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Trial Title:
Safety of Endoscopic Thyroidectomy Via Retro-Auricular Single-Site Approach, Transoral Approach and Transareola
NCT ID:
NCT05760690
Condition:
Papillary Thyroid Carcinoma
Conditions: Official terms:
Carcinoma
Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Conditions: Keywords:
Papillary Thyroid Carcinoma Laparoscopy
Endoscopic Thyroidectomy
Retroauricular Single-site approach
Transoral Endoscopic Thyroidectomy Vestibular Approach
Transareola Endoscopic Thyroidectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Retro-Auricular Single-Site Endoscopic Thyroidectomy
Description:
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.
Arm group label:
Retro-Auricular Single-Site Endoscopic Thyroidectomy group
Intervention type:
Procedure
Intervention name:
Transoral Endoscopic Thyroidectomy Vestibular Approach
Description:
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.
Arm group label:
Transoral Endoscopic Thyroidectomy Vestibular Approach group
Intervention type:
Procedure
Intervention name:
Transareola Endoscopic Thyroidectomy
Description:
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
Arm group label:
Transareola Endoscopic Thyroidectomy group
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Dian Ouyang
Phone:
+8615626278408
Email:
ouyd@sysucc.org.cn
Start date:
January 1, 2015
Completion date:
December 28, 2023
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05760690
