Measuring swallowing difficulties after thyroid surgery
Dysphagia After Thyroidectomy
This study is trying to create a questionnaire to help people who have had thyroid surgery or have a goiter report their swallowing and throat discomfort symptoms better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06296420 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a questionnaire that accurately measures swallowing and throat discomfort symptoms in patients with goiter or those who have undergone thyroidectomy. The questionnaire will be created using the Rasch model to ensure it meets essential measurement criteria such as unidimensionality and generalizability. Initially, interviews will be conducted with affected patients to identify relevant items and response categories, followed by administering the questionnaire to patients before and after their surgery to assess changes in symptoms. Additionally, the study will evaluate the psychological effects of goiter and thyroidectomy, as well as the characteristics of surgical scars.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with goiter or those who have undergone thyroidectomy.
Not a fit: Patients with neurological disorders or other conditions affecting the aerodigestive tract that could cause swallowing issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable tool for clinicians to assess and improve the quality of life for patients experiencing swallowing difficulties after thyroid surgery.
How similar studies have performed: While this approach is focused on developing a specific measurement tool, similar studies have successfully utilized psychometric methods to assess patient-reported outcomes in other medical conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan, MI
- IRCCS Istituto Auxologico Italiano — Milan, Mi, Italy (Recruiting)
Study contacts
- Principal investigator: Stefano Scarano, MD — University of Milan, IRCCS Istituto Auxologico Italiano
- Study coordinator: Stefano Scarano, MD
- Email: s.scarano@auxologico.it
- Phone: +3902619116717
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.