- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07582562
Risk Factors for Hypoparathyroidism Following Thyroidectomy
A Prospective Study to Assess Risk Factors for Hypoparathyroidism Following Thyroidectomy
The goal of this observational study is to identify the risk factors for post-thyroidectomy hypoparathyroidism in Estonia and to determine whether the magnesium level plays a significant role in the development of hypoparathyroidism. The main questions it aims to answer are:
- How common is post-thyroidectomy hypoparathyroidism in Estonia?
- What are the most significant risk factors for the development of post-thyroidectomy hypoparathyroidism in Estonia?
- Are magnesium levels a risk factor for the development of hypoparathyroidism? Participants will be asked to answer a questionnaire about risk factors. The study collects data on risk factors for hypoparathyroidism following thyroid surgery, including patient questionnaires and comorbidities, pre- and postoperative laboratory tests and surgery-related risk factors.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hanna Hollman, MD
- Phone Number: +37259037517
- Email: hanna.hollman@ut.ee
Study Locations
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Tallinn, Estonia
- Recruiting
- East Tallinn Central Hospital
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Contact:
- Hanna Hollman, MD
- Phone Number: +372 59037517
- Email: hanna.hollman@itk.ee
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Tartu, Estonia
- Recruiting
- Tartu University Hospital
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Contact:
- Ceith Nikkolo, PhD
- Phone Number: +372 53319082
- Email: ceith.nikkolo@kliinikum.ee
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients over the age of 18 undergoing surgery involving both lobes of the thyroid gland (thyroidectomy, "near-total" thyroidectomy, subtotal thyroidectomy, and "completed" thyroidectomy)
- patients who are capable of giving informed consent
Exclusion Criteria:
- patients undergoing unilateral thyroid lobectomy only
- patients with concomitant hyperparathyroidism undergoing simultaneous thyroidectomy and parathyroidectomy for a parathyroid adenoma
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative early hypoparathyroidism
Time Frame: first postoperative day
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Incidence of early post-thyroidectomy hypoparathyroidism, based on serum PTH levels measured on the morning of the first postoperative day
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first postoperative day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factor assessment of post-thyroidectomy hypoparathyroidism
Time Frame: Preoperative and intraoperative periods
|
Risk factors will be categorized as patient-related, disease-related, and surgery-related variables. Risk factors will be assessed using multivariable logistic regression analysis, and results will be reported as odds ratios with 95% confidence intervals. Patient-related risk factors will be assessed using a structured study-specific questionnaire (including demographic and clinical history variables) and review of electronic medical records. Disease-related risk factors will be assessed using also preoperative laboratory measurements. Surgery-related risk factors will be assessed using standardized operative reports, including variables such as extent of thyroidectomy, identification and preservation of parathyroid glands, and intraoperative findings, recorded according to institutional surgical protocols. Patient- and disease-related variables will be assessed preoperatively, while surgery-related variables will be assessed intraoperatively. |
Preoperative and intraoperative periods
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Serum magnesium levels as predictors of post-thyroidectomy hypoparathyroidism
Time Frame: Preoperative (baseline) and postoperative day 1; hypoparathyroidism assessed within 24 hours postoperatively
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Serum magnesium levels will be measured preoperatively (baseline, prior to surgery) and on postoperative day 1.
The predictive value of preoperative and postoperative day 1 serum magnesium levels for early post-thyroidectomy hypoparathyroidism will be assessed using univariable and multivariable logistic regression analysis, with results reported as odds ratios and 95% confidence intervals.
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Preoperative (baseline) and postoperative day 1; hypoparathyroidism assessed within 24 hours postoperatively
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Postoperative permanent hypoparathyroidism
Time Frame: 12 months after surgery
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Incidence of permanent post-thyroidectomy hypoparathyroidism, defined as persistently low serum PTH levels and/or ongoing requirement for calcium and/or vitamin D supplementation at 12 months after surgery.
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12 months after surgery
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TartuUH-ETCH_403/T-13_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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