Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02509715

Enrollment

100

Registered

2015-07-28

Start date

2015-08-31

Completion date

2016-01-31

Last updated

2015-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid

Keywords

thyroidectomy, nerve monitoring

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.

Interventions

PROCEDUREIntraoperative nerve monitoring

Intraoperative nerve monitoring during thyroid surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Voice analysis	up to 2nd week voice recording	Comparison of Jitter(microseconds) and Shimmer(dB) values of recorded voices

Secondary

Measure	Time frame	Description
Operation time	duration of surgery, up to 3 hours	Comparison of differences in operation time period between the groups whether IONM used or not

Countries

Turkey (Türkiye)

Contacts

Primary ContactTurgut Donmez, MD

surgeont73@hotmail.com905347400967

Backup ContactErdinc Cekic, MD

erdinc82@gmail.com905358108712

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026