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NCT Number: NCT03158961

The Feasibility and Safety of the TOETVA 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.

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Key information

Conditions

Thyroid Diseases Endocrine System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transoral endoscopic thyroidectomy vestibular approach

Procedure

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

Primary outcomes

  1. The complication rate after TOETVA in 12 months

    Time frame: 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 outcomes

  1. The open conversion rate of TOETVA

    Time frame: 12 months

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

  2. The wound infection rate after TOETVA

    Time frame: 12 months

    To record the situation of wound infection after surgery

  3. The hematoma rate after TOETVA

    Time frame: 12 months

    To record the situation of hematoma after surgery

  4. The vocal cord palsy rate after TOETVA

    Time frame: 12 months

    To calculate the vocal cord situation after surgery within 12 months

  5. The hypoparathyroidism rate after TOETVA

    Time frame: 12 months

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

  6. The pain score of patient after TOETVA

    Time frame: 12 months

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

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

    Time frame: 12 months

    The satisfaction in 0-10 scoring after the surgery

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 18, 2017
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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