Development and Validation of a Virtual Bariatric Endoscopic (ViBE) simulator

虚拟减肥内窥镜(VIBE)模拟器的开发与验证 摘要 肥胖是一种慢性、复发性、多因素和神经行为疾病，需要终生、 超越单一干预的多学科管理。目前对慢性阻塞性肺疾病患者的治疗选择 病态肥胖症包括药物疗法和减肥手术，药物疗法只能导致不理想的体重减轻， 只有一小部分符合条件的患者使用。内窥镜套式胃成形术(ESG)迅速 成为抗击肥胖流行的新工具，它既被用作(I)主要的减肥程序 以及(Ii)对手术后体重增加的患者进行内窥镜翻修。它是一种安全有效的 通过口腔引入的柔性内窥镜进行的非手术、非手术的非手术技术， 它通过在胃腔内放置全厚度缝合线来减少胃体积。这是一天的 快速恢复工作的门诊程序。然而，从技术上讲，学习执行ESG 要求很高，至少需要35个案例才能达到基本熟练程度。虽然是内窥镜检查 缝合技巧是ESG的关键，仅仅学习内窥镜缝合是不足以进行ESG的。 除了以患者为中心之外，ESG没有正式的课程或能力标准 医学和程序性教育的学徒制模式，预计将是一种基于虚拟现实(VR)的教育 Trader具有视觉和触觉(触摸)反馈，对于ESG培训将是无价的，使受训人员能够获得 在受控环境中的能力，不会对患者造成风险；支持定制学习，并提供 实时反馈、指导和客观评估。本提案的目标是设计， 开发和验证可用于培训的虚拟减肥内窥镜(VIBE)模拟器 内窥镜减肥手术，如ESG。该项目的重大技术创新包括(1) 开发基于物理的ESG过程的真实实时模拟，包括有效的 用于内窥镜缝合建模的约束样条线动力学(CSD)算法，(2)一种创新的硬件 用于ESG过程中准确的力反馈的接口，(3)在活体猪实验中表征 内窥镜缝合程序；以及(4)认知辅助模块，基于详细的认知任务 分析，为学员提供实时反馈。我们将在自愿入伍的人身上进行试验 参与者要确保学习到关于氛围和绩效的适当技能 Vibe反映了适当的技术技能。此外，我们将检验这样的假设，即培训的受训者 VIBE模拟器的学习速度将与在体外培养的猪相同或更好 这项培训将转移到临床环境中。 这个项目的意义在于，它聚焦于肥胖症的流行，并建议开发一种 模拟器，以实现ESG的安全采用。在Vibe上学到的内窥镜缝合技能将转化为 其他内窥镜手术，例如支架固定和减肥手术并发症的处理。

Development and Validation of a Virtual Bariatric Endoscopic (ViBE) Simulator Abstract Obesity is a chronic, relapsing, multifactorial, and neurobehavioral disease that requires life-long, multidisciplinary management beyond a single intervention. The current treatment options for patients with morbid obesity include pharmacotherapy, which only induces suboptimal weight loss, and bariatric surgery, utilized only by a small fraction of the eligible patients. Endoscopic Sleeve Gastroplasty (ESG) is rapidly emerging as a new tool to combat the obesity epidemic used both as (i) primary weight loss procedure and (ii) endoscopic revision for patients experiencing weight gain following surgery. It is a safe and effective, incision-less, non-surgical technique performed with a flexible endoscope, introduced through the mouth, which reduces the gastric volume by placing full-thickness sutures from within the gastric lumen. It is a one-day outpatient procedure with rapid return to work. However, learning to perform ESG is technically demanding, with a minimum of 35 cases necessary to attain basic proficiency. Though endoscopic suturing skills are critical for ESG, just learning endoscopic suturing is not sufficient for performing ESG. With no formal curriculum or competency standards in place for ESG outside the patient-centric apprenticeship model of medical and procedural education, it is anticipated that a virtual reality (VR)-based trainer, with visual and haptic (touch) feedback, will be invaluable for training in ESG, allowing trainees to attain competence in a controlled environment with no risk to patients; to enable customized learning, and to offer real-time feedback, mentoring and objective assessment. The goal of the present proposal is to design, develop and validate a Virtual Bariatric Endoscopic (ViBE) simulator that can be used to train endoscopic bariatric procedures such as ESG. Significant technical innovations of this project include (1) developing realistic physics-based real-time simulations of the ESG procedure, including an efficient constrained spline dynamics (CSD) algorithm for modeling endoscopic suturing, (2) an innovative hardware interface for accurate force feedback during ESG, (3) in vivo porcine experiments to characterize the endoscopic suturing procedure; and (4) a cognitive assistant module, based on detailed cognitive task analysis, to provide real-time feedback to the trainee. We will conduct experiments on voluntarily enrolled participants to ensure that appropriate skills are being learned on the ViBE and performance measured on the ViBE reflects the appropriate technical skills. Further, we will test the hypothesis that trainees who train on the ViBE simulator will learn at the same rate or better than those trained on ex vivo porcine gastrointestinal specimens and that this training will transfer to the clinical environment. The significance of this project is that it focuses on the obesity epidemic and proposes to develop a simulator to enable the safe adoption of ESG. Endoscopic suturing skills learned on the ViBE will translate to other endoscopic procedures, e.g., stent fixation and management of bariatric surgical complications.