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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Diseases; Simulation Training; Competency-Based Education
• Intervention / Treatment: Other: Progression and structured surgical training.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camilo A Velandia-Sánchez, MD; Phone Number: 3214236062; Email: camiloa.velandia@urosario.edu.co
• Study Contact Backup: Name: Juan G Barrera-Carvajal, MD; Phone Number: 3163806687; Email: jbarrerac@lacardio.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Will receive the complete structured and progressive training program involving specific micro-surgical skills, VA, and AAOR.	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.
Active Comparator: Group II; Will only receive VA and AAOR training.	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.
Active Comparator: Group III; Will only receive AAOR training.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fundación Cardioinfantil Instituto de Cardiología

Study record dates

Study Major Dates

• Study Start (Estimated): July 21, 2024
• Primary Completion (Estimated): January 15, 2025
• Study Completion (Estimated): January 15, 2025

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: CEIC-013-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data may not be available for public access due to participant privacy concerns but may be available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No