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Postoperativ hypokalcemi efter thyreoidektomi

19. september 2026 opdateret af: Saleh Khairy Saleh MD, Minia University

Et tiårigt kohortestudie af kliniske og kirurgiske prædiktorer for hypokalcæmi efter thyroidektomi

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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

600

Kontakter og lokationer

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Studiekontakt

Studiesteder

  • Egypten
    • Minya Governorate
      • Minya, Minya Governorate, Egypten, 61519

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: RETROSPECTIVE

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Postoperative Hypocalcemia
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Transient Hypocalcemia
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Sponsor

Minia University

Efterforskere

  • Ledende efterforsker: Saleh K Saleh, MD, Minia University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2014

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. januar 2027

Datoer for studieregistrering

Først indsendt

17. februar 2026

Først indsendt, der opfyldte QC-kriterier

17. februar 2026

Først opslået (Faktiske)

23. februar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1878/02/2026

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