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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
These endpoints will be compared to historical age/indication controls for analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOETVA | Experimental | Transoral Endoscopic Thyroidectomy Vestibular Approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOETVA | Procedure | Transoral Endoscopic Thyroidectomy Vestibular Approach |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Score | EORTC Thyroid specific Health related quality of life | 12 months |
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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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesse D Pasternak, MD | Contact | 14163405195 | jesse.pasternak@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jesse D Pasternak, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy Health Network | Recruiting | Toronto | Ontario | M5G2C4 | Canada |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.
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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 |