Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery

Lütfiye Nuri Burat Government Hospital

Status: Unknown

Conditions: Thyroid

Treatments: Procedure: Intraoperative nerve monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02509715

TEAH-2015-17

Details and patient eligibility

About

"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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Standard Conventional group

No Intervention group

Description:

Standard conventional thyroid surgery

IONM group

Active Comparator group

Description:

Intraoperative nerve monitoring used thyroid surgery

Treatment:

Procedure: Intraoperative nerve monitoring