Aneurysm Clinical Trial
Official title:
Impact of a Patient-specific Simulation on the Learning Curve of Infra-renal Aneurysm Endovascular Repair
NCT number | NCT02372214 |
Other study ID # | 3Daneurysm |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2014 |
Est. completion date | July 2016 |
Verified date | July 2016 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | July 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Clinics Hospital of São Paulo University Medical School | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fluoroscopy time | The total fluoroscopy time in every surgery will be counted, measured in minutes | 2 years - all the surgeries | |
Secondary | Number of participants with Myocardial infarction. | The Number of participants with Myocardial infarction (CKMB or Troponin positive curve or change in ECG) within 30 days of the surgery. | 30 days | |
Secondary | Number of participants with Renal disfunction | Number of participants with renal disfunction (necessity of hemodialysis or enhance of creatinine level) within 30 days of the surgery. | 30 days | |
Secondary | Death | 30 days | ||
Secondary | Number of participants with Pulmonary complications | Number of participants with Pulmonary complications (Pneumonia, Pulmonary congestion) within 30 days of the surgery. | 30 days | |
Secondary | Technical success (Endoprosthesis located in the right position, no endoleak type 1) | Endoprosthesis located in the right position, no endoleak type 1 | 30 days | |
Secondary | Contrast volume in each surgery | The volume of contrast used in all the surgeries will be measured in milliliters during the period of the study. | 2 years |
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