Impact of Total Thyroidectomy on Voice and Swallowing

NCT ID: NCT01607242

Last Updated: 2012-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Thyroidectomy Voice Alteration Swallowing Alteration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients

patients undergoing total thyroidectomy

Endoscopy of larynx

Intervention Type OTHER

Endoscopic Laryngeal mobility assessment

Voice Handicap Index

Intervention Type OTHER

Subjective Evaluation of Voice disorders

Swallowing Assesment

Intervention Type OTHER

Swallowing function questionnaire

Interventions

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Endoscopy of larynx

Endoscopic Laryngeal mobility assessment

Intervention Type OTHER

Voice Handicap Index

Subjective Evaluation of Voice disorders

Intervention Type OTHER

Swallowing Assesment

Swallowing function questionnaire

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients submitted to total thyroidectomy during the study period

Exclusion Criteria

* Previous thyroid/ neck surgery
* Documented voice disorders
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Jiannis Hajiioannou

ENT Consultant Lecturer University of Thessaly

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ioannis Bizakis, Professor

Role: STUDY_CHAIR

University of Thessaly

Jiannis Hajiioannou, Lecturer

Role: PRINCIPAL_INVESTIGATOR

University of Thessaly

Evangelos Athanasiou, As Professor

Role: STUDY_CHAIR

University of Thessaly

Dimitrios Zacharoulis, As Professor

Role: STUDY_DIRECTOR

University of Thessaly

Eleni Sioka, MD

Role: STUDY_DIRECTOR

University of Thessaly

Vassilios Lachanas, MD

Role: STUDY_DIRECTOR

University of Thessaly

Locations

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University Hospital of Larissa

Larissa, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Jiannis Hajiioannou, Lecturer

Role: CONTACT

00306945792028

Eleni Sioka, MD

Role: CONTACT

00306937063591

References

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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. doi: 10.1016/j.jvoice.2008.06.005. Epub 2008 Aug 26.

Reference Type BACKGROUND
PMID: 18752925 (View on PubMed)

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. doi: 10.1002/hed.20480.

Reference Type BACKGROUND
PMID: 16933312 (View on PubMed)

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. doi: 10.1007/s00268-007-9443-2.

Reference Type BACKGROUND
PMID: 18259807 (View on PubMed)

Other Identifiers

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thyro25

Identifier Type: -

Identifier Source: org_study_id

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