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

Primary Purpose

Thyroid Carcinoma, Robot Surgery, Endoscopic Surgery

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Robot
Total endoscopic
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Carcinoma focused on measuring Thyroid carcinoma, Robot surgery, Endoscopic surgery

Eligibility Criteria

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

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.

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting
  • Wen-xin ZHAORecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Robot lateral neck lymph node dissection

Total endoscopic lateral cervical lymph node dissection

Arm Description

Robot neck lateral lymph node dissection was performed in patients with thyroid cancer and lateral cervical lymph node metastasis.

Patients with thyroid cancer and lateral cervical lymph node metastases underwent total endoscopic neck dissection.

Outcomes

Primary Outcome Measures

Lateral cervical lymph node cleaning time
Lateral cervical lymph node clean time from that beginning of cut the SCM leading edge to the end of the specimen
Accessory nerve injury
Accessory nerve injury
Intraoperative internal jugular vein bleeding.
Internal carotid vein hemorrhage affect that surgical procedure

Secondary Outcome Measures

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

Full Information

First Posted
April 2, 2018
Last Updated
April 15, 2018
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03500666
Brief Title
Comparative Study of Robot BABA Approach and Chest Breast Approach for Lateral Neck Dissection
Official Title
A Comparative Study of Robot Assisted BABA Approach and Chest Breast Approach for Lateral Neck Dissection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 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
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective to compare the advantages and disadvantages of robotic and conventional endoscopic thyroidectomy for thyroid cancer.
Detailed Description
To compare the difference of operative time and complication between two operative methods in robot neck surgery and routine endoscopic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Carcinoma, Robot Surgery, Endoscopic Surgery
Keywords
Thyroid carcinoma, Robot surgery, Endoscopic surgery

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Robot lateral neck lymph node dissection
Arm Type
Experimental
Arm Description
Robot neck lateral lymph node dissection was performed in patients with thyroid cancer and lateral cervical lymph node metastasis.
Arm Title
Total endoscopic lateral cervical lymph node dissection
Arm Type
Experimental
Arm Description
Patients with thyroid cancer and lateral cervical lymph node metastases underwent total endoscopic neck dissection.
Intervention Type
Device
Intervention Name(s)
Robot
Other Intervention Name(s)
Robot lateral neck lymph node dissection
Intervention Description
Robot lateral neck lymph node dissection
Intervention Type
Device
Intervention Name(s)
Total endoscopic
Other Intervention Name(s)
Total endoscopic lateral cervical lymph node dissection
Intervention Description
Total endoscopic lateral cervical lymph node dissection
Primary Outcome Measure Information:
Title
Lateral cervical lymph node cleaning time
Description
Lateral cervical lymph node clean time from that beginning of cut the SCM leading edge to the end of the specimen
Time Frame
During surgery
Title
Accessory nerve injury
Description
Accessory nerve injury
Time Frame
During surgery
Title
Intraoperative internal jugular vein bleeding.
Description
Internal carotid vein hemorrhage affect that surgical procedure
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
The time of the thyroid gland removal
Description
The time of the thyroid gland removal , including the opening of the white line to the thyroid, and the end of the specimen
Time Frame
During surgery
Title
Number of participants with HypoParathyroidism
Description
The parathyroid function was examined six months after surgery.
Time Frame
6 months after surgery
Title
Recurrent laryngeal nerve injury.
Description
The recurrent laryngeal nerve function due to nerve injury or thermal damage can not be recovered for 6 months.
Time Frame
6 months after surgery

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: papillary thyroid carcinoma with clinically suspected or confirmed lateral lymph node metastasis; 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.
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
FuZhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
bo wang, md
Phone
13705947900
Email
wangbo@fjmu.edu.cn
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
No

Learn more about this trial

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

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