Impact of Total Thyroidectomy on Voice and Swallowing

May 24, 2012 updated by: Jiannis Hajiioannou, University of Thessaly

Study of Total Thyroidectomy Effect on Voice and Swallowing Function

Purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and swallowing function.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Voice and swallowing alterations are frequently reported after thyroidectomy, even in the absence of nerve injury. These impair quality of life.

Purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and swallowing function.

Patients will be assessed using the Greek- version of Voice Handicap Index (VHI) and a questionnaire developed by the authors regarding swallowing symptoms.

Furthermore they will undergo flexible laryngoscopy for evaluation of laryngeal mobility.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Larissa, Greece, 41110
        • Recruiting
        • University Hospital Of Larissa
        • Principal Investigator:
          • Jiannis Hajiioannou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing total thyroidectomy

Description

Inclusion Criteria:

  • All patients submitted to total thyroidectomy during the study period

Exclusion Criteria:

  • Previous thyroid/ neck surgery
  • Documented voice disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients
patients undergoing total thyroidectomy
Other: Endoscopy of larynx
Endoscopic Laryngeal mobility assessment
Other: Voice Handicap Index
Subjective Evaluation of Voice disorders
Other: Swallowing Assesment
Swallowing function questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective voice evaluation
Time Frame: 1 Day preoperatively
Greek- version of Voice Handicap Index (VHI)
1 Day preoperatively
Subjective voice evaluation
Time Frame: 1 week postoperatively
Greek- version of Voice Handicap Index (VHI)
1 week postoperatively
Subjective Voice Evaluation
Time Frame: 1 month postoperatively
Greek- version of Voice Handicap Index (VHI)
1 month postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swallowing evaluation
Time Frame: 1 day preoperatively
questionnaire on swallowing symptoms
1 day preoperatively
Swallowing evaluation
Time Frame: 1 week postoperatively
questionnaire on swallowing symptoms
1 week postoperatively
Swallowing evaluation
Time Frame: 1 month postoperatively
questionnaire on swallowing symptoms
1 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Investigators

  • Study Chair: Ioannis Bizakis, Professor, University of Thessaly
  • Principal Investigator: Jiannis Hajiioannou, Lecturer, University of Thessaly
  • Study Chair: Evangelos Athanasiou, As Professor, University of Thessaly
  • Study Director: Dimitrios Zacharoulis, As Professor, University of Thessaly
  • Study Director: Eleni Sioka, MD, University of Thessaly
  • Study Director: Vassilios Lachanas, MD, University of Thessaly

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Study Registration Dates

First Submitted

May 22, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimate)

May 30, 2012

Study Record Updates

Last Update Posted (Estimate)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 24, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • thyro25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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