The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules

Sponsor

The University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT03158961

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

Recruit patients from the clinic.
Patients will receive treatment within 3 months
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.
Patients will be monitoring by the same team after the study.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Diseases	Procedure: Transoral endoscopic thyroidectomy vestibular approach	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

May 31, 2019

Actual Study Completion Date :

Jul 31, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The complication rate after TOETVA in 12 months [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.