Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital
Hong Kong
Location status: Recruiting
Location contact
Thomas Hui, BSc
CONTACT
Zenon Yeung, MbChB
CONTACT
NCT Number: NCT06225765
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hong Kong
Location status: Recruiting
Thomas Hui, BSc
CONTACT
Zenon Yeung, MbChB
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Remote access thyroid surgery
Open thyroidectomy via trans-cervical approach
Time frame: Post-operative day 1
Visual analogue scale 0-10
Time frame: Post-operative 2 weeks
Visual analogue scale 0-10
Time frame: Post-operative 6 months
Visual analogue scale 0-10
Time frame: Post-operative day 1
Visual analogue scale 0-10
Time frame: Post-operative 2 weeks
Visual analogue scale 0-10
Time frame: Post-operative 6 months
Visual analogue scale 0-10
Time frame: Post-operative day 1
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Time frame: Post-operative 2 weeks
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Time frame: Post-operative 6 months
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Time frame: Post-operative day 1
MD Anderson dysphagia inventory (MDADI)
Time frame: Post-operative 2 weeks
MD Anderson dysphagia inventory (MDADI)
Time frame: Post-operative 6 months
MD Anderson dysphagia inventory (MDADI)
Time frame: Post-operative 2 weeks
Lower lip numbness, skin bruising or injury, wound infection, vocal cord paralysis, temporary hypoparathyroidism
Time frame: Post-operative 6 months
Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism
Time frame: An average of 0-2 days after the operation
Number of days of inpatient stay
Time frame: Intra-operatively
Minutes
Time frame: Intra-operatively
Volume
Time frame: Intra-operatively
Percentage of conversion
Contact information is provided by the study sponsor or research team.
Tseung Kwan O Hospital, Hong Kong
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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