Different Types of Electrostimulation Probes During IONM

Completed

• Conditions: Thyroid Diseases
• Interventions: Device: Bipolar and monopolar probes (SPESS MEDICA S.r.l. Via Buccari 16153 Genova (GE), Italy) administered to all participants.

• Registration Number: NCT03460912
• Lead Sponsor: Ege University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-26
• Primary Completion: 2016-12-26
• Study Completion: 2017-09-30
• Study First Submitted: 2018-02-05
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-04
• Last Update Submitted: 2018-03-08
• Study First Posted: 2018-03-09
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Bipolar and monopolar probes (SPESS MEDICA S.r.l. Via Buccari 16153 Genova (GE), Italy) administered to all participants.	-

Primary Outcome Measures

Name	Time	Method
Comparison of amplitude values of bipolar vs. monopolar stimulation	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.
Comparison of Latency values of bipolar vs. monopolar stimulation	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of stimulation with vs. without overlying fascia on nerve	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.
Comparison of stimulation pre- vs. post-resection without overlying fascia on nerve	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.
Comparison of stimulation of inferior vs. superior parts of recurrent nerve.	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.