Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 6
- 主要终点
- Mental health
研究概览
简要总结
Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. The hypothesis of the investigators is that the mental health is impaired in hypoparathyroid patients compared with thyroidectomized patients without hypoparathyroidism. The investigators evaluated the quality of life using the SF-36 survey in comparison with a control population of patients thyroidectomized but free from this complication. The voice quality, the cardiovascular risk, the kidney function and the incidence of urinary lithiasis were also evaluated.
详细描述
Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. In this retrospective, observational, multicentre study, the investigators evaluated the quality of life using the SF-36 survey in comparison with a control population of patients thyroidectomized but free from this complication. Patients in six centers in France (Angers, Le Mans, Limoges, Nancy, Nantes, la Pitié-Salpétrière) and in the association "Hypoparathyroïdisme France" were contacted by mail. The primary endpoint was the mental health. The physic and global quality of life scores were assessed as secondary endpoints. Medical and VHI surveys were also send to the patients. The voice quality, the cardiovascular risk, the kidney function and the incidence of urinary lithiasis were also evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients operated of total thyroidectomy
- •Patients suffering from persistent hypoparathyroidism defined as serum PTH inferior to 15 pg/mL 6 months after the surgery, requiring vitamin-calcic supplementation.
- •Age superior to 18
- •Answering the survey
排除标准
- •Pregnancy at the time of the study
- •Age inferior to 18 or adult under guardianship
- •Patients with vitamino-calcic supplementation without serum PTH measurement
- •Cause of hypoparathyroidism other than post-operatory.
结局指标
主要结局
Mental health
时间窗: Through study completion, an average of 1 year
Items from mental quality of life score defined by the SF36 (Short Form 36) survey
次要结局
- Renal function quality(Through study completion, an average of 1 year)
- Physical quality score(Through study completion, an average of 1 year)
- Presence of urinary lithiasis(Through study completion, an average of 1 year)
- Voice quality(Through study completion, an average of 1 year)
- Presence of cardiovascular complications(Through study completion, an average of 1 year)
- Global quality of life score(Through study completion, an average of 1 year)