Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452901
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-20
Brief Title:
PROgressive struCturEd Simulation-based Surgical Training Program PROCESS - Open Vascular Surgery
Sponsor:
Fundación Cardioinfantil Instituto de Cardiología
Organization:
Fundación Cardioinfantil Instituto de Cardiología
Study Overview
Official Title:
PROgressive struCturEd Simulation-based Surgical Training Program PROCESS - Open Vascular Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROCESS
Brief Summary:
A triple-arm randomized simple-blinded clinical trial will be conducted A control sequence and an intervention sequence of three subgroups with different exposure levels to the simulation program are proposed Group 1 open abdominal aortic repair AAOR Group 2 vascular anastomosis VA and AAOR and Group 3 specific micro-surgical skills VA and AAOR Surgical residents of general vascular or cardiovascular surgery programs will be included Sample size calculation resulted in 45 participants 15 in each group Simple blinding will involve external evaluators Randomization will occur as a simple randomization
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None