An interventional study of Transoral endoscopic thyroidectomy vestibular approach (TOETVA) and Traditional Open Thyroidectomy in Benign Thyroid Nodule and Suspicious Malignant Thyroid Nodule, sponsored by Tseung Kwan O Hospital, Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Tseung Kwan O Hospital, Hong Kong · Not applicable, Interventional, and Treatment
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.
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.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's planned enrollment of 40 is below the median of 75 across 121 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Tseung Kwan O Hospital, Hong Kong is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA)
Procedure: Transoral endoscopic thyroidectomy vestibular approach (TOETVA)
Control group receiving traditional open thyroidectomy
Procedure: Traditional Open Thyroidectomy
Remote access thyroid surgery
Open thyroidectomy via trans-cervical approach
Patient's satisfactory score
Visual analogue scale 0-10
Time frame: Post-operative day 1
Patient's satisfactory score
Visual analogue scale 0-10
Time frame: Post-operative 2 weeks
Patient's satisfactory score
Visual analogue scale 0-10
Time frame: Post-operative 6 months
Post-operative pain
Visual analogue scale 0-10
Time frame: Post-operative day 1
Post-operative pain
Visual analogue scale 0-10
Time frame: Post-operative 2 weeks
Post-operative pain
Visual analogue scale 0-10
Time frame: Post-operative 6 months
Voice quality of life
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Time frame: Post-operative day 1
Voice quality of life
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Time frame: Post-operative 2 weeks
Voice quality of life
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Time frame: Post-operative 6 months
Swallowing quality of life
MD Anderson dysphagia inventory (MDADI)
Time frame: Post-operative day 1
Swallowing quality of life
MD Anderson dysphagia inventory (MDADI)
Time frame: Post-operative 2 weeks
Swallowing quality of life
MD Anderson dysphagia inventory (MDADI)
Time frame: Post-operative 6 months
Complication rate and types
Lower lip numbness, skin bruising or injury, wound infection, vocal cord paralysis, temporary hypoparathyroidism
Time frame: Post-operative 2 weeks
Complication rate and types
Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism
Time frame: Post-operative 6 months
Inpatient stay
Number of days of inpatient stay
Time frame: An average of 0-2 days after the operation
Operative time
Minutes
Time frame: Intra-operatively
Blood loss
Volume
Time frame: Intra-operatively
Rate of conversion to open surgery
Percentage of conversion
Time frame: Intra-operatively
Plan to share: No
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Tseung Kwan O Hospital, Hong Kong