Retro-Auricular Single-Site Endoscopic to Papillary Thyroid Carcinoma

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05263141

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Papillary Thyroid Carcinoma	Procedure: retro-auricular single-site endoscopic thyroidectomy Procedure: traditional open surgery thyroidectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RASSET group 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 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. Other Names: RASSET
Active Comparator: traditional open thyroid lobectomy group Patients in the traditional open thyroid lobectomy group will receive thyroid lobectomy and central lymph node dissection.	Procedure: 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.

Arm

Intervention/Treatment

Experimental: RASSET group

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

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.

Other Names:

RASSET

Active Comparator: traditional open thyroid lobectomy group

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

Procedure: 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.

Outcome Measures

Primary Outcome Measures

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

postoperative Vancouver Scar Scale [3 months 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 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.
Intra-operative, peri-operative, post-operative clinicopathologic characteristics [1 week from surgery]
Baseline clinicopathologic characteristics of patients
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.