Actively Recruiting
A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy
Led by Tseung Kwan O Hospital, Hong Kong · Updated on 2024-07-09
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a safe and effective alternative to traditional open thyroidectomy for patients with benign or suspicious malignant thyroid nodules. This prospective case control study involves 40 patients divided into two groups: one receiving TOETVA and the other undergoing conventional open surgery. The study aims to assess surgical outcomes, patient satisfaction, voice quality, and swallowing function. Participants will either have surgery using the TOETVA, which is a remote access procedure through the mouth, or the traditional open thyroidectomy through the neck. The study is non-randomized, assigning 20 patients to each group. Outcomes such as lower lip numbness, skin injury, operation time, blood loss, vocal cord paralysis, and hypoparathyroidism will be monitored. The study also evaluates patient satisfaction and quality of life related to voice and swallowing using specific questionnaires. After surgery, patients will be followed up with assessments on days 1, 14, and 6 months post-operation to measure satisfaction, pain, voice, and swallowing quality of life. Surgical complications will be recorded at 2 weeks and 6 months. Secondary measures include hospital stay duration, operative time, blood loss, and conversion rates to open surgery. The total study duration spans from surgery through 6 months of follow-up.
CONDITIONS
Brief Title
A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Benign thyroid nodule less than 4cm
- Suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery
- Age 18 years or older
You will not qualify if you...
- 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 greater than 2cm
- Presence of another malignancy, lateral neck, or distant metastasis
- Retrosternal goitre
- Cervical spine disease precluding extension of the neck
- Obesity with BMI greater than 35kg/m2
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- Untreated active infection
- Non-correctable coagulopathy
- Emergency surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 0 to 2 days
Participants undergo either transoral endoscopic thyroidectomy vestibular approach (TOETVA) or traditional open thyroidectomy surgery, followed by immediate post-operative care.
1 surgical procedure and inpatient stay of up to 2 days
Duration - 6 months
Participants are monitored for recovery, pain, voice and swallowing quality of life, and any complications after surgery.
Visits on post-operative day 1, 2 weeks, and 6 months
Trial Site Locations
Total: 1 location
1
Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
C
Cherrie Ng
T
Thomas Hui
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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