Aneurysm Clinical Trial
Official title:
Impact of a Patient-specific Simulation on the Learning Curve of Infra-renal Aneurysm Endovascular Repair
The purpose of this study is to produce a patient-specific simulator for endovascular infra-renal aneurysm repair training and than analyze the effect of simulator training on the performance of vascular surgery residents.
Title: Production of a patient-specific simulator for endovascular aneurysm repair training.
Clinics Hospital of São Paulo University Medical School
Introduction
The aorta aneurysm is a common clinical condition that implies in considerable threatening to
the life of patients. Before the year 2000, 99% of the abdominal aortic aneurysm (AAA) repair
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 increased to 52%. This changing venue
requires a shift in our approach to training both fellows as well as general surgical
residents during their exposure to vascular surgery.
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 in flexible materials that are
helpful for training surgeons while simulating surgical procedures in a very realistic
manner.
The possibility of training surgical procedures in general as well as patient-specific
procedures might improve the surgeon's abilities and results . Rapid prototyping models allow
for intensive training of young surgeons, e.g., for endovascular stent implantation
simulating in vivo conditions and real tissues without any risk of patient complications and
with no exposure of the surgeon to radiation or biologic risks.
After being adequately trained on models, surgeons feel more confident while going to the
operating room for actual surgery. Besides, the pre-operative simulation of a specific and
complex surgery provides a unique opportunity to employ surgical steps in order to determine
the best operating strategy.
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.
Objectives:
Primary: Production of a patient-specific simulator for training in endovascular infra-renal
aneurysm repair.
Secondary: Analyze the effect of simulator training on the performance of vascular surgery
residents.
Methods:
Production of a patient-specific simulator: The process chain on the production of a
three-dimensional rapid prototype 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.
Analyze the effect of simulator training on the performance of vascular surgery residents:
The study will be performed during a period of two years (2014 and 2015), at the Clinics
Hospital of São Paulo University Medical School.
All the endovascular aneurysm repair (EVAR) performed in during this time will be analyzed.
According to the average number of EVAR in this service, we calculate that this research will
include at least 60 patients.
Ten vascular surgery residents coursing the last year of practice will be randomized into the
2 groups (this is the total number of residents in our service).
Inclusion Criteria:
- Patients with infra-renal aneurysm with diameter of 5,5cm or more
- Residents of the last year of vascular surgery at Clinics Hospital of São Paulo
University Medical School
Exclusion Criteria:
- Patients not suitable for endovascular aneurysm repair
- Patients with iliac aneurysm that require iliac bifurcated grafts
- Residents who don't want participate
- Group 1 (30 patients/5residents): patients will undergo endovascular aneurysm
repair according to the hospital routine. The residents will perform the procedure
under supervision of a senior surgeon. It is an observational part of the study,
which has already been done during the year 2014.
- Group 2 (30 patients/5residents): patients will have their aneurysm impressed by a
3D printing. The senior vascular surgeon and the residents of this group will be
able to practice the procedure in the model as many times as they wish before the
surgery. After the training, the EVAR will be performed according to the routine of
the hospital.
During the surgery, objective parameters will be analyzed: radioscopy time, volume of
contrast injected, total procedure time, number of catheters and guide-wires used, technical
success. 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.
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