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Dysphagia After Thyroidectomy

NCT ID: NCT06296420

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2026-11-30

Brief Summary

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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

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Conditions

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Goiter Thyroid Disease

Keywords

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Nodular goiter Thyroidectomy Dysphagia Psychometrics Rasch analysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefano Scarano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Milan, IRCCS Istituto Auxologico Italiano

Locations

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IRCCS Istituto Auxologico Italiano

Milan, MI, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Stefano Scarano, MD

Role: CONTACT

Phone: +3902619116717

Email: [email protected]

Gianlorenzo Dionigi, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Stefano Scarano, MD

Role: primary

Other Identifiers

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24C304

Identifier Type: -

Identifier Source: org_study_id