ThyroidectomyNCT01607242
Impact of Total Thyroidectomy on Voice and Swallowing
An observational study of Thyroidectomy and Voice Alteration, run by University of Thessaly at 1 site in Greece.
Trial summary
Purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and swallowing function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroidectomy, Voice Alteration, Swallowing Alteration
- What is being tested?
- Endoscopy of larynx, Voice Handicap Index and Swallowing Assesment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing total thyroidectomy
Who may be able to join
- All patients submitted to total thyroidectomy during the study period
Who cannot join
- Previous thyroid/ neck surgery
- Documented voice disorders
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Larissa
Larissa, 41110
Jiannis Hajiioannou
About this study
Official title: Study of Total Thyroidectomy Effect on Voice and Swallowing Function
Purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and swallowing function.
Read the 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.
- Conditions
- Thyroidectomy, Voice Alteration, Swallowing Alteration
- Being tested
- Endoscopy of larynx, Voice Handicap Index, Swallowing Assesment
- Keywords
- total thyroidectomy, voice handicap index, swallowing disorders, thyroid surgery, voice disorders
- Medical subject headings
- Dysphonia, Deglutition Disorders, Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopy of larynxOther
Endoscopic Laryngeal mobility assessment
Voice Handicap IndexOther
Subjective Evaluation of Voice disorders
Swallowing AssesmentOther
Swallowing function questionnaire
| Study group | Role | What they receive |
|---|---|---|
| patients | patients undergoing total thyroidectomy Receives: Other: Endoscopy of larynx; Other: Voice Handicap Index; Other: Swallowing Assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective voice evaluation
Greek- version of Voice Handicap Index (VHI)
Measured: 1 Day preoperatively
Subjective voice evaluation
Greek- version of Voice Handicap Index (VHI)
Measured: 1 week postoperatively
Subjective Voice Evaluation
Greek- version of Voice Handicap Index (VHI)
Measured: 1 month postoperatively
Secondary outcomes (3)
Swallowing evaluation
questionnaire on swallowing symptoms
Measured: 1 day preoperatively
Swallowing evaluation
questionnaire on swallowing symptoms
Measured: 1 week postoperatively
Swallowing evaluation
questionnaire on swallowing symptoms
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiannis Hajiioannou, University of Thessaly
- Investigators
- Ioannis Bizakis, Professor, Study chair, University of ThessalyJiannis Hajiioannou, Lecturer, Principal investigator, University of ThessalyEvangelos Athanasiou, As Professor, Study chair, University of ThessalyDimitrios Zacharoulis, As Professor, Study director, University of ThessalyEleni Sioka, MD, Study director, University of ThessalyVassilios Lachanas, MD, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607242
- Sponsor's protocol ID
- thyro25
- Status last verified
- May 2012
- First submitted
- 22 May 2012
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18752925de 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.
PubMed 16933312Lombardi 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.
PubMed 18259807
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Total Thyroidectomy Effect on Voice and Swallowing Function
- ClinicalTrials.gov ID
- NCT01607242
- Acronym / sponsor ID
- thyro25
- Conditions
- Thyroidectomy, Voice Alteration, Swallowing Alteration
- Keywords
- total thyroidectomy, voice handicap index, swallowing disorders, thyroid surgery, voice disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- Mar 2012
- First posted
- 30 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Other: Endoscopy of larynx, Other: Voice Handicap Index, Other: Swallowing Assesmentpatients undergoing total thyroidectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing total thyroidectomy
Key inclusion criteria (1 listed)
- All patients submitted to total thyroidectomy during the study period
Key exclusion criteria (2 listed)
- Previous thyroid/ neck surgery
- Documented voice disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopy of larynxEndoscopic Laryngeal mobility assessment | Other | patients |
| Voice Handicap IndexSubjective Evaluation of Voice disorders | Other | patients |
| Swallowing AssesmentSwallowing function questionnaire | Other | patients |
Primary outcome
Subjective voice evaluation
Time frame: 1 Day preoperatively
Greek- version of Voice Handicap Index (VHI)
Subjective voice evaluation
Time frame: 1 week postoperatively
Greek- version of Voice Handicap Index (VHI)
Subjective Voice Evaluation
Time frame: 1 month postoperatively
Greek- version of Voice Handicap Index (VHI)
3 secondary outcomes
Swallowing evaluation
Time frame: 1 day preoperatively
Swallowing evaluation
Time frame: 1 week postoperatively
Swallowing evaluation
Time frame: 1 month postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2012.
- Background: PubMed 18752925Helidoni 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.
- Background: PubMed 16933312de 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.
- Background: PubMed 18259807Lombardi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis Bizakis, Professor study chair
University of Thessaly
Jiannis Hajiioannou, Lecturer principal investigator
University of Thessaly
Evangelos Athanasiou, As Professor study chair
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroidectomy and Voice Alteration, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiannis Hajiioannou, Lecturer (00306945792028, irakliotis@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective voice evaluation (time frame: 1 Day preoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01607242, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2012.