Back to resultsStudy on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery
Primary Purpose
Thyroid Cancer, Hypoparathyroidism, Marker; Structural
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The suture marks the location of the parathyroid gland
Sponsored by
About this trial
This is an interventional prevention trial for Thyroid Cancer focused on measuring Thyroid Cancer, Hypoparathyroidism, parathyroid marker
Eligibility Criteria
Inclusion Criteria:
- Patients with thyroid cancer who need central compartment dissection
- Routine neck incision surgery
- Patients undergoing primary neck surgery
Exclusion Criteria:
- Benign thyroid tumor patients
- Selecting patients with endoscopes, small incisions, or robotic surgery
- Patients with hyperparathyroidism
Sites / Locations
- Fujian Medical University Union HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Parathyroid marker group
Arm Description
Routine thyroidectomy and central lymph node dissection
When the lower parathyroid gland is first seen, the parathyroid gland is sutured with a suture during the operation, and then during this subsequent cleaning, rapid parathyroid localization and parathyroid glands are performed through this marker.
Outcomes
Primary Outcome Measures
The stitch marking operation time
The time required for making a parathyroid marker by a suture method
Specimen inspection time
The time required for finding parathyroid glands in surgical specimens
The number of transplanted parathyroid glands
The number of parathyroid glands required for autotransplantation of parathyroid glands
Parathyroid hormone level testing
Parathyroid hormone levels before and after surgery
Calcium levels
Calcium level before and after surgery to detect
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03514251
Brief Title
Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery
Official Title
Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bo Wang,MD
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
To study the protective effect of suture parathyroid marker method on the function of parathyroid gland in thyroid cancer surgery
Detailed Description
This is a prospective randomized controlled study.In the experimental group, the suture parathyroid marker method was used to mark the parathyroid gland at the first time when it shows, and this marker was further used to identify and locating the inferior parathyroid marker in subsequent central region dissection. In the control group, the central area was routinely cleaned without suture parathyroid marker .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Hypoparathyroidism, Marker; Structural, Complication of Surgical Procedure, Parathyroid Function Low Adverse Event
Keywords
Thyroid Cancer, Hypoparathyroidism, parathyroid marker
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine thyroidectomy and central lymph node dissection
Arm Title
Parathyroid marker group
Arm Type
Experimental
Arm Description
When the lower parathyroid gland is first seen, the parathyroid gland is sutured with a suture during the operation, and then during this subsequent cleaning, rapid parathyroid localization and parathyroid glands are performed through this marker.
Intervention Type
Procedure
Intervention Name(s)
The suture marks the location of the parathyroid gland
Intervention Description
When the lower parathyroid gland is first seen, the parathyroid gland is sutured with a suture during the operation, and then during this subsequent cleaning, rapid parathyroid localization and parathyroid glands are performed through this marker. Vascular protection.
Primary Outcome Measure Information:
Title
The stitch marking operation time
Description
The time required for making a parathyroid marker by a suture method
Time Frame
During surgery
Title
Specimen inspection time
Description
The time required for finding parathyroid glands in surgical specimens
Time Frame
During surgery
Title
The number of transplanted parathyroid glands
Description
The number of parathyroid glands required for autotransplantation of parathyroid glands
Time Frame
When the surgery is completed
Title
Parathyroid hormone level testing
Description
Parathyroid hormone levels before and after surgery
Time Frame
0 days, 1 day, 2 weeks after surgery
Title
Calcium levels
Description
Calcium level before and after surgery to detect
Time Frame
0 days, 1 day, 2 weeks 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:
Patients with thyroid cancer who need central compartment dissection
Routine neck incision surgery
Patients undergoing primary neck surgery
Exclusion Criteria:
Benign thyroid tumor patients
Selecting patients with endoscopes, small incisions, or robotic surgery
Patients with hyperparathyroidism
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery
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