Surgery, Thyroid Diseases
Conditions
Keywords
TOETVA, Transoral Endoscopic Thyroidectomy Vestibular Approach
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.
Interventions
PROCEDURETOETVA
Transoral Endoscopic Thyroidectomy Vestibular Approach
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | until surgical discharge, average of 24 hours | Length of stay in days |
| Post-operative recurrent laryngeal nerve palsy | 12 months | Number of participants with post-operative recurrent laryngeal nerve palsy |
| Postoperative hypocalcemia | 12 months | Number of participants with postoperative hypocalcemia |
| Neck incision | 1 month | Number of conversions to open |
| Rate of oral infections | 12 months | Number of participants with oral infections |
| Rate of hematoma | 1 month | Number of participants with hematomas |
| Rate of seroma | 1 month | Number of participants with seromas |
| Rate of neck infection | 12 months | Number of participants with neck infections |
| Rate of subcutaneous emphysema | 12 months | Number of participants with subcutaneous emphysema |
| Rate of gas-induced embolism | 12 months | Number of participants with gas-induced embolism |
| Surgical time | until surgical discharge, average of 24 hours | Surgical time in hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Score | 12 months | EORTC Thyroid specific Health related quality of life |
Countries
Canada
Contacts
Primary ContactJesse D Pasternak, MD
Outcome results
None listed