Risk Factors for Hypoparathyroidism Following Thyroidectomy
ConditionPost-Surgical Hypoparathyroidism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTartu University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
patients undergoing unilateral thyroid lobectomy only
patients with concomitant hyperparathyroidism undergoing simultaneous thyroidectomy and parathyroidectomy for a parathyroid adenoma
Trial population
Patients over the age of 18 at Tartu University Hospital and East Tallinn Central Hospital who are undergoing surgery involving both lobes of the thyroid gland (thyroidectomy, "near-total" thyroidectomy, subtotal thyroidectomy, and "completed" thyroidectomy), and who provide informed consent for this.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
postoperative early hypoparathyroidism
Incidence of early post-thyroidectomy hypoparathyroidism, based on serum PTH levels measured on the morning of the first postoperative day
Time frame
first postoperative daySecondary outcomes
1
Risk factor assessment of post-thyroidectomy hypoparathyroidism
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 and intraoperative periods2
Serum magnesium levels as predictors of post-thyroidectomy hypoparathyroidism
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
Preoperative (baseline) and postoperative day 1; hypoparathyroidism assessed within 24 hours postoperatively3
Postoperative permanent hypoparathyroidism
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.
Time frame
12 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Tartu University Hospital
Lead sponsor
East Tallinn Central Hospital
Collaborator
Source ClinicalTrials.gov