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Postoperativ hypokalcemi efter tireoidektomi

19 september 2026 uppdaterad av: Saleh Khairy Saleh MD, Minia University

En tioårig kohortstudie av kliniska och kirurgiska prediktorer för hypokalcemi efter tyreoidektomi

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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

600

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Saleh K Saleh, MD
Telefonnummer: +2 01201765401
E-post: salehkhairy@mu.edu.eg

Studieorter

Egypten
- Minya Governorate
  - Minya, Minya Governorate, Egypten, 61519
    - Rekrytering
    - Minia University Hospital
    - Kontakt:
      
      Saleh K Saleh, MD
      
      Telefonnummer: +2 01201765401
      
      E-post: salehkhairy@mu.edu.eg
    - Underutredare:
      
      Rabeh K Saleh, MD
    - Kontakt:
      
      E-post: salehkhairy@mu.edu.eg

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: COHORT
Tidsperspektiv: RETROSPECTIVE

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Incidence of Postoperative Hypocalcemia Tidsram: 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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Incidence of Transient Hypocalcemia Tidsram: 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 Tidsram: 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 Tidsram: 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
Hospital Length of Stay Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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)	Up to 6 months post-surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Minia University

Utredare

Huvudutredare: Saleh K Saleh, MD, Minia University

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2014

Primärt slutförande (Beräknad)

1 december 2026

Avslutad studie (Beräknad)

1 januari 2027

Studieregistreringsdatum

Först inskickad

17 februari 2026

Först inskickad som uppfyllde QC-kriterierna