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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Hanna Hollman, MD
- Telefonnummer: +37259037517
- E-mail: hanna.hollman@ut.ee
Studiesteder
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-
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Tallinn, Estland
- Rekruttering
- East Tallinn Central Hospital
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Kontakt:
- Hanna Hollman, MD
- Telefonnummer: +372 59037517
- E-mail: hanna.hollman@itk.ee
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Tartu, Estland
- Rekruttering
- Tartu University Hospital
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Kontakt:
- Ceith Nikkolo, PhD
- Telefonnummer: +372 53319082
- E-mail: ceith.nikkolo@kliinikum.ee
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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postoperative early hypoparathyroidism
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Risk factor assessment of post-thyroidectomy hypoparathyroidism
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TartuUH-ETCH_403/T-13_1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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