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Status unknownNCT02509715Updated Aug 5, 2015

Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery

An interventional study of Intraoperative nerve monitoring in Thyroid, sponsored by Lütfiye Nuri Burat Government Hospital. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-08-05.

Sponsored by Lütfiye Nuri Burat Government Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thyroid

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Keywords

  • thyroidectomy
  • nerve monitoring
03

In context

Thyroid Diseases

967 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 544 interventional studies indexed under Thyroid Diseases.

Browse Thyroid Diseases studies →

Lead sponsor

Lütfiye Nuri Burat Government Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pregnancy
  • Previous thyroid surgery
  • Previous laryngeal operations
  • Professional voice users (e.g. singers)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • No intervention
    Standard Conventional group

    Standard conventional thyroid surgery

  • Active comparator
    IONM group

    Intraoperative nerve monitoring used thyroid surgery

    Procedure: Intraoperative nerve monitoring

Interventions

  • ProcedureIntraoperative nerve monitoring

    Intraoperative nerve monitoring during thyroid surgery

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What researchers measure

Primary outcomes

  1. Voice analysis

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

    Time frame: up to 2nd week voice recording

Secondary outcomes

  1. Operation time

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

    Time frame: duration of surgery, up to 3 hours

07

Study locations

1 site
  • Lutfiye NBGH
    İstanbul, 34300, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02509715
Lead sponsor
Lütfiye Nuri Burat Government Hospital
Responsible party
TURGUT DONMEZ (General Surgeon, MD, Lütfiye Nuri Burat Government Hospital) — Principal investigator
First posted
Jul 28, 2015
Start date
Aug 2015
Primary completion
Sep 2015 (estimated)
Completion
Jan 2016 (estimated)
Last update
Aug 5, 2015

Study contacts

Turgut Donmez, MD
Contact
surgeont73@hotmail.com
905347400967
Erdinc Cekic, MD
Contact
erdinc82@gmail.com
905358108712
Turgut Donmez, MD
principal investigator · Lutfiye Nuri Burat Goverment Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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