Department of General, Visceral and Transplant Surgery, University Medical Center Mainz, Mainz, Germany.
Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center Mainz, Mainz, Germany.
Trials. 2022 May 13;23(1):403. doi: 10.1186/s13063-022-06347-0.
A multitude of different diseases-benign and malign-can require surgery of the liver. The liver is an especially challenging organ for resection planning due to its unique and interindividually variable anatomy. This demands a high amount of mental imagination from the surgeon in order to plan accordingly - a skill, which takes years of training to acquire and which is difficult to teach. Since the volume of the functional remnant liver is of great importance, parenchyma sparing resections are favoured. 3D reconstructions of computed tomography imaging enable a more precise understanding of anatomy and facilitate resection planning. The modality of presentation of these 3D models ranges from 2D monitors to 3D prints and virtual reality applications.
The presented trial compares three different modes of demonstration of a 3D reconstruction of CT scans of the liver, which are 3D print, a demonstration on a regular computer screen or using a head-mounted virtual reality headset, with the current gold standard of viewing the CT scan on a computer screen. The group size was calculated with n=25 each. Patients with major liver resections in a laparoscopic or open fashion are eligible for inclusion. Main endpoint is the comparison of the quotient between planned resection volume and actual resection volume between these groups. Secondary endpoints include usability for the surgical team as well as patient specifics and perioperative outcome measures and teaching issues.
The described study will give insight in systematic planning of liver resections and the comparison of different demonstration modalities of 3D reconstruction of preoperative CT scans and the preference of technology. Especially teaching of these demanding operations is underrepresented in prior investigations.
Prospective trials registration at the German Clinical Trials register with the registration number DRKS00027865 . Registration Date: January 24, 2022.
许多不同的疾病——良性和恶性——都可能需要进行肝脏手术。由于肝脏具有独特的、个体间差异较大的解剖结构,因此对于肝脏切除术的规划来说,它是一个极具挑战性的器官。这就要求外科医生具备很高的想象力,以便进行相应的规划——这是一种需要多年训练才能获得的技能,并且很难教授。由于功能性剩余肝脏的体积非常重要,因此倾向于进行保肝切除术。计算机断层扫描成像的三维重建可以更精确地了解解剖结构,并有助于规划切除术。这些 3D 模型的呈现方式从 2D 显示器到 3D 打印和虚拟现实应用程序不等。
本试验比较了三种不同的方式展示肝脏 CT 扫描的三维重建,即 3D 打印、在常规计算机屏幕上演示或使用头戴式虚拟现实耳机演示,与当前在计算机屏幕上查看 CT 扫描的金标准相比。每组的样本量为 25 例。符合腹腔镜或开放性大肝切除术的患者有资格入组。主要终点是比较这些组之间计划切除体积与实际切除体积之间的商。次要终点包括手术团队的可用性以及患者的具体情况、围手术期结果测量和教学问题。
本研究将深入了解肝脏切除术的系统规划,并比较术前 CT 扫描的三维重建的不同演示方式和对技术的偏好。特别是这些高难度手术的教学在之前的研究中代表性不足。
在德国临床试验注册处进行前瞻性试验注册,注册号为 DRKS00027865。注册日期:2022 年 1 月 24 日。