Retro-Auricular Single-Site Endoscopic to Papillary Thyroid Carcinoma

Not Applicable

Completed

• Conditions: Papillary Thyroid Carcinoma
• Interventions: Procedure: retro-auricular single-site endoscopic thyroidectomy; Procedure: traditional open surgery thyroidectomy

• Registration Number: NCT05263141
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-02-20
• Study Start: 2022-03-01
• Study First Posted: 2022-03-02
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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
RASSET 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.
traditional open thyroid lobectomy group	traditional open surgery thyroidectomy	Patients in the traditional open thyroid lobectomy group will receive thyroid lobectomy and central lymph node dissection.

Primary Outcome Measures

Name	Time	Method
postoperative cosmetic satisfaction scores	3 months from surgery	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).

Secondary Outcome Measures

Name	Time	Method
Intra-operative, peri-operative, post-operative clinicopathologic characteristics	1 week from surgery	Baseline clinicopathologic characteristics of patients
postoperative Vancouver Scar Scale	1 month from surgery	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.
postoperative cosmetic satisfaction scores	1 month from surgery	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).

Trial Locations

Locations (1)

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