Retro-Auricular Single-Site Endoscopic to Papillary Thyroid Carcinoma

Study Overview
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Brief Summary
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The goal of this non randomized control clinical research study is to compare the cosmetic outcomes and efficiacy of retro-auricular single-site endoscopic thyroid lobectomy and central lymph node dissection against conventional resection.

Official Title
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Single-center, Prospective, Non-Randomized Control Clinical Trial of Retro-Auricular Single-Site Endoscopic Versus Open Surgery 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: traditional open surgery 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: RASSET 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>* Other names: RASSET;|
| Active Comparator: traditional open thyroid lobectomy group<br>Patients in the traditional open thyroid lobectomy group will receive thyroid lobectomy and central lymph node dissection. | Procedure: traditional open surgery thyroidectomy<br>* The strap muscles were separated in the midline to expose the thyroid gland. 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative cosmetic satisfaction scores | The cosmetic satisfaction score(CSS) was defined as the sum of the scores on questions about the scar. Q1 and Q2 was using a verbal response scale from 1 to 5 (corresponding to decreasing satisfaction). The other four questions, each on a scale of 0 to 3 (again of decreasing satisfaction). | 3 months from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative Vancouver Scar Scale | The Vancouver Scar Scale(VSS) is used for scar assessment. It has six domains: vascularity, pigmentation, pliability, height, pain and itchiness. The maximum score for the sum of the domain scores is 18, which corresponds to the worst scar, while 0 indicates normal skin. | 3 months from surgery | 
| postoperative Vancouver Scar Scale | The Vancouver Scar Scale(VSS) is used for scar assessment. It has six domains: vascularity, pigmentation, pliability, height, pain and itchiness. The maximum score for the sum of the domain scores is 18, which corresponds to the worst scar, while 0 indicates normal skin. | 1 month from surgery | 
| Intra-operative, peri-operative, post-operative clinicopathologic characteristics | Baseline clinicopathologic characteristics of patients | 1 week from surgery | 
| postoperative cosmetic satisfaction scores | The cosmetic satisfaction score(CSS) was defined as the sum of the scores on questions about the scar. Q1 and Q2 was using a verbal response scale from 1 to 5 (corresponding to decreasing satisfaction). The other four questions, each on a scale of 0 to 3 (again of decreasing satisfaction). | 1 month from surgery | 

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