Clinical trial NCT03158961: 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
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Diseases
Keywords: Thyroid
Thyroidectomy
Transoral
Endoscopic
Surgery
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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.


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.

Primary outcomes:
measure: The complication rate after TOETVA in 12 months
timeFrame: 12 months
Secondary outcomes:
measure: The open conversion rate of TOETVA
timeFrame: 12 months
measure: The wound infection rate after TOETVA
timeFrame: 12 months
measure: The hematoma rate after TOETVA
timeFrame: 12 months
measure: The vocal cord palsy rate after TOETVA
timeFrame: 12 months
measure: The hypoparathyroidism rate after TOETVA
timeFrame: 12 months
measure: The pain score of patient after TOETVA
timeFrame: 12 months
measure: The satisfaction of patients after having TOETVA in 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Hung Hin, Brian Lang, MBBS(Hons)
role: PRINCIPAL_INVESTIGATOR
References:
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