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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04425499
Other study ID # CERSES 20-068-D
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2020
Est. completion date June 2020

Study information

Verified date June 2020
Source Université de Montréal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Traditionally, medical students learn surgical skills through the observation of a resident or a surgeon performing the technique. Due to inconsistent practice opportunities in the clinical setting, a disparity of skill levels among students has been observed. In addition, the poor availability of faculty professors is a limiting factor in teaching and adequately preparing medical students for clerkship years. With the ongoing COVID-19 pandemic, medical students do not have access to traditional suturing learning opportunities. Didactic courses are available on videoconferencing platforms, but they do not include technical training.

Objective: Our overarching goal is to evaluate the efficacy of web-based peer-learning for advanced suturing techniques (i.e., running subcuticular sutures). The investigators will use GEN (Gamified Educational Network), a newly developed online learning tool. The investigators will assess students' ability to identify and to perform the right technique. The investigators will also assess students' satisfaction with regards to GEN.

Methods: The investigators will conduct a prospective randomized controlled trial with blinding of expert examiners. First-year medical students in the Faculty of Medicine of Université de Montréal will be randomized to four groups: 1) control group, 2) self-learning, 3) peer-learning, and 4) peer-learning with expert feedback. Each arm will have 15 participants who will learn how to perform running subcuticular sutures through videos on GEN. For our primary outcome, students' ability to identify the right technique will be evaluated before and after the intervention on GEN. They will view eight videos and rate the surgical technique using the OSATS (Objective Structured Assessment of Technical Skills) Global Rating Scale (GRS) and the Subcuticular Suture Checklist as evaluation criteria. For our secondary outcomes, students will anonymously record themselves performing a running subcuticular suture and will be evaluated using the same scales. Then, a survey will be sent to analyze the overall performance of the platform.

Results: The study will be conducted in accordance with the Declaration of Helsinki and has been approved by our institutional review board (CERSES 20-068-D). No participants have been recruited yet.

Conclusions: Peer-learning through GEN has the potential to overcome significant limitations related to the pandemic and the lack of availability of faculty professors. Further, a decrease of the anxiety related to traditional suturing classes can be expected. The investigators aim to create an innovative and sustainable method of teaching surgical skills to improve the efficiency and the quality of surgical training in medical faculties. With the current world events of COVID-19, the necessity for such tools are imperative.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Students must be enrolled in their first year of medical school at Université de Montréal.

Exclusion Criteria:

- Students who have returned after a leave such as a sabbatical year/sick leave/maternity leave.

- Students who have already obtained a medical degree in another country.

- Students who studied medicine in another country.

- Any student injured at the beginning of the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Learning running subcuticular sutures on the Gamified Educational Network
Each arm will have 15 participants who will learn how to perform running subcuticular sutures through videos on GEN.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Université de Montréal

Outcome

Type Measure Description Time frame Safety issue
Primary Retention of the correct technique for running subcuticular sutures The Global Rating Scale and Subcuticular Suture Checklist will be used to measure three days
Secondary Technical ability to perform a subcuticular suture The Global Rating Scale and Subcuticular Suture Checklist will be used to assess students' skills half a day
Secondary Satisfaction with the GEN platform A survey will be sent to students five minutes
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