Postoperative Hypocalcemia After Thyroidectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMinia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 years or older at time of surgery
Underwent thyroidectomy at Minia University Hospital
Availability of medical records with complete surgical and postoperative data
Documented serum calcium levels measured postoperatively
Disqualifiers
Age less than 18 years at time of surgery
Preoperative hypocalcemia (serum calcium <8.0 mg/dL or ionized calcium <1.0 mmol/L)
Pre-existing parathyroid disorders (primary hyperparathyroidism, hypoparathyroidism, secondary or tertiary hyperparathyroidism)
Chronic kidney disease Stage 3 or higher (estimated glomerular filtration rate <60 mL/min/1.73m²)
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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-surgerySecondary outcomes
1
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-surgery2
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-surgery3
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-surgery4
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 daysSponsors and contacts
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Source ClinicalTrials.gov