Dysphagia After Thyroidectomy

Goiter Clinical Trial

— DYSPHATHYR  

Official title:

Dysphagia After Thyroidectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296420
• Other study ID #: 24C304
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Goiter
• Thyroid Disease
• Thyroid Diseases

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.