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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06296420
Other study ID # 24C304
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 31, 2024
Est. completion date November 30, 2026

Study information

Verified date March 2024
Source Istituto Auxologico Italiano
Contact Stefano Scarano, MD
Phone +3902619116717
Email s.scarano@auxologico.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 420
Est. completion date November 30, 2026
Est. primary completion date November 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
Italy IRCCS Istituto Auxologico Italiano Milan MI

Sponsors (1)

Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. In the week before surgery, three months after surgery, and six months after surgery.
Secondary 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). The POSAS 2.0 will be administered 10 days after surgery and 2 months after surgery.
Secondary 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. The DASS-21 will be administered 10 days before surgery and 2 months after surgery.
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