| NCT ID | NCT06296420 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Auxologico Italiano |
| Condition | Goiter |
| Study Type | OBSERVATIONAL |
| Enrollment | 420 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 420 participants in total. It began in 2024-01-31 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Stefano Scarano, MD
PRINCIPAL INVESTIGATOR
University of Milan, IRCCS Istituto Auxologico Italiano
Frequently Asked Questions
Who can join the NCT06296420 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Goiter. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06296420 currently recruiting?
Yes, NCT06296420 is actively recruiting participants. Contact the research team at s.scarano@auxologico.it for enrollment information.
Where is the NCT06296420 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06296420 clinical trial?
NCT06296420 is sponsored by Istituto Auxologico Italiano. The principal investigator is Stefano Scarano, MD at University of Milan, IRCCS Istituto Auxologico Italiano. The trial plans to enroll 420 participants.