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NCT Number: NCT07582562

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

East Tallinn Central Hospital, Tallinn, Estonia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. postoperative early hypoparathyroidism

    Time frame: first postoperative day

    Incidence of early post-thyroidectomy hypoparathyroidism, based on serum PTH levels measured on the morning of the first postoperative day

Secondary outcomes

  1. 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.

  2. Serum magnesium levels as predictors of post-thyroidectomy hypoparathyroidism

    Time frame: Preoperative (baseline) and postoperative day 1; hypoparathyroidism assessed within 24 hours postoperatively

    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.

  3. Postoperative permanent hypoparathyroidism

    Time frame: 12 months after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanna Hollman, MD

CONTACT

[email protected]

+37259037517

Sponsors and collaborators

Lead sponsor

Tartu University Hospital

Other

Collaborators

  • East Tallinn Central Hospital

Registry information

Official study title

A Prospective Study to Assess Risk Factors for Hypoparathyroidism Following Thyroidectomy

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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