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Impact of Total Thyroidectomy on Voice and Swallowing

The recruitment status of this study is unknown because the information has not been verified recently.
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

May 22, 2012
May 24, 2012
March 2012
Not Provided
  • 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)
Same as current
Complete list of historical versions of study NCT01607242 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Impact of Total Thyroidectomy on Voice and Swallowing
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients undergoing total thyroidectomy

  • Thyroidectomy
  • Voice Alteration
  • Swallowing Alteration
  • Other: Endoscopy of larynx
    Endoscopic Laryngeal mobility assessment
  • Other: Voice Handicap Index
    Subjective Evaluation of Voice disorders
  • Other: Swallowing Assesment
    Swallowing function questionnaire
patients
patients undergoing total thyroidectomy
Interventions:
  • Other: Endoscopy of larynx
  • Other: Voice Handicap Index
  • Other: Swallowing Assesment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
Not Provided

Inclusion Criteria:

  • All patients submitted to total thyroidectomy during the study period

Exclusion Criteria:

  • Previous thyroid/ neck surgery
  • Documented voice disorders
Both
Not Provided
No
Contact: Jiannis Hajiioannou, Lecturer 00306945792028 irakliotis@yahoo.com
Contact: Eleni Sioka, MD 00306937063591 konstantinasioka@gmail.com
Greece
 
NCT01607242
thyro25
Yes
Jiannis Hajiioannou, University of Thessaly
University of Thessaly
Not Provided
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
University of Thessaly
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP