The Impact of Immersive Virtual Reality Training in Thyroid Surgery
NCT ID: NCT06917755
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
12 participants
INTERVENTIONAL
2025-02-20
2025-05-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Residents who have completed their 1st year of training programm.
Exclusion Criteria
* 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
ALL
Yes
Sponsors
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G.Gennimatas General Hospital
OTHER
Responsible Party
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Anestis Basios
Principal Investigator, Anestis Basios
Principal Investigators
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Ioannis Koutelidakis, Professor of Surgery
Role: STUDY_DIRECTOR
2nd Surgical Department of Aristotle University of Thessaloniki
Locations
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"Georgios Gennimatas" General Hospital of Thessaloniki
Thessaloniki, , Greece
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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17010/2910-2024
Identifier Type: -
Identifier Source: org_study_id
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