Dysphagia After Thyroidectomy

NCT06296420 | Recruiting

• 1 other identifier: 24C304
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Goiter; Thyroid Disease

Keywords

Nodular goiter; Thyroidectomy; Dysphagia; Psychometrics; Rasch analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

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

  The DASS-21 will be administered 10 days before surgery and 2 months after surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosis of goiter or thyroidectomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

IRCCS Istituto Auxologico Italiano

Milan, MI, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Goiter; Thyroid Diseases; Goiter, Nodular; Deglutition Disorders

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Stefano Scarano, MD

  University of Milan, IRCCS Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Scarano, MD

CONTACT

+3902619116717; s.scarano@auxologico.it

Gianlorenzo Dionigi, MD

CONTACT

g.dionigi@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: January 31, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

IT (1)