Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy

Overview

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

Full Title of Study: “From the Endoscope to the Robot, the Initial Experience of Robotic Thyroidectomy is Summarized”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 1, 2018

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 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.
  • Experimental: endoscopic thyroidectomy
    • Patients who met the inclusion criteria were selected to undergo thyroid surgery via endoscopic thyroidectomy
  • Experimental: robotic thyroidectomy
    • Patients who met the inclusion criteria chose the Da Vinci robot for thyroid surgery.

Clinical Trial Outcome Measures

Primary Measures

  • operation time
    • Time Frame: The first day after surgery
    • Assess the operation time
  • recurrent laryngeal nerve palsy
    • Time Frame: 2 months post operation
    • the number of recurrent laryngeal nerve palsy

Secondary Measures

  • thyroid volume
    • Time Frame: The day before the operation
    • thyroid volume
  • cosmetic effect
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fujian Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bo Wang,MD, clinical professor – Fujian Medical University
  • Overall Contact(s)
    • bo wang, md, 13705947900, wangbo@fjmu.edu.cn

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