Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery

August 4, 2015 updated by: TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital

"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

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34300
        • Lutfiye NBGH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Procedure: Intraoperative nerve monitoring
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

This is where you will find people and organizations involved with this study.

Sponsor

Lütfiye Nuri Burat Government Hospital

Investigators

  • Principal Investigator: Turgut Donmez, MD, Lutfiye Nuri Burat Goverment Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 28, 2015

Study Record Updates

Last Update Posted (Estimate)

August 5, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2015

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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