- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06524297
The Training of Resident Surgeons in Single-Port Thoracoscopic Surgery Wound Position Selection (OpVerse)
The Role of a Metaverse Surgical Simulation System in Guiding Incision Site Selection for Uniportal Video-Assisted Thoracoscopic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The evolution of single-port thoracoscopic surgery, due to advancements in instrumentation and video technology, has seen a leap in progress since the 2010s.
Today, single-port thoracoscopic surgery has become the mainstream at NTU Thoracic Surgery, capable of performing simple wedge resections or complex pneumonectomies. Single-port thoracoscopic surgery, using only a single wound, aids patients in quickly regaining their preoperative normal life functions, with further reductions in pain. However, its learning curve is steep, with the appropriate choice of wound location being one of the most important thresholds for resident physicians to master this technique. Currently, NTU Surgery and the Media Lab have jointly developed a metaverse surgical simulation platform (OpVerse), creating digital twin organ models through 3D reconstruction software and modeling engines. In mixed reality, including lesion location and anatomical variations, are no different from specific real patients. Users can view and operate CT images and 3D models arbitrarily, mark important structural positions and directions, and measure distances with an XR helmet. The model can also be cross-referenced with CT through cross-sectional positioning. The investigators set up a thoracoscopic simulation lens in the system, superimposing the digital twin model on the patient on the operating table, and using the CT cross-section comparison function in the metaverse system to find the lesion location, resident physicians can repeatedly simulate the wound position through the system, and mark the expected entry wound position on the patient through virtual reality overlay. This project plans to conduct a randomized trial to explore the effectiveness of the metaverse system applied to the training of wound location selection for singleport thoracoscopic surgery. The experimental design is two groups of 40 computer tomography located superficially less than 2 cm lung nodule patients, one group uses the metaverse system to let resident physicians simulate the wound position on the digital twin organs of each patient, and the other group does not use it. The investigators will evaluate the surgeon's satisfaction with the surgical wound position and surgical related results (such as surgery time, blood loss, etc.).
The investigators expect that the system will help improve the appropriateness of resident physicians' choice of wound location for high-difficulty single-port thoracoscopic surgery, help them cross the first threshold necessary to familiarize themselves with the surgery faster, and accelerate learning.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chiang
- Phone Number: +886972655136
- Email: lycansblueray@gmail.com
Study Contact Backup
- Name: Chiang
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 years or older.
- Diagnosed with a lung nodule no larger than 2cm in diameter. The lesion depth must be located within the outer third of the lung.
- Scheduled to undergo computer tomography-guided single-port thoracoscopic wedge resection at National Taiwan University Hospital (NTUH) or National Taiwan Cancer Center (NTUCC).
- Participants who have provided written informed consent for their imaging data to be used by the team to create digital twin models.
Exclusion Criteria:
- Patients with lesions larger than 2 cm.
- Patients not planned for single-port thoracoscopic wedge resection with computed tomography localization.
- Patients who have not provided written consent.
- Members of vulnerable populations.
Inclusion Criteria (Resident Physician):
- Third-year to fifth-year residents in the Department of Thoracic Surgery at National Taiwan University Hospital.
Exclusion Criteria (Resident Physician):
- Residents who are unwilling to participate in the study and decline to sign the consent form.
- Residents with a history of cybersickness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Metaverse system
Residents use the Metaverse system before surgery to simulate wound closure locations on digital twin organs of the patient.
|
The experimental group will undergo preoperative training using the metaverse surgical simulation system for 15 minutes before selecting the surgical incision site (this refers to residents receiving the assisted training).
The trial process requires participants' consent to provide high-resolution CT images as the basis for reconstructing digital twin organs.
Except for the intervention training, the surgery, postoperative care, follow-up, and other treatment processes the participants receive will be the same as those for typical patients.
The participants (residents) will receive 15 minutes of preoperative training using the Metaverse surgical simulation system.
They will superimpose the digital twin model onto the patient on the operating table and use the CT cross-sectional matching function within the Metaverse system to locate the lesion.
The participants (residents) can use the system to repeatedly simulate incision sites and mark planned entry points on the patient by overlaying the virtual model onto the real patient.
Except for the intervention training with the system, the subsequent surgery, postoperative care, follow-up, and other treatment processes the patients receive will be the same as usual.
|
|
No Intervention: Crontrol group
The control group do not use the Metaverse system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operation time
Time Frame: 24 hours
|
Compare the length of operation time between the experimental group (trained using the Metaverse surgical simulation system for 15 minutes pre-operatively) and the control group.
This analysis will assess whether pre-operative simulation training reduces operation time for residents.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction Questionnaire for Attending Physicians
Time Frame: Through study completion, an average of 1 year.
|
To improve the residents selection of wound locations during single-port thoracoscopic surgery, the attending physician will complete a post-operative questionnaire regarding the residents' pre-operative simulation training.
|
Through study completion, an average of 1 year.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Xu-Heng Chiang, MD, Department of Surgery, National Taiwain University Hospital
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
Keywords
Other Study ID Numbers
- 202407156RINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Surgical Education
-
Nordlandssykehuset HFOlympusNot yet recruitingSurgical Education | Surgical TelementoringNorway
-
Mayo ClinicEnrolling by invitation
-
McGill UniversityCompletedSurgical EducationCanada
-
University of Missouri, Kansas CityWithdrawnSurgical Education
-
McGill UniversityNot yet recruitingSurgical EducationCanada
-
Sunnybrook Health Sciences CentreSunnybrook Research InstituteNot yet recruiting
-
McGill UniversityCompletedSurgical EducationCanada
-
Unity Health TorontoCompletedSurgical EducationCanada
-
McGill UniversityRecruitingSurgical EducationCanada
-
McGill UniversityCompletedSurgical EducationCanada
Clinical Trials on Metaverse system (Patients)
-
Suleyman Demirel UniversityNot yet recruitingNursing Education | Intramuscular Injection | Metaverse
-
Qu ShenNot yet recruiting
-
Suleyman Demirel UniversityCompleted
-
Suleyman Demirel UniversityCompleted
-
Baskent UniversityRecruitingNursing Education | Gamification | Patient Safety | Mixed Method Implementation StudyTurkey (Türkiye)
-
Qu ShenThe First Affiliated Hospital of Xiamen UniversityRecruiting
-
Ewha Womans UniversityCompletedDepression and Suicide IdeationKorea, Republic of
-
Baskent UniversityRecruitingNursing Education | Gamification | Self-Efficacy | Pressure Ulcers, Bedsores, Decubitus UlcerTurkey (Türkiye)
-
Port Said UniversityNot yet recruiting
-
University of BucharestRecruitingMental Health Wellness 1 | Well-Being, PsychologicalRomania