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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

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)

June 26, 2016

Primary Completion (ACTUAL)

December 26, 2016

Study Completion (ACTUAL)

September 30, 2017

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

March 4, 2018

First Posted (ACTUAL)

March 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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