Clinical trial NCT06296420: Dysphagia After Thyroidectomy
Official title: Dysphagia After Thyroidectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Goiter
Thyroid Disease
Keywords: Nodular goiter
Thyroidectomy
Dysphagia
Psychometrics
Rasch analysis
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Primary outcomes:
measure: The primary outcome measure will be the questionnaire which will be developed in the first phase of the study itself.
timeFrame: In the week before surgery, three months after surgery, and six months after surgery.
Secondary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS) 2.0.
timeFrame: The POSAS 2.0 will be administered 10 days after surgery and 2 months after surgery.
measure: Depression Anxiety Stress Scales-21 (DASS-21).
timeFrame: The DASS-21 will be administered 10 days before surgery and 2 months after surgery.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Auxologico Italiano
state: MI
Study officials:
affiliation: University of Milan, IRCCS Istituto Auxologico Italiano
name: Stefano Scarano, MD
role: PRINCIPAL_INVESTIGATOR
References: