Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)
- Conditions
- Thyroid DiseasesThyroid Cancer
- Interventions
- Procedure: TOETVAProcedure: conventional thyroidectomy
- Registration Number
- NCT05412680
- Lead Sponsor
- Fábio de Aquino Capelli
- Brief Summary
Prospective study carried out with ICESP (instituto do Câncer do Estado de São Paulo) patients with thyroid disease with surgical indication
- Detailed Description
Prospective study carried out with ICESP patients with thyroid disease with surgical indication, according to the aforementioned inclusion criteria, totaling 60 cases, which will be randomized into two groups:
* Conventional Thyroidectomy (30 patients)
* Transoral Endoscopic Thyroidectomy By Vestibular Approach (30 patients)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TOETVA TOETVA Patients submitted to transoral endoscopic thyroidectomy by vestibular approach CONVENTIONAL THYROIDECTOMY conventional thyroidectomy Patients submitted to conventional open thyroidectomy by cervical approach
- Primary Outcome Measures
Name Time Method To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as laryngeal nerve dysfunction 1 year This outcome will be accessed by performing laryngoscopy before and after the surgery
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as skin injury 1 year This outcome will be accessed by qualitative analysis
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as seroma formation 1 year This outcome will be accessed by qualitative analysis
To compare TOETVA technique with conventional thyroidectomy in terms of time of hospitalization 1 year This outcome will be accessed by number of days spent in the hospital
To compare TOETVA technique with conventional thyroidectomy in terms of post operative pain 1 year This outcome will be accessed by visual pain scale from grade 1 (better) to 10 (worse)
To compare TOETVA technique with conventional thyroidectomy in terms of operative time 1 year Operative time will be measured by minutes
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hypoparathyroidism 1 year This outcome will be accessed by accessing de blood calcium and parathormone levels after the surgery
To compare TOETVA technique with conventional thyroidectomy in terms of post operative surgical complications, such as hematoma formation 1 year This outcome will be accessed by qualitative analysis
- Secondary Outcome Measures
Name Time Method Comparison on quality of life - questionnaire 1. 1 year Quality of life evaluated by specific questionnaires, such as University of Washington version 4 - 0 (worse) 1200 (better)
Comparison on quality of life - questionnaire 2. 1 year Quality of life evaluated by specific questionnaires, such as Dermatology life quality index - 0 (better) 30 (worse)
Comparison on quality of life - questionnaire 3. 1 year Quality of life evaluated by specific questionnaires, such as Euroqol - 5D - 5 (better) 15 (worse)
Trial Locations
- Locations (1)
ICESP
🇧🇷São Paulo, SP, Brazil