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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05263141
Other study ID # B2022-012-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date December 30, 2023

Study information

Verified date December 2023
Source Sun Yat-sen University
Contact Dian Ouyang
Phone +86-20-87343302
Email ouyd@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Procedure:
retro-auricular single-site endoscopic thyroidectomy
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.
traditional open surgery thyroidectomy
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.

Locations

Country Name City State
China Sun Yat-Sen University Cancer Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (11)

Anuwong A, Ketwong K, Jitpratoom P, Sasanakietkul T, Duh QY. Safety and Outcomes of the Transoral Endoscopic Thyroidectomy Vestibular Approach. JAMA Surg. 2018 Jan 1;153(1):21-27. doi: 10.1001/jamasurg.2017.3366. — View Citation

Berber E, Bernet V, Fahey TJ 3rd, Kebebew E, Shaha A, Stack BC Jr, Stang M, Steward DL, Terris DJ; American Thyroid Association Surgical Affairs Committee. American Thyroid Association Statement on Remote-Access Thyroid Surgery. Thyroid. 2016 Mar;26(3):331-7. doi: 10.1089/thy.2015.0407. — View Citation

Chung EJ, Park MW, Cho JG, Baek SK, Kwon SY, Woo JS, Jung KY. A prospective 1-year comparative study of endoscopic thyroidectomy via a retroauricular approach versus conventional open thyroidectomy at a single institution. Ann Surg Oncol. 2015 Sep;22(9):3014-21. doi: 10.1245/s10434-014-4361-7. Epub 2015 Jan 21. — View Citation

Dong F, Ao Y, Li MT, Zhan ZR, Lin YQ, Tan QJ, Li H, Yang AK, Ouyang D. [A comparative study between retro-auricular single-site endoscopic thyroidectomy and transoral endoscopic thyroidectomy vestibular approach: a single-center retrospective analysis]. Zhonghua Wai Ke Za Zhi. 2021 Nov 1;59(11):891-896. doi: 10.3760/cma.j.cn112139-20210903-00420. Chinese. — View Citation

Duek I, Duek OS, Fliss DM. Minimally Invasive Approaches for Thyroid Surgery-Pitfalls and Promises. Curr Oncol Rep. 2020 Jun 29;22(8):77. doi: 10.1007/s11912-020-00939-2. — View Citation

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

Nakajo A, Arima H, Hirata M, Mizoguchi T, Kijima Y, Mori S, Ishigami S, Ueno S, Yoshinaka H, Natsugoe S. Trans-Oral Video-Assisted Neck Surgery (TOVANS). A new transoral technique of endoscopic thyroidectomy with gasless premandible approach. Surg Endosc. 2013 Apr;27(4):1105-10. doi: 10.1007/s00464-012-2588-6. Epub 2012 Nov 21. — View Citation

Nguyen HX, Nguyen HX, Nguyen HV, Nguyen LT, Nguyen TTP, Le QV. Transoral Endoscopic Thyroidectomy by Vestibular Approach with Central Lymph Node Dissection for Thyroid Microcarcinoma. J Laparoendosc Adv Surg Tech A. 2021 Apr;31(4):410-415. doi: 10.1089/lap.2020.0411. Epub 2020 Jul 17. — View Citation

Russell JO, Razavi CR, Al Khadem MG, Lopez M, Saraf S, Prescott JD, Starmer HM, Richmon JD, Tufano RP. Anterior cervical incision-sparing thyroidectomy: Comparing retroauricular and transoral approaches. Laryngoscope Investig Otolaryngol. 2018 Sep 24;3(5):409-414. doi: 10.1002/lio2.200. eCollection 2018 Oct. — View Citation

Schardey HM, Barone M, Portl S, von Ahnen M, von Ahnen T, Schopf S. Invisible scar endoscopic dorsal approach thyroidectomy: a clinical feasibility study. World J Surg. 2010 Dec;34(12):2997-3006. doi: 10.1007/s00268-010-0769-9. — View Citation

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 allClick here to view all references

Outcome

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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