The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules

Not Applicable

Completed

• Conditions: Thyroid Diseases
• Interventions: Procedure: Transoral endoscopic thyroidectomy vestibular approach

• Registration Number: NCT03158961
• Lead Sponsor: The University of Hong Kong

Brief Summary

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:

1. Recruit patients from the clinic.

2. Patients will receive treatment within 3 months

3. 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.

4. Patients will be monitoring by the same team after the study.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-18
• Study Start: 2017-07-01
• Primary Completion: 2019-05-31
• Study Completion: 2019-07-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TOETVA	Transoral endoscopic thyroidectomy vestibular approach	a new approach in surgery which can treat the thyroid disease

Primary Outcome Measures

Name	Time	Method
The complication rate after TOETVA in 12 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong