Safety of Endoscopic Thyroidectomy Via Retro-Auricular Single-Site Approach, Transoral Approach and Transareola

Not Applicable

Completed

• Conditions: Papillary Thyroid Carcinoma
• Interventions: Procedure: Transareola Endoscopic Thyroidectomy; Procedure: Retro-Auricular Single-Site Endoscopic Thyroidectomy; Procedure: Transoral Endoscopic Thyroidectomy Vestibular Approach

• Registration Number: NCT05760690
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The goal of this retrospective study is to compare the safety and efficiacy of endoscopic thyroidectomy via retro-auricular single-site approach, transoral endoscopic thyroidectomy vestibular approach and transareola approach.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-08
• Status Verified: 2024-12
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transareola Endoscopic Thyroidectomy group	Transareola Endoscopic Thyroidectomy	Patients in the Transareola Endoscopic Thyroidectomy group will receive endoscopic thyroid lobectomy and central lymph node dissection.
Retro-Auricular Single-Site Endoscopic Thyroidectomy group	Retro-Auricular Single-Site Endoscopic Thyroidectomy	Patients in the retro-auricular single-site endoscopic thyroidectomy (RASSET) group will receive endoscopic thyroid lobectomy and central lymph node dissection.
Transoral Endoscopic Thyroidectomy Vestibular Approach group	Transoral Endoscopic Thyroidectomy Vestibular Approach	Patients in the Transoral Endoscopic Thyroidectomy Vestibular Approach group will receive endoscopic thyroid lobectomy and central lymph node dissection.

Primary Outcome Measures

Name	Time	Method
C-reactive protein，CRP	1 week	the level of CRP before and after operation

Secondary Outcome Measures

Name	Time	Method
blood loss	1 week	The volume of blood loss during operation
number of lymph nodes	1 week after operation	Postoperative specimen Postoperative specimen Postoperative specimen Postoperative specimen the number of lymph nodes in postoperative specimens
Serum Amyloid A，SAA	1 week	the level of CRP before and after operation
VAS pain score	2 days after operation	Postoperative VAS score was recorded

Trial Locations

Locations (1)

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China