Vascular DiseasesPROCESSNCT06452901
PROgressive struCturEd Simulation-based Surgical Training Program (PROCESS) - Open Vascular Surgery
A study testing Progression and structured surgical training. in people with Vascular Diseases and Competency-Based Education, run by Fundación Cardioinfantil Instituto de Cardiología.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases, Competency-Based Education, Simulation Training
- What is being tested?
- Progression and structured surgical training.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 21 Jul 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Vascular Surgery, Cardiothoracic Surgery, and General Surgery residents.
- Over 18 years old.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- Progression and structured surgical training.
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Will receive the complete structured and progressive training program involving specific micro-surgical skills, VA, and AAOR. Receives: Other: Progression and structured surgical training. |
| Group II | Active comparator | Will only receive VA and AAOR training. Receives: Other: Progression and structured surgical training. |
| Group III | Active comparator | Will only receive AAOR training. Receives: Other: Progression and structured surgical training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start21 Jul 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Cardioinfantil Instituto de Cardiología
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilo Alejandro Velandia Sánchez, Fundación Cardioinfantil Instituto de Cardiología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452901
- Sponsor's protocol ID
- CEIC-013-2024
- Acronym
- PROCESS
- Status last verified
- Jun 2024
- First submitted
- 20 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROgressive struCturEd Simulation-based Surgical Training Program (PROCESS) - Open Vascular Surgery
- ClinicalTrials.gov ID
- NCT06452901
- Acronym / sponsor ID
- PROCESS / CEIC-013-2024
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fundación Cardioinfantil Instituto de CardiologíaUniversity, hospital or other
- Study start
- 21 Jul 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Progression and structured surgical training.Will receive the complete structured and progressive training program involving specific micro-surgical skills, VA, and AAOR. |
| Group II | Active comparator | Other: Progression and structured surgical training.Will only receive VA and AAOR training. |
| Group III | Active comparator | Other: Progression and structured surgical training.Will only receive AAOR training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Vascular Surgery, Cardiothoracic Surgery, and General Surgery residents.
- Over 18 years old.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group I, Group II, Group III |
Primary outcome
Efficacy in the acquisition of technical surgical skills.
Time frame: 4 months
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.
2 secondary outcomes
The efficacy given by the progression through the different structured modules.
Time frame: 4 months
The satisfaction of the residents
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Progression and structured surgical training. in people with Vascular Diseases and Competency-Based Education, run by Fundación Cardioinfantil Instituto de Cardiología.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camilo A Velandia-Sánchez, MD (3214236062, camiloa.velandia@urosario.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in the acquisition of technical surgical skills. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.