An observational study in Thyroid Nodule, Thyroid Dysfunction and Hypocalcemia, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Minia University · Observational
This retrospective cohort study investigates predictors of postoperative hypocalcemia following thyroidectomy procedures at Minia University Hospital over a 10-year period (2014-2024). Postthyroidectomy hypocalcemia is one of the most common complications of thyroid surgery, affecting 20-50% of patients. The study aims to identify demographic, clinical, laboratory, and surgical factors associated with the development of both transient and permanent hypocalcemia. Results will inform risk stratification, patient counseling, and perioperative management strategies.
Hypocalcemia is a frequent complication following thyroidectomy, resulting from inadvertent parathyroid gland injury, removal, or devascularization. While most cases resolve within 6 months (transient hypocalcemia),permanent hypocalcemia occurs in 1-3% of patients and requires lifelong calcium and vitamin D supplementation, significantly impacting quality of life.
This single-center retrospective study will systematically review medical records of all patients who underwent thyroidectomy (total, subtotal, or completion) at Minia University Hospital between January 1, 2014, andDecember 31, 2024. The primary objective is to identify independent predictors of postoperative hypocalcemia using multiple logistic regression analysis.
Data extraction will include:
Demographics: age, gender, BMI Clinical factors: indication for surgery, thyroid disease type, presence of Graves' disease, substernal extension Preoperative laboratory values: calcium, vitamin D, PTH, thyroid function tests Surgical details: extent of thyroidectomy, central/lateral lymph node dissection, surgeon experience,operative time, parathyroid gland identification and autotransplantation Postoperative data: calcium levels (24h, 48h, 1 week, 6 weeks, 3 months, 6 months), PTH levels,supplementation requirements Pathology: thyroid weight, presence of parathyroid tissue in specimen, thyroiditis, malignancy The study will employ robust statistical methods including univariate analysis to screen potential predictors and multiple logistic regression to identify independent risk factors. A clinical risk prediction score will be developed and internally validated using split-sample methodology. Subgroup analyses will examine differences between transient and permanent hypocalcemia and stratify results by extent of surgery and surgeon experience.
Target sample size of 500-600 patients was calculated using G*Power to ensure adequate statistical power(>80%) .
Findings will contribute to evidence-based perioperative protocols, improved patient selection for outpatient thyroidectomy, tailored monitoring strategies, and informed decision-making regarding prophylactic calcium supplementation.
This retrospective cohort study will include adult patients (aged 18 years and older) who underwent a thyroidectomy procedure at Minia University Hospital, a tertiary care centre in Egypt, between January 1, 2014, and December 31, 2024. The target population consists of approximately 600 consecutive patients who meet the eligibility criteria. This includes patients with available medical records containing complete surgical and postoperative data, documented postoperative serum calcium levels, and a minimum of 6 months of follow-up or a documented outcome status. Patients will be excluded if they have preoperative hypocalcemia, pre-existing parathyroid disorders, chronic kidney disease (Stage 3 or higher), or other conditions that significantly affect calcium metabolism. The study population represents a consecutive sample of all patients meeting these criteria over the 10-year study period at this single academic center.
Exclusion Criteria:
Incidence of Postoperative Hypocalcemia
Development of hypocalcemia defined as: Serum total calcium \<8.0 mg/dL (2.0 mmol/L) OR Ionized calcium \<1.0 mmol/L OR Symptomatic hypocalcemia (perioral numbness, paresthesias, carpopedal spasm, positive Chvostek's orTrousseau's sign) requiring calcium supplementation Measured at: 24 hours, 48 hours, 1 week, 6 weeks, 3 months, and 6 months postoperatively
Time frame: Within 6 months post-surgery
Incidence of Transient Hypocalcemia
Hypocalcemia that resolves within 6 months of surgery without need for continued calcium and/or vitamin D supplementation beyond 6-month follow-up
Time frame: Up to 6 months post-surgery
Incidence of Permanent Hypocalcemia
Hypocalcemia requiring ongoing calcium and/or vitamin D supplementation persisting beyond 6months postoperatively, indicating permanent hypoparathyroidism
Time frame: 6 months post-surgery
Incidence of Symptomatic Hypocalcemia
Clinical manifestations of hypocalcemia including: Neuromuscular irritability (perioral tingling, paresthesias) Tetany or carpopedal spasm Positive Chvostek's sign (facial nerve twitching) Positive Trousseau's sign (carpal spasm with blood pressure cuff inflation) Seizures (rare) Cardiac manifestations: prolonged QT interval, arrhythmias (rare)
Time frame: Within 2 weeks post-surgery
Hospital Length of Stay
Duration of hospitalization in days following thyroidectomy, measured from date of surgery to date of hospital discharge
Time frame: From surgery to discharge, typically 2-5 days
Calcium and Vitamin D Supplementation Requirement
Need for oral calcium supplementation (yes/no and total daily dose in mg) Need for vitamin D supplementation (yes/no and total daily dose in IU) Duration of supplementation (days/weeks) Need for intravenous calcium administration (yes/no)
Time frame: Up to 6 months post-surgery
Emergency Department Visits for Hypocalcemia
Unplanned emergency department visits related to symptoms of hypocalcemia or complications of calcium/vitamin D therapy
Time frame: Within 30 days post-discharge
Hospital Readmission Related to Hypocalcemia
Unplanned hospital readmission related to symptomatic hypocalcemia or its complications
Time frame: Within 30 days post-discharge
Postoperative Parathyroid Hormone (PTH) Level
Serum intact parathyroid hormone level measured within 24 hours postoperatively (pg/mL), used as predictor of sustained hypocalcemia
Time frame: 24 hours post-surgery
Nadir Calcium Level
Lowest serum calcium level (total or ionized) recorded during initial hospitalization or within first week postoperatively
Time frame: Within 7 days post-surgery
Time to Calcium Normalization
Duration in days from surgery to sustained normalization of serum calcium levels without supplementation (for those who develop hypocalcemia)
Time frame: Up to 6 months post-surgery
Plan to share: No
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Minia University