- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509715
Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery
"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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Turgut Donmez, MD
- Phone Number: 905347400967
- Email: surgeont73@hotmail.com
Study Contact Backup
- Name: Erdinc Cekic, MD
- Phone Number: 905358108712
- Email: erdinc82@gmail.com
Study Locations
-
-
-
İstanbul, Turkey, 34300
- Lutfiye NBGH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical and radiological diagnosis of nodular or multinodular goiter
- Clinical, radiological and pathologically diagnosed thyroid cancer
- Must be able to speak (for voice recording)
Exclusion Criteria:
- Pregnancy
- Previous thyroid surgery
- Previous laryngeal operations
- Professional voice users (e.g. singers)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard Conventional group
Standard conventional thyroid surgery
|
|
Active Comparator: IONM group
Intraoperative nerve monitoring used thyroid surgery
|
Intraoperative nerve monitoring during thyroid surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Voice analysis
Time Frame: up to 2nd week voice recording
|
Comparison of Jitter(microseconds) and Shimmer(dB) values of recorded voices
|
up to 2nd week voice recording
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operation time
Time Frame: duration of surgery, up to 3 hours
|
Comparison of differences in operation time period between the groups whether IONM used or not
|
duration of surgery, up to 3 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Turgut Donmez, MD, Lutfiye Nuri Burat Goverment Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEAH-2015-17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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