Comparative Study of Robot BABA Approach and Chest Breast Approach for Lateral Neck Dissection

Fujian Medical University10 enrolled

Overview

Objective to compare the advantages and disadvantages of robotic and conventional endoscopic thyroidectomy for thyroid cancer.

To compare the difference of operative time and complication between two operative methods in robot neck surgery and routine endoscopic surgery.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Thyroid Carcinoma Robot Surgery Endoscopic Surgery

Interventions

RobotDEVICE

Robot lateral neck lymph node dissection

Total endoscopicDEVICE

Total endoscopic lateral cervical lymph node dissection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. papillary thyroid carcinoma with clinically suspected or confirmed lateral lymph node metastasis; 2. patient's concerns of neck scars and cosmetic requirement. The exclusion criteria were as follows: 1\) tumor size \>4cm; 2) previous neck surgical history； 3）residual or recurrent tumors; 4) suspicious primary tumor or metastatic lymph node invasion of major vascular structures or recurrent laryngeal nerve. 5）metastatic lymph nodes occurred below the sternoclavicular joint.

Locations (2)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

Wen-xin ZHAO

Fuzhou, Fujian, China

RECRUITING

Outcomes

Primary Outcomes

Lateral cervical lymph node cleaning time

Lateral cervical lymph node clean time from that beginning of cut the SCM leading edge to the end of the specimen

Time frame: During surgery

Accessory nerve injury

Time frame: During surgery

Intraoperative internal jugular vein bleeding.

Internal carotid vein hemorrhage affect that surgical procedure

Time frame: 6 months after surgery

Secondary Outcomes

The time of the thyroid gland removal

The time of the thyroid gland removal , including the opening of the white line to the thyroid, and the end of the specimen

Time frame: During surgery

Number of participants with HypoParathyroidism

The parathyroid function was examined six months after surgery.

Time frame: 6 months after surgery

Recurrent laryngeal nerve injury.

The recurrent laryngeal nerve function due to nerve injury or thermal damage can not be recovered for 6 months.

Time frame: 6 months after surgery

Data from ClinicalTrials.gov

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