Clinical trial NCT06225765: A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy
Official title: A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Thyroid Nodule
Suspicious Malignant Thyroid Nodule
Keywords: Thyroid nodule
Lead sponsor: Tseung Kwan O Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective case control study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient's satisfactory score
timeFrame: Post-operative day 1
measure: Patient's satisfactory score
timeFrame: Post-operative 2 weeks
measure: Patient's satisfactory score
timeFrame: Post-operative 6 months
measure: Post-operative pain
timeFrame: Post-operative day 1
measure: Post-operative pain
timeFrame: Post-operative 2 weeks
measure: Post-operative pain
timeFrame: Post-operative 6 months
measure: Voice quality of life
timeFrame: Post-operative day 1
measure: Voice quality of life
timeFrame: Post-operative 2 weeks
measure: Voice quality of life
timeFrame: Post-operative 6 months
measure: Swallowing quality of life
timeFrame: Post-operative day 1
measure: Swallowing quality of life
timeFrame: Post-operative 2 weeks
measure: Swallowing quality of life
timeFrame: Post-operative 6 months
measure: Complication rate and types
timeFrame: Post-operative 2 weeks
measure: Complication rate and types
timeFrame: Post-operative 6 months
Secondary outcomes:
measure: Inpatient stay
timeFrame: An average of 0-2 days after the operation
measure: Operative time
timeFrame: Intra-operatively
measure: Blood loss
timeFrame: Intra-operatively
measure: Rate of conversion to open surgery
timeFrame: Intra-operatively
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital
Study officials:
affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
name: Jason YK Chan
role: STUDY_DIRECTOR
affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
name: Zenon Yeung
role: PRINCIPAL_INVESTIGATOR
References: