Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy

September 17, 2018 updated by: Bo Wang,MD, Fujian Medical University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Wen-xin ZHAO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: conventional open surgery
conventional open surgery
Experimental: endoscopic thyroidectomy
Patients who met the inclusion criteria were selected to undergo thyroid surgery via endoscopic thyroidectomy
Procedure: endoscopic thyroidectomy
endoscopic thyroidectomy
Experimental: robotic thyroidectomy
Patients who met the inclusion criteria chose the Da Vinci robot for thyroid surgery.
Device: robotic thyroidectomy
robotic thyroidectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thyroid volume
Time Frame: The day before the operation
thyroid volume
The day before the operation
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.
2 months post operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Robotic thyroidectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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