The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach

University Health Network, Toronto

Status and phase: Unknown; Phase 1

Conditions: Thyroid Diseases; Surgery

Treatments: Procedure: TOETVA

Study type: Interventional

Funder types: Other

Identifiers

NCT04842942

19-5679

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

TOETVA

Experimental group

Description:

Transoral Endoscopic Thyroidectomy Vestibular Approach

Treatment:

Procedure: TOETVA