NCT02509715

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

1 month

First QC Date

July 24, 2015

Last Update Submit

August 4, 2015

Conditions

Thyroid

Keywords

thyroidectomynerve monitoring

Outcome Measures

Primary Outcomes (1)

  • Voice analysis

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

    up to 2nd week voice recording

Secondary Outcomes (1)

  • Operation time

    duration of surgery, up to 3 hours

Study Arms (2)

Standard Conventional group

NO INTERVENTION

Standard conventional thyroid surgery

IONM group

ACTIVE COMPARATOR

Intraoperative nerve monitoring used thyroid surgery

Procedure: Intraoperative nerve monitoring

Interventions

Intraoperative nerve monitoringPROCEDURE

Intraoperative nerve monitoring during thyroid surgery

IONM group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical and radiological diagnosis of nodular or multinodular goiter
  • Clinical, radiological and pathologically diagnosed thyroid cancer
  • Must be able to speak (for voice recording)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lutfiye NBGH

Istanbul, 34300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Intraoperative Neurophysiological Monitoring

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, IntraoperativeMonitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosisNeurophysiological MonitoringSurgical Procedures, Operative

Study Officials

  • Turgut Donmez, MD

    Lutfiye Nuri Burat Goverment Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Turgut Donmez, MD

CONTACT

905347400967surgeont73@hotmail.com

Erdinc Cekic, MD

CONTACT

905358108712erdinc82@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon, MD

Study Record Dates

First Submitted

July 24, 2015

First Posted

July 28, 2015

Study Start

August 1, 2015

Primary Completion

September 1, 2015

Study Completion

January 1, 2016

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations

TU(1)