Dysphagia After Thyroidectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Goiter, Thyroid Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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.]
Secondary outcome measures (2)
- Patient and Observer Scar Assessment Scale (POSAS) 2.0. [Time frame: The POSAS 2.0 will be administered 10 days after surgery and 2 months after surgery.]
- Depression Anxiety Stress Scales-21 (DASS-21). [Time frame: The DASS-21 will be administered 10 days before surgery and 2 months after surgery.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Istituto Auxologico Italiano — Milan
Identifiers
NCT: NCT06296420 · 24C304