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Ipocalcemia postoperatoria dopo tiroidectomia

19 settembre 2026 aggiornato da: Saleh Khairy Saleh MD, Minia University

Uno Studio di Cohorte Decennale sui Predittori Clinici e Chirurgici per l'Ipocalcemia Post-Tiroidectomia

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

600

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Saleh K Saleh, MD
Numero di telefono: +2 01201765401
Email: salehkhairy@mu.edu.eg

Luoghi di studio

Egitto
- Minya Governorate
  - Minya, Minya Governorate, Egitto, 61519
    - Reclutamento
    - Minia University Hospital
    - Contatto:
      
      Saleh K Saleh, MD
      
      Numero di telefono: +2 01201765401
      
      Email: salehkhairy@mu.edu.eg
    - Sub-investigatore:
      
      Rabeh K Saleh, MD
    - Contatto:
      
      Email: salehkhairy@mu.edu.eg

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Modelli osservazionali: COHORT
Prospettive temporali: RETROSPECTIVE

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Incidence of Postoperative Hypocalcemia Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Incidence of Transient Hypocalcemia Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Minia University

Investigatori

Investigatore principale: Saleh K Saleh, MD, Minia University

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2014

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 gennaio 2027

Date di iscrizione allo studio

Primo inviato

17 febbraio 2026

Primo inviato che soddisfa i criteri di controllo qualità