Different Types of Electrostimulation Probes During IONM

March 8, 2018 updated by: Ozer Makay, Ege University

Comparison of Different Types of Electrostimulation Probes for Intraoperative Nerve Monitoring During Thyroidectomy

Intraoperative nerve monitoring is often used in many centers during thyroidectomy. According to the investigators' knowledge, there's no study showing superiority between bipolar and monopolar stimulation probes used for nerve monitoring during thyroid surgery. In this study, the investigators aimed to compare two different types of probes and find out superiorities.Twenty-one patients who underwent primary total thyroidectomy or hemithyroidectomy were included in the study. During surgery, amplitude and latency values obtained in the same patient with both bipolar and monopolar stimulation probes from 10 different anatomical spots [vagal nerve, recurrent laryngeal nerve inferior portion, recurrent laryngeal nerve superior portion, external branch of superior laryngeal nerve (EBSLN)] were recorded prospectively, both when sheath was intact and after being dissected.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consequtive patients who underwent thyroid surgery

Description

Inclusion Criteria:

  • who underwent thyroid surgery

Exclusion Criteria:

  • Perioperative loss of electromyographic(EMG) signal (LOS) during intraoperative nerve monitorization
  • patients with additional pathology that may affect vocal cord function,
  • abnormal preoperative laryngeal examination
  • history of thyroid, vocal cord or other neck surgery
  • advanced cancer, RLN, esophageal or trachea invasion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
All participants
Device: Bipolar and monopolar probes (SPESS MEDICA S.r.l. Via Buccari 16153 Genova (GE), Italy) administered to all participants.
Bipolar and monopolar probes (SPESS MEDICA S.r.l. Via Buccari 16153 Genova (GE), Italy) administered to all participants.They compared each others(bipolar vs monopolar) via amplitudes and latency values.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of amplitude values of bipolar vs. monopolar stimulation
Time Frame: One week
Bipolar and monopolar probes were compared regarding amplitudes(mA), at each spot and on both sides (right & left) via Wilcoxon Signed Rank Test.
One week
Comparison of Latency values of bipolar vs. monopolar stimulation
Time Frame: One week
Bipolar and monopolar probes were compared regarding latencies(ms) , at each spot and on both sides (right & left) via Wilcoxon Signed Rank Test.
One week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of stimulation with vs. without overlying fascia on nerve
Time Frame: One week
The assessment was based on the presence or absence of nerve sheaths in this group in amplitude values via Wilcoxon Signed Rank Test.
One week
Comparison of stimulation pre- vs. post-resection without overlying fascia on nerve
Time Frame: One week
The assessment in this group was made according to pre- and post-resection amplitude values from vagus and recurrent nerve, that were compared to each other on both sides (right & left) and with both (bipolar & monopolar) probes via Wilcoxon Signed Rank Test.
One week
Comparison of stimulation of inferior vs. superior parts of recurrent nerve.
Time Frame: One week
The assessment in this group was based on the latency values between the inferior and superior part of the recurrent nerve via Wilcoxon Signed Rank Test.
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • yturk1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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