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NCT Number: NCT06296420

Dysphagia After Thyroidectomy

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.

Recruiting

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Key information

Conditions

Goiter Deglutition Disorders Digestive System Diseases Endocrine System Diseases Esophageal Diseases Gastrointestinal Diseases Goiter, Nodular Otorhinolaryngologic Diseases Pharyngeal Diseases Thyroid Disease Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Auxologico Italiano

Milan, MI, 20122, Italy

Location status: Recruiting

Location contact

Stefano Scarano, MD

CONTACT

[email protected]

+3902619116717

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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).

  2. Depression Anxiety Stress Scales-21 (DASS-21).

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gianlorenzo Dionigi, MD

CONTACT

[email protected]

Stefano Scarano, MD

CONTACT

[email protected]

+3902619116717

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Acronym: DYSPHATHYR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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