The Impact of Immersive Virtual Reality Training in Thyroid Surgery

NCT06917755 | Recruiting

• 1 other identifier: 17010/2910-2024
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Virtual Reality Simulation; Thyroid Surgery

Keywords

Endocrine Surgery; Thyroid Surgery; Virtual Reality; Training

Outcome Measures

Primary Outcomes (1)

• OSATS Score

  As the Primary Outcome Measure of the study will be the OSATS(Objective Structured Assessment of Technical Skills) score of participants in each group. Statistical significance of this score between groups will be measured.OSATS is a worlwide tool which measure surgical performance using 7 measurements and scoring system from 7 to 35. Its main advantage is that can measure with a quantitative manner surgical performance.

  From enrollment to the end of assesment of the FEBS certicied surgeon at 1 day

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Other: Convetional Training

Virtual Reality Group

EXPERIMENTAL

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.

Other: Virtual Reality Training in Thyroid Surgery

Interventions

Virtual Reality Training in Thyroid Surgery 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.

Virtual Reality Group

Convetional Training 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.

Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• G.Gennimatas General Hospital: lead

Study Sites (1)

"Georgios Gennimatas" General Hospital of Thessaloniki

Thessaloniki, 54635, Greece

RECRUITING

Related Publications (13)

• 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.

  PMID: 38375774 BACKGROUND

• 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.

  PMID: 32386709 BACKGROUND

• 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.

  PMID: 36764847 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 34542639 BACKGROUND

• 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.

  PMID: 31867864 BACKGROUND

• 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.

  PMID: 31972694 BACKGROUND

• 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.

  PMID: 33369660 BACKGROUND

• 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 Dec;77(8):2535-2543. doi: 10.1007/s13304-025-02387-8. Epub 2025 Aug 29.

  PMID: 40879873 DERIVED

Study Officials

• Ioannis Koutelidakis, Professor of Surgery

  2nd Surgical Department of Aristotle University of Thessaloniki

  STUDY DIRECTOR

Central Study Contacts

Stefanos Atmatzidis, Assistant Professor of Surgery

CONTACT

+306977095756; atmatzidis.stef@gmail.com

Nikolaos Voloudakis, Academic Fellow

CONTACT

+306947200452; nickvolou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anestis Basios

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: February 20, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The start date is from enrollment date and end date until study completion

Locations

GR (1)