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

NCT06452901 | Not Yet Recruiting DMC

• 1 other identifier: CEIC-013-2024
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vascular Diseases; Competency-Based Education; Simulation Training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The efficacy given by the progression through the different structured modules.

  4 months

• The satisfaction of the residents

  4 months

Study Arms (3)

Group I

EXPERIMENTAL

Will receive the complete structured and progressive training program involving specific micro-surgical skills, VA, and AAOR.

Other: Progression and structured surgical training.

Group II

ACTIVE COMPARATOR

Will only receive VA and AAOR training.

Other: Progression and structured surgical training.

Group III

ACTIVE COMPARATOR

Will only receive AAOR training.

Other: Progression and structured surgical training.

Interventions

Progression and structured surgical training. OTHER

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.

Group I; Group II; Group III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fundación Cardioinfantil Instituto de Cardiología: lead

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Camilo A Velandia-Sánchez, MD

CONTACT

3214236062; camiloa.velandia@urosario.edu.co

Juan G Barrera-Carvajal, MD

CONTACT

3163806687; jbarrerac@lacardio.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluators, who are external to the researchers, will be single-blinded to assess the effectiveness of different interventions. They will remain unaware of the participants' group assignments. Privacy will be maintained through coding and presenting de-identified data. Data will also be presented without voices, glove usage, and image distortion to prevent identification of personal details such as gender, race, or other characteristics.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mandatory Social Service Medical Doctor

Model Details: 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

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 11, 2024
• Study Start: July 21, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share