Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy

Endoscopy Clinical Trial

Official title:

From the Endoscope to the Robot, the Initial Experience of Robotic Thyroidectomy is Summarized

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03454477
• Other study ID #: Robotic thyroidectomy
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: September 2018
• Source: Fujian Medical University
• Contact: bo wang, md
• Phone: 13705947900
• Email: wangbo[@]fjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of endoscopic thyroidectomy, robotic thyroidectomy and conventional open surgery, the safety of the operation, the timing of the operation and the complications.

Description:

With the further development of endoscopic technique, thyroid surgery of the robot has emerged, which may become a trend of endoscopic technology due to its convenience and accuracy.In this study, the advantages and disadvantages of endoscopic thyroidectomy and robotic thyroid surgery were compared, and the experience in the transition stage of thyroid surgery in robotic and endoscopic thyroidectomy was summarized.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Thyroid papillary carcinoma.

• The tumor diameter is less than or equal to 1cm.

• The lymph nodes are limited to the VI level.

• Voluntary choice of endoscopy or robotic surgery.

Exclusion Criteria:

• Patients without beauty needs.

• There is lateral neck or mediastinal lymph node metastasis.

• The tumor invades the nerve and surrounding organs.

Related Conditions & MeSH terms

• Carcinoma
• Endoscopy
• Papillary Thyroid Carcinoma
• Robotics
• Thyroid Neoplasms
• Thyroidectomy

Intervention

Procedure:
• conventional open surgery
conventional open surgery
• endoscopic thyroidectomy
endoscopic thyroidectomy

Device:
• robotic thyroidectomy
robotic thyroidectomy

Locations

Country	Name	City	State
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	operation time	Assess the operation time	The first day after surgery
Primary	recurrent laryngeal nerve palsy	the number of recurrent laryngeal nerve palsy	2 months post operation
Secondary	thyroid volume	thyroid volume	The day before the operation
Secondary	cosmetic effect	The satisfaction with cosmetic outcomes was analyzed quantitatively using a scoring system that ranged from 1 to 4(1, extremely; 2, fairly; 3, normal; 4: not at all) that was rated by patients at the outpatient clinic 2 months after the operation.	2 months post operation