Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery

Thyroid Clinical Trial

Official title:

Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02509715
• Other study ID #: TEAH-2015-17
• Status: Not yet recruiting
• Phase: N/A
• First received: July 24, 2015
• Last updated: August 4, 2015
• Start date: August 2015
• Est. completion date: January 2016

Study information

• Verified date: August 2015
• Source: Lütfiye Nuri Burat Government Hospital
• Contact: Turgut Donmez, MD
• Phone: 905347400967
• Email: surgeont73[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid
• Thyroid Diseases

Intervention

Procedure:
• Intraoperative nerve monitoring
Intraoperative nerve monitoring during thyroid surgery

Locations

Country	Name	City	State
Turkey	Lutfiye NBGH	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Lütfiye Nuri Burat Government Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voice analysis	Comparison of Jitter(microseconds) and Shimmer(dB) values of recorded voices	up to 2nd week voice recording	No
Secondary	Operation time	Comparison of differences in operation time period between the groups whether IONM used or not	duration of surgery, up to 3 hours	No