The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach
The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach
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.
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.
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