The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach

Study Overview
=================
Brief 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 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.

Official Title
-----------------
The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach

Conditions
-----------------
Thyroid Diseases, Surgery

Intervention / Treatment
-----------------
* Procedure: TOETVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients needing surgery for: Benign or indeterminate nodule less than 6 cm in size or; T1 well differentiated papillary carcinoma less than 2 cm in size or; Well-controlled Grave's disease or; Parathyroid adenoma. Total thyroid size is 7-8 cm (no more than 10 cm) Their age is ≥18 years and ≤80 years Able to give written consent Exclusion Criteria: - History of neck surgery or neck radiotherapy Recurrent thyroid disease Lymph node metastases Presence of intraoral infections Presence of extrathyroidal or substernal extensions Smoking Morbid obesity Contra-indication to general anesthesia with nasotracheal intubation Previous mediastinal surgery Any anatomical anomaly that in the opinion of the investigator may render the intervention more difficult (ex. variations in the structure of the platysmas muscle) Any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOETVA<br>Transoral Endoscopic Thyroidectomy Vestibular Approach | Procedure: TOETVA<br>* Transoral Endoscopic Thyroidectomy Vestibular Approach<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative recurrent laryngeal nerve palsy | Number of participants with post-operative recurrent laryngeal nerve palsy | 12 months | 
| Postoperative hypocalcemia | Number of participants with postoperative hypocalcemia | 12 months | 
| Neck incision | Number of conversions to open | 1 month | 
| Rate of oral infections | Number of participants with oral infections | 12 months | 
| Rate of hematoma | Number of participants with hematomas | 1 month | 
| Rate of seroma | Number of participants with seromas | 1 month | 
| Rate of neck infection | Number of participants with neck infections | 12 months | 
| Rate of subcutaneous emphysema | Number of participants with subcutaneous emphysema | 12 months | 
| Rate of gas-induced embolism | Number of participants with gas-induced embolism | 12 months | 
| Surgical time | Surgical time in hours | until surgical discharge, average of 24 hours | 
| Length of stay | Length of stay in days | until surgical discharge, average of 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Score | EORTC Thyroid specific Health related quality of life | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TOETVA, Transoral Endoscopic Thyroidectomy Vestibular Approach