Thyroid CancerNCT06432257
The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery
An observational study of Thyroid Cancer, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
This study collected data on open thyroidectomy patients admitted to the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023 by reviewing medical records. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- head mounted magnifying glass assistance
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: This study collected patients who underwent open thyroidectomy surgery at the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023. All patients included in the study had complete clinical and research data, with approximately 2000 participants.
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 collected data on open thyroidectomy patients admitted to the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023 by reviewing medical records. 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 patient\'s 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 Cancer
- Being tested
- head mounted magnifying glass assistance
- Keywords
- thyroid cancer, PTH, Head mounted magnifying glass
- 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 glass assistanceDevice
When performing thyroid surgery for patients in the experimental group, the surgeon uses a head mounted magnifying glass for assistance
| Study group | Role | What they receive |
|---|---|---|
| Using the head mounted magnifying glass | 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. Receives: Device: head mounted magnifying glass assistance |
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 by examining changes in PTH levels before and after surgery.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 Jan 2020
- Primary completion31 Dec 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Shandong University
- Responsible party
- Principal investigator, Guojun Wu, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432257
- Sponsor's protocol ID
- NO.SWYX2024-280
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are not publicly available due to privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. 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
- ClinicalTrials.gov ID
- NCT06432257
- Acronym / sponsor ID
- NO.SWYX2024-280
- Conditions
- Thyroid Cancer
- Keywords
- thyroid cancer, PTH, Head mounted magnifying glass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Collaborators
- Shandong University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 29 May 2024 (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 collected data on open thyroidectomy patients admitted to the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023 by reviewing medical records. 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 patient\'s 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Using the head mounted magnifying glass | – | Device: head mounted magnifying glass assistanceThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study collected patients who underwent open thyroidectomy surgery at the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023. All patients included in the study had complete clinical and research data, with approximately 2000 participants.
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 glass assistanceWhen performing thyroid surgery for patients in the experimental group, the surgeon uses a head mounted magnifying glass for assistance | Device | Using the head mounted magnifying glass |
Primary outcome
PTH level
Time frame: 4 weeks
To verify the practical effectiveness of wearing a magnifying glass in thyroid surgery by examining changes in PTH levels before and after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No. The data are not publicly available due to privacy and ethical restrictions.
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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?
An observational study of Thyroid Cancer, 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: finished, as of the sponsor's last update on 29 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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). 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 29 May 2024.