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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05620186
Other study ID # BC-877
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 17, 2017
Est. completion date October 1, 2027

Study information

Verified date December 2023
Source University Hospital, Ghent
Contact Isabelle Van Herzeele, MD, PhD
Phone 09 332 51 08
Email isabelle.vanherzeele@ugent.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this multicentric registry is to gather data from trainees completing PROSPECT: a PROficiency Based StePwise Endovascular Curricular Training to obtain basic cognitive and technical skills. The main goals are to identify if: - Results from a previous randomised controlled trail can be reproduced in real life. - Evaluate skills retention after program completion. - Assess real life implementation of the training program.


Description:

A validated PROSPECT (PROficiency-based StePwise Endovascular Curricular Training) training has been integrated into the training of surgical residents to teach basic cognitive, technical and non-technical endovascular skills. The program uses virtual reality simulation and E-learning. During the four modules of the program, formative feedback is given after each training session. Only after achieving a predetermined benchmark score, trainees can progress to the next module. Surgical trainees completing PROSPECT showed superior real live endovascular performance compared to the traditionally trained in a single centre randomised controlled trial (RCT). The curriculum was integrated locally, but also introduced in other centers: national and international. Local tutors teach the curriculum to trainees after standardized training on the modalities of PROSPECT by the researchers of the Ghent. A registry is maintained and coordinated by the Ghent research group in which all educational data regarding this training is collected and processed anonymously.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date October 1, 2027
Est. primary completion date October 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Surgical trainee - Knowledge and technical skill level evaluated - Demographics questionnaire and general MCQ test completed - Endovascular simulated exercise completed after familiarization with the simulator Exclusion Criteria: - N/A

Study Design


Related Conditions & MeSH terms


Intervention

Other:
PROSPECT
PROficiency Based StePwise Endovascular Curricular Training

Locations

Country Name City State
Belgium University Hospital Ghent Ghent
Belgium KU Leuven Leuven
Denmark CAMES Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Countries where clinical trial is conducted

Belgium,  Denmark, 

References & Publications (2)

Soenens G, Lawaetz J, Bamelis AS, Nayahangan LJ, Konge L, Eiberg J, Van Herzeele I. International Implementation of a PROficiency based StePwise Endovascular Curricular Training (PROSPECT) in Daily Practice. Eur J Vasc Endovasc Surg. 2021 Dec;62(6):992-998. doi: 10.1016/j.ejvs.2021.09.029. Epub 2021 Nov 12. — View Citation

Soenens G, Lawaetz J, Doyen B, Fourneau I, Moreels N, Konge L, Eiberg J, Van Herzeele I. Massed Training is Logistically Superior to Distributed Training in Acquiring Basic Endovascular Skills. Eur J Vasc Endovasc Surg. 2023 Nov;66(5):730-737. doi: 10.101 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive skills Multiple Choice Question test (min: 0, max: 20, the higher the score, the better) comparison before program start and after completion. This means through study completion.
Primary Technical skills Rating scale assessment and simulator metrics comparison before program start and after completion. This means through study completion.
Secondary Cognitive skills retention Multiple Choice Question test (min: 0, max: 20, the higher the score, the better) 3, 6 and 12 months after program completion
Secondary Technical skills retention Rating scale assessment and simulator metrics 3, 6 and 12 months after program completion
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