Comparative Study of Robot BABA Approach and Chest Breast Approach for Lateral Neck Dissection

Study Overview
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Brief Summary
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Objective to compare the advantages and disadvantages of robotic and conventional endoscopic thyroidectomy for thyroid cancer.

Detailed Description
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To compare the difference of operative time and complication between two operative methods in robot neck surgery and routine endoscopic surgery.

Official Title
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A Comparative Study of Robot Assisted BABA Approach and Chest Breast Approach for Lateral Neck Dissection

Conditions
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Thyroid Carcinoma, Robot Surgery, Endoscopic Surgery

Intervention / Treatment
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* Device: Robot
* Device: Total endoscopic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: papillary thyroid carcinoma with clinically suspected or confirmed lateral lymph node metastasis; patient's concerns of neck scars and cosmetic requirement. The exclusion criteria were as follows: 1) tumor size >4cm; 2) previous neck surgical history； 3）residual or recurrent tumors; 4) suspicious primary tumor or metastatic lymph node invasion of major vascular structures or recurrent laryngeal nerve. 5）metastatic lymph nodes occurred below the sternoclavicular joint.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot lateral neck lymph node dissection<br>Robot neck lateral lymph node dissection was performed in patients with thyroid cancer and lateral cervical lymph node metastasis. | Device: Robot<br>* Robot lateral neck lymph node dissection<br>* Other names: Robot lateral neck lymph node dissection;|
| Experimental: Total endoscopic lateral cervical lymph node dissection<br>Patients with thyroid cancer and lateral cervical lymph node metastases underwent total endoscopic neck dissection. | Device: Total endoscopic<br>* Total endoscopic lateral cervical lymph node dissection<br>* Other names: Total endoscopic lateral cervical lymph node dissection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lateral cervical lymph node cleaning time | Lateral cervical lymph node clean time from that beginning of cut the SCM leading edge to the end of the specimen | During surgery | 
| Accessory nerve injury | Accessory nerve injury | During surgery | 
| Intraoperative internal jugular vein bleeding. | Internal carotid vein hemorrhage affect that surgical procedure | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of the thyroid gland removal | The time of the thyroid gland removal , including the opening of the white line to the thyroid, and the end of the specimen | During surgery | 
| Number of participants with HypoParathyroidism | The parathyroid function was examined six months after surgery. | 6 months after surgery | 
| Recurrent laryngeal nerve injury. | The recurrent laryngeal nerve function due to nerve injury or thermal damage can not be recovered for 6 months. | 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid carcinoma, Robot surgery, Endoscopic surgery