The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Surgery
- Thyroid Diseases
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.Masking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
Type of Study This is a single center, prospective case series Sample Size Since this is a feasibility study we will first include 15 patients. If we find the TOETVA a safe and feasible approach, we will perform the same study in more patients using the results of this study for a power size calcula...
Type of Study This is a single center, prospective case series Sample Size Since this is a feasibility study we will first include 15 patients. If we find the TOETVA a safe and feasible approach, we will perform the same study in more patients using the results of this study for a power size calculation. Study Population Patients (> 18 years) undergoing (para)thyroid surgery for the indication of a benign or indeterminate thyroid nodule, well differentiated papillary thyroid carcinoma, well-controlled Grave's disease or a parathyroid adenoma. Study Design This is a single center, prospective case series designed to assess the safety and feasibility of TOETVA in a small cohort of patients at University Health Network Toronto. Included patients will undergo a TOETVA-procedure in stead of the standard open surgical procedure. Study Intervention The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach. Primary Objective The study objective is to assess the safety and feasibility of this procedure in a small cohort of patients at University Health Network Toronto, Ontario. Endpoints of the study The main study endpoints consist of Surgical Outcomes: rate of post-operative recurrent laryngeal nerve palsy, rate of post-operative hypocalcemia, and rate of neck incision (conversion to open), oral infections, neck infection, hematoma, seroma, subcutaneous emphysema, gas-induced embolism, surgical time, and length of stay. Quality of Life - EORTC Thyroid specific Health related quality of life These endpoints will be compared to historical age/indication controls for analysis.
Tracking Information
- NCT #
- NCT04842942
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jesse D Pasternak, MD University Health Network, Toronto