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To design, validate and prove cost-effectiveness of a comprehensive endovascular simulation curriculum consisting of cognitive and psychomotor skills training for endovascular management of symptomatic vascular disease in the lower limbs.
The main goal is to design a comprehensive endovascular simulation curriculum consisting of cognitive and psychomotor skills training for endovascular management of symptomatic vascular disease in the lower limbs (Rutherford classification 2-5; stenosis or occlusion in the iliac, superficial femoral and popliteal arteries). The curriculum will consist of E-learning, video-based learning and simulation exercises on the Virtual Reality simulator on which an endovascular procedure will be simulated.
Skills transferability to real life practice will be verified by means of a RCT. In this RCT the investigators will compare the cognitive knowledge and technical performance of curricular trained surgical trainees with conventionally trained trainees during treatment of patients under supervision. The hypothesis states that surgeons trained within the PROSPECT curriculum will show improved technical knowledge of endovascular treatment of atherosclerotic disease in the iliac, superficial femoral and popliteal arteries and will demonstrate increased technical proficiency in the angiosuite in comparison with surgeons who received only conventional training. Subjects will be surgical trainees (N=32). They will be randomized into a three groups: a control group (N=11), a group that only has access to E-learning (N=10) and a PROSPECT group (N=11). Both groups will continue their traditional clinical education and the PROSPECT group will additionally be trained within this endovascular curriculum. The investigators hope that this study may ultimately lead to an improvement in the quality of patient care by standardizing competencies of endovascular operators in training and practice.
Additionally a cost-effectiveness analysis of PROSPECT compared to traditional training modalities will be executed. A successful training program is expected to lead to a shortening of the learning curve, reduction in number of errors during real life procedures and more efficient use of hybrid angio suites. The financial impact of potentially shorter duration of endovascular interventions will be studied and compared to time investment and additional costs associated with stepwise, supervised training using VR simulators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROSPECT | Experimental | the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module). After studying each module the trainee will complete a Multiple Choice Questionnaire and perform a simple and a complex exercise on the simulator. |
|
| CONTROL | No Intervention | The trainee will continue clinical education without additional curriculum, but will be allowed to study independently. | |
| E-LEARNING | Experimental | the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module). After studying each module the trainee will complete a Multiple Choice Questionnaire, no simulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| additional curriculum (E-learning + simulation) | Other |
| ||
| additional E-learning |
| Measure | Description | Time Frame |
|---|---|---|
| Technical and Global Performance of the Surgical Trainee in Real Life Procedures | The consultant will assess the trainee during the intervention.
For both scales, the higher the score, the better. Surrogate measures of performance are also evaluated (total procedure and fluoroscopy time, radiation dose, contrast volume and number of endovascular tools used). Post-hoc videos of hand movements and the fluoroscopy imaging recorded during the real procedure will be rated using the same scoring systems. Two real life endovascular procedures will be performed within six weeks after completing the curriculum. Evaluation will occur during the intervention and videos of hand movements and fluoroscopy imaging will be evaluated afterwards. | 6 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | The cognitive and technical skills retention of the surgical trainee is measured by a MCQ test and a simulation based exercise, pre and post PROSPECT. MCQ test: validated Multiple Choice Test - Range 0-20 GRS: Global Rating Scale of Endovascular Performance, modified OSATS (Objective Structured Assessment of Technical Skills) scale: to assess global performance (same as primary outcome) - Range: 11-55 Examiners checklist: Examiner Checklist for Diagnostic Angiography, Angioplasty and Stenting: to assess technical performance (same as primary objective) - Range: 17-85 For al outcome measures: the higher the score, the better |
| Measure | Description | Time Frame |
|---|---|---|
| PROSPECT Proficiency | After the RCT, a registry was started with all participants that started PROSPECT. Outcome: do PROSPECT participants pass the curriculum, do they become proficient? | After RCT |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Van Herzeele, MD, PhD | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26276301 | Background | Maertens H, Aggarwal R, Desender L, Vermassen F, Van Herzeele I. Development of a PROficiency-Based StePwise Endovascular Curricular Training (PROSPECT) Program. J Surg Educ. 2016 Jan-Feb;73(1):51-60. doi: 10.1016/j.jsurg.2015.07.009. Epub 2015 Aug 11. | |
| 28734705 | Result | Maertens H, Aggarwal R, Moreels N, Vermassen F, Van Herzeele I. A Proficiency Based Stepwise Endovascular Curricular Training (PROSPECT) Program Enhances Operative Performance in Real Life: A Randomised Controlled Trial. Eur J Vasc Endovasc Surg. 2017 Sep;54(3):387-396. doi: 10.1016/j.ejvs.2017.06.011. Epub 2017 Jul 19. |
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7 people declined to participate before randomisation during the RCT
Recruitment for RCT (before 02/2016): general surgery trainees from Ghent University Recruitment for registry (after 02/2016): general surgery trainees from Ghent University, Leuven University, Nancy University, Lille University, CAMES Copenhagen
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| ID | Title | Description |
|---|---|---|
| FG000 | PROSPECT | the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire and perform a simple and a complex exercise on the simulator. additional curriculum |
| FG001 | E-LEARNING | the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire. No simulation exercises. |
| FG002 | CONTROL | The trainee will continue clinical education without additional curriculum, but will be allowed to study independently. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
39 surgical trainees were eligible to start the RCT. Randomisation took place after screening for eligibility.
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| ID | Title | Description |
|---|---|---|
| BG000 | PROSPECT | the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire and perform a simple and a complex exercise on the simulator. additional curriculum |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Row population differs from overall as participants are spread accross study arms. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Technical and Global Performance of the Surgical Trainee in Real Life Procedures | The consultant will assess the trainee during the intervention.
For both scales, the higher the score, the better. Surrogate measures of performance are also evaluated (total procedure and fluoroscopy time, radiation dose, contrast volume and number of endovascular tools used). Post-hoc videos of hand movements and the fluoroscopy imaging recorded during the real procedure will be rated using the same scoring systems. Two real life endovascular procedures will be performed within six weeks after completing the curriculum. Evaluation will occur during the intervention and videos of hand movements and fluoroscopy imaging will be evaluated afterwards. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after intervention |
|
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Participants were not at risk of adverse events as they were not patients but healthy trainees. There was monitoring/assesment for all-cause mortality, serious and other (not including serious) adverse events, but none occured.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PROSPECT | the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire and perform a simple and a complex exercise on the simulator. additional curriculum |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Isabelle Van Herzeele | Ghent University | 93325108 | +32 | isabelle.vanherzeele@ugent.be |
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Initially 39 participants were enrolled, 7 excluded because they declined to participate. 32 people were randomized.
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| Other |
|
| Pre curriculum, 6 weeks and 3 months after completion of the curriculum (3 months only for intervention arms) |
| 30131277 | Result | Maertens H, Vermassen F, Aggarwal R, Doyen B, Desender L, Van Herzeele I, Annemans L. Endovascular Training Using a Simulation Based Curriculum is Less Expensive than Training in the Hybrid Angiosuite. Eur J Vasc Endovasc Surg. 2018 Oct;56(4):583-590. doi: 10.1016/j.ejvs.2018.07.011. Epub 2018 Aug 18. |
| BG001 |
| E-LEARNING |
the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire. No simulation exercises. |
| BG002 | CONTROL | The trainee will continue clinical education without additional curriculum, but will be allowed to study independently. |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Row population differs from the overall as participants are spread accross study arms. | Count of Participants | Participants |
|
| Postgraduate year | Row population differs from the overall as participants are spread accross study arms | Count of Participants | Participants |
|
| No. endovascular cases assisted | Row population differs from the overall as participants are spread accross study arms | Count of Participants | Participants |
|
| OG000 |
| PROSPECT |
the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire and perform a simple and a complex exercise on the simulator. additional curriculum |
| OG001 | E-LEARNING | the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire. No simulation exercises. |
| OG002 | CONTROL | The trainee will continue clinical education without additional curriculum, but will be allowed to study independently. |
|
|
| Secondary | Improved Knowledge and Technical Performance of the Surgical Trainee on a Simulated Complex Module | The cognitive and technical skills retention of the surgical trainee is measured by a MCQ test and a simulation based exercise, pre and post PROSPECT. MCQ test: validated Multiple Choice Test - Range 0-20 GRS: Global Rating Scale of Endovascular Performance, modified OSATS (Objective Structured Assessment of Technical Skills) scale: to assess global performance (same as primary outcome) - Range: 11-55 Examiners checklist: Examiner Checklist for Diagnostic Angiography, Angioplasty and Stenting: to assess technical performance (same as primary objective) - Range: 17-85 For al outcome measures: the higher the score, the better | Posted | Mean | Standard Deviation | score on a test or scale | Pre curriculum, 6 weeks and 3 months after completion of the curriculum (3 months only for intervention arms) |
|
|
|
|
| Other Pre-specified | PROSPECT Proficiency | After the RCT, a registry was started with all participants that started PROSPECT. Outcome: do PROSPECT participants pass the curriculum, do they become proficient? | Not Posted | Sep 2025 | After RCT | Participants |
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | E-LEARNING | the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module. After studying each module the trainee will complete a Multiple Choice Questionnaire. No simulation exercises. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | CONTROL | The trainee will continue clinical education without additional curriculum, but will be allowed to study independently. | 0 | 11 | 0 | 11 | 0 | 11 |
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| Post test MCQ 3m |
|
| Pre GRS |
|
| Post GRS 6w |
|
| Post GRS 3m |
|
| Pre Examiner Checklist |
|
| Post Examiner Checklist 6w |
|
| Post Examiner Checklist 3m |
|
| Null Hypothesis: There is no difference in Pre and Post test MCQ score | ANOVA | 0.003 | Other |
| Null Hypothesis: There is no difference in Pre and Post test MCQ score | ANOVA | 0.001 | Other |
| Null Hypothesis: There is no difference in Pre and Post test MCQ score | ANOVA | 0.228 | Other |
| Null Hypothesis: There is no difference in Pre and Post test GRS score | ANOVA | 0.001 | Other |
| Null Hypothesis: There is no difference in Pre and Post test GRS score | ANOVA | 0.008 | Other |
| Null Hypothesis: There is no difference in Pre and Post test GRS score | ANOVA | 0.164 | Other |
| Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score | ANOVA | 0.001 | Other |
| Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score | ANOVA | 0.001 | Other |
| Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score | ANOVA | 0.190 | Other |