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NCT Number: NCT06225765

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transoral endoscopic thyroidectomy vestibular approach (TOETVA)

Procedure

Remote access thyroid surgery

Traditional Open Thyroidectomy

Procedure

Open thyroidectomy via trans-cervical approach

Primary outcomes

  1. Patient's satisfactory score

    Time frame: Post-operative day 1

    Visual analogue scale 0-10

  2. Patient's satisfactory score

    Time frame: Post-operative 2 weeks

    Visual analogue scale 0-10

  3. Patient's satisfactory score

    Time frame: Post-operative 6 months

    Visual analogue scale 0-10

  4. Post-operative pain

    Time frame: Post-operative day 1

    Visual analogue scale 0-10

  5. Post-operative pain

    Time frame: Post-operative 2 weeks

    Visual analogue scale 0-10

  6. Post-operative pain

    Time frame: Post-operative 6 months

    Visual analogue scale 0-10

  7. Voice quality of life

    Time frame: Post-operative day 1

    Voice Handicap Index - 30 assessing functional, physical and emotional scales

  8. Voice quality of life

    Time frame: Post-operative 2 weeks

    Voice Handicap Index - 30 assessing functional, physical and emotional scales

  9. Voice quality of life

    Time frame: Post-operative 6 months

    Voice Handicap Index - 30 assessing functional, physical and emotional scales

  10. Swallowing quality of life

    Time frame: Post-operative day 1

    MD Anderson dysphagia inventory (MDADI)

  11. Swallowing quality of life

    Time frame: Post-operative 2 weeks

    MD Anderson dysphagia inventory (MDADI)

  12. Swallowing quality of life

    Time frame: Post-operative 6 months

    MD Anderson dysphagia inventory (MDADI)

  13. Complication rate and types

    Time frame: Post-operative 2 weeks

    Lower lip numbness, skin bruising or injury, wound infection, vocal cord paralysis, temporary hypoparathyroidism

  14. Complication rate and types

    Time frame: Post-operative 6 months

    Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism

Secondary outcomes

  1. Inpatient stay

    Time frame: An average of 0-2 days after the operation

    Number of days of inpatient stay

  2. Operative time

    Time frame: Intra-operatively

    Minutes

  3. Blood loss

    Time frame: Intra-operatively

    Volume

  4. Rate of conversion to open surgery

    Time frame: Intra-operatively

    Percentage of conversion

Study contacts

Contact information is provided by the study sponsor or research team.

Cherrie Ng

CONTACT

[email protected]

+85235051409

Thomas Hui

CONTACT

[email protected]

+85239493549

Sponsors and collaborators

Lead sponsor

Tseung Kwan O Hospital, Hong Kong

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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