A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy
NCT ID: NCT06225765
Last Updated: 2024-07-09
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
40 participants
INTERVENTIONAL
2024-07-01
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transoral endoscopic thyroidectomy vestibular approach (TOETVA)
Test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA)
Transoral endoscopic thyroidectomy vestibular approach (TOETVA)
Remote access thyroid surgery
Traditional open surgery
Control group receiving traditional open thyroidectomy
Traditional Open Thyroidectomy
Open thyroidectomy via trans-cervical approach
Interventions
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Transoral endoscopic thyroidectomy vestibular approach (TOETVA)
Remote access thyroid surgery
Traditional Open Thyroidectomy
Open thyroidectomy via trans-cervical approach
Eligibility Criteria
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Inclusion Criteria
* Suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery
Exclusion Criteria
* Contraindication to general anaesthesia
* Vulnerable population (e.g. Cognitive impairment, pregnant)
* Previous anterior neck surgery
* Previous radiotherapy at the head and neck region
* Malignant thyroid nodule \> 2cm
* Presence of another malignancy, lateral neck, or distant metastasis
* Retrosternal goitre
* Cervical spine disease precluding extension of the neck
* Obesity with BMI \> 35kg/m2
* Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
* Untreated active infection
* Non-correctable coagulopathy
* Emergency surgery
18 Years
ALL
No
Sponsors
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Tseung Kwan O Hospital, Hong Kong
OTHER
Responsible Party
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YEUNG WING CHI ZENON
Consultant, Department of Otorhinolaryngology, Head and Neck Surgery
Principal Investigators
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Jason YK Chan
Role: STUDY_DIRECTOR
Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
Zenon Yeung
Role: PRINCIPAL_INVESTIGATOR
Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
Locations
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Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KC/KE-23-0006/FR-4
Identifier Type: -
Identifier Source: org_study_id
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