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Impact of Total Thyroidectomy on Voice and Swallowing

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Jiannis Hajiioannou, University of Thessaly.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01607242
First Posted: May 30, 2012
Last Update Posted: May 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jiannis Hajiioannou, University of Thessaly
  Purpose
Purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and swallowing function.

Condition Intervention
Thyroidectomy Voice Alteration Swallowing Alteration Other: Endoscopy of larynx Other: Voice Handicap Index Other: Swallowing Assesment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Total Thyroidectomy Effect on Voice and Swallowing Function

Further study details as provided by Jiannis Hajiioannou, University of Thessaly:

Primary Outcome Measures:
  • Subjective voice evaluation [ Time Frame: 1 Day preoperatively ]
    Greek- version of Voice Handicap Index (VHI)

  • Subjective voice evaluation [ Time Frame: 1 week postoperatively ]
    Greek- version of Voice Handicap Index (VHI)

  • Subjective Voice Evaluation [ Time Frame: 1 month postoperatively ]
    Greek- version of Voice Handicap Index (VHI)


Secondary Outcome Measures:
  • Swallowing evaluation [ Time Frame: 1 day preoperatively ]
    questionnaire on swallowing symptoms

  • Swallowing evaluation [ Time Frame: 1 week postoperatively ]
    questionnaire on swallowing symptoms

  • Swallowing evaluation [ Time Frame: 1 month postoperatively ]
    questionnaire on swallowing symptoms


Estimated Enrollment: 100
Study Start Date: March 2012
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing total thyroidectomy
Criteria

Inclusion Criteria:

  • All patients submitted to total thyroidectomy during the study period

Exclusion Criteria:

  • Previous thyroid/ neck surgery
  • Documented voice disorders
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607242


Contacts
Contact: Jiannis Hajiioannou, Lecturer 00306945792028 irakliotis@yahoo.com
Contact: Eleni Sioka, MD 00306937063591 konstantinasioka@gmail.com

Locations
Greece
University Hospital of Larissa Recruiting
Larissa, Greece, 41110
Principal Investigator: Jiannis Hajiioannou         
Sponsors and Collaborators
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