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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Remote access thyroid surgery
Open thyroidectomy via trans-cervical approach
Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital
Hong Kong, Hong Kong
RECRUITINGPatient's satisfactory score
Visual analogue scale 0-10
Time frame: Post-operative day 1
Patient's satisfactory score
Visual analogue scale 0-10
Time frame: Post-operative 2 weeks
Patient's satisfactory score
Visual analogue scale 0-10
Time frame: Post-operative 6 months
Post-operative pain
Visual analogue scale 0-10
Time frame: Post-operative day 1
Post-operative pain
Visual analogue scale 0-10
Time frame: Post-operative 2 weeks
Post-operative pain
Visual analogue scale 0-10
Time frame: Post-operative 6 months
Voice quality of life
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Time frame: Post-operative day 1
Voice quality of life
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Time frame: Post-operative 2 weeks
Voice quality of life
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Time frame: Post-operative 6 months
Swallowing quality of life
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MD Anderson dysphagia inventory (MDADI)
Time frame: Post-operative day 1
Swallowing quality of life
MD Anderson dysphagia inventory (MDADI)
Time frame: Post-operative 2 weeks
Swallowing quality of life
MD Anderson dysphagia inventory (MDADI)
Time frame: Post-operative 6 months
Complication rate and types
Lower lip numbness, skin bruising or injury, wound infection, vocal cord paralysis, temporary hypoparathyroidism
Time frame: Post-operative 2 weeks
Complication rate and types
Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism
Time frame: Post-operative 6 months
Inpatient stay
Number of days of inpatient stay
Time frame: An average of 0-2 days after the operation
Operative time
Minutes
Time frame: Intra-operatively
Blood loss
Volume
Time frame: Intra-operatively
Rate of conversion to open surgery
Percentage of conversion
Time frame: Intra-operatively