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Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy

Primary Purpose

Endoscopy, Robotics, Thyroidectomy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
conventional open surgery
endoscopic thyroidectomy
robotic thyroidectomy
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endoscopy focused on measuring Endoscopy, Robotics, Thyroidectomy, Papillary Thyroid Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wen-xin ZHAORecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

conventional open surgery

endoscopic thyroidectomy

robotic thyroidectomy

Arm Description

Patients who met the inclusion criteria were selected for a conventional open surgery procedure for a conventional neck incision for thyroid surgery.

Patients who met the inclusion criteria were selected to undergo thyroid surgery via endoscopic thyroidectomy

Patients who met the inclusion criteria chose the Da Vinci robot for thyroid surgery.

Outcomes

Primary Outcome Measures

operation time
Assess the operation time
recurrent laryngeal nerve palsy
the number of recurrent laryngeal nerve palsy

Secondary Outcome Measures

thyroid volume
thyroid volume
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.

Full Information

First Posted
February 7, 2018
Last Updated
September 17, 2018
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03454477
Brief Title
Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy
Official Title
From the Endoscope to the Robot, the Initial Experience of Robotic Thyroidectomy is Summarized
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopy, Robotics, Thyroidectomy, Papillary Thyroid Carcinoma
Keywords
Endoscopy, Robotics, Thyroidectomy, Papillary Thyroid Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional open surgery
Arm Type
Experimental
Arm Description
Patients who met the inclusion criteria were selected for a conventional open surgery procedure for a conventional neck incision for thyroid surgery.
Arm Title
endoscopic thyroidectomy
Arm Type
Experimental
Arm Description
Patients who met the inclusion criteria were selected to undergo thyroid surgery via endoscopic thyroidectomy
Arm Title
robotic thyroidectomy
Arm Type
Experimental
Arm Description
Patients who met the inclusion criteria chose the Da Vinci robot for thyroid surgery.
Intervention Type
Procedure
Intervention Name(s)
conventional open surgery
Intervention Description
conventional open surgery
Intervention Type
Procedure
Intervention Name(s)
endoscopic thyroidectomy
Intervention Description
endoscopic thyroidectomy
Intervention Type
Device
Intervention Name(s)
robotic thyroidectomy
Intervention Description
robotic thyroidectomy
Primary Outcome Measure Information:
Title
operation time
Description
Assess the operation time
Time Frame
The first day after surgery
Title
recurrent laryngeal nerve palsy
Description
the number of recurrent laryngeal nerve palsy
Time Frame
2 months post operation
Secondary Outcome Measure Information:
Title
thyroid volume
Description
thyroid volume
Time Frame
The day before the operation
Title
cosmetic effect
Description
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.
Time Frame
2 months post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
bo wang, md
Phone
13705947900
Email
wangbo@fjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
wenxin zhao, md
Phone
13365910359
Email
zhaowx@fjmu.edu.cn
Facility Information:
Facility Name
Wen-xin ZHAO
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-xin ZHAO, MD
Phone
8613365910359
Email
zhaowx@fjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Bo WANG, MD
Phone
8613705947900
Email
wangbo@fjmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy

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