Thyroid SurgeryNCT06838728
The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery: Stage II
A study testing Head Mounted Magnifying Glasses in people with Thyroid Surgery, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Surgery
- What is being tested?
- Head Mounted Magnifying Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Thyroid Surgery
- Being tested
- Head Mounted Magnifying Glasses
- Keywords
- thyroid cancer, thyroid surgery, Head Mounted Magnifying Glasses
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head Mounted Magnifying GlassesDevice
This study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | When the experimental group undergoes surgery, the surgeon uses a head mounted magnifying glass to assist in the surgical operation. Receives: Device: Head Mounted Magnifying Glasses |
| control group | No intervention | When the experimental group undergoes surgery, the surgeon don't use a head mounted magnifying glass to assist in the surgical operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTH level
To verify the practical effectiveness of wearing a magnifying glass in thyroid surgery, investigators examine changes in PTH levels before and after surgery.
Measured: 4 weeks
lymph nodes number
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Jan 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Second Affiliated Hospital of Zhengzhou University
- Responsible party
- Principal investigator, Guojun Wu, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838728
- Sponsor's protocol ID
- SWYX2024-280
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery: Stage II
- ClinicalTrials.gov ID
- NCT06838728
- Acronym / sponsor ID
- SWYX2024-280
- Conditions
- Thyroid Surgery
- Keywords
- thyroid cancer, thyroid surgery, Head Mounted Magnifying Glasses
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Collaborators
- Second Affiliated Hospital of Zhengzhou University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Head Mounted Magnifying GlassesWhen the experimental group undergoes surgery, the surgeon uses a head mounted magnifying glass to assist in the surgical operation. |
| control group | No intervention | –When the experimental group undergoes surgery, the surgeon don't use a head mounted magnifying glass to assist in the surgical operation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head Mounted Magnifying GlassesThis study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used. | Device | experimental group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head Mounted Magnifying Glasses in people with Thyroid Surgery, run by Shandong Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTH level (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.