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

Not Applicable

• Conditions: Endoscopic Surgery; Robot Surgery; Thyroid Carcinoma
• Interventions: Device: Total endoscopic; Device: Robot

• Registration Number: NCT03500666
• Lead Sponsor: Fujian Medical University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-04
• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-15
• Last Update Submitted: 2018-04-15
• Study First Posted: 2018-04-18
• Last Update Posted: 2018-04-18
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total endoscopic lateral cervical lymph node dissection	Total endoscopic	Patients with thyroid cancer and lateral cervical lymph node metastases underwent total endoscopic neck dissection.
Robot lateral neck lymph node dissection	Robot	Robot neck lateral lymph node dissection was performed in patients with thyroid cancer and lateral cervical lymph node metastasis.

Primary Outcome Measures

Name	Time	Method
Lateral cervical lymph node cleaning time	During surgery	Lateral cervical lymph node clean time from that beginning of cut the SCM leading edge to the end of the specimen
Intraoperative internal jugular vein bleeding.	6 months after surgery	Internal carotid vein hemorrhage affect that surgical procedure
Accessory nerve injury	During surgery	Accessory nerve injury

Secondary Outcome Measures

Name	Time	Method
Number of participants with HypoParathyroidism	6 months after surgery	The parathyroid function was examined six months after surgery.
Recurrent laryngeal nerve injury.	6 months after surgery	The recurrent laryngeal nerve function due to nerve injury or thermal damage can not be recovered for 6 months.
The time of the thyroid gland removal	During surgery	The time of the thyroid gland removal , including the opening of the white line to the thyroid, and the end of the specimen

Trial Locations

Locations (2)

Fujian Medical University Union Hospital; 🇨🇳 FuZhou, Fujian, China

Wen-xin ZHAO; 🇨🇳 Fuzhou, Fujian, China