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Retro-Auricular Single-Site Endoscopic to Papillary Thyroid Carcinoma

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05263141
Enrollment
80
Registered
2022-03-02
Start date
2022-03-01
Completion date
2024-11-30
Last updated
2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papillary Thyroid Carcinoma

Keywords

Papillary Thyroid Carcinoma, Thyroidectomy, Laparoscopy, Retroauricular approach, Single-site

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.

Interventions

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.

PROCEDUREtraditional 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.

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
postoperative cosmetic satisfaction scores3 months from surgeryThe 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

MeasureTime frameDescription
postoperative Vancouver Scar Scale3 months from surgeryThe 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 characteristics1 week from surgeryBaseline clinicopathologic characteristics of patients
postoperative cosmetic satisfaction scores1 month from surgeryThe 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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026