NCT06225765

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tseung Kwan O Hospital, Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Thyroid Nodule
• Suspicious Malignant Thyroid Nodule

Interventions

Type	Name	Description
PROCEDURE	Transoral endoscopic thyroidectomy vestibular approach (TOETVA)	Remote access thyroid surgery
PROCEDURE	Traditional Open Thyroidectomy	Open thyroidectomy via trans-cervical approach

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2024-01-26
• Last updated: 2024-07-09

Locations

1 site across 1 country: Hong Kong