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

Sponsor
Fujian Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03500666
Collaborator
(none)
10
Enrollment
2
Locations
2
Arms
12
Anticipated Duration (Months)
5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Robot
  • Device: Total endoscopic
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Comparative Study of Robot Assisted BABA Approach and Chest Breast Approach for Lateral Neck Dissection
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2018
Anticipated Study Completion Date :
Dec 31, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Lateral cervical lymph node cleaning time [During surgery]

      Lateral cervical lymph node clean time from that beginning of cut the SCM leading edge to the end of the specimen

    2. Accessory nerve injury [During surgery]

      Accessory nerve injury

    3. Intraoperative internal jugular vein bleeding. [6 months after surgery]

      Internal carotid vein hemorrhage affect that surgical procedure

    Secondary Outcome Measures

    1. The time of the thyroid gland removal [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

    2. Number of participants with HypoParathyroidism [6 months after surgery]

      The parathyroid function was examined six months after surgery.

    3. Recurrent laryngeal nerve injury. [6 months after surgery]

      The recurrent laryngeal nerve function due to nerve injury or thermal damage can not be recovered for 6 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fujian Medical University Union Hospital FuZhou Fujian China 350001
    2 Wen-xin ZHAO Fuzhou Fujian China 350001

    Sponsors and Collaborators

    • Fujian Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bo Wang,MD, clinical professor, Fujian Medical University
    ClinicalTrials.gov Identifier:
    NCT03500666
    Other Study ID Numbers:
    • BND and RND
    First Posted:
    Apr 18, 2018
    Last Update Posted:
    Apr 18, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bo Wang,MD, clinical professor, Fujian Medical University
    Thyroid carcinoma
    Robot surgery
    Endoscopic surgery
    Additional relevant MeSH terms:
    Thyroid Neoplasms

    Study Results

    No Results Posted as of Apr 18, 2018