Comparing two surgical methods for thyroid nodules
A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy
This study is testing whether a new minimally invasive thyroid surgery is safer and more effective than the traditional open surgery for people with thyroid nodules.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tseung Kwan O Hospital, Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06225765 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of the transoral endoscopic thyroidectomy vestibular approach (TOETVA) compared to traditional open thyroidectomy in patients with benign or suspicious malignant thyroid nodules. A total of 40 patients will be involved, with 20 undergoing TOETVA and 20 receiving the conventional open approach. The study will assess various surgical outcomes, patient satisfaction, and quality of life related to voice and swallowing using validated assessment tools. The patients will be assigned to groups without randomization, allowing for a direct comparison of outcomes between the two surgical techniques.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with benign thyroid nodules less than 4cm or suspicious malignant thyroid nodules less than 2cm suitable for transoral endoscopic surgery.
Not a fit: Patients with malignant thyroid nodules larger than 2cm or those with significant comorbidities that increase surgical risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to less invasive surgical options for patients with thyroid nodules, potentially improving recovery times and quality of life.
How similar studies have performed: While the TOETVA approach is gaining interest, this specific comparison with traditional open thyroidectomy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hong Kong
- Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Zenon Yeung — Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
- Study coordinator: Cherrie Ng
- Email: cherrieng@ent.cuhk.edu.hk
- Phone: +85235051409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.