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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transoral endoscopic thyroidectomy vestibular approach (TOETVA) | Experimental | Test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA) |
|
| Traditional open surgery | Active Comparator | Control group receiving traditional open thyroidectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transoral endoscopic thyroidectomy vestibular approach (TOETVA) | Procedure | Remote access thyroid surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Inpatient stay | Number of days of inpatient stay | An average of 0-2 days after the operation |
| Operative time | Minutes | Intra-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cherrie Ng | Contact | +85235051409 | cherrieng@ent.cuhk.edu.hk | |
| Thomas Hui | Contact | +85239493549 | hsc526@ha.org.hk |
| Name | Affiliation | Role |
|---|---|---|
| Jason YK Chan | Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong | Study Director |
| Zenon Yeung | Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital | Recruiting | Hong Kong | Hong Kong |
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Prospective case control study
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| Traditional Open Thyroidectomy | Procedure | Open thyroidectomy via trans-cervical approach |
|
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 |
| Blood loss | Volume | Intra-operatively |
| Rate of conversion to open surgery | Percentage of conversion | Intra-operatively |
| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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