Clinical Trials Directory

Trials / Completed

CompletedNCT03460912

Different Types of Electrostimulation Probes During IONM

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

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Ege University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
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.

Timeline

Start date
2016-06-26
Primary completion
2016-12-26
Completion
2017-09-30
First posted
2018-03-09
Last updated
2018-03-12

Source: ClinicalTrials.gov record NCT03460912. Inclusion in this directory is not an endorsement.