Dysphagia After Thyroidectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Goiter
- Sponsor
- Istituto Auxologico Italiano
- Enrollment
- 420
- Locations
- 1
- Primary Endpoint
- The primary outcome measure will be the questionnaire which will be developed in the first phase of the study itself.
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of goiter or thyroidectomy.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The primary outcome measure will be the questionnaire which will be developed in the first phase of the study itself.
Time Frame: 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.
Secondary Outcomes
- 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.)