- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07533214
Impact of Left-Handed Tailored Endoscopic Mitral Simulation Training on Skill Acquisition for Left-handed Surgeons
Study Characteristics and Structure are as follows:
All Left-handed cardiac surgeons and residents attending the 2024 EACTS annual meeting (october 2024) are invited to any of the 3-day 8-endoscopic sessions as part of this study trial. The Left-handed cardiac surgeons and residents may participte in any of the sessions which best fits their schedule. Time frame includes all three days of endoscopic simulation sessions as walk-ins according to the availability of each surgeon. The exclusion criteria will be experienced endoscopic left-handed surgeons who are already experts. Left-handed surgeons will be randomized to either the standard right-handed guided simulation training session or to a Left-handed tailored simulation session.
Study Intervention: Left-handed surgeons and residents will be randomized to either a 2-hour Left-handed tailored-guided session (Group 1) or a standard right-handed guided 2-hour endoscopic simulation training session (Group 2).
Setting: EACTS 2024 annual meeting (october 2024 - 3-day convention)
Group 1 will be guided by a left-handed intructor using Left-handed endoscopic suture maps Group 2 will be guided by a right-handed intructor using Standard right-handed suture maps
Pre-course tests will evaluate accuracy and time of endoscopic suture placement in comparison to post-course tests to assess improvements. Pre-session assessments will be carried out evaluating endoscopic suture placement accuracy and time to suture placement. These include:
- Time to suture placement under <60 seconds
- Accuracy of suture placement considered to be between 2-8 mm
- Suture placement locations will be both Anterior and Posterior annular placements
Post-skills sessions assessment: finalizing the 2-hour workshop the participants will be asked to repeat both the anterior and posterior annular endoscopic suture placement.
Final study evaluations and delta time comparisons will be performed to determine if Left-handed surgeons guided by left-handed surgeons outperform or at least fair better then when guided by right-handed instructors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Determine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors.
Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training.
We hypothesize that the pairing of same dexterity tailored training will improve endoscopic skill performance.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Portugal, Portugal
- EACTS ANNUAL MEETING AT Lisbon convention center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Left handed cardiac surgeons and residents
Exclusion Criteria:
- experienced endoscopic left handed surgeons
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Left-handed surgeons with left-handed instructors
Determine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors.
|
Endoscopic suture placement efficiency guided by left hamded instructors
|
|
No Intervention: Left-handed surgeons with right-handed instructor
Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delta time difference of suture placement
Time Frame: From the randomisation (start of the training) to the end of two-hours training
|
Final study evaluations and delta time comparisons will be performed to determine if Left-handed surgeons guided by left-handed surgeons outperform or at least fair better then when guided by right-handed instructors. Study Objectives: Determine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors. Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training. We hypothesize that the pairing of same dexterity tailored training will improve endoscopic skill performance. |
From the randomisation (start of the training) to the end of two-hours training
|
|
improvement in seconds taken to perform mitral suturing
Time Frame: this will be performed during a two hour course
|
time duration it takes to successfully place mitral annular sutures on simulators
|
this will be performed during a two hour course
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024-0391
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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