Efficacy of goal-directed minimally invasive surgery simulation training with the Lübeck Toolbox-Curriculum prior to first operations on patients: Study protocol for a multi-centre randomized controlled validation trial (NOVICE)

Michael Thomaschewski , Tilman Laubert , Markus Zimmermann , Hamed Esnaashari , Reinhard Vonthein , Tobias Keck , Claudia Benecke
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引用次数: 1

Abstract

Background

Minimally invasive surgery (MIS) procedures require special psychomotoric skills. Learning of these MIS basic skills is often performed in the operating room (OR). This is economically inefficient and could be improved in terms of patient safety. Against the background of this problem, various MIS simulators have been developed to train MIS basic skills outside the OR. Aim of this study is to evaluate to what extent MIS training programs and simulators improve the residents’ skills in performing their first MIS procedures on patients.

Method

The current multicentric RCT will be performed with surgical residents without prior active experience in MIS (n = 14). After the participants have completed their first laparoscopic cholecystectomy as baseline evaluation (CHE I), they will be randomized into two groups: 1) The intervention group will perform the Lübeck Toolbox curriculum, whereas 2) the control group will not undergo any MIS training. After 6 weeks, both groups will perform the second laparoscopic CHE (CHE II). Changes or improvements in operative performance (between CHE I and CHE II) will be analyzed and evaluated according to the Global Operative Assessment of Laparoscopic Skill (GOALS) Score (primary endpoint).

Discussion

The multicentric randomized controlled trial will help to determine the value of MIS training outside the operation room. Proof of effectiveness in practice transfer could be of considerable relevance with regard to an integration of MIS training programs into surgical education.

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患者首次手术前使用l beck工具箱课程进行目标导向微创手术模拟训练的效果:一项多中心随机对照验证试验的研究方案(新手)
背景:微创手术(MIS)需要特殊的精神运动技能。这些MIS基本技能的学习通常是在手术室(OR)进行的。这在经济上是低效的,在患者安全方面可以得到改善。在这个问题的背景下,各种MIS模拟器被开发出来,用于培训手术室外的MIS基本技能。本研究的目的是评估资讯系统训练计划和模拟程序在多大程度上提高住院医师对病人进行第一次资讯系统手术的技能。方法目前的多中心随机对照试验将在没有MIS积极经验的外科住院医师中进行(n = 14)。在参与者完成第一次腹腔镜胆囊切除术作为基线评估(CHE I)后,他们将被随机分为两组:1)干预组将执行贝克工具箱课程,而2)对照组将不接受任何MIS培训。6 周后,两组均进行第二次腹腔镜CHE (CHE II)。根据全球腹腔镜手术技能评估(GOALS)评分(主要终点)分析和评估手术表现(CHE I和CHE II之间)的变化或改善。多中心随机对照试验将有助于确定手术室外MIS培训的价值。实践转移的有效性证明对于将MIS培训计划整合到外科教育中具有相当大的相关性。
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期刊介绍: IJS Protocols is the first peer-reviewed, international, open access journal seeking to publish research protocols across across the full breadth of the surgical field. We are aim to provide rapid submission to decision times whilst maintaining a high quality peer-review process.
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