Minia University Hospital
Minya, Minya Governorate, 61519, Egypt
Location status: Recruiting
NCT Number: NCT07428057
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Minya, Minya Governorate, 61519, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Within 6 months post-surgery
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: Up to 6 months post-surgery
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: 6 months post-surgery
Hypocalcemia requiring ongoing calcium and/or vitamin D supplementation persisting beyond 6months postoperatively, indicating permanent hypoparathyroidism
Time frame: Within 2 weeks post-surgery
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: From surgery to discharge, typically 2-5 days
Duration of hospitalization in days following thyroidectomy, measured from date of surgery to date of hospital discharge
Time frame: Up to 6 months post-surgery
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: Within 30 days post-discharge
Unplanned emergency department visits related to symptoms of hypocalcemia or complications of calcium/vitamin D therapy
Time frame: Within 30 days post-discharge
Unplanned hospital readmission related to symptomatic hypocalcemia or its complications
Time frame: 24 hours post-surgery
Serum intact parathyroid hormone level measured within 24 hours postoperatively (pg/mL), used as predictor of sustained hypocalcemia
Time frame: Within 7 days post-surgery
Lowest serum calcium level (total or ionized) recorded during initial hospitalization or within first week postoperatively
Time frame: Up to 6 months post-surgery
Duration in days from surgery to sustained normalization of serum calcium levels without supplementation (for those who develop hypocalcemia)
Contact information is provided by the study sponsor or research team.
Minia University
Other
A Ten-Year Cohort Study of Clinical and Surgical Predictors for Hypocalcemia Post-Thyroidectomy
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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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