Different Types of Electrostimulation Probes During IONM

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Thyroid Diseases

Intervention / Treatment
-----------------
* Device: Bipolar and monopolar probes (SPESS MEDICA S.r.l. Via Buccari 16153 Genova (GE), Italy) administered to all participants.


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br> | Device: Bipolar and monopolar probes (SPESS MEDICA S.r.l. Via Buccari 16153 Genova (GE), Italy) administered to all participants.<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of amplitude values of bipolar vs. monopolar stimulation | 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 | 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 | 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 | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IONM, thyroidectomy, bipolar probe, monopolar probe