PTH-independent Effects of Encaleret
NCT05735015
Calcium Metabolism Disorders, Endocrine System Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT07582562
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
East Tallinn Central Hospital, Tallinn, Estonia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Tartu University Hospital
Other
A Prospective Study to Assess Risk Factors for Hypoparathyroidism Following Thyroidectomy
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