NCT01607242

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

First QC Date

May 22, 2012

Last Update Submit

May 24, 2012

Conditions

ThyroidectomyVoice AlterationSwallowing Alteration

Keywords

total thyroidectomyvoice handicap indexswallowing disordersthyroid surgeryvoice disorders

Outcome Measures

Primary Outcomes (3)

  • Subjective voice evaluation

    Greek- version of Voice Handicap Index (VHI)

    1 Day preoperatively

  • Subjective voice evaluation

    Greek- version of Voice Handicap Index (VHI)

    1 week postoperatively

  • Subjective Voice Evaluation

    Greek- version of Voice Handicap Index (VHI)

    1 month postoperatively

Secondary Outcomes (3)

  • Swallowing evaluation

    1 day preoperatively

  • Swallowing evaluation

    1 week postoperatively

  • Swallowing evaluation

    1 month postoperatively

Study Arms (1)

patients

patients undergoing total thyroidectomy

Other: Endoscopy of larynxOther: Voice Handicap IndexOther: Swallowing Assesment

Interventions

Endoscopy of larynxOTHER

Endoscopic Laryngeal mobility assessment

patients
Voice Handicap IndexOTHER

Subjective Evaluation of Voice disorders

patients
Swallowing AssesmentOTHER

Swallowing function questionnaire

patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing total thyroidectomy

You may qualify if:

  • All patients submitted to total thyroidectomy during the study period

You may not qualify if:

  • Previous thyroid/ neck surgery
  • Documented voice disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Larissa

Larissa, 41110, Greece

RECRUITING

Related Publications (3)

  • 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.

    PMID: 18752925BACKGROUND

  • 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.

    PMID: 16933312BACKGROUND

  • 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.

    PMID: 18259807BACKGROUND

MeSH Terms

Conditions

DysphoniaDeglutition DisordersVoice Disorders

Interventions

Laryngoscopy

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOtorhinolaryngologic Surgical Procedures

Study Officials

  • Ioannis Bizakis, Professor

    University of Thessaly

    STUDY CHAIR

  • Jiannis Hajiioannou, Lecturer

    University of Thessaly

    PRINCIPAL INVESTIGATOR

  • Evangelos Athanasiou, As Professor

    University of Thessaly

    STUDY CHAIR

  • Dimitrios Zacharoulis, As Professor

    University of Thessaly

    STUDY DIRECTOR

  • Eleni Sioka, MD

    University of Thessaly

    STUDY DIRECTOR

  • Vassilios Lachanas, MD

    University of Thessaly

    STUDY DIRECTOR

Central Study Contacts

Jiannis Hajiioannou, Lecturer

CONTACT

00306945792028irakliotis@yahoo.com

Eleni Sioka, MD

CONTACT

00306937063591konstantinasioka@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ENT Consultant Lecturer University of Thessaly

Study Record Dates

First Submitted

May 22, 2012

First Posted

May 30, 2012

Study Start

March 1, 2012

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

GR(1)