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Pooperacyjna hipokalcemia po tyreoidektomii

19 września 2026 zaktualizowane przez: Saleh Khairy Saleh MD, Minia University

Dziesięcioletnie badanie kohortowe klinicznych i chirurgicznych predyktorów hipokalcemii po tyreoidektomii

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

600

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: Saleh K Saleh, MD
Numer telefonu: +2 01201765401
E-mail: salehkhairy@mu.edu.eg

Lokalizacje studiów

Egipt
- Minya Governorate
  - Minya, Minya Governorate, Egipt, 61519
    - Rekrutacyjny
    - Minia University Hospital
    - Kontakt:
      
      Saleh K Saleh, MD
      
      Numer telefonu: +2 01201765401
      
      E-mail: salehkhairy@mu.edu.eg
    - Pod-śledczy:
      
      Rabeh K Saleh, MD
    - Kontakt:
      
      E-mail: salehkhairy@mu.edu.eg

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Modele obserwacyjne: COHORT
Perspektywy czasowe: RETROSPECTIVE

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Incidence of Postoperative Hypocalcemia Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Incidence of Transient Hypocalcemia Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Minia University

Śledczy

Główny śledczy: Saleh K Saleh, MD, Minia University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 stycznia 2014

Zakończenie podstawowe (Szacowany)

1 grudnia 2026

Ukończenie studiów (Szacowany)

1 stycznia 2027

Daty rejestracji na studia

Pierwszy przesłany

17 lutego 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości