NCT02167529已完成不适用
A Prospective, Multicenter and Observational Trial to Evaluate Evolution of Quality of Life (SF-36) After Total Thyroidectomy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 890
- 试验地点
- 7
- 主要终点
- Evaluate the differences in terms of impact on quality of life among patients without sequelae 6 months after thyroidectomy (laryngeal paralysis or hypoparathyroidism) and patients with hypoparathyroidism. (SF36 v1,3, self-administered questionnaire)
研究概览
简要总结
The purpose of this study is to evaluate the evolution of quality of life and voice function with different questionnaires (VIH, SF36) before and after total thyroidectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adult over 18 years
- •Notice to total thyroidectomy
- •Thyroidectomy under cervicotomy or videoscopy
- •Existence of a written informed consent of the patient
- •Affiliation to a social security
- •Possible follow-up for 6 months
排除标准
- •Impossibility for the patient to complete the forms
- •Impossibility to follow the patient patient with serious disease which impact the quality of life
- •Medullary thyroid cancers
- •Preoperative examination of vocal cords (if performed) finding a violation of the vocal cords
- •Lack of monitoring possible during the 6 months after surgery
- •Pregnant women or during lactation
- •Minors and adults under guardianship
结局指标
主要结局
Evaluate the differences in terms of impact on quality of life among patients without sequelae 6 months after thyroidectomy (laryngeal paralysis or hypoparathyroidism) and patients with hypoparathyroidism. (SF36 v1,3, self-administered questionnaire)
时间窗: Evaluation at 6 months
次要结局
- Evaluation of the impact of post thyroidectomy laryngeal paralysis on the quality of life (SF36 v1,3, self-administered questionnaire)(Evaluation at 2 and 6 months)
- Evaluation of difficulties voice after total thyroidectomy (with or without laryngeal complication) (VIH questionnaire)(Evaluation at 2 and 6 months)
研究者
研究点 (7)
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