Different Types of Electrostimulation Probes During IONM

Thyroid Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03460912
• Other study ID #: yturk1
• Status: Completed
• Phase: N/A
• First received: February 5, 2018
• Last updated: March 8, 2018
• Start date: June 26, 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: March 2018
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2017
• Est. primary completion date: December 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases

Intervention

Device:
• Bipolar 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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