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

January 25, 2024 updated by: YEUNG WING CHI ZENON, Tseung Kwan O Hospital, Hong Kong
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transoral endoscopic thyroidectomy vestibular approach (TOETVA)
Test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA)
Procedure: Transoral endoscopic thyroidectomy vestibular approach (TOETVA)
Remote access thyroid surgery
Active Comparator: Traditional open surgery
Control group receiving traditional open thyroidectomy
Procedure: Traditional Open Thyroidectomy
Open thyroidectomy via trans-cervical approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's satisfactory score
Time Frame: Post-operative day 1
Visual analogue scale 0-10
Post-operative day 1
Patient's satisfactory score
Time Frame: Post-operative 2 weeks
Visual analogue scale 0-10
Post-operative 2 weeks
Patient's satisfactory score
Time Frame: Post-operative 6 months
Visual analogue scale 0-10
Post-operative 6 months
Post-operative pain
Time Frame: Post-operative day 1
Visual analogue scale 0-10
Post-operative day 1
Post-operative pain
Time Frame: Post-operative 2 weeks
Visual analogue scale 0-10
Post-operative 2 weeks
Post-operative pain
Time Frame: Post-operative 6 months
Visual analogue scale 0-10
Post-operative 6 months
Voice quality of life
Time Frame: Post-operative day 1
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Post-operative day 1
Voice quality of life
Time Frame: Post-operative 2 weeks
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Post-operative 2 weeks
Voice quality of life
Time Frame: Post-operative 6 months
Voice Handicap Index - 30 assessing functional, physical and emotional scales
Post-operative 6 months
Swallowing quality of life
Time Frame: Post-operative day 1
MD Anderson dysphagia inventory (MDADI)
Post-operative day 1
Swallowing quality of life
Time Frame: Post-operative 2 weeks
MD Anderson dysphagia inventory (MDADI)
Post-operative 2 weeks
Swallowing quality of life
Time Frame: Post-operative 6 months
MD Anderson dysphagia inventory (MDADI)
Post-operative 6 months
Complication rate and types
Time Frame: Post-operative 2 weeks
Lower lip numbness, skin bruising or injury, wound infection, vocal cord paralysis, temporary hypoparathyroidism
Post-operative 2 weeks
Complication rate and types
Time Frame: Post-operative 6 months
Lower lip numbness, vocal cord paralysis, permanent hypoparathyroidism
Post-operative 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inpatient stay
Time Frame: An average of 0-2 days after the operation
Number of days of inpatient stay
An average of 0-2 days after the operation
Operative time
Time Frame: Intra-operatively
Minutes
Intra-operatively
Blood loss
Time Frame: Intra-operatively
Volume
Intra-operatively
Rate of conversion to open surgery
Time Frame: Intra-operatively
Percentage of conversion
Intra-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tseung Kwan O Hospital, Hong Kong

Investigators

  • Study Director: Jason YK Chan, Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
  • Principal Investigator: Zenon Yeung, Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Estimated)

January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC/KE-23-0006/FR-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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