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Completed

NCT Number: NCT05760690

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

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.

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Key information

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, 510060, 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.

Transoral endoscopic thyroidectomy vestibular approach

Procedure

The patient was placed in a supine position with slight neck extension under nasotracheal intubation. The mouth was garbled with povidone iodine before surgery. Three laparoscopic ports (a 10- to 15-mm port at midline and two 5-mm ports at the lateral junction between the canine and first premolar teeth)were inserted under the lower lip at the oral vestibular area.The strap muscleswere separated in the midline to expose the thyroid and trachea. The recurrent laryngeal nerve (RLN) was identified at the insertion to the larynx, then followed downandparallel tothe trachea inferiorly.

Transareola Endoscopic Thyroidectomy

Procedure

The patient was in supine position. Incision was made inside the right areola and a 10mm puncture device was placed, subcutaneous separation rod was used to separate the space, and a 30° endoscope was introduced, puncture device was placed in a 5mm incision on the left areola, ultrasonic knife free flap was used, subcutaneous separation space was placed in the upper sternal segment, and a 5mm puncture device was placed outside the right areola. The anterior cervical flap was further dissociated to establish a space. The median cervical line was cut to cut off the isthmus of the thyroid, and the tracheal fascia ligament of the thyroid was separated and the nerve was exposed to protect the nerves. Then remove the lobe of thyroid and central lymph nodes

Primary outcomes

  1. C-reactive protein,CRP

    Time frame: 1 week

    the level of CRP before and after operation

Secondary outcomes

  1. Serum Amyloid A,SAA

    Time frame: 1 week

    the level of CRP before and after operation

  2. blood loss

    Time frame: 1 week

    The volume of blood loss during operation

  3. VAS pain score

    Time frame: 2 days after operation

    Postoperative VAS score was recorded

  4. number of lymph nodes

    Time frame: 1 week after operation

    Postoperative specimen Postoperative specimen Postoperative specimen Postoperative specimen the number of lymph nodes in postoperative specimens

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Single-center, Retrospective Study of Retro-Auricular Single-Site Endoscopic, Transoral Endoscopic Thyroidectomy Vestibular Approach and Transareola Endoscopic Thyroidectomy in Patients With Early Stage Papillary Thyroid Carcinoma

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2023
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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