The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach

NCT04842942 | Unknown Phase 1

• 1 other identifier: 19-5679
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Diseases; Surgery

Keywords

TOETVA; Transoral Endoscopic Thyroidectomy Vestibular Approach

Outcome Measures

Primary Outcomes (11)

• 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

  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

Secondary Outcomes (1)

• Quality of Life Score

  12 months

Study Arms (1)

TOETVA

EXPERIMENTAL

Transoral Endoscopic Thyroidectomy Vestibular Approach

Procedure: TOETVA

Interventions

TOETVA PROCEDURE

Transoral Endoscopic Thyroidectomy Vestibular Approach

TOETVA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Univeristy Health Network

Toronto, Ontario, M5G2C4, Canada

RECRUITING

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Jesse D Pasternak, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesse D Pasternak, MD

CONTACT

14163405195; jesse.pasternak@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: April 13, 2021
• Study Start: December 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)