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
About this trial
This is an interventional treatment trial for Thyroid Diseases focused on measuring Thyroid, Thyroidectomy, Transoral, Endoscopic, Surgery
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.
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
NCT ID
NCT03158961
First Posted
May 15, 2017
Last Updated
April 27, 2021
Sponsor
The University of Hong Kong
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
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The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules
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