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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01607242
Other study ID # thyro25
Secondary ID
Status Recruiting
Phase N/A
First received May 22, 2012
Last updated May 24, 2012
Start date March 2012

Study information

Verified date May 2012
Source University of Thessaly
Contact Jiannis Hajiioannou, Lecturer
Phone 00306945792028
Email irakliotis@yahoo.com
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients submitted to total thyroidectomy during the study period

Exclusion Criteria:

- Previous thyroid/ neck surgery

- Documented voice disorders

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Greece University Hospital of Larissa Larissa

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective voice evaluation Greek- version of Voice Handicap Index (VHI) 1 Day preoperatively No
Primary Subjective voice evaluation Greek- version of Voice Handicap Index (VHI) 1 week postoperatively No
Primary Subjective Voice Evaluation Greek- version of Voice Handicap Index (VHI) 1 month postoperatively No
Secondary Swallowing evaluation questionnaire on swallowing symptoms 1 day preoperatively No
Secondary Swallowing evaluation questionnaire on swallowing symptoms 1 week postoperatively No
Secondary Swallowing evaluation questionnaire on swallowing symptoms 1 month postoperatively No
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