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Recruiting NCT06225765

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

No phase Interventional Benign Thyroid Nodule Suspicious Malignant Thyroid Nodule

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transoral endoscopic thyroidectomy vestibular approach (TOETVA), Traditional Open Thyroidectomy.
Who it may be relevant to
Registry conditions: Benign Thyroid Nodule, Suspicious Malignant Thyroid Nodule. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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.

Interventions

  • Procedure Transoral endoscopic thyroidectomy vestibular approach (TOETVA)
    Remote access thyroid surgery
  • Procedure Traditional Open Thyroidectomy
    Open thyroidectomy via trans-cervical approach

Primary outcome measures

  • Patient's satisfactory score [Time frame: Post-operative day 1]
  • Patient's satisfactory score [Time frame: Post-operative 2 weeks]
  • Patient's satisfactory score [Time frame: Post-operative 6 months]
  • Post-operative pain [Time frame: Post-operative day 1]
  • Post-operative pain [Time frame: Post-operative 2 weeks]
  • Post-operative pain [Time frame: Post-operative 6 months]
  • Voice quality of life [Time frame: Post-operative day 1]
  • Voice quality of life [Time frame: Post-operative 2 weeks]
  • Voice quality of life [Time frame: Post-operative 6 months]
  • Swallowing quality of life [Time frame: Post-operative day 1]
Secondary outcome measures (4)
  • Inpatient stay [Time frame: An average of 0-2 days after the operation]
  • Operative time [Time frame: Intra-operatively]
  • Blood loss [Time frame: Intra-operatively]
  • Rate of conversion to open surgery [Time frame: Intra-operatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Ts — Hong Kong

Identifiers

NCT: NCT06225765 · KC/KE-23-0006/FR-4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗