search
Back to results

The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules

Primary Purpose

Thyroid Diseases

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Transoral endoscopic thyroidectomy vestibular approach
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Diseases focused on measuring Thyroid, Thyroidectomy, Transoral, Endoscopic, Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Queen Mary Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TOETVA

Arm Description

a new approach in surgery which can treat the thyroid disease

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The open conversion rate of TOETVA
To record any cases which need to apply open surgery necessary during the procedure of TOETVA
The wound infection rate after TOETVA
To record the situation of wound infection after surgery
The hematoma rate after TOETVA
To record the situation of hematoma after surgery
The vocal cord palsy rate after TOETVA
To calculate the vocal cord situation after surgery within 12 months
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
The pain score of patient after TOETVA
The pain scoring with 0-10 to assess the pain level of having TOETVA
The satisfaction of patients after having TOETVA in 12 months
The satisfaction in 0-10 scoring after the surgery

Full Information

First Posted
May 15, 2017
Last Updated
April 27, 2021
Sponsor
The University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT03158961
Brief Title
The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Diseases
Keywords
Thyroid, Thyroidectomy, Transoral, Endoscopic, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TOETVA
Arm Type
Experimental
Arm Description
a new approach in surgery which can treat the thyroid disease
Intervention Type
Procedure
Intervention Name(s)
Transoral endoscopic thyroidectomy vestibular approach
Intervention Description
TOVETA is a new approach in surgery of thyroidectomy no longer open on the neck
Primary Outcome Measure Information:
Title
The complication rate after TOETVA in 12 months
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The open conversion rate of TOETVA
Description
To record any cases which need to apply open surgery necessary during the procedure of TOETVA
Time Frame
12 months
Title
The wound infection rate after TOETVA
Description
To record the situation of wound infection after surgery
Time Frame
12 months
Title
The hematoma rate after TOETVA
Description
To record the situation of hematoma after surgery
Time Frame
12 months
Title
The vocal cord palsy rate after TOETVA
Description
To calculate the vocal cord situation after surgery within 12 months
Time Frame
12 months
Title
The hypoparathyroidism rate after TOETVA
Description
To record the thyroid function from blood test in 12 months after surgery and calculate the rate of hypo-parathyroid function
Time Frame
12 months
Title
The pain score of patient after TOETVA
Description
The pain scoring with 0-10 to assess the pain level of having TOETVA
Time Frame
12 months
Title
The satisfaction of patients after having TOETVA in 12 months
Description
The satisfaction in 0-10 scoring after the surgery
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung Hin, Brian Lang, MBBS(Hons)
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12588812
Citation
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.
Results Reference
background
PubMed Identifier
17121528
Citation
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.
Results Reference
background
PubMed Identifier
18633639
Citation
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.
Results Reference
background
PubMed Identifier
20919522
Citation
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.
Results Reference
background
PubMed Identifier
16402290
Citation
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.
Results Reference
background
PubMed Identifier
22720153
Citation
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.
Results Reference
background
PubMed Identifier
18163167
Citation
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.
Results Reference
background
PubMed Identifier
19263151
Citation
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.
Results Reference
background
PubMed Identifier
20035350
Citation
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.
Results Reference
background
PubMed Identifier
21088839
Citation
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.
Results Reference
background
PubMed Identifier
26546193
Citation
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.
Results Reference
background
PubMed Identifier
27834022
Citation
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.
Results Reference
background
PubMed Identifier
27649533
Citation
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.
Results Reference
background

Learn more about this trial

The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules

We'll reach out to this number within 24 hrs