The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules

April 27, 2021 updated by: Dr. Lang Hung Hin, Brian, The University of Hong Kong

A Prospective Evaluation of the Feasibility and Safety of the Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) as a Treatment for Benign Thyroid Nodules

Thyroid surgery has been developed as a new technique for zero scar in surgery by applying transoral endoscopic thyroidectomy with sublingual approach. The new technique is locating the surgery which pierced through floor of mouth, cause severe tissue damage, high complication, and conversion rates to open surgery and surgical difficulties due to limitation of movement. Nevertheless, each report is still including small number of patients. Recently, the transoral endoscopic thyroidectomy vestibular approach (TOETVA) has been proven feasible and safe in several overseas centers. Moreover, a successful TOETVA case was reported in local media in the late last year. Hence, this study is for evaluating the feasibility and safety of the TOETVA prospectively at a tertiary referral center in Hong Kong.

The following are the procedure of the study:

  1. Recruit patients from the clinic.
  2. Patients will receive treatment within 3 months
  3. Patients will have different assessments like Ultrasonography assessment, Fine needle biopsy, Direct laryngoscopy, and Cosmectic scoring in Pre-operation, post-operation 2 week, post 1 month, post 3 month, post 6 month and post 12 month.
  4. Patients will be monitoring by the same team after the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • have a cyst, nodule or a goiter which has been shown to be benign on fine needle aspiration cytology,
  • need to undergo a unilateral thyroid resection,
  • have a nodule size no larger than 4cm in largest diameter,
  • willing to undergo this new approach rather than the traditional open approach.

Exclusion Criteria:

  • unfit for surgery,
  • has had previous surgery or radiation at the neck,
  • unable to tolerate a general anesthesia,
  • wearing dental braces,
  • absence of vocal cord mobility at laryngoscopy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TOETVA
a new approach in surgery which can treat the thyroid disease
Procedure: Transoral endoscopic thyroidectomy vestibular approach
TOVETA is a new approach in surgery of thyroidectomy no longer open on the neck

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The complication rate after TOETVA in 12 months
Time Frame: 12 months
To record any complication of surgery in every post-operation visit after 12 months. The record will be used for the calculation of complication rate.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The open conversion rate of TOETVA
Time Frame: 12 months
To record any cases which need to apply open surgery necessary during the procedure of TOETVA
12 months
The wound infection rate after TOETVA
Time Frame: 12 months
To record the situation of wound infection after surgery
12 months
The hematoma rate after TOETVA
Time Frame: 12 months
To record the situation of hematoma after surgery
12 months
The vocal cord palsy rate after TOETVA
Time Frame: 12 months
To calculate the vocal cord situation after surgery within 12 months
12 months
The hypoparathyroidism rate after TOETVA
Time Frame: 12 months
To record the thyroid function from blood test in 12 months after surgery and calculate the rate of hypo-parathyroid function
12 months
The pain score of patient after TOETVA
Time Frame: 12 months
The pain scoring with 0-10 to assess the pain level of having TOETVA
12 months
The satisfaction of patients after having TOETVA in 12 months
Time Frame: 12 months
The satisfaction in 0-10 scoring after the surgery
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 17-144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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