Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery

Not Applicable

• Conditions: Thyroid
• Interventions: Procedure: Intraoperative nerve monitoring

• Registration Number: NCT02509715
• Lead Sponsor: Lütfiye Nuri Burat Government Hospital

Brief 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. 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 Timeline

• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-28
• Status Verified: 2015-08
• Study Start: 2015-08
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-05
• Primary Completion: 2015-09
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IONM group	Intraoperative nerve monitoring	Intraoperative nerve monitoring used thyroid surgery

Primary Outcome Measures

Name	Time	Method
Voice analysis	up to 2nd week voice recording	Comparison of Jitter(microseconds) and Shimmer(dB) values of recorded voices

Secondary Outcome Measures

Name	Time	Method
Operation time	duration of surgery, up to 3 hours	Comparison of differences in operation time period between the groups whether IONM used or not

Trial Locations

Locations (1)

Lutfiye NBGH; 🇹🇷 İstanbul, Turkey