The Impact of Immersive Virtual Reality Training in Thyroid Surgery

Официальное название

The Impact of Immersive Virtual Reality Training in Thyroid Surgery: A Prospective Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• OSATS Score [Срок оценки: From enrollment to the end of assesment of the FEBS certicied surgeon at 1 day]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Греция · 1 центр

• "Georgios Gennimatas" General Hospital of Thessaloniki — Thessaloniki

Публикации

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• 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. PMID 32820649
• 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. PMID 34840738
• 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. PMID 36908307
• 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. PMID 35162742
• 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. PMID 33610770

Идентификаторы

NCT: NCT06917755 · 17010/2910-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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