Dysphagia After Thyroidectomy

Recruiting

• Conditions: Thyroid Disease; Goiter

• Registration Number: NCT06296420
• Lead Sponsor: Istituto Auxologico Italiano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-31
• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-02-29
• Status Verified: 2024-03
• Study First Posted: 2024-03-06
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• Diagnosis of goiter or thyroidectomy.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be the questionnaire which will be developed in the first phase of the study itself.	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.

Secondary Outcome Measures

Name	Time	Method
Patient and Observer Scar Assessment Scale (POSAS) 2.0.	The POSAS 2.0 will be administered 10 days after surgery and 2 months after surgery.	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).
Depression Anxiety Stress Scales-21 (DASS-21).	The DASS-21 will be administered 10 days before surgery and 2 months after surgery.	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.

Trial Locations

Locations (1)

IRCCS Istituto Auxologico Italiano; 🇮🇹 Milan, MI, Italy