The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules

NCT03158961 | Completed DMC

• 1 other identifier: UW 17-144
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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. 1.Recruit patients from the clinic.
2. 2.Patients will receive treatment within 3 months
3. 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. 4.Patients will be monitoring by the same team after the study.

Conditions

Thyroid Diseases

Keywords

Thyroid; Thyroidectomy; Transoral; Endoscopic; Surgery

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (7)

• The open conversion rate of TOETVA

  12 months

• The wound infection rate after TOETVA

  12 months

• The hematoma rate after TOETVA

  12 months

• The vocal cord palsy rate after TOETVA

  12 months

• The hypoparathyroidism rate after TOETVA

  12 months

Study Arms (1)

TOETVA

EXPERIMENTAL

a new approach in surgery which can treat the thyroid disease

Procedure: Transoral endoscopic thyroidectomy vestibular approach

Interventions

Transoral endoscopic thyroidectomy vestibular approach PROCEDURE

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

TOETVA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (13)

• 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.

  PMID: 12588812 BACKGROUND

• 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.

  PMID: 17121528 BACKGROUND

• 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.

  PMID: 18633639 BACKGROUND

• 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.

  PMID: 20919522 BACKGROUND

• 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.

  PMID: 16402290 BACKGROUND

• 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.

  PMID: 22720153 BACKGROUND

• 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.

  PMID: 18163167 BACKGROUND

• 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.

  PMID: 19263151 BACKGROUND

• 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.

  PMID: 20035350 BACKGROUND

• 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.

  PMID: 21088839 BACKGROUND

• 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.

  PMID: 26546193 BACKGROUND

• 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.

  PMID: 27834022 BACKGROUND

• 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.

  PMID: 27649533 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Hung Hin, Brian Lang, MBBS(Hons)

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 18, 2017
• Study Start: July 1, 2017
• Primary Completion: May 31, 2019
• Study Completion: July 31, 2019
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)