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Thyroid DiseasesNCT03158961

The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules

A study testing Transoral endoscopic thyroidectomy vestibular approach in people with Thyroid Diseases, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Thyroid surgery has been developed as a new technique for zero scar in surgery by applying transoral endoscopic thyroidectomy with sublingual approach. The new technique is locating the surgery which pierced through floor of mouth, cause severe tissue damage, high complication, and conversion rates to open surgery and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Diseases
What is being tested?
Transoral endoscopic thyroidectomy vestibular approach
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteHong Kong
Study dates
1 Jul 2017to 31 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • have a cyst, nodule or a goiter which has been shown to be benign on fine needle aspiration cytology,
  • need to undergo a unilateral thyroid resection,
  • have a nodule size no larger than 4cm in largest diameter,
  • willing to undergo this new approach rather than the traditional open approach.

Who cannot join

  • unfit for surgery,
  • has had previous surgery or radiation at the neck,
  • unable to tolerate a general anesthesia,
  • wearing dental braces,
  • absence of vocal cord mobility at laryngoscopy.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Prospective Evaluation of the Feasibility and Safety of the Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) as a Treatment for Benign Thyroid Nodules

Thyroid surgery has been developed as a new technique for zero scar in surgery by applying transoral endoscopic thyroidectomy with sublingual approach. The new technique is locating the surgery which pierced through floor of mouth, cause severe tissue damage, high complication, and conversion rates to open surgery and surgical difficulties due to limitation of movement. Nevertheless, each report is still including small number of patients. Recently, the transoral endoscopic thyroidectomy vestibular approach (TOETVA) has been proven feasible and safe in several overseas centers. Moreover, a successful TOETVA case was reported in local media in the late last year. Hence, this study is for evaluating the feasibility and safety of the TOETVA prospectively at a tertiary referral center in Hong Kong.

The following are the procedure of the study:

  1. Recruit patients from the clinic.
  2. Patients will receive treatment within 3 months
  3. Patients will have different assessments like Ultrasonography assessment, Fine needle biopsy, Direct laryngoscopy, and Cosmectic scoring in Pre-operation, post-operation 2 week, post 1 month, post 3 month, post 6 month and post 12 month.
  4. Patients will be monitoring by the same team after the study.
Being tested
Transoral endoscopic thyroidectomy vestibular approach
Keywords
Thyroid, Thyroidectomy, Transoral, Endoscopic, Surgery
Medical subject headings
Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transoral endoscopic thyroidectomy vestibular approachProcedure or surgery

    TOVETA is a new approach in surgery of thyroidectomy no longer open on the neck

Study groups in NCT03158961
Study groupRoleWhat they receive
TOETVAExperimentala new approach in surgery which can treat the thyroid disease
Receives: Procedure: Transoral endoscopic thyroidectomy vestibular approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The complication rate after TOETVA in 12 months

    To record any complication of surgery in every post-operation visit after 12 months. The record will be used for the calculation of complication rate.

    Measured: 12 months

Secondary outcomes (7)

  1. The open conversion rate of TOETVA

    To record any cases which need to apply open surgery necessary during the procedure of TOETVA

    Measured: 12 months

  2. The wound infection rate after TOETVA

    To record the situation of wound infection after surgery

    Measured: 12 months

  3. The hematoma rate after TOETVA

    To record the situation of hematoma after surgery

    Measured: 12 months

  4. The vocal cord palsy rate after TOETVA

    To calculate the vocal cord situation after surgery within 12 months

    Measured: 12 months

  5. The hypoparathyroidism rate after TOETVA

    To record the thyroid function from blood test in 12 months after surgery and calculate the rate of hypo-parathyroid function

    Measured: 12 months

  6. The pain score of patient after TOETVA

    The pain scoring with 0-10 to assess the pain level of having TOETVA

    Measured: 12 months

  7. The satisfaction of patients after having TOETVA in 12 months

    The satisfaction in 0-10 scoring after the surgery

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2017
  2. Study start1 Jul 2017
  3. Primary completion31 May 2019
  4. Study completion31 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03158961
Sponsor's protocol ID
UW 17-144
Status last verified
Apr 2021
First submitted
15 May 2017
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hegedus L, Bonnema SJ, Bennedbaek FN. Management of simple nodular goiter: current status and future perspectives. Endocr Rev. 2003 Feb;24(1):102-32. doi: 10.1210/er.2002-0016.

    PubMed 12588812

  • Erdogan MF, Gursoy A, Erdogan G. Natural course of benign thyroid nodules in a moderately iodine-deficient area. Clin Endocrinol (Oxf). 2006 Dec;65(6):767-71. doi: 10.1111/j.1365-2265.2006.02664.x.

    PubMed 17121528

  • Bergenfelz A, Jansson S, Kristoffersson A, Martensson H, Reihner E, Wallin G, Lausen I. Complications to thyroid surgery: results as reported in a database from a multicenter audit comprising 3,660 patients. Langenbecks Arch Surg. 2008 Sep;393(5):667-73. doi: 10.1007/s00423-008-0366-7. Epub 2008 Jul 17.

    PubMed 18633639

  • Lang BH. Minimally invasive thyroid and parathyroid operations: surgical techniques and pearls. Adv Surg. 2010;44:185-98. doi: 10.1016/j.yasu.2010.05.012.

    PubMed 20919522

  • Rattner D, Kalloo A; ASGE/SAGES Working Group. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery. October 2005. Surg Endosc. 2006 Feb;20(2):329-33. doi: 10.1007/s00464-005-3006-0. No abstract available.

    PubMed 16402290

  • Clark MP, Qayed ES, Kooby DA, Maithel SK, Willingham FF. Natural orifice translumenal endoscopic surgery in humans: a review. Minim Invasive Surg. 2012;2012:189296. doi: 10.1155/2012/189296. Epub 2012 Jun 6.

    PubMed 22720153

  • Witzel K, von Rahden BH, Kaminski C, Stein HJ. Transoral access for endoscopic thyroid resection. Surg Endosc. 2008 Aug;22(8):1871-5. doi: 10.1007/s00464-007-9734-6. Epub 2007 Dec 28.

    PubMed 18163167

  • Benhidjeb T, Wilhelm T, Harlaar J, Kleinrensink GJ, Schneider TA, Stark M. Natural orifice surgery on thyroid gland: totally transoral video-assisted thyroidectomy (TOVAT): report of first experimental results of a new surgical method. Surg Endosc. 2009 May;23(5):1119-20. doi: 10.1007/s00464-009-0347-0. Epub 2009 Mar 5.

    PubMed 19263151

  • Wilhelm T, Metzig A. Video. Endoscopic minimally invasive thyroidectomy: first clinical experience. Surg Endosc. 2010 Jul;24(7):1757-8. doi: 10.1007/s00464-009-0820-9. Epub 2009 Dec 25.

    PubMed 20035350

  • Wilhelm T, Metzig A. Endoscopic minimally invasive thyroidectomy (eMIT): a prospective proof-of-concept study in humans. World J Surg. 2011 Mar;35(3):543-51. doi: 10.1007/s00268-010-0846-0.

    PubMed 21088839

  • Anuwong A. Transoral Endoscopic Thyroidectomy Vestibular Approach: A Series of the First 60 Human Cases. World J Surg. 2016 Mar;40(3):491-7. doi: 10.1007/s00268-015-3320-1.

    PubMed 26546193

  • Inabnet WB 3rd, Suh H, Fernandez-Ranvier G. Transoral endoscopic thyroidectomy vestibular approach with intraoperative nerve monitoring. Surg Endosc. 2017 Jul;31(7):3030. doi: 10.1007/s00464-016-5322-y. Epub 2016 Nov 10.

    PubMed 27834022

  • Udelsman R, Anuwong A, Oprea AD, Rhodes A, Prasad M, Sansone M, Brooks C, Donovan PI, Jannitto C, Carling T. Trans-oral Vestibular Endocrine Surgery: A New Technique in the United States. Ann Surg. 2016 Dec;264(6):e13-e16. doi: 10.1097/SLA.0000000000002001. No abstract available.

    PubMed 27649533

Questions about this trial

What is this clinical trial studying?

A study testing Transoral endoscopic thyroidectomy vestibular approach in people with Thyroid Diseases, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The complication rate after TOETVA in 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03158961, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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