Papillary Thyroid Carcinoma Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Age 18-70 years old, no gender restrictions. 2. Fine-needle aspiration cytology(FNA) confirmed papillary thyroid carcinoma(PTC). 3. Early stage PTC (stage T1N0M0). 4. 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. 5. Patients undergoing thyroid lobectomy and central lymph node dissection. 6. Patients who have signed an approved Informed Consent. Exclusion Criteria: 1. Patients who do not accept case data collection for various reasons. 2. The clinical data unfit this study (at the discretion of the investigator). 3. Patients who have undergone neck surgery or radiotherapy before this trail. 4. Patients who have uncontrolled hyperthyroidism. |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
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Lee DW, Ko SH, Song CM, Ji YB, Kim JK, Tae K. Comparison of postoperative cosmesis in transaxillary, postauricular facelift, and conventional transcervical thyroidectomy. Surg Endosc. 2020 Aug;34(8):3388-3397. doi: 10.1007/s00464-019-07113-1. Epub 2019 Sep 12. — View Citation
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Schardey HM, Schopf S, Kammal M, Barone M, Rudert W, Hernandez-Richter T, Portl S. Invisible scar endoscopic thyroidectomy by the dorsal approach: experimental development of a new technique with human cadavers and preliminary clinical results. Surg Endosc. 2008 Apr;22(4):813-20. doi: 10.1007/s00464-008-9761-y. Epub 2008 Feb 23. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Intra-operative, peri-operative, post-operative clinicopathologic characteristics | Baseline clinicopathologic characteristics of patients | 1 week from surgery | |
Secondary | 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 |
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