Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07428057

Postoperative Hypocalcemia After Thyroidectomy

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Minia University Hospital

Minya, Minya Governorate, 61519, Egypt

Location status: Recruiting

Location contact

Rabeh K Saleh, MD

SUB_INVESTIGATOR

Saleh K Saleh, MD

CONTACT

[email protected]

01201765401 ext. +2

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Minimum follow-up of 6 months postoperatively or documented outcome status

Exclusion criteria

  • 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)
  • Malabsorption syndromes affecting calcium metabolism (celiac disease, inflammatory bowel disease,short bowel syndrome)
  • Concurrent planned parathyroidectomy
  • History of neck irradiation
  • Chronic use of medications significantly affecting calcium metabolism (bisphosphonates, denosumab,cinacalcet, chronic corticosteroids)
  • Incomplete medical records lacking essential data including surgical details, postoperative calcium levels,or follow-up data
  • Patients lost to follow-up before 6-month endpoint without documented outcome status

Treatment and study plan

Primary outcomes

  1. Incidence of Postoperative Hypocalcemia

    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

Secondary outcomes

  1. Incidence of Transient Hypocalcemia

    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

  2. Incidence of Permanent Hypocalcemia

    Time frame: 6 months post-surgery

    Hypocalcemia requiring ongoing calcium and/or vitamin D supplementation persisting beyond 6months postoperatively, indicating permanent hypoparathyroidism

  3. Incidence of Symptomatic Hypocalcemia

    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)

  4. Hospital Length of Stay

    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

  5. Calcium and Vitamin D Supplementation Requirement

    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)

  6. Emergency Department Visits for Hypocalcemia

    Time frame: Within 30 days post-discharge

    Unplanned emergency department visits related to symptoms of hypocalcemia or complications of calcium/vitamin D therapy

  7. Hospital Readmission Related to Hypocalcemia

    Time frame: Within 30 days post-discharge

    Unplanned hospital readmission related to symptomatic hypocalcemia or its complications

  8. Postoperative Parathyroid Hormone (PTH) Level

    Time frame: 24 hours post-surgery

    Serum intact parathyroid hormone level measured within 24 hours postoperatively (pg/mL), used as predictor of sustained hypocalcemia

  9. Nadir Calcium Level

    Time frame: Within 7 days post-surgery

    Lowest serum calcium level (total or ionized) recorded during initial hospitalization or within first week postoperatively

  10. Time to Calcium Normalization

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Saleh K Saleh, MD

CONTACT

[email protected]

01201765401 ext. +2

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

A Ten-Year Cohort Study of Clinical and Surgical Predictors for Hypocalcemia Post-Thyroidectomy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.