The Impact of Immersive Virtual Reality Training in Thyroid Surgery

NCT ID: NCT06917755

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-20

Study Completion Date

2025-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Up to this date, there have been no reports on virtual reality (VR) training in thyroid surgery. The purpose of this study is to determine the impact of VR training in residents' education.

Investigators intend to include general surgery residents in the trial, subgrouped in a VR training group and another one with traditional learning, utilizing a technical textbook as a control. For the purpose of this study, a commercial available VR mask will be given for training in the VR group. Randomization will be used to secure balance in the distribution of residents according to their experience. The task which will be examined include surgical steps from neck incision up to the placement of the C-IONM electrode and will be evaluated by a blinded FEBS certified endocrine surgeon in the operating theatre.

Training superiority will be assessed by the outcome measures of Objective Structured Assessment of Technical Skills (OSATS) score, need for the main surgeon to intervene (NTI), verbal answers and time to task completion. Participants will complete questionnaires regarding satisfaction of the whole educational process.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Virtual Reality Simulation Thyroid Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

This group will be trained via traditional methods which consists of reading specific chapters of a technical book specialised in Endocrine Surgery (Atlas of Thyroid Surgery- Alexander Shifrin). Also, this group will be provided with videos of the clinic's archive which will support them with specific surgical steps : neck incision up to Continious Neuromonitoring Device placement on Vagus nerve.

Group Type ACTIVE_COMPARATOR

Convetional Training

Intervention Type OTHER

This intervation consists of traditional methods of training. Participants will read specific chapters of a technical book specialised in Endocrine Surgery (Atlas of Thyroid Surgery- Alexander Shifrin). Also, they will be provided with videos of the clinic's archive which will support them with specific surgical steps : neck incision up to Continious Neuromonitoring Device placement on Vagus nerve.

Virtual Reality Group

Participants of this group will be provided with a VR device- MetaQuest3- with an application which will guide them to completion of specific surgical steps from incision up to Continious Neuromonitoring Device placement on Vagus nerve.

Group Type EXPERIMENTAL

Virtual Reality Training in Thyroid Surgery

Intervention Type OTHER

Participants will use an application in an Immersive Virtual Reality environment. In this module, the participant will be the chief surgeon and will be guided to accomplise the first steps of thyroidectomy: from neck incision until continious neuromonitoring device placement in vagus nerve.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual Reality Training in Thyroid Surgery

Participants will use an application in an Immersive Virtual Reality environment. In this module, the participant will be the chief surgeon and will be guided to accomplise the first steps of thyroidectomy: from neck incision until continious neuromonitoring device placement in vagus nerve.

Intervention Type OTHER

Convetional Training

This intervation consists of traditional methods of training. Participants will read specific chapters of a technical book specialised in Endocrine Surgery (Atlas of Thyroid Surgery- Alexander Shifrin). Also, they will be provided with videos of the clinic's archive which will support them with specific surgical steps : neck incision up to Continious Neuromonitoring Device placement on Vagus nerve.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Residents of the 2nd Surgical Department of Aristotle University of Thessaloniki
* Residents who have completed their 1st year of training programm.

Exclusion Criteria

* Disagreement of participants' randomisation
* Prolonged surgical time of completion
* Participant's experience beyond the included limits
* Participants who are completely incapable of using VR devices or have specific helath restrictions of using these
* Patients with complex thyroid disease such as recurrent disease, concominant primary hyperparathyroidism, lymph node disease or metastasis, Graves disease and intrathoracic goiter
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

G.Gennimatas General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anestis Basios

Principal Investigator, Anestis Basios

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ioannis Koutelidakis, Professor of Surgery

Role: STUDY_DIRECTOR

2nd Surgical Department of Aristotle University of Thessaloniki

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

"Georgios Gennimatas" General Hospital of Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Greece

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stefanos Atmatzidis, Assistant Professor of Surgery

Role: CONTACT

+306977095756

Nikolaos Voloudakis, Academic Fellow

Role: CONTACT

+306947200452

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Giannis Koutelidakis, Professor of Surgery

Role: primary

+306944697077

References

Explore related publications, articles, or registry entries linked to this study.

Ochs V, Saad B, Taha-Mehlitz S, Staubli S, Neumann K, Fischer L, Honaker MD, Lamm S, Rosenberg R, Taha A, Cattin PC. An analysis of virtual reality in abdominal surgery-A scoping review. Int J Med Robot. 2024 Feb;20(1):e2623. doi: 10.1002/rcs.2623.

Reference Type BACKGROUND
PMID: 38375774 (View on PubMed)

Rizzetto F, Bernareggi A, Rantas S, Vanzulli A, Vertemati M. Immersive Virtual Reality in surgery and medical education: Diving into the future. Am J Surg. 2020 Oct;220(4):856-857. doi: 10.1016/j.amjsurg.2020.04.033. Epub 2020 Apr 30. No abstract available.

Reference Type BACKGROUND
PMID: 32386709 (View on PubMed)

Long AS, Almeida MN, Chong L, Prsic A. Live Virtual Surgery and Virtual Reality in Surgery: Potential Applications in Hand Surgery Education. J Hand Surg Am. 2023 May;48(5):499-505. doi: 10.1016/j.jhsa.2023.01.004. Epub 2023 Feb 9.

Reference Type BACKGROUND
PMID: 36764847 (View on PubMed)

Portelli M, Bianco SF, Bezzina T, Abela JE. Virtual reality training compared with apprenticeship training in laparoscopic surgery: a meta-analysis. Ann R Coll Surg Engl. 2020 Nov;102(9):672-684. doi: 10.1308/rcsann.2020.0178. Epub 2020 Aug 21.

Reference Type BACKGROUND
PMID: 32820649 (View on PubMed)

Nassar AK, Al-Manaseer F, Knowlton LM, Tuma F. Virtual reality (VR) as a simulation modality for technical skills acquisition. Ann Med Surg (Lond). 2021 Oct 27;71:102945. doi: 10.1016/j.amsu.2021.102945. eCollection 2021 Nov.

Reference Type BACKGROUND
PMID: 34840738 (View on PubMed)

Ntakakis G, Plomariti C, Frantzidis C, Antoniou PE, Bamidis PD, Tsoulfas G. Exploring the use of virtual reality in surgical education. World J Transplant. 2023 Feb 18;13(2):36-43. doi: 10.5500/wjt.v13.i2.36.

Reference Type BACKGROUND
PMID: 36908307 (View on PubMed)

Mishra R, Narayanan MDK, Umana GE, Montemurro N, Chaurasia B, Deora H. Virtual Reality in Neurosurgery: Beyond Neurosurgical Planning. Int J Environ Res Public Health. 2022 Feb 2;19(3):1719. doi: 10.3390/ijerph19031719.

Reference Type BACKGROUND
PMID: 35162742 (View on PubMed)

Falguiere A, LeGruiec C, Herry H, Genest-Beucher S, Dessus JM, Boisrame S. Contribution of virtual reality in oral surgery: A literature review. J Stomatol Oral Maxillofac Surg. 2021 Sep;122(4):405-410. doi: 10.1016/j.jormas.2021.02.004. Epub 2021 Feb 18.

Reference Type BACKGROUND
PMID: 33610770 (View on PubMed)

Arjomandi Rad A, Vardanyan R, Thavarajasingam SG, Zubarevich A, Van den Eynde J, Sa MPBO, Zhigalov K, Sardiari Nia P, Ruhparwar A, Weymann A. Extended, virtual and augmented reality in thoracic surgery: a systematic review. Interact Cardiovasc Thorac Surg. 2022 Jan 18;34(2):201-211. doi: 10.1093/icvts/ivab241.

Reference Type BACKGROUND
PMID: 34542639 (View on PubMed)

Verhey JT, Haglin JM, Verhey EM, Hartigan DE. Virtual, augmented, and mixed reality applications in orthopedic surgery. Int J Med Robot. 2020 Apr;16(2):e2067. doi: 10.1002/rcs.2067. Epub 2020 Feb 6.

Reference Type BACKGROUND
PMID: 31867864 (View on PubMed)

Lohre R, Bois AJ, Athwal GS, Goel DP; Canadian Shoulder and Elbow Society (CSES). Improved Complex Skill Acquisition by Immersive Virtual Reality Training: A Randomized Controlled Trial. J Bone Joint Surg Am. 2020 Mar 18;102(6):e26. doi: 10.2106/JBJS.19.00982.

Reference Type BACKGROUND
PMID: 31972694 (View on PubMed)

Lohre R, Bois AJ, Pollock JW, Lapner P, McIlquham K, Athwal GS, Goel DP. Effectiveness of Immersive Virtual Reality on Orthopedic Surgical Skills and Knowledge Acquisition Among Senior Surgical Residents: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2031217. doi: 10.1001/jamanetworkopen.2020.31217.

Reference Type BACKGROUND
PMID: 33369660 (View on PubMed)

Basios A, Voloudakis N, Atmatzidis S, Velikoudi M, Bellou E, Vamvakidis K, Papaziogas B, Koutelidakis I. The impact of immersive virtual reality training in thyroid surgery: a prospective randomized controlled trial. Updates Surg. 2025 Aug 29. doi: 10.1007/s13304-025-02387-8. Online ahead of print.

Reference Type DERIVED
PMID: 40879873 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17010/2910-2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.