Status:

RECRUITING

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

Lead Sponsor:

Tseung Kwan O Hospital, Hong Kong

Conditions:

Benign Thyroid Nodule

Suspicious Malignant Thyroid Nodule

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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

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) a...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

July 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2026

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06225765

Start Date

July 1 2024

End Date

September 30 2026

Last Update

July 9 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

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

Hong Kong, Hong Kong