Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy

NCT ID: NCT03454477

Last Updated: 2018-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2018-10-01

Brief Summary

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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

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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.

Conditions

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Endoscopy Robotics Thyroidectomy Papillary Thyroid Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

conventional open surgery

Intervention Type PROCEDURE

conventional open surgery

endoscopic thyroidectomy

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

Group Type EXPERIMENTAL

endoscopic thyroidectomy

Intervention Type PROCEDURE

endoscopic thyroidectomy

robotic thyroidectomy

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

Group Type EXPERIMENTAL

robotic thyroidectomy

Intervention Type DEVICE

robotic thyroidectomy

Interventions

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conventional open surgery

conventional open surgery

Intervention Type PROCEDURE

endoscopic thyroidectomy

endoscopic thyroidectomy

Intervention Type PROCEDURE

robotic thyroidectomy

robotic thyroidectomy

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Bo Wang,MD

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wen-xin ZHAO

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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bo wang, md

Role: CONTACT

13705947900

wenxin zhao, md

Role: CONTACT

13365910359

Facility Contacts

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Wen-xin ZHAO, MD

Role: primary

8613365910359

Bo WANG, MD

Role: backup

8613705947900

Other Identifiers

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Robotic thyroidectomy

Identifier Type: -

Identifier Source: org_study_id

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