Impact of Total Thyroidectomy on Voice and Swallowing

Thyroidectomy Clinical Trial

Official title:

Study of Total Thyroidectomy Effect on Voice and Swallowing Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01607242
• Other study ID #: thyro25
• 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
• 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

• Swallowing Alteration
• Thyroidectomy
• Voice Alteration

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