guided the user using surgical videos, auditory, and visual cues. The coach recorded data for each subject including the number of times borders of the nasal cavity were encountered and time to completion. Users graded the usefulness of the virtual coach on a Likert questionnaire., Results: Face validity of our NRS simulator was replicated by user questionnaires, and construct validity replicated by differentiation between novice and expert level surgeons (p < 0.01). Novices contacted a significantly higher number of anatomic borders (n = 17) and had a longer operative time (t = 370 seconds). All users reported high scores on the benefit and usefulness of the virtual coach., Conclusion: The virtual coach provides a useful tool to enhance FESS education by providing objective real-time data in a novel mixed-reality surgical environment., (© 2019 ARS-AAOA, LLC.)

Background: During Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) the surgeon operates exclusively through a single vaginal entry point, leaving no external scarring., Objectives: To evaluate the learning curve of vNOTES hysterectomy by experienced gynecologists based on surgical times and short-term outcomes., Methods: A retrospective study was conducted of the first 25 vNOTES hysterectomy surgeries performed from July to December 2018 at Rambam Health Care Campus by a single surgeon. The primary outcome was hysterectomy time. Secondary outcomes included intra-operative bleeding, length of hospitalization, postoperative pain, and need for analgesia. Socio-demographic and clinical data were retrieved from patient electronic medical charts., Results: Median age was 64.5 years (range 40-79). Median hysterectomy time was 38 minutes (range 30-49) from the first cut until completion. Comparisons between median hysterectomy time in the first 10 hysterectomies and in the 15 subsequent procedures demonstrated a significant decrease in median total time: 45 minutes (range 41-49) vs. 32 minutes (range 30-38), respectively (P = 0.024). The median estimated intraoperative blood loss decreased from 100 ml (range 70-200) in the first 10 hysterectomies to 40 ml (range 20-100) in the subsequent procedures (P = 0.011)., Conclusions: vNOTES hysterectomy is feasible by an experienced gynecologist, with an exponential improvement in surgical performance in a short period as expressed by the improvement in hysterectomy time, low complication rates, negligible blood loss, minimal post-surgical pain, fast recovery, and short hospitalization. vNOTES allows easier and safer access to adnexal removal compared to conventional vaginal surgery.

Post-operative hemorrhage is the most concerning complication after minimally invasive transoral surgery, as can result in airway compromise. Simulation-based medical education provides trainees with structured learning in an intensive and immersive environment allowing deliberate practice of skills and behaviors in the management of real-life situations. We implemented a novel post-oropharyngeal surgery bleeding model in a nationwide otolaryngology emergencies bootcamp, to teach and evaluate technical and non-technical skills required to competently manage this clinical scenario. 28 Otolaryngology residents from 11 programs in Canada participated in the annual Otolaryngology Emergencies Bootcamp of Western University in London, Ontario. After teaching technical aspects of emergency surgical airways in models, the course culminated with a complex scenario of a post-minimally invasive transoral surgery bleeding model using a fresh cadaver. The Non-Technical Skills for Surgeons (NOTSS) rating scale was applied to video analysis and a scenario-specific Medical Expert Checklist was implemented. The model design in a cadaveric torso is described for use in a simulation of a high-volume oropharyngeal bleed after a minimally invasive approach. Participants agreed that the model evoked an elevated degree of realism and conveyed the emotion of a life-threatening event. NOTSS analysis identified a marginal score in the domains of decision-making and communication and teamwork. Critical action checklist analysis highlighted the early mobilization of available resources and time to decision for surgical airway. We present the first report of a post-minimally invasive transoral surgery bleeding model. It was successful in recreating with high fidelity such a high-stake event and to teach technical and non-technical skills.

Objective: The aim of the present study was to investigate the practical value of a multimaterial and multicolor 3D-printed model in anatomical teaching, surgical training, and preoperative planning of transnasal endoscopic surgery for pituitary adenoma., Methods: Multimodality neuroimaging data were obtained in a 42-year-old healthy male volunteer and a 40-year-old female patient with an invasive nonfunctional pituitary adenoma. Three 3D-printed models were produced: a monomaterial and monocolor model, a monomaterial and multicolor model, and a multimaterial and multicolor model. The effects on anatomical teaching and surgical training for exposing the vidian nerve were assessed by 12 residents, and the training effect was validated on cadavers. The practical values for preoperative planning were evaluated by 6 experienced neurosurgeons. All evaluations were based on 5-point Likert questionnaires., Results: The multimaterial and multicolor model was superior to the monomaterial models in surgical training for exposing the vidian nerve (Fisher test; p < 0.05). In addition, the multimaterial and multicolor model was superior to the monomaterial models in anatomical teaching and preoperative planning (Friedman test; p < 0.05)., Conclusions: Multimaterial and multicolor 3D printing technology makes it convenient and efficient to produce a practical model for simulating individualized and complex anatomical structures in the sellar region. Furthermore, the multimaterial model can provide a more realistic manipulative experience for surgical training and facilitate the preoperative planning.

Objective: A five-level training program was first proposed 10 years ago for surgeons learning endoscopic endonasal surgery (EES) of the skull base. Levels were based on the complexity of anatomy, risk of neurovascular injury, intradural dissection, technical difficulty and vascularity of tumors., Method: A three-phase validation concept is proposed: 1) face validity (the classification is related to clinically significant elements), 2) construct validity (the classification predicts the outcome), and 3) inter-team validation (the classification applies to other surgical teams). Consecutive cases over a 1-year time span were retrospectively classified. Primary outcome measures included: complication rates (cranial nerve injury, stroke and vascular injury, cerebrospinal fluid [CSF] leak and infection), estimated blood loss and duration of surgery., Results: Two hundred and nine consecutive cases were analyzed. The distribution of cases for each category was: 63 cases in level II, 70 cases in level III, 66 cases in level IV, and 10 cases in level V. Construct validity demonstrated statistical difference with increasing rate of complications from level II to level III and from level III to level IV; also, specific rates of cranial nerve injury and CSF leak increased between levels III and IV. Face validity identified 162 citations since publication of the original article. Inter-team validation demonstrated no difference between two teams of surgeons., Conclusion: This study provides a three-phase validation of training levels for endoscopic skull base surgery. Adoption of a progressive systematic approach to learning EES from least complex to advanced procedures is expected to minimize the risks while surgical teams gain experience., Level of Evidence: 3 Laryngoscope, 129:2253-2257, 2019., (© 2019 The American Laryngological, Rhinological and Otological Society, Inc.)

Background: No data are available to assess the learning curve for transvaginal natural orifice transluminal endoscopic hysterectomy for non-prolapsed uteri in benign gynecologic diseases. The lack of exposure to transvaginal natural orifice transluminal endoscopic hysterectomy during training, in addition to a poorly defined learning curve, further deters interested physicians from applying this technique to daily practice. The aim of this study was to evaluate the learning curve and perioperative outcome of transvaginal natural orifice transluminal endoscopic hysterectomy by an experienced endoscopist., Methods: A total of 240 cases of transvaginal natural orifice transluminal endoscopic hysterectomies with or without adnexectomy for various benign gynecologic diseases were included. Demographic data and various perioperative parameters were reviewed from the prospectively collected database. Operative time was set as a surrogate marker for surgical competency. The learning curve was evaluated using the cumulative sum method., Results: The overall mean operative time (OT) was 76.5 min ± 22.4. Four unique phases of the learning curve were derived using cumulative sum analysis: the mean OT of phase I (the initial learning curve of 20 cases) was 86.3 ± 23.7 min, phase II (acquisition of competence of 80 cases) was 71.0 ± 21.4 min, phase III (proficiency and plateau of 80 cases) was 76.0 ± 20.4 min, and phase IV (post-learning in which more challenging cases were managed) was 81.3 ± 23.6 min. No major complications were encountered. One case in phase III converted to laparoscopy due to difficulty in performing anterior colpotomy., Conclusion: Our data demonstrated four distinct phases of the learning curve of transvaginal natural orifice transluminal endoscopic hysterectomy. In a well-trained endoscopist, surgical competence in transvaginal natural orifice transluminal endoscopic hysterectomy can be reached after 20 cases.

Background: Three-dimensional (3D) printed models have been shown to be promising in surgical training in rhinology. The objectives of this study were to develop a set of 3D-printed models including the pediatric and adult nasal cavity, and the postsurgical paranasal sinuses, and to assess the face and content validity in endoscopic training., Methods: The computed tomography (CT) data of a pediatric patient without nasal disorders and an adult patient with nasal septal deviation were selected to produce the models of the pediatric and adult nasal cavity, and the CT data of an adult patient who underwent endoscopic sinus surgery 4 months ago was chosen to create the paranasal sinus model. After the models were printed by our desktop-level 3D printer, 5 rhinologists used the 5-point Likert scales to evaluate the fidelity and utility. Additionally, a group of prespecified tasks were completed by the rhinologists and 5 residents respectively for supplementary content validation. The difference of time used in completing each task was analyzed by Mann-Whitney U test., Results: All the models were prototyped in 24 hours, and the total cost for each model was less than 100 CNY (15 USD). The overall scores for fidelity and usefulness in endoscopic training were above 4.0. The experts accomplished all tasks using significantly less time than the residents (all p < 0.05)., Conclusion: The models of nasal cavities and paranasal sinuses made by our desktop-level 3D printer are high-fidelity, low-cost, and useful in training basic endoscopic skills., (© 2019 ARS-AAOA, LLC.)

Objectives: To assess the perspectives of OHNS residents with regards to their training in the following advanced head and neck surgery techniques: transoral robotic surgery (TORS), transoral laser microsurgery (TLM), sialendoscopy, and surgeon-performed ultrasound (SP-US) for possible curricula development., Methods: Cross-sectional survey. A 20-item questionnaire was electronically distributed to OHNS residency programs assessing volume of cases, training barriers, satisfaction, additional training preferences, and pertinence to future practice., Results: One hundred thirty-one residents completed the questionnaire. Trainee satisfaction with advanced techniques did not vary significantly with level of training (PGY) or intent to pursue fellowship. Residents who participated in more TLM, sialendoscopy, and SP-US cases were significantly more likely to be satisfied with their training (all p<0.05). The most frequently reported limitation to training was low home institution procedure volume. Seventy-eight of 123 respondents (63.4%) indicated insufficient opportunity to participate in TORS, with most residents reporting that TORS was preferentially performed by attendings (59/78, 75.6%). Forty-five of 126 (35.7%) reported having adequate access to skills training in TORS, compared to 43.6%, 48.4%, and 54.8% for sialendoscopy, TLM, and SP-US, respectively. A vast majority expressed interest in home institution-sponsored training courses in SP-US (120/127, 94.5%) and sialendoscopy (105/129, 81.4%). Many anticipated using SP-US (63.3%) and sialendoscopy (49.6%) in their future practices., Conclusion: Greater resident participation in advanced head and neck surgical procedures is associated with higher trainee satisfaction. There is a possible need for additional home institution-sponsored training courses, especially in sialendoscopy and SP-US., Level of Evidence: N/A., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: For selected patients, endoscopic thyroidectomy via the oral-vestibular approach (ETOVA) can be used to achieve a very good esthetic effect. This study aimed to assess the learning curve for ETOVA and identify improvements., Patients and Methods: This retrospective study evaluated the outcomes of 101 patients who underwent ETOVA by surgeons A and B. The patients were classified according to whether they had undergone surgery during the primary or advanced stage of the learning curve, respectively. Proficiency with the procedure in various types of cases and the operation time, operative blood loss, hospital stay length, and postoperative complications were analyzed., Results: In total, 56 and 45 patients were treated by surgeons A and B, respectively. For both surgeons, the operation times decreased considerably after 20 cases. Statistically significant differences with respect to stage were observed in terms of operation time (P<0.05) and drainage tube reservation (P<0.05). By contrast, significant differences were not observed between stages in terms of operative blood loss (P>0.05) or postoperative hospital stay length (P>0.05). The total postoperative complication rate was low and comparable with that of open surgery., Conclusions: The specific learning curve identified for ETOVA suggests that surgeons with sufficient endoscopic surgery experience could achieve a stable proficiency after ∼20 cases. A standardized training program and exposure to more cases would reduce the learning curve.

Purpose: Cerebrospinal fluid leakage is always the primary complication during the endoscopic endonasal skull base surgery. Dural suturing technique may supply a rescue method. However, suturing and knotting in such a deep and narrow space are difficult. Training in the model can improve skills and setting a stepwise curriculum can increase trainers' interest and confidence., Methods: We constructed an easy model using silicone and acrylic as sphenoid sinus and using the egg-shell membrane as skull base dura. The training is divided into three steps: Step 1: extracorporeal knot-tying suture on the silicone of sphenoid sinus, Step 2: intra-nasal knot-tying suture on the same silicone, and Step 3: intra-nasal egg-shell membrane knot-tying suture. Fifteen experienced microneurosurgical neurosurgeons (Group A) and ten inexperienced PGY residents (Group B) were recruited to perform the tasks. Performance measures were time, suturing and knotting errors, and needle and thread manipulations. The third step was assessed through the injection of full water into the other side of the egg to verify the watertight suture. The results were compared between two groups., Results: Group A finishes the first and second tasks in significantly less time (total time, 125.1 ± 10.8 vs 195.8 ± 15.9 min) and fewer error points (2.4 ± 1.3 vs 5.3 ± 1.0) than group B. There are five trainers in group A who passed the third step, this number in group B was only one., Conclusions: This low cost and stepwise training model improved the suture and knot skills for skull base repair during endoscopic endonasal surgery. Experienced microneurosurgical neurosurgeons perform this technique more competent.

Background: Per oral endoscopic myotomy (POEM) has emerged as a promising option for the treatment of achalasia. This study assessed POEM training process, outcomes, and improvement in quality of life after POEM performed by an interventional endoscopist (mentor) with trainees., Methods: We performed a retrospective review of data for patients who underwent POEM with involvement of trainees. Trainees were trained in performing mucosotomy, submucosal dissection, creating submucosal tunnel, identifying gastroesophageal junction, myotomy, and closure of mucosal incision in a step-by-step fashion. Trainees' performance on each step was evaluated by the mentor based on several key points in each step. The short form 36 (SF36) was obtained before and certain times after the primary POEM procedure was performed., Results: Sixty-two patients, 26 males and 36 females with a mean age of 59 years, who underwent POEM were enrolled. A checklist included all related items for each step was established. All trainees obtained competence within 6 cases for each step. 61/62 (98.3%) patients had a significant improvement in the Eckardt's score post POEM: 9.3 ± 1.5 prior to POEM and 2.6 ± 1.2 after the POEM (P = 0.001) and a decrease in mean lower esophageal sphincter pressure (LES): pre- and post-procedure mean LES pressures were 28.5 ± 11.4 and 12.1 ± 4.5 mmHg, respectively (P = 0.001). The SF-36 questionnaire demonstrated a significant improvement in quality of life and comparable with those without trainees in other studies., Conclusion: This preliminary study showed for the first time that training for POEM can be performed in a step-by-step fashion, learning mucosal incision, submucosal dissection, myotomy, and mucosal incision closure from an expert interventional endoscopist without increasing adverse events. The checklist for each step could be used as an important guide in training POEM. The outcomes of POEM in this study were similar to those reported by others without trainees. Further multiple center studies are needed to verify this training process and to establish a formal training protocol.

Introduction: With the increasing adoption of peroral endoscopic myotomy (POEM) as a first-line therapy for achalasia as well as a growing list of other indications, it is apparent that there is a need for effective training methods for both endoscopists in training and those already in practice. We present a hands-on-focused with pre- and post-testing methodology to teach these skills., Methods: Six POEM courses were taught by 11 experienced POEM endoscopists at two independent simulation laboratories. The training curriculum included a pre-training test, lectures and discussion, mentored hands-on instruction using live porcine and ex-plant models, and a post-training test. The scoring sheet for the pre- and post-tests assessed the POEM performance with a Likert-like scale measuring equipment setup, mucosotomy creation, endoscope navigation, visualization, myotomy, and closure. Participants were stratified by their experience with upper-GI endoscopy (Novices <100 cases vs. Experts ≥100 cases), and their data were analyzed and compared., Results: Sixty-five participants with varying degrees of experience in upper-GI endoscopy and laparoscopic achalasia cases completed the training curriculum. Participants improved knowledge scores from 69.7 ± 17.1 (pre-test) to 87.7 ± 10.8 (post-test) (p < 0.01). POEM performance increased from 15.1 ± 5.1 to 25.0 ± 5.5 (out of 30) (p < 0.01) with the greatest gains in mucosotomy [1.7-4.4 (out of 5), p < 0.01] and equipment (3.4-4.7, p < 0.01). Novices had significantly lower pre-test scores compared with Experts in upper-GI endoscopy (overall pre-score: 11.9 ± 5.6 vs. 16.3 ± 4.6, p < 0.01). Both groups improved significantly after the course, and there were no differences in post-test scores (overall post-score: 23.9 ± 6.6 vs. 25.4 ± 5.1, p = 0.34) between Novices and Experts., Conclusions: A multimodal curriculum with procedural practice was an effective curricular design for teaching POEM to practitioners. The curriculum was specifically helpful for training surgeons with less upper-GI endoscopy experience.

Background: Variations on the endoscopic transsphenoidal approach present unique surgical techniques that have unique effects on surgical outcomes, extent of resection (EOR), and anatomical complications., Objective: To analyze the learning curve and perioperative outcomes of the 3-hand endoscopic endonasal mononostril transsphenoidal technique., Methods: Prospective case series and retrospective data analysis of patients who were treated with the 3-hand transsphenoidal technique between January 2007 and May 2015 by a single neurosurgeon. Patient characteristics, preoperative presentation, tumor characteristics, operative times, learning curve, and postoperative outcomes were analyzed. Volumetric EOR was evaluated, and a logistic regression analysis was used to assess predictors of EOR., Results: Two hundred seventy-five patients underwent an endoscopic transsphenoidal surgery using the 3-hand technique. One hundred eighteen patients in the early group had surgery between 2007 and 2010, while 157 patients in the late group had surgery between 2011 and 2015. Operative time was significantly shorter in the late group (161.6 min) compared to the early group (211.3 min, P = .001). Both cohorts had similar EOR (early group 84.6% vs late group 85.5%, P = .846) and postoperative outcomes. The learning curve showed that it took 54 cases to achieve operative proficiency with the 3-handed technique. Multivariate modeling suggested that prior resections and preoperative tumor size are important predictors for EOR., Conclusion: We describe a 3-hand, mononostril endoscopic transsphenoidal technique performed by a single neurosurgeon that has minimal anatomic distortion and postoperative complications. During the learning curve of this technique, operative time can significantly decrease, while EOR, postoperative outcomes, and complications are not jeopardized., (Copyright © 2017 by the Congress of Neurological Surgeons)

The objective of the present study was to upgrade the rhinological simulator employed as a tool for the teaching of the basic technical skills in endoscopic sinus surgery (ESS). The new ESS simulator providing a model of the nasal cavity consists of the replaceable cylinders and the adaptable table stand. It includes a set of 3D printed nasal models. Each of them is the elliptical tube of a specific size. The participants of the study performed different tasks depending on the structural properties of the tubes. A wide variety of surgical instruments and esndoscopes could be fitted to the simulator. 16 otorhinolaryngologists having no previous experience with ESS were recruited into the study to evaluate the effectiveness of the training procedures. After a brief tutorial, the participants practiced an one hour-long exercise per day during 5 days. The pre-training and post-training performances were videotaped. The task-performance time and the number of technical errors made by the operators were estimated immediately before and after the training session. To assess the subjective attitudes of the operators toward the new technology, the participants of the study were asked to complete the model questionnaire soon after the termination of the training course. The questionnaire contained 34 items. The correctness of the answers was assessed based on the 5-point Likert scale, with score 1 meaning 'totally disagree' and score 5 - 'totally agree'. The statistically significant reduction of the performance time and the number of technical mistakes was documented within the first 5 hours after the onset of teaching (p<0.05) which suggests the effectiveness of the training procedures. The questionnaire study has demonstrated the positive attitude of the trainees toward the proposed technology. The average score based on the Likert scale was higher than 3 for all kinds of questions. It is concluded that the results of this study give evidence of the positive assessment of the upgraded rhinological simulator as an effective tool for the teaching of the basic skills necessary to operate various surgical instruments and endoscopes by the novice surgeons in the field of endoscopic sinus surgery .

The endoscopic endonasal approach is considered an alternative minimally invasive approach for suprasellar craniopharyngiomas. However, the complicated surgical manipulations required by this approach have limited its application. We evaluate whether the approach features a learning curve. Thirty-three patients were retrospectively reviewed and grouped as early (17 patients) and late (16 patient) groups. The operation time, extent of removal, ophthalmology, endocrinology, reconstruction and modifications of standard technique were evaluated. Between the two groups, the operation time decreased from 201.1±105.3min in the early group to 107.6±90.0min in the late group (p<0.05). Regarding clinical outcomes, non-significantly increasing trends toward the rate of gross total resection, visual improvement and (from 76.5% to 87.5%, 73.3% to 93.3%), significantly decreasing trends toward the rate of tumor recurrence (from 23.5% to 0% p<0.05) and non-significantly decreasing trends toward the rate of hypopituitarism recovery (26.7% to 0%) were observed between the two groups. With respect to complications, non-statistically significant decreasing trends toward transient cranial nerve paralysis (from 5.9% to 0%) and non-statistically significant increasing trends toward rate of CSF leakage, meningitis and new hypothyroidism (from 11.8% to 25%, 11.8% to 31.3%, 0 to 3%) were observed. We identified a learning curve for the endoscopic endonasal approach for suprasellar craniopharyngiomas. The exact number of patients necessary to establish a significant improvement in the clinical outcomes and decrease in the complications warrants further investigation. The outcomes of tumor recurrence may be associated with duration of follow-up. The CSF leakage represented the most common complication., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Background: Esophageal bougination is a worldwide standard endoscopic procedure. Clinical methods and recommendations are based on clinical experiences only. Mechanical properties have never been described. Aim of the study was to establish a realistic ex vivo training model. Therefore, detailed assessment of relevant mechanical features of esophageal bougination should be evaluated ex vivo and in patient setting and correlated against., Patients and Methods: A three-step concept was used to evaluate mechanical properties at stenosis level. First, insertion forces were evaluated in an ex vivo linear single stenosis model during steady mechanical insertion. Second, adding friction and properties of the pharynx and upper esophagus, the model was integrated in an artificial endoscopic training model (ELITE training model). Third, in vivo measurements were taken to correlate ex vivo data with parameters of a realistic patient setting., Results: With the presented setup, we were able to assess insertion force and pressure levels in an artificial stricture using different sizes of commercially available standard bougies. In all models, there was a relevant increase in insertion force with higher stricture pressure levels. Insertion force levels in the ELITE model show higher levels compared to the linear stenosis model. Having regard to the maximum forces in patients, there is also a constant increase in mean insertion force according to higher bougie sizes, but lower forces were measured as in the ELITE model., Discussion: The applied models are suitable to appraise mechanical properties of esophageal bougination in an ex vivo model and patient setting. Forces could be constituted reliable, significant increase was documented according to stenosis level and results were comparable to patient data. This was comparable to patient data. Further clinical evaluation in different kinds of stenosis is necessary.

The goal of this study was to establish face, content, and construct validity of NOViSE-the first force-feedback enabled virtual reality (VR) simulator for natural orifice transluminal endoscopic surgery (NOTES). Fourteen surgeons and surgical trainees performed 3 simulated hybrid transgastric cholecystectomies using a flexible endoscope on NOViSE. Four of them were classified as "NOTES experts" who had independently performed 10 or more simulated or human NOTES procedures. Seven participants were classified as "Novices" and 3 as "Gastroenterologists" with no or minimal NOTES experience. A standardized 5-point Likert-type scale questionnaire was administered to assess the face and content validity. NOViSE showed good overall face and content validity. In 14 out of 15 statements pertaining to face validity (graphical appearance, endoscope and tissue behavior, overall realism), ≥50% of responses were "agree" or "strongly agree." In terms of content validity, 85.7% of participants agreed or strongly agreed that NOViSE is a useful training tool for NOTES and 71.4% that they would recommend it to others. Construct validity was established by comparing a number of performance metrics such as task completion times, path lengths, applied forces, and so on. NOViSE demonstrated early signs of construct validity. Experts were faster and used a shorter endoscopic path length than novices in all but one task. The results indicate that NOViSE authentically recreates a transgastric hybrid cholecystectomy and sets promising foundations for the further development of a VR training curriculum for NOTES without compromising patient safety or requiring expensive animal facilities., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Fernando Bello is also a founder shareholder and Director from Convincis Ltd, outside the submitted work.

Background: Novel, less invasive approaches such as single-incision laparoscopic cholecystectomy or natural orifice transluminal endoscopic surgery require preclinical evaluation and training. Therefore, there is a need for an experimental model closely mimicking the clinical situation. The aim of our study was to create an experimental model of calculous cholecystitis in a large laboratory animal and test its feasibility for the evaluation of different techniques of cholecystectomy., Methods: In 11 laboratory pigs, gallstones were placed inside the gallbladder laparoscopically. Levels of inflammatory markers-leucocytes (WBC), C-reactive protein (CRP) and interleukin 6 (IL-6)-were monitored on the postoperative days (POD) 1, 2, 3, 7 and 30. Abdominal ultrasound was performed 2 and 4 weeks after the operation. Four weeks after the lithiasis induction, laparoscopic cholecystectomy was performed. The control group consisted of ten healthy animals in which a cholecystectomy was performed. The pigs were monitored for 30 days after surgery. All removed gallbladders were assessed histologically., Results: The induction of lithiasis took 42 (35-52) min with no morbidity and mortality. The values of WBC, CRP and IL-6 increased significantly (vs. baseline) on POD 1, 2 and 3 (p < 0.05) and then normalised. Ultrasonography confirmed the presence of chronic calculous cholecystitis in all cases after 4 weeks. Laparoscopic cholecystectomy was significantly longer in animals with lithiasis, 63 (42-91) versus 46 (31-62) min (p = 0.018). Perioperative gallbladder wall perforation was significantly more frequent in the model group (8/11 vs. 1/10; p = 0.04). In contrast to healthy animals, all gallbladders with stones showed histological signs of chronic inflammation., Conclusions: A new animal model of calculous cholecystitis was created. Laparoscopic cholecystectomy was more technically difficult compared to operating on a healthy gallbladder. This model may be a suitable tool for effective preclinical training and also for the evaluation of different techniques of cholecystectomy.

Background: Natural orifice translumenal endoscopic surgery (NOTES) is an emerging surgical paradigm, where peritoneal access is achieved through one of the natural orifices of the body. It is being reported as a safe and feasible surgical technique with significantly reduced external scarring. Virtual Translumenal Endoscopic Surgical Trainer (VTEST™) is the first virtual reality simulator for the NOTES. The VTEST™ simulator was developed to train surgeons in the hybrid transvaginal NOTES cholecystectomy procedure. The initial version of the VTEST™ simulator underwent face validation at the 2013 Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) summit. Several areas of improvement were identified as a result, and the corresponding modifications were implemented in the simulator. This manuscript outlines the results of the subsequent evaluation study, performed in order to assess the face and content validity of the latest VTEST™ simulator., Methods: Twelve subjects participated in an institutional review board-approved study that took place at the 2014 NOSCAR summit. Six of the 12 subjects, who are experts with NOTES experience, were used for face and content validation. The subjects performed the hybrid transvaginal NOTES cholecystectomy procedure on VTEST™ that included identifying the Calot's triangle, clipping and cutting the cystic duct/artery, and detaching the gallbladder. The subjects then answered five-point Likert scale feedback questionnaires for face and content validity., Results: Overall, subjects rated 12/15 questions as 3.0 or greater (60 %), for face validity questions regarding the realism of the anatomical features, interface, and the tasks. Subjects also highly rated the usefulness of the simulator in learning the fundamental NOTES technical skills (3.50 ± 0.84). Content validity results indicate a high level of usefulness of the VTEST™ for training prior to operating room experience (4.17 ± 0.75)., Competing Interests: Dr. Kurt Roberts: NovaTract Surgical (ownership, intellectual property). Drs. Denis Dorozhkin, Arun Nemani, Woojin Ahn, Tansel Halic, Saurabh Dargar, Jinling Wang, Caroline Cao, Ganesh Sankaranarayanan, and Suvranu De have no conflicts of interest or financial ties to disclose.

Purpose: Endoscope-assisted surgery has widely been adopted as a basic surgical procedure, with various training systems using virtual reality developed for this procedure. In the present study, a basic training system comprising virtual reality for the removal of submandibular glands under endoscope assistance was developed. The efficacy of the training system was verified in novice oral surgeons., Material and Methods: A virtual reality training system was developed using existing haptic devices. Virtual reality models were constructed from computed tomography data to ensure anatomical accuracy. Novice oral surgeons were trained using the developed virtual reality training system., Results: The developed virtual reality training system included models of the submandibular gland and surrounding connective tissues and blood vessels entering the submandibular gland. Cutting or abrasion of the connective tissue and manipulations, such as elevation of blood vessels, were reproduced by the virtual reality system. A training program using the developed system was devised. Novice oral surgeons were trained in accordance with the devised training program., Conclusions: Our virtual reality training system for endoscope-assisted removal of the submandibular gland is effective in the training of novice oral surgeons in endoscope-assisted surgery., (Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Advanced endoscopy has evolved from diagnostic ERCP to an ever-increasing array of therapeutic procedures including EUS with FNA, ablative therapies, deep enteroscopy, luminal stenting, endoscopic suturing and endoscopic mucosal resection among others. As these procedures have become increasingly more complex, the risk of potential complications has also risen. Training in advanced endoscopy involves more than obtaining a minimum number of therapeutic procedures. The means of assessing a trainee's competence level and ability to practice independently continues to be a matter of debate. The use of quality indicators to measure performance levels may be beneficial as more advanced techniques and procedures become available., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Natural orifice transluminal endoscopic surgery (NOTES) is a newer field of endoscopic surgery that allows for scarless treatment of pathologic entities, using novel transluminal approaches. There has been a shift of focus from a clinical and research standpoint from the development and dissemination of "first-generation" NOTES procedures to "new NOTES" procedures that traverse the mucosa of luminal structures, yet do not stray far into the peritoneal cavity. It has been a challenge to find appropriate and effective ways to train gastroenterologists and surgeons in these novel approaches. We review the importance of simulation in training and discuss available simulation options., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Natural orifice translumenal endoscopic surgery (NOTES) is an intense area of research, and is arguably the most significant endoscopic innovation of this decade. Training for new NOTES is a relatively long, encompassing advanced endoscopy training, mastery of endoscopic dexterity within the narrow submucosal or "third space" with an in-depth understanding of the tissue planes. Proficiency with new closure and hemostatic devices is also essential. Few institutions worldwide can provide all the cognitive and technical elements essential to train new NOTES trainees. Trainees may need to spend time across several institutions to ensure safe and effective practice of new NOTES., (Copyright © 2016 Elsevier Inc. All rights reserved.)

In this paper, the authors present a physical model developed to teach surgeons the requisite drilling techniques when using an endoscopic endonasal approach (EEA) to the skull base. EEA is increasingly used for treating pathologies of the ventral and ventrolateral cranial base. Endonasal drilling is a unique skill in terms of the instruments used, the long reach required, and the restricted angulation, and gaining competency requires much practice. Based on the successful experience in creating custom simulators, the authors used 3D printing to build an EEA training model from post-processed thin-cut head CT scans, formulating the materials to provide realistic haptic feedback and endoscope handling. They performed a preliminary assessment at 2 institutions to evaluate content validity of the simulator as the first step of the validation process. Overall results were positive, particularly in terms of bony landmarks and haptic response, though minor refinements were suggested prior to use as a training device.

Natural orifice translumenal endoscopic surgery (NOTES) procedures are rapidly being developed in diverse surgical fields. We are developing a Virtual Translumenal Endoscopic Surgery Trainer (VTEST™) built on a modularized platform that facilitates rapid development of virtual reality (VR) NOTES simulators. Both the hardware interface and software components consist of independent reusable and customizable modules. The developed modules are integrated to build a VR-NOTES simulator for training in the hybrid transvaginal NOTES cholecystectomy. The simulator was demonstrated and evaluated by expert NOTES surgeons at the 2015 Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) summit.

Background: Over the last decade new innovative minimally invasive techniques (e.g. transvaginal cholecystectomy and single incision laparoscopic cholecystectomy) have been developed to reduce operative trauma, postoperative pain and to achieve better cosmetic results. Nevertheless, most of these techniques are more difficult and time-consuming than conventional laparoscopic cholecystectomy (CLC). A new approach, the Minden technique for combined suprapubic transumbilical cholecystectomy (MI-CHE) has been proven to provide a very good cosmetic outcome with reduced operative trauma. The aim of this study was to survey whether MI-CHE prolongs operation times to a relevant degree compared to CLC., Methods: A total of 40 patients undergoing laparoscopic cholecystectomy were randomized between both techniques. The duration of the operation and other perioperative data were recorded. Surgery was performed by four resident surgeons who had not yet performed any technique of laparoscopic cholecystectomy, neither MI-CHE nor CLC but were assisted by the same senior staff surgeon in all cases. The two patient groups showed no differences in age, gender and body mass index. The study was registered (DRKS00003271). Non-inferiority was tested using 95% confidence intervals (95% CI)., Results: The mean operation time was shorter by - 4.2 min (95% CI, + 6.4 min to - 14.8 min) in the MI-CHE as compared to the CLC group (65.5 min versus 69.7 min). There were no open conversions but in one patient intestinal injury occurred during the umbilical mini-laparotomy. There were no differences in patient satisfaction and perioperative pain between both procedures., Conclusion: The MI-CHE, which provides very good cosmetic results, is not more time-consuming than CLC. Additionally, it seems to be safe and not more difficult to learn than CLC.

The use of image-guided navigation systems in the training of FESS is discussed controversy. Many experienced sinus surgeons report a better spatial orientation and an improved situational awareness intraoperatively. But many fear that the navigation system could be a disadvantage in the surgical training because of a higher mental demand and a possible loss of surgical skills. This clinical field study investigates mental and physical demands during transnasal surgery with and without the aid of a navigation system at an early stage in FESS training. Thirty-two endonasal sinus surgeries done by eight different trainee surgeons were included. After randomization, one side of each patient was operated by use of a navigation system, the other side without. During the whole surgery, the surgeons were connected to a biofeedback device measuring the heart rate, the heart rate variability, the respiratory frequency and the masticator EMG. Stress situations could be identified by an increase of the heart rate frequency and a decrease of the heart rate variability. The mental workload during a FESS procedure is high compared to the baseline before and after surgery. The mental workload level when using the navigation did not significantly differ from the side without using the navigation. Residents with more than 30 FESS procedures already done, showed a slightly decreased mental workload when using the navigation. An additional workload shift toward the navigation system could not be observed in any surgeon. Remarkable other stressors could be identified during this study: the behavior of the supervisor or the use of the 45° endoscope, other colleagues or students entering the theatre, poor vision due to bleeding and the preoperative waiting when measuring the baseline. The mental load of young surgeons in FESS surgery is tremendous. The application of a navigation system did not cause a higher mental workload or distress. The device showed a positive effort to engage for the trainees with more than 30 FESS procedures done. In this subgroup it even leads to decreased mental workload.

Background: Surgical training in virtual, animal and cadaver models is essential for minimally invasive surgery. Thiel cadavers are suitable for laparoscopy, but there are few data about the use of embalmed (Tutsch method) and slightly embalmed (Thiel method) cadavers in procedures of Natural Orifice Transluminal Endoscopic Surgery (NOTES), which are usually developed and learned on swine models and fresh frozen cadavers. The aim of this study was thus to assess the use of these cadavers for NOTES approaches., Methods: The following surgical procedures were evaluated: transanal total mesorectal excision (four cadavers: one Tutsch, two Thiel, one fresh frozen), transanal ileorectal bypass (five cadavers: one Tutsch, three Thiel, one fresh frozen), and transvaginal appendectomy (two Tutsch cadaver)., Results: The Thiel method ensured tissue flexibility and consistency suitable for performing the above surgical procedures with good results and without complications, with only a small increase in rigidity with respect to fresh specimens. Cadavers embalmed with higher formalin concentrations (Tutsch method) were more difficult to use, due to high tissue rigidity and resistance of the abdominal wall to pneumoperitoneum, although NOTES accesses were possible., Conclusions: Thiel cadavers are suitable for transanal/transrectal and transvaginal NOTES approaches, for training surgical residents/specialists and also for surgical research. In minimally invasive surgery (and particularly in NOTES), integration between cadaver (fresh frozen and/or Thiel) and animal models would represent the gold standard, allowing guaranteed knowledge of and respect for human surgical anatomy and correct management of surgery on living subjects. NOTES approaches to human cadavers may also be proposed for the anatomical education of medical students.

Background: We examined the impact of tool complexity on surgeons' performance and evaluated the value of using a simulation-based program for reducing training cost., Methods: Three pairs of surgical graspers with increasing mechanical complexity, which were designed for open, laparoscopic, and endoscopic procedures, were used in performing a simple object transportation task. Task times and mental workload of 17 surgeons were compared using all 3 variations of the graspers to test the impact of tool complexity on surgical performance. Subsequently, 4 of these surgeons decided to enter a 3-week training phase and practiced with these 3 surgical instruments on a daily basis. Learning curves were plotted to examine the value of using simulation for proficiency training with these tools., Results: Task time was significantly prolonged as tool complexity increased. Practice in a simulated environment shortened the task time significantly and moderately reduced mental workloads. However, the difference in task time varied among the 3 types of tools. Between days 1 and 9, task times for each types of grasper were reduced by 55% (endoscopic), 42% (open), and 22% (laparoscopic)., Conclusions: Tool complexity may degrade a surgeon's performance. Extensive simulation training programs are important for surgeons to gain proficiency in handling a tool before they practice on patients., (© The Author(s) 2014.)

Background: There is no evidence demonstrating the feasibility of colorectal natural orifice transluminal endoscopic surgery (NOTES) resection with currently available endoscopic instrumentation., Objective: This study aimed to evaluate the responsiveness of surgical endoscopists to simulated transanal NOTES sigmoidectomy training., Design: Participants were trained in simulated NOTES sigmoidectomy by using disposable abdominal trays with tattooed sigmoid cancer in a hybrid simulator., Setting: Endoscopy simulation laboratory in a university hospital., Interventions: NOTES sigmoidectomy included 8 steps performed transanally with 2 colonoscopes, endoscopic scissors, and clip applier: (1) colonoscopic viscerotomy with a balloon; (2) retroperitoneal dissection; (3) left ureter identification, inferior mesenteric vessels division; (4) colonoscopy; (5) splenic flexure mobilization; (6) left side of the colon/rectal mobilization; (7) transanal specimen transection; (8) extracorporeal colorectal anastomosis., Main Outcome Measurements: Responsiveness was defined as a change in performance over time and assessed comparing baseline testing with unmentored final testing. Content-valid measures included the length of the specimen, the distance of the anastomosis from the anal verge, and the proximal and distal resection margins and operating time (minutes)., Results: Four participants performed 21 resections. Tumor distance from the anal verge was 29.2 cm (range 26-2.5 cm). Operating time overall (127.5 vs 74 minutes, P = .068), viscerotomy (17.5 vs 9 minutes, P = .197), colonoscopy (4.5 vs 3.5 minutes, P = .655), flexure mobilization (19.5 vs 10 minutes, P = .144), colon mobilization (20 vs 14.5 minutes, P = .461), specimen extraction (9.5 vs 8.5 minutes, P = .465), and anastomosis (14 vs 11 minutes, P = .715) times improved., Limitations: Ceiling effects because of fixed anatomy., Conclusions: Simulated NOTES sigmoidectomy training affected responsiveness of surgical endoscopists with a 42% reduction in operating time., (Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Introduction: Transanal endoscopic microsurgery (TEM) was first published by the late Professor Buess in 1983. The procedure initially had a slow acceptance due to its perceived difficulty, the cost of the equipment, and limited indications. However, the widespread adoption of laparoscopic colorectal surgery provided an impetus to increase the penetration of the platform. The purpose of this study was to evaluate the TEM learning curve (LC)., Methods: After institutional review board approval, all patients who underwent TEM, from November 2005 to October 2008 were identified from a prospective database. The operations were performed by a single, board-certified colorectal surgeon (DRS), after learning the technique from Professor Buess. Patient, operative, and postoperative variables were obtained by retrospective chart review. Rates of excision in minutes per cm(2) of tissue were calculated. The CUSUM method was used to plot the LC. Variables were compared using χ (2) and Student's t test. A p < 0.05 was considered significant., Results: Twenty-three patients underwent TEM (median age 61 years, 69.5 % male). Mean operative time was 130.5 (range 39-254) min, and the mean specimen size was 16.6 (7.4-42) cm(2). Average rate of excision (ARE) was 8.9 min/cm(2). A stabilization of the LC was observed after the first four cases, showing an ARE of 13.8 min/cm(2) for the first four cases versus 7.9 min/cm(2) for the last 19 cases (p = 0.001). An additional rising and leveling of the LC was observed after the first 10 cases, when an increasing number of lesions located cephalad to 8 cm from the dentate line were being resected (lesions above 8 cm in the first 10 cases: 20 % vs. last 13 cases: 61 %; p = 0.04)., Conclusions: The ARE significantly declined after the first four cases. The LC for TEM is associated with a significant decrease in operative time after four cases.

Background: Rectal tumors can be excised through a number of minimally invasive transanal techniques including transanal excision, transanal endoscopic microsurgery, and transanal minimally invasive surgery (TAMIS). Specialty training is often required to master the nuances of these approaches. This study aimed to create a reproducible transanal excision training model that is suited for laparoendoscopic techniques., Methods: Frozen porcine rectum and anus with intact perianal skin were commercially obtained. Thawed specimens were then cut to approximately 20 cm in length. The proximal end of the rectum was then everted and suction applied to the mucosa to create pseudopolyps of various sizes (sessile and pedunculated). Larger pedunculated lesions were made by tying the base of the pseudopolyps with 5-0 monofilament sutures to gather more tissue. Methylene blue dye was injected submucosally into the lesions to simulate tattoos. The proximal rectum was then closed with sutures. The model was suspended in a trainer box by clamping the distal end in a ringed clamp and the proximal end to the box. Transanal excisions using TAMIS were then performed. The procedures were done by trained community colorectal surgeons attending courses on transanal minimally invasive surgery., Results: Both partial- and full-thickness excisions of sessile and pedunculated rectal lesions were successfully performed during simulated TAMIS by trained community surgeons learning this laparoendoscopic technique., Conclusion: Transanal laparoendoscopic procedures to excise rectal tumors can be successfully and reproducibly performed in an ex vivo porcine anorectal model.

Background: The NOSCAR white paper lists training as an important step to the safe clinical application of natural orifice translumenal endoscopic surgery (NOTES). The aim of this randomized controlled trial was to evaluate whether training novices in either a laparoscopic or endoscopic simulator curriculum would affect performance in a NOTES simulator task., Methods: A total of 30 third-year medical undergraduates were recruited. They were randomized to 3 groups: no training (control; n = 10), endoscopy training on a validated colonoscopy simulator protocol (n = 10), and training on a validated laparoscopy simulator curriculum (n = 10). All participants subsequently completed a simulated NOTES task, consisting of 7 steps, on the ELITE (endoscopic-laparoscopic interdisciplinary training entity) model. Performance was assessed as time taken to complete individual steps, overall task time, and number of errors., Results: The endoscopy group was significantly faster than the control group at accessing the peritoneal cavity through the gastric incision (median 27 vs 78 s; P = .015), applying diathermy to the base of the appendix (median 103.5 vs 173 s; P = .014), and navigating to the gallbladder (median 76 vs 169.5 s; P = .049). Endoscopy participants completed the full NOTES procedure in a shorter time than the laparoscopy group (median 863 vs 2074 s; P < .001)., Conclusion: This study highlights the importance of endoscopic training for a simulated NOTES task that involves both navigation and resection with operative maneuvers. Although laparoscopic training confers some benefit for operative steps such as applying diathermy to the gallbladder fossa, this was not as beneficial as training in endoscopy.

Importance: Simulation-based standardized training is important for the clinical training of physicians practicing robotic surgery., Objective: To train robotic surgery-naïve student volunteers using the da Vinci Skills Simulator (dVSS) for transoral robotic surgery (TORS)., Design: Prospective inception cohort in 2012., Setting: Academic referral center., Participants: Sixteen medical student volunteers lacking experience in robotic surgery., Interventions: Participants trained with the dVSS in 12 exercises until competent, defined as an overall score of at least 91%. After a 1-, 3-, 5-, or 7-week postinitial training hiatus (n = 4 per group), participants reachieved competence on follow-up., Main Outcomes and Measures: Total training time (TTT) to achieve competency, total follow-up time (TFT) to reachieve competency, and performance metrics., Results: All participants became competent. The TTT distribution was normal based on the Anderson-Darling normality test (P > .50), but our sample was divided into a short training time (STT) group (n = 10 [63%]) and long training time (LTT) group (n = 6 [37%]). The mean (SD) TTT was 2.4 (0.6) hours for the STT group and 4.7 (0.5) hours for the LTT group. All participants reachieved competence with a mean TFT that was significantly shorter than TTT. There was no significant difference between STT and LTT in mean TFT at 1 and 3 weeks (P = .79), but the LTT group had a longer TFT at 5 and 7 weeks (P = .04) but with no difference in final follow-up scores (P = .12)., Conclusions and Relevance: Physicians in training can acquire robotic surgery competency. Participants who acquire skills faster regain robotic skills faster after a training hiatus, but, on retraining, all participants can regain equivalent competence. This information provides a benchmark for a simulator training program.

Background: Transanal endoscopic microsurgery (TEM) is a technically demanding key technique in minimally invasive rectal surgery. We investigated the learning curve of colorectal surgeons commencing with TEM., Methods: All TEM procedures of four colorectal surgeons were analyzed. Procedures were ranked chronologically per surgeon. Outcomes included conversion, postoperative complications, procedure time, and recurrence. Backward multivariable regression analysis identified learning curve effects and other predictors., Results: Four surgeons resected 693 rectal lesions [69.9 % adenoma/25.5 % carcinoma; median size 20 cm(2); interquartile range (IQR) 11-35; 7 ± 4 cm ab ano]. A total of 555 resections (80.1 %) were histopathologically radical (R0). Conversion (4.3 %) was influenced by a learning curve [odds ratio (OR) 0.991 per additional procedure; 95 % confidence interval (CI) 0.984-0.998] and by lesion size. Postoperative complications depended only on the individual surgeon and lesion size in benign lesions (10.4 % complications). A learning curve (OR 0.99; 95 % CI 0.988-0.998) and peritoneal entrance affected complications in malignant lesions (13.3 %). Procedure time [median 55 min (IQR 30-90)] was influenced by a learning curve [B -0.11 (95 % CI -0.14 to -0.09)], individual surgeon, single-piece resection, peritoneal entrance, lesion size, and rectal quadrant. Recurrence of benign lesions (4.5 %) depended on lesion size, R0 resection, and prior resection attempts. Recurrence of malignant lesions (8.9 %) depended on 3D stereoscopic view, lesion size, full-thickness resection, and length of follow-up. Recurrence-free survival of patients operated during the 36th through 80th procedure per surgeon was significantly shorter than in patients operated during procedures 1-35 and 81 onwards., Conclusions: A surgical learning curve affected conversion rate, procedure time, and complication rate. It did not influence recurrence rates, possibly due to evolving patient populations. This first insight into the learning curve of TEM stresses the importance of quality monitoring and centralisation of care.

Background: TransAnal Minimally Invasive Surgery (TAMIS) has been proposed as an alternative to Transanal Endoscopic Microsurgery (TEM) for resection of benign polyps and early cancers of rectum. Since clinical application has begun in the absence of any experimental validation, we assessed its feasibility and efficacy ex vivo in a pilot study., Methods: In a dedicated trainer box for transanal procedures, 10 surgeons with no experience in transanal surgery were asked to perform a dissection/suture task using both TAMIS and TEM in randomly allocated order. Surgeons were asked to dissect two identically drawn lesions of ~3 cm in larger diameter. Precision of dissection was assessed using a quantitative photographic method, while the time needed for dissection and suturing was considered a measure of quantitative evaluation. Each participant expressed a subjective opinion regarding difficulty with dissection, difficulty with suturing, vision quality, and conflict between instruments on a scale from 1 to 5., Results: No difference was observed between the two techniques regarding the accuracy of dissection as the margin was interrupted along 4.1 % of the circumference in the TEM group compared with 2.48 % in the SILS group (P = 0.271). Dissection and suturing were significantly quicker in the TEM group [04:30 vs. 06:35 min (P = 0.049) and 14:34 versus 19:18 min (P = 0.003)]. In three cases in the SILS group, completing the suture was not considered possible, and the procedures were terminated by TEM. Subjective evaluation revealed a better appreciation of TEM in all proposed comparisons: dissection (2.6 vs. 3.5, P = 0.004), suturing difficulty (3.1 vs. 4.6, P < 0.001), quality of vision (2.3 vs. 2.8, P = 0.18), and instrument conflicts (3.1 vs. 4.0, P = 0.054)., Conclusions: In the ex vivo setting, both techniques were comparable for achieving a good dissection, although TAMIS failed to prove effective in suturing the rectal wall. Moreover, TEM was significantly quicker despite the small groups and was better appreciated by the surgeons.

Introduction: Modern medicine uses increasingly innovative techniques that require more and more capabilities for acquisition. In the urological department is increasing the presence of patients with lower urinary tract symptoms (LUTS) and transurethral resection of the prostate (TURP) is the standard of care in their surgical treatment. We report our surgical experience and learning curve of using bipolar plasmakinetic devices in the training of urological residents to benign prostatic hyperplasia (BPH) treatment., Materials and Methods: 80 patients with benign prostatic enlargement due to BPH were enrolled in the study. TURP has been performed by three urological residents and by an expe- rienced urologist. Patients were evaluated before and 6 months after the endoscopic bipolar plasmakinetic resection using the International Prostate Symptom Score (IPSS), maximum uri- nary flow rate (Qmax), postvoid residual urine (PVR) and prostate specific antigen (PSA)., Results: Overall 60 procedures were performed, 18 PlasmaKinetic (PK)-TURP procedures were completed by the three residents. In the other 42 cases the procedures were completed by the experienced urologist. In eight cases there was a capsular perforation and the experienced urol- ogist replaced the resident to complete the resection. No complications have been reported in the procedures completed by the senior urologist. All complications caused by the residents were man- aged intraoperatively without changing the course of the procedure. Statistical differences were observed regarding IPSS, quality of life (QoL), and PVR at 6-month follow-up when procedures completed by urological residents were compared to those completed by the senior urologist., Conclusion: Bipolar device represents appropriate tools to acquire endoscopic skills. It is safe and it can be used at the first experience of BPH treatment by a resident who has not previ- ously approached this endoscopic surgical procedure.

Introduction: Since the first published work on natural orifice translumenal endoscopic surgery (NOTES) a decade ago, progress has been made in the domain of education and training, although questions posed by the original White Paper remain. This article aims to review the current status of education and training in NOTES., Methods: A review of the literature was conducted to evaluate the following: (1) What are the current training methods/modalities used for NOTES; what is the level of evidence to support their use? (2) How has NOTES clinical training been quantified; what is the evidence relating to performance of different NOTES operators? (3) What clinical NOTES training programs have been established and what are the wider training needs?, Results: A total of 25 studies were included: 11 nonanimal studies, 8 animal studies, and 6 descriptions of education programs. Several animal and simulator models demonstrated construct validity, but no study showed human predictive validity. Logarithmic learning curves in animal models demonstrate 10 to 15 cases achieving a proficiency level. Current trends are that gastroenterologists prefer it for diagnostic and basic procedures, whereas surgeons prefer it for complex therapeutic cases., Conclusion: The development of a new specialty is intriguing but currently unviable. Training programs have been initiated, but information is limited; the common theme is surgeons receiving endoscopic training. Despite the research done, our knowledge of training and educating in NOTES procedures is limited, preventing a meta-analysis or formal review from being performed. Further research is needed to integrate NOTES into routine clinical procedure.

Unlabelled: INTRODUCTION AND STUDY AIM: Natural orifice translumenal endoscopic surgery (NOTES) is an emerging surgical technique that requires a cautious adoption approach to ensure patient safety. High-fidelity virtual-reality-based simulators allow development of new surgical procedures and tools and train medical personnel without risk to human patients. As part of a project funded by the National Institutes of Health, we are developing the virtual transluminal endoscopic surgery trainer (VTEST) for this purpose. The objective of this study is to conduct a structured needs analysis to identify the design parameters for such a virtual-reality-based simulator for NOTES., Methods: A 30-point questionnaire was distributed at the 2011 National Orifice Surgery Consortium for Assessment and Research meeting to obtain responses from experts. Ordinal logistic regression and the Wilcoxon rank-sum test were used for analysis., Results: A total of 22 NOTES experts participated in the study. Cholecystectomy (CE, 68 %) followed by appendectomy (AE, 63 %) (CE vs AE, p = 0.0521) was selected as the first choice for simulation. Flexible (FL, 47 %) and hybrid (HY, 47 %) approaches were equally favorable compared with rigid (RI, 6 %) with p < 0.001 for both FL versus RI and HY versus RI. The transvaginal approach was preferred 3 to 1 to the transgastric. Most participants preferred two-channel (2C) scopes (65 %) compared with single (1C) or three (3C) or more channels with p < 0.001 for both 2C versus 1C and 2C versus 3C. The importance of force feedback and the utility of a virtual NOTES simulator in training and testing new tools for NOTES were rated very high by the participants., Conclusion: Our study reinforces the importance of developing a virtual NOTES simulator and clearly presents expert preferences. The results of this analysis will direct our initial development of the VTEST platform.