The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery: Stage II

February 20, 2025 updated by: Guojun Wu, Shandong Provincial Hospital
This study is a prospective research. This study aims to investigate and follow up patients who undergo open thyroidectomy in the Department of Breast and Thyroid Surgery at Shandong Provincial Hospital from January 2020 to December 2025. This study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used, with the main calculation indicator being changes in PTH levels before and after surgery. This study investigated whether the application of head mounted magnifying glasses had an impact on preoperative and postoperative changes in PTH levels through inter group and self pre - and post control, in order to verify the practical effectiveness of head mounted magnifying glasses in thyroid surgery and provide reasonable suggestions for the selection of subsequent surgical treatment methods.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

In thyroid surgery, changes in postoperative parathyroid hormone (PTH) levels have a significant impact on the patients recovery and long-term health status. Parathyroid hormone is responsible for regulating blood calcium levels, and its dysfunction can cause serious electrolyte imbalance and metabolic problems. In the process of thyroid surgery, especially in total thyroidectomy, protecting the function of the parathyroid gland is an important operation. The diameter of the parathyroid gland is small and similar to the morphology of lymph nodes, making it susceptible to damage during surgery. Although traditional magnification tools such as surgical microscopes have certain effects, their operation is complex and their adaptability to surgical scenes is limited.

In recent years, as an emerging magnifying tool, head mounted magnifying glasses have been increasingly used in thyroid surgery due to their portability, ease of operation, and providing a larger field of view. Wearing a head mounted magnifying glass can not only improve the clarity of vision during surgery, increase the recognition rate of parathyroid glands and nerves, but also reduce the risk of parathyroid injury by improving surgical accuracy, thereby more effectively maintaining the stability of postoperative PTH levels. In addition, the use of head mounted magnifying glasses can reduce surgical time, intraoperative uncertainty, and the risk of postoperative complications.

This study systematically evaluates the changes in PTH levels before and after surgery to verify the practical effectiveness of head mounted magnifying glasses in thyroid surgery, and further explores the effectiveness of parathyroid gland protection strategies, optimizing surgical techniques, and improving patient surgical safety and postoperative quality of life. In addition, the results of this study also have guiding significance for the innovation and improvement of surgical instruments, which may promote the development of related technologies and equipment, and thus promote their application in a wider range of surgical fields.

Study Type

Interventional

Enrollment (Actual)

2000

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
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All cases were the first to undergo open thyroidectomy surgery.
  • All clinical data and research materials of the cases are complete.
  • All cases underwent thyroid function examination before and after surgery.
  • All cases in the experimental group were treated with a head mounted magnifying glass during surgery.

Exclusion Criteria:

  • Except for cases of recurrence.
  • Cases with incomplete clinical data and research materials are excluded.
  • Cases that have not undergone thyroid function tests before and after surgery are excluded.
  • Excluding cases of secondary surgery.
  • Excluding cases in the experimental group who did not use a head mounted magnifying glass during surgery.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
When the experimental group undergoes surgery, the surgeon uses a head mounted magnifying glass to assist in the surgical operation.
Device: Head Mounted Magnifying Glasses
This study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used.
No Intervention: control group
When the experimental group undergoes surgery, the surgeon don't use a head mounted magnifying glass to assist in the surgical operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTH level
Time Frame: 4 weeks
To verify the practical effectiveness of wearing a magnifying glass in thyroid surgery, investigators examine changes in PTH levels before and after surgery.
4 weeks
lymph nodes number
Time Frame: 2 weeks
To verify the practical effectiveness of wearing a magnifying glass in thyroid surgery, investigators follow up on the number of lymph nodes removed in the postoperative pathology report.
2 weeks

Collaborators and Investigators

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

Sponsor

Shandong Provincial Hospital

Collaborators

Second Affiliated Hospital of Zhengzhou 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, 2020

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 15, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWYX2024-280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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