Safety of Endoscopic Thyroidectomy Via Retro-Auricular Single-Site Approach, Transoral Approach and Transareola

Study Overview
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Brief Summary
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The goal of this retrospective study is to compare the safety and efficiacy of endoscopic thyroidectomy via retro-auricular single-site approach, transoral endoscopic thyroidectomy vestibular approach and transareola approach.

Official Title
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Single-center, Retrospective Study of Retro-Auricular Single-Site Endoscopic, Transoral Endoscopic Thyroidectomy Vestibular Approach and Transareola Endoscopic Thyroidectomy in Patients With Early Stage Papillary Thyroid Carcinoma

Conditions
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Papillary Thyroid Carcinoma

Intervention / Treatment
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* Procedure: Retro-Auricular Single-Site Endoscopic Thyroidectomy
* Procedure: Transoral Endoscopic Thyroidectomy Vestibular Approach
* Procedure: Transareola Endoscopic Thyroidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 years old, no gender restrictions. Fine-needle aspiration cytology(FNA) confirmed papillary thyroid carcinoma(PTC). Early stage PTC (stage T1N0M0). Preoperative ultrasonography showed unilateral glandular lobe malignant tumor and the largest diameter was not more than 2cm, without cervical lymph node metastasis and extensive metastasis. Patients undergoing thyroid lobectomy and central lymph node dissection. Patients who have signed an approved Informed Consent. Exclusion Criteria: Patients who do not accept case data collection for various reasons. The clinical data unfit this study (at the discretion of the investigator). Patients who have undergone neck surgery or radiotherapy before this trail. Patients who have uncontrolled hyperthyroidism.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retro-Auricular Single-Site Endoscopic Thyroidectomy group<br>Patients in the retro-auricular single-site endoscopic thyroidectomy (RASSET) group will receive endoscopic thyroid lobectomy and central lymph node dissection. | Procedure: Retro-Auricular Single-Site Endoscopic Thyroidectomy<br>* The strap muscles and the sternocleidomastoid muscle were separated. Upper parathyroid and lower parathyroid glands were identified and preserved. The recurrent laryngeal nerve (RLN) was identified，A lobe of thyroid specimen and central lymph nodes were dissected.<br>|
| Active Comparator: Transoral Endoscopic Thyroidectomy Vestibular Approach group<br>Patients in the Transoral Endoscopic Thyroidectomy Vestibular Approach group will receive endoscopic thyroid lobectomy and central lymph node dissection. | Procedure: Transoral Endoscopic Thyroidectomy Vestibular Approach<br>* The patient was placed in a supine position with slight neck extension under nasotracheal intubation. The mouth was garbled with povidone iodine before surgery. Three laparoscopic ports (a 10- to 15-mm port at midline and two 5-mm ports at the lateral junction between the canine and first premolar teeth)were inserted under the lower lip at the oral vestibular area.The strap muscleswere separated in the midline to expose the thyroid and trachea. The recurrent laryngeal nerve (RLN) was identified at the insertion to the larynx, then followed downandparallel tothe trachea inferiorly.<br>|
| Active Comparator: Transareola Endoscopic Thyroidectomy group<br>Patients in the Transareola Endoscopic Thyroidectomy group will receive endoscopic thyroid lobectomy and central lymph node dissection. | Procedure: Transareola Endoscopic Thyroidectomy<br>* The patient was in supine position. Incision was made inside the right areola and a 10mm puncture device was placed, subcutaneous separation rod was used to separate the space, and a 30° endoscope was introduced, puncture device was placed in a 5mm incision on the left areola, ultrasonic knife free flap was used, subcutaneous separation space was placed in the upper sternal segment, and a 5mm puncture device was placed outside the right areola. The anterior cervical flap was further dissociated to establish a space. The median cervical line was cut to cut off the isthmus of the thyroid, and the tracheal fascia ligament of the thyroid was separated and the nerve was exposed to protect the nerves. Then remove the lobe of thyroid and central lymph nodes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein，CRP | the level of CRP before and after operation | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Amyloid A，SAA | the level of CRP before and after operation | 1 week | 
| blood loss | The volume of blood loss during operation | 1 week | 
| VAS pain score | Postoperative VAS score was recorded | 2 days after operation | 
| number of lymph nodes | Postoperative specimen Postoperative specimen Postoperative specimen Postoperative specimen the number of lymph nodes in postoperative specimens | 1 week after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Papillary Thyroid Carcinoma Laparoscopy, Endoscopic Thyroidectomy, Retroauricular Single-site approach, Transoral Endoscopic Thyroidectomy Vestibular Approach, Transareola Endoscopic Thyroidectomy