ThyroidNCT02509715
Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery
A study testing Intraoperative nerve monitoring in people with Thyroid, run by Lütfiye Nuri Burat Government Hospital at 1 site in Turkey (Türkiye).
Trial summary
"Effect of intraoperative nerve monitoring on voice quality during thyroid surgery" Thyroidectomy is a quite often surgical procedure applied by both head and neck surgeons and endocrine surgeons.Recent advances in surgical and technological area achieve a remarkable decrease in the complication rates. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid
- What is being tested?
- Intraoperative nerve monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2015to Jan 2016
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiological diagnosis of nodular or multinodular goiter
- Clinical, radiological and pathologically diagnosed thyroid cancer
- Must be able to speak (for voice recording)
Who cannot join
- Pregnancy
- Previous thyroid surgery
- Previous laryngeal operations
- Professional voice users (e.g. singers)
Trial locations and contacts
1 site in 1 country.
About this study
"Effect of intraoperative nerve monitoring on voice quality during thyroid surgery"
Thyroidectomy is a quite often surgical procedure applied by both head and neck surgeons and endocrine surgeons.Recent advances in surgical and technological area achieve a remarkable decrease in the complication rates. In case of these advances, patients still have fear related with their voice. In this study, investigators aimed to investigate voice changes during thyroid surgery and effect of intraoperative nerve monitoring to the voice quality.
Read the detailed description
In order to minimize the complication rates and voice disturbances during thyroidectomy, intraoperative nerve monitoring(IONM) is a widely used intervention. In this study investigators will compare conventional surgery with IONM used surgery. Randomly chosen half of the patients will be operated with IONM. Vagus, recurrent and superior laryngeal nerves will be monitored during surgery and measured for nerve integrity . Rest of the patients will be operated with standard conventional method. All participants will be analyzed with a computer program for their voice quality preoperatively and postoperatively at 14th day of surgery.
- Conditions
- Thyroid
- Being tested
- Intraoperative nerve monitoring
- Keywords
- thyroidectomy, nerve monitoring
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative nerve monitoringProcedure or surgery
Intraoperative nerve monitoring during thyroid surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard Conventional group | No intervention | Standard conventional thyroid surgery |
| IONM group | Active comparator | Intraoperative nerve monitoring used thyroid surgery Receives: Procedure: Intraoperative nerve monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice analysis
Comparison of Jitter(microseconds) and Shimmer(dB) values of recorded voices
Measured: up to 2nd week voice recording
Secondary outcomes (1)
Operation time
Comparison of differences in operation time period between the groups whether IONM used or not
Measured: duration of surgery, up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lütfiye Nuri Burat Government Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital
- Investigators
- Turgut Donmez, MD, Principal investigator, Lutfiye Nuri Burat Goverment Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509715
- Sponsor's protocol ID
- TEAH-2015-17
- Status last verified
- Aug 2015
- First submitted
- 24 Jul 2015
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery
- ClinicalTrials.gov ID
- NCT02509715
- Acronym / sponsor ID
- TEAH-2015-17
- Conditions
- Thyroid
- Keywords
- thyroidectomy, nerve monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lütfiye Nuri Burat Government HospitalOther government
- Study start
- Aug 2015
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 28 Jul 2015 (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.
"Effect of intraoperative nerve monitoring on voice quality during thyroid surgery"
Thyroidectomy is a quite often surgical procedure applied by both head and neck surgeons and endocrine surgeons.Recent advances in surgical and technological area achieve a remarkable decrease in the complication rates. In case of these advances, patients still have fear related with their voice. In this study, investigators aimed to investigate voice changes during thyroid surgery and effect of intraoperative nerve monitoring to the voice quality.
Detailed description
In order to minimize the complication rates and voice disturbances during thyroidectomy, intraoperative nerve monitoring(IONM) is a widely used intervention. In this study investigators will compare conventional surgery with IONM used surgery. Randomly chosen half of the patients will be operated with IONM. Vagus, recurrent and superior laryngeal nerves will be monitored during surgery and measured for nerve integrity . Rest of the patients will be operated with standard conventional method. All participants will be analyzed with a computer program for their voice quality preoperatively and postoperatively at 14th day of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Conventional group | No intervention | –Standard conventional thyroid surgery |
| IONM group | Active comparator | Procedure: Intraoperative nerve monitoringIntraoperative nerve monitoring used thyroid surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical and radiological diagnosis of nodular or multinodular goiter
- Clinical, radiological and pathologically diagnosed thyroid cancer
- Must be able to speak (for voice recording)
Key exclusion criteria (4 listed)
- Pregnancy
- Previous thyroid surgery
- Previous laryngeal operations
- Professional voice users (e.g. singers)
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 |
|---|---|---|
| Intraoperative nerve monitoringIntraoperative nerve monitoring during thyroid surgery | Procedure or surgery | IONM group |
Primary outcome
Voice analysis
Time frame: up to 2nd week voice recording
Comparison of Jitter(microseconds) and Shimmer(dB) values of recorded voices
1 secondary outcome
Operation time
Time frame: duration of surgery, up to 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
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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.
Turgut Donmez, MD principal investigator
Lutfiye Nuri Burat Goverment Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative nerve monitoring in people with Thyroid, run by Lütfiye Nuri Burat Government Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 5 Aug 2015. 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 Turkey (Türkiye). 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 Turgut Donmez, MD (905347400967, surgeont73@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice analysis (time frame: up to 2nd week voice recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2015.