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Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery

Primary Purpose

Thyroid

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intraoperative nerve monitoring
Sponsored by
Lütfiye Nuri Burat Government Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid focused on measuring thyroidectomy, nerve monitoring

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Lutfiye NBGH

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard Conventional group

IONM group

Arm Description

Standard conventional thyroid surgery

Intraoperative nerve monitoring used thyroid surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Operation time
Comparison of differences in operation time period between the groups whether IONM used or not

Full Information

First Posted
July 24, 2015
Last Updated
August 4, 2015
Sponsor
Lütfiye Nuri Burat Government Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02509715
Brief Title
Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery
Official Title
Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lütfiye Nuri Burat Government Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid
Keywords
thyroidectomy, nerve monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Conventional group
Arm Type
No Intervention
Arm Description
Standard conventional thyroid surgery
Arm Title
IONM group
Arm Type
Active Comparator
Arm Description
Intraoperative nerve monitoring used thyroid surgery
Intervention Type
Procedure
Intervention Name(s)
Intraoperative nerve monitoring
Intervention Description
Intraoperative nerve monitoring during thyroid surgery
Primary Outcome Measure Information:
Title
Voice analysis
Description
Comparison of Jitter(microseconds) and Shimmer(dB) values of recorded voices
Time Frame
up to 2nd week voice recording
Secondary Outcome Measure Information:
Title
Operation time
Description
Comparison of differences in operation time period between the groups whether IONM used or not
Time Frame
duration of surgery, up to 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Turgut Donmez, MD
Phone
905347400967
Email
surgeont73@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Erdinc Cekic, MD
Phone
905358108712
Email
erdinc82@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Turgut Donmez, MD
Organizational Affiliation
Lutfiye Nuri Burat Goverment Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lutfiye NBGH
City
İstanbul
ZIP/Postal Code
34300
Country
Turkey

12. IPD Sharing Statement

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Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery

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