Schmidt Mona Wanda, Friedrich Mirco, Kowalewski Karl-Friedrich, De La Garza Javier, Bruckner Thomas, Müller-Stich Beat-Peter, Nickel Felix
Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.
Institute for Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, 69120 Heidelberg, Germany.
Int J Surg Protoc. 2017 Jan 23;3:7-13. doi: 10.1016/j.isjp.2017.01.001. eCollection 2017.
Surgical proficiency is highly dependent on continuous and efficient training. However, efficacy of training hinges on questions such as accessibility and how intuitively the training can be translated into reality. Minimally invasive surgery (MIS) in particular relies on adequate training modalities in order to compensate for its additional psychomotor and visuospatial challenges. The increasing demand for MIS procedures longs for further enhancement of training and steep learning curves. We are investigating a nouveau training concept that continuously utilizes the first person view as addendum to laparoscopic view. We hypothesize this approach to be more intuitive thus faster and more naturally to apprehend than a laparoscopic view only and aim to establish a new standard to implement into training curricula.
The present study is conducted as a monocentric, two-arm randomized trial. Participants undergo a training curriculum in laparoscopic suturing and knot tying, using e-learning video material with either the first-person perspective of the surgeon or the laparoscopic view only. Primary endpoint is the total training time needed to reach a predefined proficiency level. Participants are evaluated by blinded raters using validated checklists. Number of attempts, procedure and knot quality subscore difference as well as metric parameter analysis from the first and last knots analyzed as secondary endpoints. Furthermore, trainees are assessed with regard to surgical background, basic skills level and spatial awareness. A total sample size of 80 participants for the analysis of the primary endpoint was determined, which will be performed as a two-sided -test.
Ethical approval was obtained from the Ethics Committee of the Medical Faculty at Heidelberg University (Code S-334/2011). This trial was registered with the German Clinical Trials Register (DRKS) in Freiburg, Germany, on May 6th (DRKS00009997). The results will be published and presented at appropriate conferences.
手术熟练程度高度依赖于持续且高效的训练。然而,训练的效果取决于诸如可及性以及训练能在多大程度上直观地转化为实际操作等问题。尤其是微创手术(MIS),依赖于适当的训练模式以应对其额外的心理运动和视觉空间挑战。对MIS手术日益增长的需求渴望进一步加强训练并缩短学习曲线。我们正在研究一种新的训练概念,即持续利用第一人称视角作为腹腔镜视角的补充。我们假设这种方法比仅使用腹腔镜视角更直观,因而能更快且更自然地理解,旨在建立一种新的标准以纳入训练课程。
本研究作为一项单中心、双臂随机试验开展。参与者使用带有外科医生第一人称视角或仅腹腔镜视角的电子学习视频材料,接受腹腔镜缝合和打结的训练课程。主要终点是达到预定义熟练水平所需的总训练时间。由不知情的评估者使用经过验证的检查表对参与者进行评估。尝试次数、操作和打结质量子评分差异以及第一个和最后一个分析的结的度量参数分析作为次要终点。此外,对受训者的手术背景、基本技能水平和空间意识进行评估。确定了用于分析主要终点的80名参与者的总样本量,将作为双侧检验进行。
已获得海德堡大学医学院伦理委员会的伦理批准(代码S - 334/2011)。该试验于5月6日在德国弗赖堡的德国临床试验注册中心(DRKS)注册(DRKS00009997)。研究结果将在适当的会议上发表和展示。