What is this study trying to find out about thyroid nodule surgery?

This study is comparing a newer surgery method called TOETVA with traditional open thyroid surgery to see if it is safe and effective. Researchers want to understand differences in patient satisfaction, voice, swallowing, and surgical outcomes. It is sponsored by Tseung Kwan O Hospital in Hong Kong and aims to improve thyroid surgery options.

Who may be eligible for this benign or suspicious malignant thyroid nodule clinical trial?

Adults aged 18 and older with benign thyroid nodules smaller than 4 cm or suspicious malignant nodules smaller than 2 cm may be eligible. Both men and women can participate. Important factors include no prior neck surgery, no severe illnesses, and suitability for general anesthesia. Please review eligibility criteria for more details.

Is there any cost to participate in this thyroid nodule surgery clinical trial?

Study-related care, including the surgery and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06225765

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

Led by Tseung Kwan O Hospital, Hong Kong · Updated on 2024-07-09

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether the transoral endoscopic thyroidectomy vestibular approach TOETVA is a safe and effective alternative to traditional open thyroidectomy for patients with benign or suspicious malignant thyroid nodules. This prospective case control study involves 40 patients divided into two groups one receiving TOETVA and the other undergoing conventional open surgery. The study aims to assess surgical outcomes, patient satisfaction, voice quality, and swallowing function. Participants will either have surgery using the TOETVA, which is a remote access procedure through the mouth, or the traditional open thyroidectomy through the neck. The study is non-randomized, assigning 20 patients to each group. Outcomes such as lower lip numbness, skin injury, operation time, blood loss, vocal cord paralysis, and hypoparathyroidism will be monitored. The study also evaluates patient satisfaction and quality of life related to voice and swallowing using specific questionnaires. After surgery, patients will be followed up with assessments on days 1, 14, and 6 months post-operation to measure satisfaction, pain, voice, and swallowing quality of life. Surgical complications will be recorded at 2 weeks and 6 months. Secondary measures include hospital stay duration, operative time, blood loss, and conversion rates to open surgery. The total study duration spans from surgery through 6 months of follow-up.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Benign thyroid nodule less than 4cm
Suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery
Age 18 years or older

You will not qualify if you...

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 greater than 2cm
Presence of another malignancy, lateral neck, or distant metastasis
Retrosternal goitre
Cervical spine disease precluding extension of the neck
Obesity with BMI greater than 35kg/m2
Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
Untreated active infection
Non-correctable coagulopathy
Emergency surgery

Research Team

Cherrie Ng

Thomas Hui

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