Pre-clinical Training for New Notes Procedures




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.


Key points








  • The field of natural orifice transluminal endoscopic surgery (NOTES) has evolved over the past decade.



  • There is immense clinical and research interest in the current new NOTES procedures, and this version of NOTES is likely here to stay.



  • With that comes the responsibility to inform health practitioners and effectively train those who may perform these procedures now and in the future.



  • Given the complexity and distinct skills required of NOTES, simulation will continue to play a prominent role in the training paradigm for NOTES.



  • It is likely that simulation will decrease the lengthy learning curves for these procedures. Simulation research will also continue to advance the developmental endoscopy field.






Introduction


Natural orifice transluminal endoscopic surgery (NOTES) is a relatively new field of advanced endoscopic surgery that has undergone dramatic development and evolution since its inception in 2004 with the seminal description of a transgastric peritoneal access by Kalloo and colleagues. The history of NOTES has been described elsewhere, and thus is not addressed within this paper.


Early in the evolution of NOTES, there was a vigorous interest in NOTES approaches to standard and frequent laparoscopic operations, such as the cholecystectomy and appendectomy. Perhaps predictably, given the high standards for safety and efficacy of existing laparoscopic techniques for those common operations, many have not been convinced that moving to a NOTES approach can improve upon the current gold standard laparoscopic approaches. Those traditional procedures are referred to as “first-generation NOTES.” The field in general has pivoted to concentrating research and clinical efforts on novel minimally invasive approaches to pathology within the luminal wall and adjacent to the luminal wall. Peroral endoscopic myotomy (POEM), submucosal endoscopy, full-thickness endoscopic resection (EFTR) of subepithelial tumors and peroral pyloromyotomy are examples of this new paradigm, which has been called new NOTES or “near NOTES.”


As with any emerging technology, simulation provides a safe introduction of the technique to the clinic. This is important for new NOTES for several reasons. First, new NOTES procedures requires unique skills that are distinct from standard advanced endoscopic procedures, such as a requirement to have expertise of transluminal anatomy, and mastery in submucosal dissection and various novel endoscopic tools. Furthermore, there needs to be crisp and collegial communication and teamwork between endoscopic and surgical interplay (or backup) for such procedures. Some procedures treat relatively rare pathologic entities (such as achalasia for POEM). Other new NOTES procedures that require submucosal tunneling are born out of endoscopic submucosal dissection (ESD) techniques that were developed in Asia. The training ground is completely different there given the vastly higher number of superficial gastric malignancies that are treated endoscopically there. For these, simulation is critical to supplement low case volumes for new NOTES procedures.


In this review of simulation and training in NOTES, we discuss the importance of simulation in NOTES, describe available simulators and comment on the need for multimodal training. We emphasize developments in ex vivo simulation in new NOTES techniques and also development of virtual reality (VR) NOTES platforms, the 2 most dynamic aspects of NOTES simulation training currently.




Introduction


Natural orifice transluminal endoscopic surgery (NOTES) is a relatively new field of advanced endoscopic surgery that has undergone dramatic development and evolution since its inception in 2004 with the seminal description of a transgastric peritoneal access by Kalloo and colleagues. The history of NOTES has been described elsewhere, and thus is not addressed within this paper.


Early in the evolution of NOTES, there was a vigorous interest in NOTES approaches to standard and frequent laparoscopic operations, such as the cholecystectomy and appendectomy. Perhaps predictably, given the high standards for safety and efficacy of existing laparoscopic techniques for those common operations, many have not been convinced that moving to a NOTES approach can improve upon the current gold standard laparoscopic approaches. Those traditional procedures are referred to as “first-generation NOTES.” The field in general has pivoted to concentrating research and clinical efforts on novel minimally invasive approaches to pathology within the luminal wall and adjacent to the luminal wall. Peroral endoscopic myotomy (POEM), submucosal endoscopy, full-thickness endoscopic resection (EFTR) of subepithelial tumors and peroral pyloromyotomy are examples of this new paradigm, which has been called new NOTES or “near NOTES.”


As with any emerging technology, simulation provides a safe introduction of the technique to the clinic. This is important for new NOTES for several reasons. First, new NOTES procedures requires unique skills that are distinct from standard advanced endoscopic procedures, such as a requirement to have expertise of transluminal anatomy, and mastery in submucosal dissection and various novel endoscopic tools. Furthermore, there needs to be crisp and collegial communication and teamwork between endoscopic and surgical interplay (or backup) for such procedures. Some procedures treat relatively rare pathologic entities (such as achalasia for POEM). Other new NOTES procedures that require submucosal tunneling are born out of endoscopic submucosal dissection (ESD) techniques that were developed in Asia. The training ground is completely different there given the vastly higher number of superficial gastric malignancies that are treated endoscopically there. For these, simulation is critical to supplement low case volumes for new NOTES procedures.


In this review of simulation and training in NOTES, we discuss the importance of simulation in NOTES, describe available simulators and comment on the need for multimodal training. We emphasize developments in ex vivo simulation in new NOTES techniques and also development of virtual reality (VR) NOTES platforms, the 2 most dynamic aspects of NOTES simulation training currently.




Overview of natural orifice transluminal endoscopic surgery simulation


NOTES procedures are universally complex and advanced. They have been developed and studied by world-renowned endoscopists and surgeons, and require exceptional endoscopic skill to be accomplished safely and effectively. Given that NOTES procedures are complex endoscopic tasks that require the development and modification of endoscopic skills that even general experienced endoscopists do not carry, simulation carries an important role in the training environment of NOTES.


Unlike using a novel endoscopic accessory such as a snare that requires little if any specific training before using in clinical practice, NOTES requires mastery of specific skills, such as detailed anatomic understanding, expertise in needle knives and electrosurgery, familiarity with novel endoscopic devices, comfort with closing full-thickness luminal defects and submucosal endoscopy, all of which require practice and dedicated study. The training environment requires repeated skills building with expert guidance, all of which lends well to simulation training.


Available simulation options for NOTES include mechanical simulators including part task trainers to fine tube basic endoscopic skills and full procedure NOTES simulators, ex vivo simulators to simulate entire specific NOTES procedures or components of NOTES procedures (such as full-thickness luminal closure, submucosal dissection), and VR simulators. With recent shifts in interest to new NOTES procedures such as POEM, EFTR, and submucosal endoscopy, the NOTES simulation arena is in a period of development and undergoing changes.




Mechanical simulators


Inanimate task trainers can be used by endoscopists to improve technical endoscopic skills used in day-to-day endoscopy. For endoscopists who wish to learn NOTES, it is absolutely essential to have mastery of standard endoscopy skills. Inanimate skills trainers can help test and improve those skills. The Thompson Endoscopic Skills Trainer was recently developed as a part task trainer for endoscopists interested in improving or maintaining endoscopic technical skill. The Thompson Endoscopic Skills Trainer is a plastic-based modular portable training center that allows for the endoscopist to perform 5 individual tasks (retroflexion, torque, knob control, polypectomy and navigation/loop reduction) that develop a particular skill used in endoscopy. The appealing component of this simulator is that it can provide objective information for skills testing and tracking for trainees. Jirapinyo and colleagues recently reported a study that confirmed validity of this skills simulator, confirming it can assess endoscopic skills objectively. Next steps for the simulator included more widespread multicenter trials of trainees skills development and defining learning curves with the simulator.


Mechanical simulators specific to NOTES have been developed. These have been developed for the first-generation NOTES, such as NOTES appendectomy and cholecystectomy. These mechanical NOTES simulators have been reviewed in detail elsewhere. Two of these simulators are the Endoscopic-Laparoscopic Interdisciplinary Training Entity (ELITE) trainer and the Natural Orifice Simulated Surgical Environment simulator. The ELITE is a plastic phantom developed in Germany, which has previously demonstrated construct validity. There was recently a study reported that used the ELITE NOTES trainer to judge whether previous endoscopic versus surgical simulation training helped novices in performing a simulated NOTES procedures. The study found that previous training in a simple endoscopy simulator was superior to a laparoscopy simulator to successfully complete a NOTES task in the ELITE simulator. The Natural Orifice Simulated Surgical Environment is similar to a surgical laparoscopic box trainer and provides skills training for tasks particular to NOTES procedures.


A recent study by Buscaglia and colleagues used the ProMIS simulator (Haptica, Dublin, Ireland) to carry out simulated transanal NOTES sigmoidectomy procedures. This is a laparoscopic, inanimate surgical simulator that was modified. In this study, 4 participants performed 21 simulated resections, and it was found that the participants had nonsignificant improvements in total procedure time and in 8 individual steps of the operation.


There has not yet been developed a validated and commercially available mechanical simulator for new NOTES procedures such as POEM or EFTR.




Ex vivo simulators


A mainstay of simulation in NOTES is the ex vivo simulator. The benefits of ex vivo simulation include the ability to simulate entire NOTES procedures or concentrate on individual tasks (eg, gastrotomy closure); ex vivo simulation is readily commercially available; realistic tissue manipulation is realized given the use of biological tissue, including electrocautery; and ex vivo simulators are relatively less expensive than mechanical simulators, VR simulators, or live animals. Drawbacks of ex vivo simulation include the inability to simulate certain components of a procedure, such as intraprocedural bleeding.


“First-generation” NOTES procedures including intraperitoneal tissue resection (eg, cholecystectomy, appendectomy) can be simulated using total organ porcine explant ( Fig. 1 ) simulators outfitted in specialized simulation trays that simulate an abdominal cavity and allow for both laparoscopic and endoscopic access (EndoSim, LLC, Hudson, MA, USA; Fig. 2 ).


Sep 7, 2017 | Posted by in GASTOINESTINAL SURGERY | Comments Off on Pre-clinical Training for New Notes Procedures

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