The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach

Surgery Clinical Trial

Official title:

The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04842942
• Other study ID #: 19-5679
• Status: Recruiting
• Phase: Phase 1
• Start date: December 1, 2019
• Est. completion date: July 2022

Study information

• Verified date: April 2021
• Source: University Health Network, Toronto
• Contact: Jesse D Pasternak, MD
• Phone: 14163405195
• Email: jesse.pasternak[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery
• Thyroid Diseases

Intervention

Procedure:
• TOETVA
Transoral Endoscopic Thyroidectomy Vestibular Approach

Locations

Country	Name	City	State
Canada	Univeristy Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative recurrent laryngeal nerve palsy	Number of participants with post-operative recurrent laryngeal nerve palsy	12 months
Primary	Postoperative hypocalcemia	Number of participants with postoperative hypocalcemia	12 months
Primary	Neck incision	Number of conversions to open	1 month
Primary	Rate of oral infections	Number of participants with oral infections	12 months
Primary	Rate of hematoma	Number of participants with hematomas	1 month
Primary	Rate of seroma	Number of participants with seromas	1 month
Primary	Rate of neck infection	Number of participants with neck infections	12 months
Primary	Rate of subcutaneous emphysema	Number of participants with subcutaneous emphysema	12 months
Primary	Rate of gas-induced embolism	Number of participants with gas-induced embolism	12 months
Primary	Surgical time	Surgical time in hours	until surgical discharge, average of 24 hours
Primary	Length of stay	Length of stay in days	until surgical discharge, average of 24 hours
Secondary	Quality of Life Score	EORTC Thyroid specific Health related quality of life	12 months