Dysphagia After Thyroidectomy (DYSPHATHYR)

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.

Study Overview

• Status: Recruiting
• Conditions: Goiter; Thyroid Disease

• Study Type: Observational
• Enrollment (Estimated): 420

Contacts and Locations

• Study Contact: Name: Stefano Scarano, MD; Phone Number: +3902619116717; Email: s.scarano@auxologico.it
• Study Contact Backup: Name: Gianlorenzo Dionigi, MD; Email: g.dionigi@auxologico.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20122
      • Recruiting
      • IRCCS Istituto Auxologico Italiano
      • Contact: Stefano Scarano, MD; Phone Number: +3902619116717; Email: s.scarano@auxologico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Investigators: Principal Investigator: Stefano Scarano, MD, University of Milan, IRCCS Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Dysphagia; Thyroidectomy; Psychometrics; Rasch analysis; Nodular goiter
• Additional Relevant MeSH Terms: Endocrine System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Thyroid Diseases; Deglutition Disorders; Goiter, Nodular; Goiter
• Other Study ID Numbers: 24C304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No