Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy

NCT03454477 — Not applicable, Unknown, 90 participants, Fujian Medical University

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

Registry	NCT03454477
Status	Unknown
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: quadruple, treatment
Enrollment	90 (Estimated)
Sponsor	Fujian Medical University (Other)
Conditions	Endoscopy, Robotics, Thyroidectomy, Papillary Thyroid Carcinoma
Interventions	conventional open surgery, endoscopic thyroidectomy, robotic thyroidectomy (Procedure, device)
Dates	start 2018-02-01, primary completion 2018-10-01 (estimated), completion 2018-10-01 (estimated), first posted 2018-03-06, last updated 2018-09-18
Locations	1 site in China

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
conventional open surgery	Experimental	Procedure: 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.
endoscopic thyroidectomy	Experimental	Procedure: endoscopic thyroidectomy	Patients who met the inclusion criteria were selected to undergo thyroid surgery via endoscopic thyroidectomy
robotic thyroidectomy	Experimental	Device: robotic thyroidectomy	Patients who met the inclusion criteria chose the Da Vinci robot for thyroid surgery.

conventional open surgery (Procedure): conventional open surgery
endoscopic thyroidectomy (Procedure): endoscopic thyroidectomy
robotic thyroidectomy (Device): robotic thyroidectomy

+Outcome measures

Primary outcomes

operation time [The first day after surgery]: Assess the operation time
recurrent laryngeal nerve palsy [2 months post operation]: the number of recurrent laryngeal nerve palsy

Secondary outcomes

thyroid volume [The day before the operation]: thyroid volume
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.

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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.

+Locations (1)

Facility	City	Country	Status
Wen-xin ZHAO	Fuzhou, Fujian	China	Recruiting

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