Advanced Suturing SkillsNCT04425499
A Gamified Network for Surgical Education During COVID-19: A Randomized Controlled Trial
A study testing Learning running subcuticular sutures on the Gamified Educational Network in people with Advanced Suturing Skills and Surgical Education, run by Université de Montréal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Suturing Skills, Surgical Education
- What is being tested?
- Learning running subcuticular sutures on the Gamified Educational Network
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Jun 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Students must be enrolled in their first year of medical school at Université de Montréal.
Who cannot join
- 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.
About this study
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.
Read more
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.
- Conditions
- Advanced Suturing Skills, Surgical Education
- Being tested
- Learning running subcuticular sutures on the Gamified Educational Network
- Keywords
- Running subcuticular sutures, Surgical education, Advanced suturing skills, Distant learning, Peer-learning, Network
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning running subcuticular sutures on the Gamified Educational NetworkOther
Each arm will have 15 participants who will learn how to perform running subcuticular sutures through videos on GEN.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | On GEN (Gamified Educational Network), each student will view individually eight videos of an expert performing a running subcuticular suture correctly. The OSATS (Objective Structured Assessment of Technical Skills) Global Rating Scale (GRS) and Subcuticular Suture Checklist will be available beside each video and students will be required to fill them out for each video. For three days, students will have access to a distinct set of videos on GEN to learn running subcuticular sutures. Three days later, students will view the same eight videos of an expert performing a running subcuticular suture, however, the videos will be shuffled in a different order. The order of the videos will be the same for all students. Receives: Other: Learning running subcuticular sutures on the Gamified Educational Network |
| Self-learning | Experimental | Each student will view eight videos individually and complete the GRS and Subcuticular Suture Checklist for each video. Six videos will contain errors and two videos will not. The errors will be technical mistakes in the execution of a running subcuticular suture. For three days, students will have access to a distinct set of videos on GEN to learn running subcuticular sutures. Three days later, all students will repeat this activity. However, the same videos will be shuffled in a different order. The order of the videos will be the same for all students. Receives: Other: Learning running subcuticular sutures on the Gamified Educational Network |
| Peer-learning | Experimental | Each student will view eight videos and complete the GRS and Subcuticular Suture Checklist for each video. Six videos will contain errors and two videos will not. After this initial test, students will interact with other medical students in their group on the GEN platform anonymously for three days. We will display distinct videos on GEN. Comments will be allowed in an interactive way to encourage exchanges. Students will be required to participate in the discussion of at least two videos. Students will not be able to modify their answers on the initial test. On the third day, students in this group will perform a post-test individually with the same eight initial videos but shuffled. The order of the videos will be the same for all students. Receives: Other: Learning running subcuticular sutures on the Gamified Educational Network |
| Peer-learning with expert feedback | Experimental | Same as group 3, the only difference is that an expert will actively participate in the discussion by commenting on each video on GEN, enhancing students' educational experience. Although anonymous, students will be able to identify the expert as the name "expert" will be used. The expert will answer any question and comment on the discussion in order to guide the students. Receives: Other: Learning running subcuticular sutures on the Gamified Educational Network |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of the correct technique for running subcuticular sutures
The Global Rating Scale and Subcuticular Suture Checklist will be used to measure
Measured: three days
Secondary outcomes (2)
Technical ability to perform a subcuticular suture
The Global Rating Scale and Subcuticular Suture Checklist will be used to assess students' skills
Measured: half a day
Satisfaction with the GEN platform
A survey will be sent to students
Measured: five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Suturing SkillsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Érica Patocskai, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425499
- Sponsor's protocol ID
- CERSES 20-068-D
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guerard-Poirier N, Meloche-Dumas L, Beniey M, Torres A, Kapralos B, Dhane M, Mercier F, Younan R, Dubrowski A, Patocskai E. The exploration of remote simulation strategies for the acquisition of psychomotor skills in medicine: a pilot randomized controlled trial. Discov Educ. 2023;2(1):19. doi: 10.1007/s44217-023-00041-2. Epub 2023 Jul 17.
PubMed 37469757Guerard-Poirier N, Beniey M, Meloche-Dumas L, Lebel-Guay F, Misheva B, Abbas M, Dhane M, Elraheb M, Dubrowski A, Patocskai E. An Educational Network for Surgical Education Supported by Gamification Elements: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Dec 14;9(12):e21273. doi: 10.2196/21273.
PubMed 33284780
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Gamified Network for Surgical Education During COVID-19: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04425499
- Acronym / sponsor ID
- CERSES 20-068-D
- Conditions
- Advanced Suturing Skills, Surgical Education
- Keywords
- Running subcuticular sutures, Surgical education, Advanced suturing skills, Distant learning, Peer-learning, Network
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 11 Jun 2020 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Learning running subcuticular sutures on the Gamified Educational NetworkOn GEN (Gamified Educational Network), each student will view individually eight videos of an expert performing a running subcuticular suture correctly. The OSATS (Objective Structured Assessment of Technical Skills) Global Rating Scale (GRS) and Subcuticular Suture Checklist will be available beside each video and students will be required to fill them out for each video. For three days, students will have access to a distinct set of videos on GEN to learn running subcuticular sutures. Three days later, students will view the same eight videos of an expert performing a running subcuticular suture, however, the videos will be shuffled in a different order. The order of the videos will be the same for all students. |
| Self-learning | Experimental | Other: Learning running subcuticular sutures on the Gamified Educational NetworkEach student will view eight videos individually and complete the GRS and Subcuticular Suture Checklist for each video. Six videos will contain errors and two videos will not. The errors will be technical mistakes in the execution of a running subcuticular suture. For three days, students will have access to a distinct set of videos on GEN to learn running subcuticular sutures. Three days later, all students will repeat this activity. However, the same videos will be shuffled in a different order. The order of the videos will be the same for all students. |
| Peer-learning | Experimental | Other: Learning running subcuticular sutures on the Gamified Educational NetworkEach student will view eight videos and complete the GRS and Subcuticular Suture Checklist for each video. Six videos will contain errors and two videos will not. After this initial test, students will interact with other medical students in their group on the GEN platform anonymously for three days. We will display distinct videos on GEN. Comments will be allowed in an interactive way to encourage exchanges. Students will be required to participate in the discussion of at least two videos. Students will not be able to modify their answers on the initial test. On the third day, students in this group will perform a post-test individually with the same eight initial videos but shuffled. The order of the videos will be the same for all students. |
| Peer-learning with expert feedback | Experimental | Other: Learning running subcuticular sutures on the Gamified Educational NetworkSame as group 3, the only difference is that an expert will actively participate in the discussion by commenting on each video on GEN, enhancing students' educational experience. Although anonymous, students will be able to identify the expert as the name "expert" will be used. The expert will answer any question and comment on the discussion in order to guide the students. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Students must be enrolled in their first year of medical school at Université de Montréal.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Learning running subcuticular sutures on the Gamified Educational NetworkEach arm will have 15 participants who will learn how to perform running subcuticular sutures through videos on GEN. | Other | Control group, Peer-learning, Peer-learning with expert feedback, Self-learning |
Primary outcome
Retention of the correct technique for running subcuticular sutures
Time frame: three days
The Global Rating Scale and Subcuticular Suture Checklist will be used to measure
2 secondary outcomes
Technical ability to perform a subcuticular suture
Time frame: half a day
Satisfaction with the GEN platform
Time frame: five minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 37469757Guerard-Poirier N, Meloche-Dumas L, Beniey M, Torres A, Kapralos B, Dhane M, Mercier F, Younan R, Dubrowski A, Patocskai E. The exploration of remote simulation strategies for the acquisition of psychomotor skills in medicine: a pilot randomized controlled trial. Discov Educ. 2023;2(1):19. doi: 10.1007/s44217-023-00041-2. Epub 2023 Jul 17.
- Derived from this study: PubMed 33284780Guerard-Poirier N, Beniey M, Meloche-Dumas L, Lebel-Guay F, Misheva B, Abbas M, Dhane M, Elraheb M, Dubrowski A, Patocskai E. An Educational Network for Surgical Education Supported by Gamification Elements: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Dec 14;9(12):e21273. doi: 10.2196/21273.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Learning running subcuticular sutures on the Gamified Educational Network in people with Advanced Suturing Skills and Surgical Education, run by Université de Montréal.
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 1 inclusion and 4 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 2020. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of the correct technique for running subcuticular sutures (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04425499, which also lists 2 linked publications.
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 2020.