Different Types of Electrostimulation Probes During IONM

NCT03460912 | Completed

• 1 other identifier: yturk1
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thyroid Diseases

Keywords

IONM; thyroidectomy; bipolar probe; monopolar probe

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Comparison of stimulation with vs. without overlying fascia on nerve

  One week

• Comparison of stimulation pre- vs. post-resection without overlying fascia on nerve

  One week

• Comparison of stimulation of inferior vs. superior parts of recurrent nerve.

  One week

Study Arms (1)

All participants

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

Interventions

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.

All participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consequtive patients who underwent thyroid surgery

You may qualify if:

• who underwent thyroid surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Ozer Makay

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: March 9, 2018
• Study Start: June 26, 2016
• Primary Completion: December 26, 2016
• Study Completion: September 30, 2017
• Last Updated: March 12, 2018

Record last verified: 2018-03