Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery

April 20, 2018 updated by: Bo Wang,MD
To study the protective effect of suture parathyroid marker method on the function of parathyroid gland in thyroid cancer surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

400

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

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:

  • 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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Routine thyroidectomy and central lymph node dissection
Experimental: Parathyroid marker group
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.
Procedure: The suture marks the location of the parathyroid gland
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The stitch marking operation time
Time Frame: During surgery
The time required for making a parathyroid marker by a suture method
During surgery
Specimen inspection time
Time Frame: During surgery
The time required for finding parathyroid glands in surgical specimens
During surgery
The number of transplanted parathyroid glands
Time Frame: When the surgery is completed
The number of parathyroid glands required for autotransplantation of parathyroid glands
When the surgery is completed
Parathyroid hormone level testing
Time Frame: 0 days, 1 day, 2 weeks after surgery
Parathyroid hormone levels before and after surgery
0 days, 1 day, 2 weeks after surgery
Calcium levels
Time Frame: 0 days, 1 day, 2 weeks after surgery
Calcium level before and after surgery to detect
0 days, 1 day, 2 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bo Wang,MD

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)

April 1, 2018

Primary Completion (Anticipated)

September 30, 2018

Study Completion (Anticipated)

September 30, 2018

Study Registration Dates

First Submitted

April 20, 2018

First Submitted That Met QC Criteria

April 20, 2018

First Posted (Actual)

May 2, 2018

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 20, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT Marker

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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