NCT04842942

The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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 1. 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. 2. Quality of Life - EORTC Thyroid specific Health related quality of life These endpoints will be compared to historical age/indication controls for analysis.

Conditions

• Thyroid Diseases
• Surgery

Interventions

Type	Name	Description
PROCEDURE	TOETVA	Transoral Endoscopic Thyroidectomy Vestibular Approach

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-12-01
• Completion: 2022-07-01
• First posted: 2021-04-13
• Last updated: 2021-04-13

Locations

1 site across 1 country: Canada