A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy

Tseung Kwan O Hospital, Hong Kong

Status: Enrolling

Conditions: Suspicious Malignant Thyroid Nodule; Benign Thyroid Nodule

Treatments: Procedure: Transoral endoscopic thyroidectomy vestibular approach (TOETVA); Procedure: Traditional Open Thyroidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06225765

KC/KE-23-0006/FR-4

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Benign thyroid nodule less than 4cm
• Suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery

Exclusion criteria

• Patients under 18 years old
• Contraindication to general anaesthesia
• Vulnerable population (e.g. Cognitive impairment, pregnant)
• Previous anterior neck surgery
• Previous radiotherapy at the head and neck region
• Malignant thyroid nodule > 2cm
• Presence of another malignancy, lateral neck, or distant metastasis
• Retrosternal goitre
• Cervical spine disease precluding extension of the neck
• Obesity with BMI > 35kg/m2
• Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
• Untreated active infection
• Non-correctable coagulopathy
• Emergency surgery

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Transoral endoscopic thyroidectomy vestibular approach (TOETVA)

Experimental group

Description:

Test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA)

Treatment:

Procedure: Transoral endoscopic thyroidectomy vestibular approach (TOETVA)

Traditional open surgery

Active Comparator group

Description:

Control group receiving traditional open thyroidectomy

Treatment:

Procedure: Traditional Open Thyroidectomy