NCT07268950

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Jan 2026May 2027

First Submitted

Initial submission to the registry

November 25, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

December 8, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 25, 2025

Last Update Submit

November 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (pre-training) and immediately after completion of the training program (within 1 week)

Study Arms (1)

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.

Behavioral: Structured Simulation-Based Surgical Training

Interventions

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.

Also known as: Component-Based Laparoscopic-Thoracoscopic Training, Simulation Skills Curriculum
Structured Simulation Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University Medical Faculty, Department of Thoracic Surgery

Samsun, Samsun, 55139, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 8, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

December 8, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Locations