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Clinical Trials/NCT02509715
NCT02509715
Unknown
Not Applicable

Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery

Lütfiye Nuri Burat Government Hospital1 site in 1 country100 target enrollmentAugust 2015
ConditionsThyroid

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroid
Sponsor
Lütfiye Nuri Burat Government Hospital
Enrollment
100
Locations
1
Primary Endpoint
Voice analysis
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
January 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Lütfiye Nuri Burat Government Hospital
Responsible Party
Principal Investigator
Principal Investigator

TURGUT DONMEZ

General Surgeon, MD

Lütfiye Nuri Burat Government Hospital

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Voice analysis

Time Frame: up to 2nd week voice recording

Comparison of Jitter(microseconds) and Shimmer(dB) values of recorded voices

Secondary Outcomes

  • Operation time(duration of surgery, up to 3 hours)

Study Sites (1)

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