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

Not Applicable

Recruiting

• Conditions: Benign Thyroid Nodule; Suspicious Malignant Thyroid Nodule

• Registration Number: NCT06225765
• Lead Sponsor: Tseung Kwan O Hospital, Hong Kong

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-01-26
• Status Verified: 2024-07
• Study Start: 2024-07-01
• Last Update Submitted: 2024-07-06
• Last Update Posted: 2024-07-09
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Voice quality of life	Post-operative 6 months	Voice Handicap Index - 30 assessing functional, physical and emotional scales
Swallowing quality of life	Post-operative 6 months	MD Anderson dysphagia inventory (MDADI)
Complication rate and types	Post-operative 6 months	Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism
Patient's satisfactory score	Post-operative 6 months	Visual analogue scale 0-10
Post-operative pain	Post-operative 6 months	Visual analogue scale 0-10

Secondary Outcome Measures

Name	Time	Method
Inpatient stay	An average of 0-2 days after the operation	Number of days of inpatient stay
Blood loss	Intra-operatively	Volume
Rate of conversion to open surgery	Intra-operatively	Percentage of conversion
Operative time	Intra-operatively	Minutes

Trial Locations

Locations (1)

Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital; 🇭🇰 Hong Kong, Hong Kong