Dysphagia After Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- The primary outcome measure will be the questionnaire which will be developed in the first phase of the study itself.
研究概览
简要总结
The goal of this observational study is to develop a questionnaire for measuring swallowing and throat discomfort symptoms in patients with goiter or thyroidectomy, which complies with the model of Rasch and which satisfies the fundamental measurement axioms (e.g., unidimensionality, linearity, generalizability). Developing a scale with such characteristics would provide clinicians and researchers with a reliable tool for assessing the impact of goiter and for measuring the outcomes after surgery.
Also, the study will assess the psychological impact of goiter and thyroidectomy, as well as the characteristics of the surgical scar after thyroidectomy.
The questionnaire will be developed in the first phase of the study. Items and response categories will be identified through interviews performed with patients affected by goiter or after thyroidectomy.
In the following phases of the study, the questionnaire will be administered to patients before and after 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
- •Diagnosis of goiter or thyroidectomy.
排除标准
- •Diagnosis of other neurological disorders or disorders involving the aerodigestive tract that could cause swallowing disorders.
- •Previous surgery of the neck or involving the aerodigestive tract.
结局指标
主要结局
The primary outcome measure will be the questionnaire which will be developed in the first phase of the study itself.
时间窗: In the week before surgery, three months after surgery, and six months after surgery.
The questionnaire will be administered to the recruited patients three times: in the week before surgery, three months after surgery, and six months after surgery.
次要结局
- Patient and Observer Scar Assessment Scale (POSAS) 2.0.(The POSAS 2.0 will be administered 10 days after surgery and 2 months after surgery.)
- Depression Anxiety Stress Scales-21 (DASS-21).(The DASS-21 will be administered 10 days before surgery and 2 months after surgery.)