Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy

Not Applicable

• Conditions: Robotics; Thyroidectomy; Endoscopy; Papillary Thyroid Carcinoma
• Interventions: Procedure: conventional open surgery; Device: robotic thyroidectomy; Procedure: endoscopic thyroidectomy

• Registration Number: NCT03454477
• Lead Sponsor: Fujian Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-18
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional open surgery	conventional open surgery	Patients who met the inclusion criteria were selected for a conventional open surgery procedure for a conventional neck incision for thyroid surgery.
robotic thyroidectomy	robotic thyroidectomy	Patients who met the inclusion criteria chose the Da Vinci robot for thyroid surgery.
endoscopic thyroidectomy	endoscopic thyroidectomy	Patients who met the inclusion criteria were selected to undergo thyroid surgery via endoscopic thyroidectomy

Primary Outcome Measures

Name	Time	Method
recurrent laryngeal nerve palsy	2 months post operation	the number of recurrent laryngeal nerve palsy
operation time	The first day after surgery	Assess the operation time

Secondary Outcome Measures

Name	Time	Method
cosmetic effect	2 months post operation	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.
thyroid volume	The day before the operation	thyroid volume

Trial Locations

Locations (1)

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