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NCT Number: NCT05263141

Retro-Auricular Single-Site Endoscopic to Papillary Thyroid Carcinoma

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.

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Key information

Conditions

Papillary Thyroid Carcinoma Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Patients who do not accept case data collection for various reasons.
  • The clinical data unfit this study (at the discretion of the investigator).
  • Patients who have undergone neck surgery or radiotherapy before this trail.
  • Patients who have uncontrolled hyperthyroidism.

Treatment and study plan

retro-auricular single-site endoscopic thyroidectomy

Procedure

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

traditional open surgery thyroidectomy

Procedure

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.

Primary outcomes

  1. postoperative cosmetic satisfaction scores

    Time frame: 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 outcomes

  1. postoperative Vancouver Scar Scale

    Time frame: 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.

  2. postoperative Vancouver Scar Scale

    Time frame: 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.

  3. Intra-operative, peri-operative, post-operative clinicopathologic characteristics

    Time frame: 1 week from surgery

    Baseline clinicopathologic characteristics of patients

  4. postoperative cosmetic satisfaction scores

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 2, 2022
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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