A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy

NCT ID: NCT06225765

Last Updated: 2024-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-09-30

Brief Summary

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To determine if transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a safe and effective procedure compared to traditional open thyroidectomy. Surgical outcomes, patients' satisfaction, voice and swallowing outcomes will be assessed.

Detailed Description

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This is a prospective case control study involving a total 40 patients, with 20 stratified into the test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA) and 20 patients to the control group under traditional open approach. Subjects will be assigned to either group without randomization. Patients satisfactory score, voice and swallowing quality of life outcomes will be assessed using Voice Handicap Index (VHI) and MD Anderson Dysphagia Inventory (MDADI) outcomes. Surgical outcomes, for instance, lower lip numbness, skin injury, operative time, blood loss, vocal cord paralysis, temporary and permanent hypoparathyroidism will be assessed.

Conditions

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Benign Thyroid Nodule Suspicious Malignant Thyroid Nodule

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective case control study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transoral endoscopic thyroidectomy vestibular approach (TOETVA)

Test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA)

Group Type EXPERIMENTAL

Transoral endoscopic thyroidectomy vestibular approach (TOETVA)

Intervention Type PROCEDURE

Remote access thyroid surgery

Traditional open surgery

Control group receiving traditional open thyroidectomy

Group Type ACTIVE_COMPARATOR

Traditional Open Thyroidectomy

Intervention Type PROCEDURE

Open thyroidectomy via trans-cervical approach

Interventions

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Transoral endoscopic thyroidectomy vestibular approach (TOETVA)

Remote access thyroid surgery

Intervention Type PROCEDURE

Traditional Open Thyroidectomy

Open thyroidectomy via trans-cervical approach

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Benign thyroid nodule less than 4cm
* Suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery

Exclusion Criteria

* Patients under 18 years old
* Contraindication to general anaesthesia
* Vulnerable population (e.g. Cognitive impairment, pregnant)
* Previous anterior neck surgery
* Previous radiotherapy at the head and neck region
* Malignant thyroid nodule \> 2cm
* Presence of another malignancy, lateral neck, or distant metastasis
* Retrosternal goitre
* Cervical spine disease precluding extension of the neck
* Obesity with BMI \> 35kg/m2
* Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
* Untreated active infection
* Non-correctable coagulopathy
* Emergency surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tseung Kwan O Hospital, Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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YEUNG WING CHI ZENON

Consultant, Department of Otorhinolaryngology, Head and Neck Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason YK Chan

Role: STUDY_DIRECTOR

Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

Zenon Yeung

Role: PRINCIPAL_INVESTIGATOR

Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

Locations

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Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Cherrie Ng

Role: CONTACT

+85235051409

Thomas Hui

Role: CONTACT

+85239493549

Facility Contacts

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Zenon Yeung, MbChB

Role: primary

+852-39495442

Thomas Hui, BSc

Role: backup

+852-39493549

Other Identifiers

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KC/KE-23-0006/FR-4

Identifier Type: -

Identifier Source: org_study_id

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