A Ten-Year Cohort Study of Clinical and Surgical Predictors for Hypocalcemia Post-Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Hypocalcemia
研究概览
简要总结
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.
详细描述
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%) .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of Postoperative Hypocalcemia
时间窗: 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
次要结局
- Hospital Length of Stay(From surgery to discharge, typically 2-5 days)
- Calcium and Vitamin D Supplementation Requirement(Up to 6 months post-surgery)
- Emergency Department Visits for Hypocalcemia(Within 30 days post-discharge)
- Hospital Readmission Related to Hypocalcemia(Within 30 days post-discharge)
- Postoperative Parathyroid Hormone (PTH) Level(24 hours post-surgery)
- Nadir Calcium Level(Within 7 days post-surgery)
- Time to Calcium Normalization(Up to 6 months post-surgery)
- Incidence of Transient Hypocalcemia(Up to 6 months post-surgery)
- Incidence of Permanent Hypocalcemia(6 months post-surgery)
- Incidence of Symptomatic Hypocalcemia(Within 2 weeks post-surgery)
研究者
Saleh Khairy Saleh MD
Lecturer
Minia University