Transoral endoscopic thyroid surgery for thyroid diseases
Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Compared to Conventional Thyroidectomy by Cervical Approach: a Randomized Clinical Trial
This study is testing a new, less invasive surgery for thyroid problems to see if it works better than the traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Instituto do Cancer do Estado de São Paulo Academic / other |
| Locations | 1 site (São Paulo, SP) |
| Trial ID | NCT05412680 on ClinicalTrials.gov |
What this trial studies
This prospective study involves patients at ICESP with thyroid diseases requiring surgical intervention. It will compare two surgical approaches: conventional thyroidectomy and transoral endoscopic thyroidectomy by vestibular approach (TOETVA). A total of 60 patients will be randomized into two groups, with 30 patients undergoing each type of surgery. The study aims to evaluate the effectiveness and outcomes of the less invasive TOETVA technique compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates include patients with thyroid conditions that meet specific criteria, such as benign lesions or suspicious nodules under 2 cm.
Not a fit: Patients with a history of head and neck surgery, clinical hyperthyroidism, or other significant complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce scarring and improve recovery times for patients undergoing thyroid surgery.
How similar studies have performed: Other studies have shown promising results with minimally invasive surgical techniques for thyroid conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * history of hypertrophic scarring and/or motivation to avoid cervical scarring, * maximum diameter of the thyroid \< 10 cm and of the dominant nodule \< 6 cm, * estimated thyroid volume \< 45 ml * benign lesion (multinodular goiter, cyst), * indeterminate nodule (Bethesda III or IV), * suspicious nodule for well-differentiated thyroid carcinoma (Bethesda V and VI) \< 2 cm Exclusion Criteria: * history of previous surgery or irradiation in the head and neck region and superior mediastinum * evidence of clinical hyperthyroidism * preoperative recurrent nerve palsy * lymph node metastasis * extra-thyroid extension * plunging goiter * oral abscess
Where this trial is running
São Paulo, SP
- Icesp — São Paulo, Sp, Brazil (Recruiting)
Study contacts
- Principal investigator: Fabio Capelli, phd — Instituto do Cancer do Estado de São Paulo
- Study coordinator: Fabio Capelli, phd
- Email: fabiocapelli81@gmail.com
- Phone: 55 11 98292-2288
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.