The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules

The University of Hong Kong (HKU)

Status: Completed

Conditions: Thyroid Diseases

Treatments: Procedure: Transoral endoscopic thyroidectomy vestibular approach

Study type: Interventional

Funder types: Other

Identifiers

NCT03158961

UW 17-144

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

TOETVA

Experimental group

Description:

a new approach in surgery which can treat the thyroid disease

Treatment:

Procedure: Transoral endoscopic thyroidectomy vestibular approach