Benign Thyroid Nodule, Suspicious Malignant Thyroid Nodule
Conditions
Keywords
Thyroid nodule
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, 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
PROCEDURETransoral endoscopic thyroidectomy vestibular approach (TOETVA)
Remote access thyroid surgery
PROCEDURETraditional Open Thyroidectomy
Open thyroidectomy via trans-cervical approach
Sponsors
Tseung Kwan O Hospital, Hong Kong
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective case control study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate and types | Post-operative 2 weeks | Lower lip numbness, skin bruising or injury, wound infection, vocal cord paralysis, temporary hypoparathyroidism |
| Patient's satisfactory score | Post-operative day 1 | Visual analogue scale 0-10 |
| Post-operative pain | Post-operative day 1 | Visual analogue scale 0-10 |
| Voice quality of life | Post-operative day 1 | Voice Handicap Index - 30 assessing functional, physical and emotional scales |
| Swallowing quality of life | Post-operative day 1 | MD Anderson dysphagia inventory (MDADI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Intra-operatively | Minutes |
| Blood loss | Intra-operatively | Volume |
| Rate of conversion to open surgery | Intra-operatively | Percentage of conversion |
| Inpatient stay | An average of 0-2 days after the operation | Number of days of inpatient stay |
Countries
Hong Kong
Contacts
Primary ContactCherrie Ng
Backup ContactThomas Hui
Outcome results
None listed