A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Benign Thyroid Nodule
- Sponsor
- Tseung Kwan O Hospital, Hong Kong
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Voice quality of life
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Detailed Description
This is a prospective case control study involving a total 40 patients, with 20 stratified into the test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA) and 20 patients to the control group under traditional open approach. Subjects will be assigned to either group without randomization. Patients satisfactory score, voice and swallowing quality of life outcomes will be assessed using Voice Handicap Index (VHI) and MD Anderson Dysphagia Inventory (MDADI) outcomes. Surgical outcomes, for instance, lower lip numbness, skin injury, operative time, blood loss, vocal cord paralysis, temporary and permanent hypoparathyroidism will be assessed.
Investigators
YEUNG WING CHI ZENON
Consultant, Department of Otorhinolaryngology, Head and Neck Surgery
Tseung Kwan O Hospital, Hong Kong
Eligibility Criteria
Inclusion Criteria
- •Benign thyroid nodule less than 4cm
- •Suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Voice quality of life
Time Frame: Post-operative 6 months
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Swallowing quality of life
Time Frame: Post-operative 6 months
MD Anderson dysphagia inventory (MDADI)
Complication rate and types
Time Frame: Post-operative 6 months
Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism
Patient's satisfactory score
Time Frame: Post-operative 6 months
Visual analogue scale 0-10
Post-operative pain
Time Frame: Post-operative 6 months
Visual analogue scale 0-10
Secondary Outcomes
- Rate of conversion to open surgery(Intra-operatively)
- Operative time(Intra-operatively)
- Inpatient stay(An average of 0-2 days after the operation)
- Blood loss(Intra-operatively)