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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Hanna Hollman, MD
- Telefonnummer: +37259037517
- E-Mail: hanna.hollman@ut.ee
Studienorte
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Tallinn, Estland
- Rekrutierung
- 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
- Rekrutierung
- Tartu University Hospital
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Kontakt:
- Ceith Nikkolo, PhD
- Telefonnummer: +372 53319082
- E-Mail: ceith.nikkolo@kliinikum.ee
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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postoperative early hypoparathyroidism
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Risk factor assessment of post-thyroidectomy hypoparathyroidism
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- TartuUH-ETCH_403/T-13_1
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