Comparative Study of Robot BABA Approach and Chest Breast Approach for Lateral Neck Dissection

April 15, 2018 updated by: Bo Wang,MD, Fujian Medical University

A Comparative Study of Robot Assisted BABA Approach and Chest Breast Approach for Lateral Neck Dissection

Objective to compare the advantages and disadvantages of robotic and conventional endoscopic thyroidectomy for thyroid cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To compare the difference of operative time and complication between two operative methods in robot neck surgery and routine endoscopic surgery.

Study Type

Interventional

Enrollment (Anticipated)

10

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
        • Fujian Medical University Union Hospital
      • 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:

  1. papillary thyroid carcinoma with clinically suspected or confirmed lateral lymph node metastasis;
  2. patient's concerns of neck scars and cosmetic requirement.

The exclusion criteria were as follows:

1) tumor size >4cm; 2) previous neck surgical history； 3）residual or recurrent tumors; 4) suspicious primary tumor or metastatic lymph node invasion of major vascular structures or recurrent laryngeal nerve.

5）metastatic lymph nodes occurred below the sternoclavicular joint.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Robot lateral neck lymph node dissection
Robot neck lateral lymph node dissection was performed in patients with thyroid cancer and lateral cervical lymph node metastasis.
Device: Robot
Robot lateral neck lymph node dissection
Other Names:
  • Robot lateral neck lymph node dissection
EXPERIMENTAL: Total endoscopic lateral cervical lymph node dissection
Patients with thyroid cancer and lateral cervical lymph node metastases underwent total endoscopic neck dissection.
Device: Total endoscopic
Total endoscopic lateral cervical lymph node dissection
Other Names:
  • Total endoscopic lateral cervical lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lateral cervical lymph node cleaning time
Time Frame: During surgery
Lateral cervical lymph node clean time from that beginning of cut the SCM leading edge to the end of the specimen
During surgery
Accessory nerve injury
Time Frame: During surgery
Accessory nerve injury
During surgery
Intraoperative internal jugular vein bleeding.
Time Frame: 6 months after surgery
Internal carotid vein hemorrhage affect that surgical procedure
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time of the thyroid gland removal
Time Frame: During surgery
The time of the thyroid gland removal , including the opening of the white line to the thyroid, and the end of the specimen
During surgery
Number of participants with HypoParathyroidism
Time Frame: 6 months after surgery
The parathyroid function was examined six months after surgery.
6 months after surgery
Recurrent laryngeal nerve injury.
Time Frame: 6 months after surgery
The recurrent laryngeal nerve function due to nerve injury or thermal damage can not be recovered for 6 months.
6 months after surgery

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)

January 1, 2018

Primary Completion (ANTICIPATED)

December 31, 2018

Study Completion (ANTICIPATED)

December 31, 2018

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 15, 2018

First Posted (ACTUAL)

April 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 15, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BND and RND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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