The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach

University Health Network, Toronto1 site in 1 country15 target enrollmentDecember 1, 2019

ConditionsThyroid Diseases Surgery

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Thyroid Diseases
Sponsor: University Health Network, Toronto
Enrollment: 15
Locations: 1
Primary Endpoint: Post-operative recurrent laryngeal nerve palsy
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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 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.

Registry

clinicaltrials.gov

Start Date

December 1, 2019

End Date

July 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Health Network, Toronto

Responsible Party

Sponsor

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
•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