Clinical trial NCT01607242: Impact of Total Thyroidectomy on Voice and Swallowing
Official title: Study of Total Thyroidectomy Effect on Voice and Swallowing Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroidectomy
Voice Alteration
Swallowing Alteration
Keywords: total thyroidectomy
voice handicap index
swallowing disorders
thyroid surgery
voice disorders
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing total thyroidectomy

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

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 criteria: Inclusion Criteria:

* All patients submitted to total thyroidectomy during the study period

Exclusion Criteria:

* Previous thyroid/ neck surgery
* Documented voice disorders

Primary outcomes:
measure: Subjective voice evaluation
timeFrame: 1 Day preoperatively
measure: Subjective voice evaluation
timeFrame: 1 week postoperatively
measure: Subjective Voice Evaluation
timeFrame: 1 month postoperatively
Secondary outcomes:
measure: Swallowing evaluation
timeFrame: 1 day preoperatively
measure: Swallowing evaluation
timeFrame: 1 week postoperatively
measure: Swallowing evaluation
timeFrame: 1 month postoperatively
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa
Study officials:
affiliation: University of Thessaly
name: Ioannis Bizakis, Professor
role: STUDY_CHAIR
affiliation: University of Thessaly
name: Jiannis Hajiioannou, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Thessaly
name: Evangelos Athanasiou, As Professor
role: STUDY_CHAIR
affiliation: University of Thessaly
name: Dimitrios Zacharoulis, As Professor
role: STUDY_DIRECTOR
affiliation: University of Thessaly
name: Eleni Sioka, MD
role: STUDY_DIRECTOR
affiliation: University of Thessaly
name: Vassilios Lachanas, MD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.