The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach

Phase 1

• Conditions: Surgery; Thyroid Diseases
• Interventions: Procedure: TOETVA

• Registration Number: NCT04842942
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study Start: 2019-12-01
• Study First Submitted: 2021-02-19
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-11
• Last Update Submitted: 2021-04-11
• Study First Posted: 2021-04-13
• Last Update Posted: 2021-04-13
• Primary Completion: 2021-12
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TOETVA	TOETVA	Transoral Endoscopic Thyroidectomy Vestibular Approach

Primary Outcome Measures

Name	Time	Method
Post-operative recurrent laryngeal nerve palsy	12 months	Number of participants with post-operative recurrent laryngeal nerve palsy
Rate of gas-induced embolism	12 months	Number of participants with gas-induced embolism
Rate of subcutaneous emphysema	12 months	Number of participants with subcutaneous emphysema
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
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

Secondary Outcome Measures

Name	Time	Method
Quality of Life Score	12 months	EORTC Thyroid specific Health related quality of life

Trial Locations

Locations (1)

Univeristy Health Network; 🇨🇦 Toronto, Ontario, Canada