Surgical EducationNCT07268950
Structured Simulation Training for Laparoscopic and Thoracoscopic Skills in Thoracic Surgery Residents
A study testing Structured Simulation-Based Surgical Training in people with Surgical Education and Simulation-based Training, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Education, Simulation-based Training, Resident Training
- What is being tested?
- Structured Simulation-Based Surgical Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University Medical Faculty, Department of Thoracic Surgery
Samsun, Samsun, 55139
About this study
Official title: 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.
- Being tested
- Structured Simulation-Based Surgical Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Simulation-Based Surgical TrainingBehavioural
Also called Component-Based Laparoscopic-Thoracoscopic Training, Simulation Skills Curriculum
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.
| Study group | Role | What they receive |
|---|---|---|
| Structured Simulation Training | Experimental | 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. Receives: Behavioral: Structured Simulation-Based Surgical Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total OSATS Score
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.
Measured: Baseline (pre-training) and immediately after completion of the training program (within 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical EducationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will receive a structured simulation-based training program consisting of standardized laparoscopic and thoracoscopic skill modules. All participants complete pre-training and post-training assessments using the same protocol.
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner İşevi, MD, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268950
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/498
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the sample size is small and performance videos, OSATS scores, and survey results may allow indirect identification of surgical trainees. Data are collected solely for educational and research purposes within a single institution and will be stored securely according to ethics committee requirements. Only aggregated and de-identified results will be reported in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Simulation-Based Training to Develop Laparoscopic and Thoracoscopic Skills in Thoracic Surgery and Rotating Surgical Residents: A Component-Based Educational Model
- ClinicalTrials.gov ID
- NCT07268950
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/498
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 8 Dec 2025 (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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will receive a structured simulation-based training program consisting of standardized laparoscopic and thoracoscopic skill modules. All participants complete pre-training and post-training assessments using the same protocol.
| Arm | Type | Receives |
|---|---|---|
| Structured Simulation Training | Experimental | Behavioral: Structured Simulation-Based Surgical TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Structured Simulation-Based Surgical TrainingAlso: Component-Based Laparoscopic-Thoracoscopic Training, Simulation Skills CurriculumParticipants 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. | Behavioural | Structured Simulation Training |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the sample size is small and performance videos, OSATS scores, and survey results may allow indirect identification of surgical trainees. Data are collected solely for educational and research purposes within a single institution and will be stored securely according to ethics committee requirements. Only aggregated and de-identified results will be reported in publications and presentations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Simulation-Based Surgical Training in people with Surgical Education and Simulation-based Training, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Total OSATS Score (time frame: Baseline (pre-training) and immediately after completion of the training program (within 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.