GoiterDYSPHATHYRNCT06296420
Dysphagia After Thyroidectomy
An observational study of Goiter and Thyroid Disease, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Goiter, Thyroid Disease
- How many people
- 420 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jan 2024to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the first phase, the study will recruit patients with diagnosis of goiter who are candidates to thyroidectomy and patients who have undergone thyroidectomy. Patients will be interviewed by the researchers. The interviews will face the symptoms of goiter or thyroidectomy, dealing (not exclusively) with throat and swallowing symptoms. The interviews will be recorded and analysed. The content of the interviews will be used to develop the items and the response categories of the questionnaire. In the second phase, the study will recruit patients who are candidates for thyroidectomy. The questionnaire (and the other outcome measures of the study) will be administered to the patients before and after surgery. All patients who are candidates for thyroidectomy at the Istituto Auxologico Italiano in Milan, Italy, will be recruited (if they comply with inclusion and exclusion criteria and if they provide consent). General, clinical and surgical data will be collected.
Who may be able to join
- Diagnosis of goiter or thyroidectomy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gianlorenzo Dionigi, MD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Auxologico Italiano
Milan, MI, 20122
Stefano Scarano, MD, +3902619116717, s.scarano@auxologico.it
About this study
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.
Read more
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.
- Conditions
- Goiter, Thyroid Disease
- Keywords
- Nodular goiter, Thyroidectomy, Dysphagia, Psychometrics, Rasch analysis
- Medical subject headings
- Goiter, Thyroid Diseases, Goiter, Nodular, Deglutition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the questionnaire which will be developed in the first phase of the study itself.
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.
Measured: In the week before surgery, three months after surgery, and six months after surgery.
Secondary outcomes (2)
Patient and Observer Scar Assessment Scale (POSAS) 2.0.
The Patient and Observer Scar Assessment Scale (POSAS) 2.0. is an assessment scale that measures the quality of the scar from the perspectives of the patient and the clinician. It is made of two separate subscales, i.e., the Observer Scar Assessment Scale and the Patient Scar Assessment Scale. The Observer Scar Assessment Scale is made of 6 items, each scored 1 to 10 (total score 6 to 60, with higher scores indicating worse scar quality). The Patient Scar Assessment Scale is made of 7 items, each scored 1 to 10, divided in three subsets (total score 7 to 70, with higher scores indicating worse scar quality).
Measured: The POSAS 2.0 will be administered 10 days after surgery and 2 months after surgery.
Depression Anxiety Stress Scales-21 (DASS-21).
The Depression Anxiety Stress Scales-21 (DASS-21) is an assessment scale used to measure the severity of symptoms of depression, anxiety and stress. It is made of 21 items, each scored 0 to 3 (total score 0 to 63, with higher scores for greater severity of depression, anxiety and/or stress.
Measured: The DASS-21 will be administered 10 days before surgery and 2 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start31 Jan 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoiterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Scarano, MD, Principal investigator, University of Milan, IRCCS Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296420
- Sponsor's protocol ID
- 24C304
- Acronym
- DYSPHATHYR
- Status last verified
- Dec 2025
- First submitted
- 29 Feb 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysphagia After Thyroidectomy
- ClinicalTrials.gov ID
- NCT06296420
- Acronym / sponsor ID
- DYSPHATHYR / 24C304
- Conditions
- Goiter, Thyroid Disease
- Keywords
- Nodular goiter, Thyroidectomy, Dysphagia, Psychometrics, Rasch analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the first phase, the study will recruit patients with diagnosis of goiter who are candidates to thyroidectomy and patients who have undergone thyroidectomy. Patients will be interviewed by the researchers. The interviews will face the symptoms of goiter or thyroidectomy, dealing (not exclusively) with throat and swallowing symptoms. The interviews will be recorded and analysed. The content of the interviews will be used to develop the items and the response categories of the questionnaire. In the second phase, the study will recruit patients who are candidates for thyroidectomy. The questionnaire (and the other outcome measures of the study) will be administered to the patients before and after surgery. All patients who are candidates for thyroidectomy at the Istituto Auxologico Italiano in Milan, Italy, will be recruited (if they comply with inclusion and exclusion criteria and if they provide consent). General, clinical and surgical data will be collected.
Key inclusion criteria (1 listed)
- Diagnosis of goiter or thyroidectomy.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gianlorenzo Dionigi, MD contact
Stefano Scarano, MD principal investigator
University of Milan, IRCCS Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Goiter and Thyroid Disease, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Scarano, MD (+3902619116717, s.scarano@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.