PROgressive struCturEd Simulation-based Surgical Training Program (PROCESS) - Open Vascular Surgery

Vascular Diseases Clinical Trial

— PROCESS  

Official title:

PROgressive struCturEd Simulation-based Surgical Training Program (PROCESS) - Open Vascular Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452901
• Other study ID #: CEIC-013-2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 21, 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: June 2024
• Source: Fundación Cardioinfantil Instituto de Cardiología
• Contact: Camilo A Velandia-Sánchez, MD
• Phone: 3214236062
• Email: camiloa.velandia[@]urosario.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Vascular Surgery, Cardiothoracic Surgery, and General Surgery residents.
• Over 18 years old.

Exclusion Criteria:

• Serious illnesses, such as advanced cancer, decompensated cardiovascular diseases, or severe neurological disorders, could be exclusion criteria due to concerns about the participant's safety and ability to complete the study.
• Participants who have known allergies to components of the interventions or have experienced severe adverse reactions in the past will be excluded from the study.
• Any medical condition that could interfere with the participant's ability to complete assessments or follow study guidelines could be a reason for exclusion. This could include, for example, severe physical disabilities or illnesses requiring continuous hospitalization.
• Individuals who cannot provide valid informed consent due to cognitive issues, mental impairment, or legal incapacity will be excluded from the study.
• Individuals who have had prior exposure to structured simulation programs in vascular surgery will be excluded. Previous familiarity with simulation could influence study outcomes, introducing a prior learning bias that could distort the assessment of the intervention's effectiveness.

Related Conditions & MeSH terms

• Competency-Based Education
• Simulation Training
• Vascular Diseases

Intervention

Other:
• Progression and structured surgical training.
Participants will be exposed to different amounts of open vascular surgical training, but only group I will receive the complete structured and progressive training program. This ensures that all participants have access to the potential benefits derived from the intervention. Current evidence supports this approach, which supports the benefits of medical simulation in the training process of surgical residents.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Cardioinfantil Instituto de Cardiología

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy in the acquisition of technical surgical skills.	Pre- and post-intervention individual measures will be taken using the OPEn Aortic Aneurysm Repair Assessment of Technical Expertise (OPERATE) tool to compare the efficacy of the simulated program. The unit of measure are the points of OPERATE Scale with a established passing score of 27.7. A higher score means a better outcome.	4 months
Secondary	The efficacy given by the progression through the different structured modules.	The results of the 3 arms will be compared. The unit of measure are the points of OPERATE Scale with a established passing score of 27.7. A higher score means a better outcome.	4 months
Secondary	The satisfaction of the residents	Surveys guided by a Likert Scale will measure the Level 1 of Kirkpatricks levels based on the reaction and satisfaction of the participants after the implementation of the interventions.; The unit of measure will be the result on the Likert scale; the minimum score is 1, and the maximum is 10. A higher score means a better outcome.	4 months