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Different Types of Electrostimulation Probes During IONM

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03460912
Enrollment
20
Registered
2018-03-09
Start date
2016-06-26
Completion date
2017-09-30
Last updated
2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Diseases

Keywords

IONM, thyroidectomy, bipolar probe, monopolar probe

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.

Interventions

DEVICEBipolar 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.

Sponsors

Ege University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of amplitude values of bipolar vs. monopolar stimulationOne weekBipolar 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 stimulationOne weekBipolar and monopolar probes were compared regarding latencies(ms) , at each spot and on both sides (right & left) via Wilcoxon Signed Rank Test.

Secondary

MeasureTime frameDescription
Comparison of stimulation with vs. without overlying fascia on nerveOne weekThe 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 nerveOne weekThe 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 weekThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026