Ethical Committee at Researches of Ege University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- compare the effectiveness of the solid model with CT screen, 3D-Standard Tessellation Language (STL) image and 1:1 scale model
研究概览
简要总结
Background: Three-dimensional (3D) printing has been increasingly used in medical applications with the creation of accurate patient-specific 3D printed models in medical imaging data. However, research on 3D printing in pancreaticobiliary disease is limited with lack of studies on validation of model accuracy.
Methods: This is a where general surgery residents, are introduced to 5 distinct hepatopancreatobiliary disease scenarios to generate a perception and required to compare their perception level of these cases with computed tomography (CT), 3D images and 1:1 solid models that the pathology, diverse diagnosis and presurgery diagnosis stages can be investigated.
详细描述
2.1.Research Design This study group are general surgery residents present in Faculty of Medicine, Ege University (n=19). A quintet with stations composed of normal pancreaticobiliary anatomy, common bile duct tumor, stony cholecystitis, pancreatic head cancer and cholelithiasis is assembled for the study. Each station containes CT, 3D-STL images and 1:1 solid models of cases. Each imaging method (CT, 3D-STL image and 3D solid model) associated with the scenarios of the quintet is created in the residents of the study. An explanatory assessment measure is being used as data collection method where the perception of each imaging method is being investigated based on their effectiveness in problem identification as well as their efficiency in diverse diagnosis and pre-surgery organization.
2.2. Selection of the sample cases The patients are chosen among the CT examinations of the ones who referred to Ege University Faculty of Medicine, Department of General Surgery for diagnose and treatment between 2016 and 2018. CT archives are screened and 5 eligible patients (age: 18-62 year) who required hepatopancreatobiliary surgery were selected. Selection of the cases is based on patients with no previous hepatopancreatobiliary operation, pathology leading to dilated biliary duct, and whose radiological imaging results are suitable for modeling. Virtual modeling of pancreaticobiliary pathways of the cases is performed and clinical histories of each case were created.
2.3. Scenarios As a mutual agreement among the specialists in medical education, general surgery, anatomy and radiology, 5 cases identified, are elected to be samples for pancreaticobiliary surgical processes. Having defined these cases, they are further converted into genuine scenarios fully equipped with a past story, medical analysis results and imaging procedures.
Scenarios for 5 cases:
Case 1. Case with normal extrahepatic biliary tract with pancreas. Case 2. Choledochal tumor leading to advanced dilatation and hydropic gallbladder appearance in extrahepatic biliary tract.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 24 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •normal pancreaticobiliary anatomy case
- •common bile duct tumor case,
- •acute calculous cholecystitis,
- •pancreatic head cancer
- •cholelithiasis
- •general surgery residents present in Faculty of Medicine, Ege University
排除标准
- •Hepatic disease
- •General surgery experts
结局指标
主要结局
compare the effectiveness of the solid model with CT screen, 3D-Standard Tessellation Language (STL) image and 1:1 scale model
时间窗: 30 minute
Our aim is to compare the effectiveness of the solid model with CT screen, 3D-Standard Tessellation Language (STL) image and 1:1 scale model in 5 different hepatopancreatobiliary disease scenarios to general surgery residents in terms of recognizing the pathology, differential diagnosis and preoperative preparation stages.
次要结局
未报告次要终点
研究者
Figen GOVSA
Prof. Dr, Senior investigator
Ege University