- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07428057
Postoperative Hypocalcemia After Thyroidectomy
A Ten-Year Cohort Study of Clinical and Surgical Predictors for Hypocalcemia Post-Thyroidectomy
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Saleh K Saleh, MD
- Phone Number: +2 01201765401
- Email: salehkhairy@mu.edu.eg
Study Locations
-
-
Minya Governorate
-
Minya, Minya Governorate, Egypt, 61519
- Recruiting
- Minia University Hospital
-
Contact:
- Saleh K Saleh, MD
- Phone Number: +2 01201765401
- Email: salehkhairy@mu.edu.eg
-
Sub-Investigator:
- Rabeh K Saleh, MD
-
Contact:
- Email: salehkhairy@mu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
Within 6 months post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From surgery to discharge, typically 2-5 days
|
|
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)
|
Up to 6 months post-surgery
|
|
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
|
Within 30 days post-discharge
|
|
Hospital Readmission Related to Hypocalcemia
Time Frame: Within 30 days post-discharge
|
Unplanned hospital readmission related to symptomatic hypocalcemia or its complications
|
Within 30 days post-discharge
|
|
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
|
24 hours post-surgery
|
|
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
|
Within 7 days post-surgery
|
|
Time to Calcium Normalization
Time Frame: Up to 6 months post-surgery
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Duration in days from surgery to sustained normalization of serum calcium levels without supplementation (for those who develop hypocalcemia)
|
Up to 6 months post-surgery
|
|
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
|
Up to 6 months post-surgery
|
|
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
|
6 months post-surgery
|
|
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) |
Within 2 weeks post-surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saleh K Saleh, MD, Minia University
Publications and helpful links
General Publications
- Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9.
- Thomusch O, Machens A, Sekulla C, Ukkat J, Brauckhoff M, Dralle H. The impact of surgical technique on postoperative hypoparathyroidism in bilateral thyroid surgery: a multivariate analysis of 5846 consecutive patients. Surgery. 2003 Feb;133(2):180-5. doi: 10.1067/msy.2003.61.
- Lorente-Poch L, Sancho JJ, Ruiz S, Sitges-Serra A. Importance of in situ preservation of parathyroid glands during total thyroidectomy. Br J Surg. 2015 Mar;102(4):359-67. doi: 10.1002/bjs.9676. Epub 2015 Jan 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Metabolic Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Water-Electrolyte Imbalance
- Parathyroid Diseases
- Thyroid Diseases
- Calcium Metabolism Disorders
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Thyroid Nodule
- Hypoparathyroidism
- Thyroid Neoplasms
- Postoperative Complications
- Hypocalcemia
Other Study ID Numbers
- 1878/02/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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