Postoperative Hypocalcemia After Thyroidectomy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Thyroid Nodule, Thyroid Dysfunction, Hypocalcemia, Thyroid Cancer. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Ten-Year Cohort Study of Clinical and Surgical Predictors for Hypocalcemia Post-Thyroidectomy
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Incidence of Postoperative Hypocalcemia [Срок оценки: Within 6 months post-surgery]
Вторичные конечные точки (10)
- Incidence of Transient Hypocalcemia [Срок оценки: Up to 6 months post-surgery]
- Incidence of Permanent Hypocalcemia [Срок оценки: 6 months post-surgery]
- Incidence of Symptomatic Hypocalcemia [Срок оценки: Within 2 weeks post-surgery]
- Hospital Length of Stay [Срок оценки: From surgery to discharge, typically 2-5 days]
- Calcium and Vitamin D Supplementation Requirement [Срок оценки: Up to 6 months post-surgery]
- Emergency Department Visits for Hypocalcemia [Срок оценки: Within 30 days post-discharge]
- Hospital Readmission Related to Hypocalcemia [Срок оценки: Within 30 days post-discharge]
- Postoperative Parathyroid Hormone (PTH) Level [Срок оценки: 24 hours post-surgery]
- Nadir Calcium Level [Срок оценки: Within 7 days post-surgery]
- Time to Calcium Normalization [Срок оценки: Up to 6 months post-surgery]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Египет · 1 центр
- Minia University Hospital — Minya
Публикации
- 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. PMID 24402815
- 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. PMID 12605179
- 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. PMID 25605285
Идентификаторы
NCT: NCT07428057 · 1878/02/2026