| Grant number: | 15/02317-7 |
| Support type: | Regular Research Grants |
| Duration: | May 01, 2015 - December 31, 2017 |
| Field of knowledge: | Health Sciences - Medicine - Surgery |
| Principal researcher: | Nelson De Luccia |
| Grantee: | Nelson De Luccia |
| Home Institution: | Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil |
| Assoc. researchers: | Inez Ohashi Torres |
Abstract
The aorta aneurysm is a common clinical condition that implies in considerable threatening to life of patients. Before the year 2000, 99% of the abdominal aortic aneurysm (AAA) repais where performed with open surgery. Nevertheless, Catheter-based minimally invasive interventions are rapidly becoming the preferred initial treatment in patients with vascular disease . After 2004, the endovascular treatment of AAA (EVAR) increased to 52%. This changing venue requires a shift in our approach to training fellows.Currently, supervised training with progressive exposure to procedures is the norm. Nevertheless, simulations based training may allow a shortening of the learning curve and avoid the exposure of the patients to unnecessary risks.Using the rapid prototyping it is possible to build models that may be helpful for training surgeons while simulating surgical procedures in a very realistic manner. Simulators for catheter-based intervention have been available for approximately 5 years, and the technology is evolving rapidly. Currently, simulators are expensive and access has been limited. The ultimate test of simulation is to demonstrate that performance improves in the operating room. To this end, we designed a randomized prospective study to describe the creation of a patient-specific simulator for training in endovascular infra-renal aneurysm correction and we will analyze the effect of simulator training on the performance of vascular surgery residents.Objetives:Primary: Production of a patient-specific simulator for training in endovacular infra-renal aneurysm repair.Secondary: Analyze the effect of simulator training on the performance of vascular surgery residents.Methods: The study will be performed on 60 patients with infra-renal aneurysm with indication for EVAR. The patients will be randomized into 2 groups. The Group 1 will have the aneurysm impressed by a 3D printing. The process produce a 3D model consists of the following three steps: Image acquisition, Image post-processing and 3D printing. Patients will undergo a angioCT, with slice thickness of 1mm. Acquired data will be saved in the common DICOM format (Digital Imaging and Communications in Medicine). Dedicated high performance workstations equipped with post-processing tools will be used for processing the DICOM images generated during acquisition. The DICOM data will be transformed into a STL (Surface Tesselation Language) file format. The 3D machine reads in data from a CAD drawing and lays down successive layers of liquid, powder, or the sheet material, and in this way builds up the model from a series of cross sections. With that, a patient-specific pulsatile model will be produced.Ten vascular surgery residents will be randomized into the 2 groups. All the procedures will be performed by the residents under the orientation of a senior vascular surgeon.The vascular surgeon and the residents of the group 1 will be able to practice the procedure in the model as many times as they wish. The patients of the two groups will be submitted to endovascular correction of their aneurysm. During the surgery, objective parameters will be analyzed: radioscopy time, contrast injection, total procedure time, number of catheters and guide-wires used. The patients will be followed until they leave the hospital. Morbidity (myocardial infarction, renal failure, pulmonary complications) and mortality during the peri-operative time (30 days) will be analyzed. The surgeon will answer a questionnaire about the experience. The data from the two groups will be compared. This study is approved by the national ethics committee under the number 19826213.1.0000.0068.The data of the control group has been collected. (AU)
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