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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Hanna Hollman, MD
- Telefoonnummer: +37259037517
- E-mail: hanna.hollman@ut.ee
Studie Locaties
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Tallinn, Estland
- Werving
- East Tallinn Central Hospital
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Contact:
- Hanna Hollman, MD
- Telefoonnummer: +372 59037517
- E-mail: hanna.hollman@itk.ee
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Tartu, Estland
- Werving
- Tartu University Hospital
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Contact:
- Ceith Nikkolo, PhD
- Telefoonnummer: +372 53319082
- E-mail: ceith.nikkolo@kliinikum.ee
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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postoperative early hypoparathyroidism
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Risk factor assessment of post-thyroidectomy hypoparathyroidism
Tijdsspanne: Preoperative and intraoperative periods
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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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TartuUH-ETCH_403/T-13_1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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