A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy
1 other identifier
interventional
40
1 country
1
Brief Summary
To determine if transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a safe and effective procedure compared to traditional open thyroidectomy. Surgical outcomes, patients' satisfaction, voice and swallowing outcomes will be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2024
CompletedFirst Posted
Study publicly available on registry
January 26, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
July 9, 2024
July 1, 2024
2 years
January 9, 2024
July 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Patient's satisfactory score
Visual analogue scale 0-10
Post-operative day 1
Patient's satisfactory score
Visual analogue scale 0-10
Post-operative 2 weeks
Patient's satisfactory score
Visual analogue scale 0-10
Post-operative 6 months
Post-operative pain
Visual analogue scale 0-10
Post-operative day 1
Post-operative pain
Visual analogue scale 0-10
Post-operative 2 weeks
Post-operative pain
Visual analogue scale 0-10
Post-operative 6 months
Voice quality of life
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Post-operative day 1
Voice quality of life
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Post-operative 2 weeks
Voice quality of life
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Post-operative 6 months
Swallowing quality of life
MD Anderson dysphagia inventory (MDADI)
Post-operative day 1
Swallowing quality of life
MD Anderson dysphagia inventory (MDADI)
Post-operative 2 weeks
Swallowing quality of life
MD Anderson dysphagia inventory (MDADI)
Post-operative 6 months
Complication rate and types
Lower lip numbness, skin bruising or injury, wound infection, vocal cord paralysis, temporary hypoparathyroidism
Post-operative 2 weeks
Complication rate and types
Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism
Post-operative 6 months
Secondary Outcomes (4)
Inpatient stay
An average of 0-2 days after the operation
Operative time
Intra-operatively
Blood loss
Intra-operatively
Rate of conversion to open surgery
Intra-operatively
Study Arms (2)
Transoral endoscopic thyroidectomy vestibular approach (TOETVA)
EXPERIMENTALTest group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA)
Traditional open surgery
ACTIVE COMPARATORControl group receiving traditional open thyroidectomy
Interventions
Remote access thyroid surgery
Open thyroidectomy via trans-cervical approach
Eligibility Criteria
You may qualify if:
- Benign thyroid nodule less than 4cm
- Suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery
You may not qualify if:
- Patients under 18 years old
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jason YK Chan
Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
- PRINCIPAL INVESTIGATOR
Zenon Yeung
Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant, Department of Otorhinolaryngology, Head and Neck Surgery
Study Record Dates
First Submitted
January 9, 2024
First Posted
January 26, 2024
Study Start
July 1, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
July 9, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share