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

T

Tseung Kwan O Hospital, Hong Kong

Status

Not yet enrolling

Conditions

Suspicious Malignant Thyroid Nodule
Benign Thyroid Nodule

Treatments

Procedure: Traditional Open Thyroidectomy
Procedure: Transoral endoscopic thyroidectomy vestibular approach (TOETVA)

Study type

Interventional

Funder types

Other

Identifiers

NCT06225765
KC/KE-23-0006/FR-4

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Transoral endoscopic thyroidectomy vestibular approach (TOETVA)
Experimental group
Description:
Test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA)
Treatment:
Procedure: Transoral endoscopic thyroidectomy vestibular approach (TOETVA)
Traditional open surgery
Active Comparator group
Description:
Control group receiving traditional open thyroidectomy
Treatment:
Procedure: Traditional Open Thyroidectomy

Trial contacts and locations

0

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Central trial contact

Thomas Hui; Cherrie Ng

Data sourced from clinicaltrials.gov

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