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

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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Voice Disorders

U.S. FDA Resources

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

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

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

More Information

Publications:

Helidoni ME, Murry T, Moschandreas J, Lionis C, Printza A, Velegrakis GA. Cross-cultural adaptation and validation of the voice handicap index into Greek. J Voice. 2010 Mar;24(2):221-7. Epub 2008 Aug 26.

de Pedro Netto I, Fae A, Vartanian JG, Barros AP, Correia LM, Toledo RN, Testa JR, Nishimoto IN, Kowalski LP, Carrara-de Angelis E. Voice and vocal self-assessment after thyroidectomy. Head Neck. 2006 Dec;28(12):1106-14.

Lombardi CP, Raffaelli M, D'alatri L, De Crea C, Marchese MR, Maccora D, Paludetti G, Bellantone R. Video-assisted thyroidectomy significantly reduces the risk of early postthyroidectomy voice and swallowing symptoms. World J Surg. 2008 May;32(5):693-700.

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

Additional relevant MeSH terms:

Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013

To Top