Comparative Study in Oral, Breast Approach and Open Thyroidectomy

Study Overview
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Brief Summary
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Purpose: Total endoscopic thyroidectomy including oral approach and breast approach has excellent cosmetic and several functional results. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. The procedure of total endoscopic thyroidectomy by breast approach only left three incisions, while by oral approach did not leave any incisions in the body surface, which is scarless in the neck, involved with a higher cosmetic result. However, the long-term property evaluation of total endoscopic thyroidectomy was not confirmed. The purpose of our study was to evaluate the surgical results of total endoscopic thyroidectomy (transoral approach and breast approach) versus conventional open thyroidectomy.

Detailed Description
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Purpose: Total endoscopic thyroidectomy including oral approach and breast approach has excellent cosmetic and several functional results. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Transoral endoscopic thyroidectomy via vestibular approach (TOETVA) and endoscopic thyroidectomy via breast approach were routinely performed in our institute. The procedures of total endoscopic thyroidectomy by breast approach only left three incisions, while by oral approach did not leave any incisions in the body surface, which is scarless in the neck, involved with a higher cosmetic result. However, the comprehensive comparison between transoral approach, breast approach and conventional open method was not confirmed. The purpose of our study was to evaluate the surgical results of total endoscopic thyroidectomy (transoral approach and breast approach) versus conventional open thyroidectomy.

Official Title
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Comparative Study of Surgical Results in Endoscopic Thyroidectomy Via Oral Approach, Via Breast Approach and Conventional Open Thyroidectomy

Conditions
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Thyroid Neoplasms

Intervention / Treatment
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* Procedure: Thyroid Surgical Methods


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 15 55 years old; Type: Differentiated thyroid carcinoma, diameter ≤ 2cm, cN0 or cN1a, M0; Thyroid lobe was less than the second degree enlargement; Thyroid benign goiter, and the diameter ≤ 6cm Exclusion Criteria: Combine the surgical history of mandibular, oral, facial, or neck; It was shown by preoperative radiological examination that the thyroid cancer has local invasion, N1b, or distant metastasis. Thyroid lobe was more than the third degree enlargement Any medical history that probably interfere the test results or increase the disease risks The patient's compliance is not very well, and cannot work as the doctors asked

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional Open<br>Conventional open thyroidectomy group (thyroid neoplasms patients who underwent conventional thyroidectomy procedure with or without postoperative central node dissection) | Procedure: Thyroid Surgical Methods<br>* Different methods of thyroid surgery, including conventional open thyroidectomy, transoral endoscopic thyroidectomy via vestibular approach, and endoscopic thyroidectomy via breast approach.<br>|
| Transoral Endoscopic Surgery<br>Transoral endoscopic thyroidectomy via vestibular approach group (thyroid neoplasms patients who underwent conventional thyroidectomy procedure with or without postoperative central node dissection) | Procedure: Thyroid Surgical Methods<br>* Different methods of thyroid surgery, including conventional open thyroidectomy, transoral endoscopic thyroidectomy via vestibular approach, and endoscopic thyroidectomy via breast approach.<br>|
| Endoscopic Thyroidectomy via Breast<br>Endoscopic thyroidectomy via breast approach or bilateral areola approach group (thyroid neoplasms patients who underwent conventional thyroidectomy procedure with or without postoperative central node dissection) | Procedure: Thyroid Surgical Methods<br>* Different methods of thyroid surgery, including conventional open thyroidectomy, transoral endoscopic thyroidectomy via vestibular approach, and endoscopic thyroidectomy via breast approach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment postoperatively | Physicians Global Assessment to measure quality of life was performed, and the assessment form had been verified. | 12 months after the surgery of thyroidectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic results of thyroidectomy postoperatively | Visual Analog Score (1-10) for the cosmetic results (evaluated by patients) was been performed. | 12 months after the surgery of thyroidectomy | 
| Surgical Complications of thyroidectomy postoperatively | The rates (percentage) of surgical complications (transient or permanent Recurrent Laryngeal Nerve paralysis, transient or permanent hypoparathyroidism, Postoperative hemorrhage) | 12 months after the surgery of thyroidectomy | 
| Surgical Completeness of thyroidectomy postoperatively | The rates (percentage) of surgical completeness (whether or not any thyroid associated tissues left by the examination of ultrasound and Iodine-131) | 12 months after the surgery of thyroidectomy |