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

Thyroid Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03500666
• Other study ID #: BND and RND
• Status: Recruiting
• Phase: N/A
• First received: April 2, 2018
• Last updated: April 15, 2018
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2018
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endoscopic Surgery
• Robot Surgery
• Thyroid Carcinoma
• Thyroid Neoplasms

Intervention

Device:
• Robot
Robot lateral neck lymph node dissection
• Total endoscopic
Total endoscopic lateral cervical lymph node dissection

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	FuZhou	Fujian
China	Wen-xin ZHAO	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During surgery
Primary	Accessory nerve injury	Accessory nerve injury	During surgery
Primary	Intraoperative internal jugular vein bleeding.	Internal carotid vein hemorrhage affect that surgical procedure	6 months after surgery
Secondary	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	During surgery
Secondary	Number of participants with HypoParathyroidism	The parathyroid function was examined six months after surgery.	6 months after surgery
Secondary	Recurrent laryngeal nerve injury.	The recurrent laryngeal nerve function due to nerve injury or thermal damage can not be recovered for 6 months.	6 months after surgery