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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 University of Thessaly.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jiannis Hajiioannou, University of Thessaly
ClinicalTrials.gov Identifier:
NCT01607242
First received: May 22, 2012
Last updated: May 24, 2012
Last verified: May 2012
  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 University of Thessaly:

Primary Outcome Measures:
  • Subjective voice evaluation [ Time Frame: 1 Day preoperatively ] [ Designated as safety issue: No ]
    Greek- version of Voice Handicap Index (VHI)

  • Subjective voice evaluation [ Time Frame: 1 week postoperatively ] [ Designated as safety issue: No ]
    Greek- version of Voice Handicap Index (VHI)

  • Subjective Voice Evaluation [ Time Frame: 1 month postoperatively ] [ Designated as safety issue: No ]
    Greek- version of Voice Handicap Index (VHI)


Secondary Outcome Measures:
  • Swallowing evaluation [ Time Frame: 1 day preoperatively ] [ Designated as safety issue: No ]
    questionnaire on swallowing symptoms

  • Swallowing evaluation [ Time Frame: 1 week postoperatively ] [ Designated as safety issue: No ]
    questionnaire on swallowing symptoms

  • Swallowing evaluation [ Time Frame: 1 month postoperatively ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607242

Locations
Greece
University Hospital of Larissa
Larissa, Greece, 41110
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
  More Information

Publications:
Responsible Party: Jiannis Hajiioannou, ENT Consultant Lecturer University of Thessaly, University of Thessaly
ClinicalTrials.gov Identifier: NCT01607242     History of Changes
Other Study ID Numbers: thyro25 
Study First Received: May 22, 2012
Last Updated: May 24, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by University of Thessaly:
total thyroidectomy
voice handicap index
swallowing disorders
thyroid surgery
voice disorders

ClinicalTrials.gov processed this record on December 02, 2016