The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
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
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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.
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Quality of Life - EORTC Thyroid specific Health related quality of life
These endpoints will be compared to historical age/indication controls for analysis.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: TOETVA Transoral Endoscopic Thyroidectomy Vestibular Approach |
Procedure: TOETVA
Transoral Endoscopic Thyroidectomy Vestibular Approach
|
Outcome Measures
Primary Outcome Measures
- 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
- Length of stay [until surgical discharge, average of 24 hours]
Length of stay in days
Secondary Outcome Measures
- Quality of Life Score [12 months]
EORTC Thyroid specific Health related quality of life
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Total thyroid size is 7-8 cm (no more than 10 cm)
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Their age is ≥18 years and ≤80 years
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Able to give written consent
Exclusion Criteria:
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- History of neck surgery or neck radiotherapy
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Recurrent thyroid disease
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Lymph node metastases
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Presence of intraoral infections
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Presence of extrathyroidal or substernal extensions
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Smoking
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Morbid obesity
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Contra-indication to general anesthesia with nasotracheal intubation
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Previous mediastinal surgery
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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)
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Any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Univeristy Health Network | Toronto | Ontario | Canada | M5G2C4 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Jesse D Pasternak, MD, University Health Network, Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-5679