- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07268950
Structured Simulation Training for Laparoscopic and Thoracoscopic Skills in Thoracic Surgery Residents
Structured Simulation-Based Training to Develop Laparoscopic and Thoracoscopic Skills in Thoracic Surgery and Rotating Surgical Residents: A Component-Based Educational Model
This study aims to improve basic laparoscopic and thoracoscopic skills in thoracic surgery residents and rotating surgical residents through a structured simulation-based training program. Participants will complete hands-on practice sessions using box trainers, artificial models, and bovine tissues in a controlled, non-patient setting.
Before and after the training, participants will complete self-assessment surveys and a standardized technical skills evaluation (OSATS). The study will compare these results to measure changes in technical performance, confidence, and learning needs. No real patients, live animals, or clinical procedures are involved, and there are no expected medical risks.
The goal of this study is to determine whether structured simulation training is effective, practical, and acceptable for surgical education, and whether it can support safer transition to real operating room experience in the future.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Samsun
-
Samsun, Samsun, Turkey (Türkiye), 55139
- Ondokuz Mayis University Medical Faculty, Department of Thoracic Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Thoracic surgery residents OR rotating general surgery/cardiovascular surgery residents
- Age ≥18 years
- Actively enrolled in an accredited residency training program
- Willingness to participate in hands-on simulation training
- Ability to provide informed consent
- Able to complete video-recorded performance assessments
Exclusion Criteria:
- Prior advanced laparoscopic or thoracoscopic fellowship training
- Inability to safely handle surgical instruments (e.g., significant musculoskeletal limitation)
- Previous participation in a similar structured simulation program within the past 12 months
- Declines consent or withdraws participation
- Unable to attend required training and assessment sessions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Structured Simulation Training
Participants will undergo a standardized simulation-based training program designed to develop laparoscopic and thoracoscopic technical skills.
Training includes camera navigation, tissue dissection, stapling, and suturing tasks performed on box trainers, artificial models, and bovine tissues in a controlled laboratory setting.
All participants complete baseline (pre-training) and post-training evaluations using OSATS scoring, self-assessment surveys, and performance timing.
No clinical procedures, live animals, or patient interactions occur during the study.
|
Participants will complete a structured simulation-based training curriculum designed to improve fundamental laparoscopic and thoracoscopic surgical skills.
The program includes standardized modules on camera navigation, tissue handling, dissection, stapling, and suturing, performed on box trainers, artificial models, and bovine tissues.
Training occurs in a controlled laboratory environment with faculty supervision and predefined performance goals.
No real patients, clinical procedures, or live animals are involved.
All participants undergo pre- and post-training performance assessment using OSATS scoring, task completion time, and self-evaluation surveys.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Total OSATS Score
Time Frame: Baseline (pre-training) and immediately after completion of the training program (within 1 week)
|
Technical skill performance will be assessed using the Objective Structured Assessment of Technical Skills (OSATS), consisting of a global rating scale and task-specific checklist (total score range 0-35).
Each participant will complete the same standardized tasks before and after the simulation training.
The primary outcome is the within-subject change (post-training minus pre-training) in total OSATS score.
|
Baseline (pre-training) and immediately after completion of the training program (within 1 week)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
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
Other Study ID Numbers
- B.30.2.ODM.0.20.08/498
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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