Impact of Total Thyroidectomy on Voice and Swallowing

This study is currently recruiting participants.

Verified May 2012 by University of Thessaly

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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 22, 2012

Last Updated Date

May 24, 2012

Start Date ^ICMJE

March 2012

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01607242 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Impact of Total Thyroidectomy on Voice and Swallowing

Official Title ^ICMJE

Study of Total Thyroidectomy Effect on Voice and Swallowing Function

Brief Summary

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

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing total thyroidectomy

Condition ^ICMJE

Thyroidectomy
Voice Alteration
Swallowing Alteration

Intervention ^ICMJE

Other: Endoscopy of larynx
Endoscopic Laryngeal mobility assessment
Other: Voice Handicap Index
Subjective Evaluation of Voice disorders
Other: Swallowing Assesment
Swallowing function questionnaire

Study Group/Cohort (s)

patients

patients undergoing total thyroidectomy

Interventions:

Other: Endoscopy of larynx
Other: Voice Handicap Index
Other: Swallowing Assesment

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

All patients submitted to total thyroidectomy during the study period

Exclusion Criteria:

Previous thyroid/ neck surgery
Documented voice disorders

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Greece

Administrative Information

NCT Number ^ICMJE

NCT01607242

Other Study ID Numbers ^ICMJE

thyro25

Has Data Monitoring Committee

Yes

Responsible Party

Jiannis Hajiioannou, University of Thessaly

Study Sponsor ^ICMJE

University of Thessaly

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University of Thessaly

Verification Date

May 2012

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

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