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

ConditionsBenign Thyroid NoduleSuspicious Malignant Thyroid Nodule
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTseung Kwan O Hospital, Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Benign thyroid nodule less than 4cm

Suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery

Disqualifiers

Patients under 18 years old

Contraindication to general anaesthesia

Vulnerable population (e.g. Cognitive impairment, pregnant)

Previous anterior neck surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transoral endoscopic thyroidectomy vestibular approach (TOETVA)

    Procedure/Surgery

    Remote access thyroid surgery

  • Traditional Open Thyroidectomy

    Procedure/Surgery

    Open thyroidectomy via trans-cervical approach

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Transoral endoscopic thyroidectomy vestibular approach (TOETVA)Experimental treatment 1 intervention
Group B: Traditional open surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient's satisfactory score

Visual analogue scale 0-10

Time frame
Post-operative day 1
2

Patient's satisfactory score

Visual analogue scale 0-10

Time frame
Post-operative 2 weeks
3

Patient's satisfactory score

Visual analogue scale 0-10

Time frame
Post-operative 6 months
4

Post-operative pain

Visual analogue scale 0-10

Time frame
Post-operative day 1

Secondary outcomes

1

Inpatient stay

Number of days of inpatient stay

Time frame
An average of 0-2 days after the operation
2

Operative time

Minutes

Time frame
Intra-operatively
3

Blood loss

Volume

Time frame
Intra-operatively
4

Rate of conversion to open surgery

Percentage of conversion

Time frame
Intra-operatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tseung Kwan O Hospital, Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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