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Completed

NCT Number: NCT03460912

Different Types of Electrostimulation Probes During IONM

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.

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Key information

Conditions

Thyroid Diseases Endocrine System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 9, 2018
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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