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

Benign Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06225765
• Other study ID #: KC/KE-23-0006/FR-4
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: January 2024
• Source: Tseung Kwan O Hospital, Hong Kong
• Contact: Cherrie Ng
• Phone: +85235051409
• Email: cherrieng[@]ent.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, voice and swallowing outcomes will be assessed.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 30, 2026
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Thyroid Nodule
• Thyroid Diseases
• Thyroid Nodule

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tseung Kwan O Hospital, Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's satisfactory score	Visual analogue scale 0-10	Post-operative day 1
Primary	Patient's satisfactory score	Visual analogue scale 0-10	Post-operative 2 weeks
Primary	Patient's satisfactory score	Visual analogue scale 0-10	Post-operative 6 months
Primary	Post-operative pain	Visual analogue scale 0-10	Post-operative day 1
Primary	Post-operative pain	Visual analogue scale 0-10	Post-operative 2 weeks
Primary	Post-operative pain	Visual analogue scale 0-10	Post-operative 6 months
Primary	Voice quality of life	Voice Handicap Index - 30 assessing functional, physical and emotional scales	Post-operative day 1
Primary	Voice quality of life	Voice Handicap Index - 30 assessing functional, physical and emotional scales	Post-operative 2 weeks
Primary	Voice quality of life	Voice Handicap Index - 30 assessing functional, physical and emotional scales	Post-operative 6 months
Primary	Swallowing quality of life	MD Anderson dysphagia inventory (MDADI)	Post-operative day 1
Primary	Swallowing quality of life	MD Anderson dysphagia inventory (MDADI)	Post-operative 2 weeks
Primary	Swallowing quality of life	MD Anderson dysphagia inventory (MDADI)	Post-operative 6 months
Primary	Complication rate and types	Lower lip numbness, skin bruising or injury, wound infection, vocal cord paralysis, temporary hypoparathyroidism	Post-operative 2 weeks
Primary	Complication rate and types	Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism	Post-operative 6 months
Secondary	Inpatient stay	Number of days of inpatient stay	An average of 0-2 days after the operation
Secondary	Operative time	Minutes	Intra-operatively
Secondary	Blood loss	Volume	Intra-operatively
Secondary	Rate of conversion to open surgery	Percentage of conversion	Intra-operatively