Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy

Study Overview
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Brief Summary
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The purpose of this study is to compare the therapeutic effects between the axillary bilateral-breast approach (ABBA) and bilateral axillo-breast approach (BABA) for robotic thyroidectomy.To explore the efficacy, safety, cosmetic results and clinical value by the two approaches.

Detailed Description
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Although several reports on operative outcomes of the robotic technique have appeared, no prospective trials comparing the clinical results of between the axillary bilateral-breast approach (ABBA) and bilateral axillo-breast approach (BABA) for robotic thyroidectomy have been described. The investigators therefore designed a prospective trial comparing outcomes, including surgical outcomes and patient satisfaction, between patients undergoing robotic and conventional open thyroidectomy.

Official Title
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Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy

Conditions
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Thyroid Papillary Carcinoma, Thyroidectomy

Intervention / Treatment
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* Procedure: The Axillary Bilateral-breast Approach
* Procedure: The bilateral Axillo-breast Approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the initial surgery preoperative needle aspiration biopsy of thyroid cancer, and the diameter of no more than 1cm, no lateral neck lymph node metastasis the tumor is confined to the thyroid membrane, not invading trachea and recurrent laryngeal nerve intraoperative frozen section diagnosis of thyroid cancer the patient informed consent. Exclusion Criteria: high-frequency ultrasound preoperative tumor diameter greater than 1cm, or lateral neck lymph node metastasis in patients there had been a history of thyroid surgery or neck radiation therapy pregnant or lactating women with severe Hashimoto's thyroiditis, thyroid volume greater than II ° coagulation disorders, hyperthyroidism or hypothyroidism patients sternal goiter.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Axillary Bilateral-breast Approach (ABBA) group<br>All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent. | Procedure: The Axillary Bilateral-breast Approach<br> <br> |
| Experimental: The bilateral Axillo-breast Approach (BABA) group<br>All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent. | Procedure: The bilateral Axillo-breast Approach<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of VAS Pain Scores for the First 24 Hours | The visual analogue scale is utilized to assess the postoperative pain change for the first 24 hours.Using a 10cm straight line, one end is marked 0 for pain free and the other end is marked 10 for unbearable pain. The pain intensity of the patient's own feelings was marked on a straight line, and the length from 0 to the marked point represented the pain level of the patient. The evaluation criteria of VAS were as follows: 0 for pain, 3 for mild pain, 4 to 6 for moderate pain and 7 to 10 for severe pain.Lower values represent better outcomes, higher values represent worse outcomes. | The pain scores of 2pm, 10pm and 6am on the first day after operation were evaluated.The mean values were calculated and recorded. | 
| Cosmetic Outcomes | The satisfaction with cosmetic outcomes was analyzed quantitatively using a scoring system that ranged from 1 to 4(1, extremely; 2, fairly; 3, normal; 4: not at all) that was rated by patients at the outpatient clinic 3 months after the operation. | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Voice | We have developed a questionnaire with a total of 30 questions, each with a score of 4, and the patients scored according to their own situation. The highest score of the questionnaire is 120, the lowest score is 0, the best, the score is 0-30, 30-60 is good, 60-90 is normal, 90-120 is poor. | After operation 8 a.m. on the 7th day | 
| Swallowing Evaluation | The patient sat upright and drank 30 ml warm boiled water to observe the time required and the cough. score (excellent) can swallow water smoothly once score (good) more than 2 times, can swallow without coughing score (middle) can swallow once, but have a choking cough score (may) more than 2 times swallowing, but with choking cough score (difference) frequent cough, not all swallowing Calculate the average value for statistical analysis | 8 a.m. on the 3rd day after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic thyroidectomy, Robotic central neck dissection, Axillary bilateral-breast approach, Bilateral axillo-breast approach