The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules

Study Overview
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Brief Summary
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Thyroid surgery has been developed as a new technique for zero scar in surgery by applying transoral endoscopic thyroidectomy with sublingual approach. The new technique is locating the surgery which pierced through floor of mouth, cause severe tissue damage, high complication, and conversion rates to open surgery and surgical difficulties due to limitation of movement. Nevertheless, each report is still including small number of patients. Recently, the transoral endoscopic thyroidectomy vestibular approach (TOETVA) has been proven feasible and safe in several overseas centers. Moreover, a successful TOETVA case was reported in local media in the late last year. Hence, this study is for evaluating the feasibility and safety of the TOETVA prospectively at a tertiary referral center in Hong Kong. The following are the procedure of the study: Recruit patients from the clinic. Patients will receive treatment within 3 months Patients will have different assessments like Ultrasonography assessment, Fine needle biopsy, Direct laryngoscopy, and Cosmectic scoring in Pre-operation, post-operation 2 week, post 1 month, post 3 month, post 6 month and post 12 month. Patients will be monitoring by the same team after the study.

Official Title
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A Prospective Evaluation of the Feasibility and Safety of the Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) as a Treatment for Benign Thyroid Nodules

Conditions
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Thyroid Diseases

Intervention / Treatment
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* Procedure: Transoral endoscopic thyroidectomy vestibular approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have a cyst, nodule or a goiter which has been shown to be benign on fine needle aspiration cytology, need to undergo a unilateral thyroid resection, have a nodule size no larger than 4cm in largest diameter, willing to undergo this new approach rather than the traditional open approach. Exclusion Criteria: unfit for surgery, has had previous surgery or radiation at the neck, unable to tolerate a general anesthesia, wearing dental braces, absence of vocal cord mobility at laryngoscopy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOETVA<br>a new approach in surgery which can treat the thyroid disease | Procedure: Transoral endoscopic thyroidectomy vestibular approach<br>* TOVETA is a new approach in surgery of thyroidectomy no longer open on the neck<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The complication rate after TOETVA in 12 months | To record any complication of surgery in every post-operation visit after 12 months. The record will be used for the calculation of complication rate. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The open conversion rate of TOETVA | To record any cases which need to apply open surgery necessary during the procedure of TOETVA | 12 months | 
| The wound infection rate after TOETVA | To record the situation of wound infection after surgery | 12 months | 
| The hematoma rate after TOETVA | To record the situation of hematoma after surgery | 12 months | 
| The vocal cord palsy rate after TOETVA | To calculate the vocal cord situation after surgery within 12 months | 12 months | 
| The hypoparathyroidism rate after TOETVA | To record the thyroid function from blood test in 12 months after surgery and calculate the rate of hypo-parathyroid function | 12 months | 
| The pain score of patient after TOETVA | The pain scoring with 0-10 to assess the pain level of having TOETVA | 12 months | 
| The satisfaction of patients after having TOETVA in 12 months | The satisfaction in 0-10 scoring after the surgery | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid, Thyroidectomy, Transoral, Endoscopic, Surgery