Thyroid DiseasesNCT03460912
Different Types of Electrostimulation Probes During IONM
An observational study of Thyroid Diseases, run by Ege University.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Diseases
- What is being tested?
- Bipolar and monopolar probes (SPESS MEDICA S.r.l. Via Buccari 16153 Genova (GE), Italy) administered to all participants.
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 26 Jun 2016to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consequtive patients who underwent thyroid surgery
Who may be able to join
- who underwent thyroid surgery
Who cannot join
- 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
About this study
Official title: Comparison of Different Types of Electrostimulation Probes for Intraoperative Nerve Monitoring During Thyroidectomy
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
- Being tested
- Bipolar and monopolar probes (SPESS MEDICA S.r.l. Via Buccari 16153 Genova (GE), Italy) administered to all participants.
- Keywords
- IONM, thyroidectomy, bipolar probe, monopolar probe
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Not described Receives: Device: Bipolar and monopolar probes (SPESS MEDICA S.r.l. Via Buccari 16153 Genova (GE), Italy) administered to all participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One week
Secondary outcomes (3)
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.
Measured: One week
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.
Measured: One week
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.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start26 Jun 2016
- Primary completion26 Dec 2016
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozer Makay, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460912
- Sponsor's protocol ID
- yturk1
- Status last verified
- Mar 2018
- First submitted
- 5 Feb 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Types of Electrostimulation Probes for Intraoperative Nerve Monitoring During Thyroidectomy
- ClinicalTrials.gov ID
- NCT03460912
- Acronym / sponsor ID
- yturk1
- Conditions
- Thyroid Diseases
- Keywords
- IONM, thyroidectomy, bipolar probe, monopolar probe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 26 Jun 2016 (actual)
- Primary completion
- 26 Dec 2016 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Device: Bipolar and monopolar probes (SPESS MEDICA S.r.l. Via Buccari 16153 Genova (GE), Italy) administered to all participants. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consequtive patients who underwent thyroid surgery
Key inclusion criteria (1 listed)
- who underwent thyroid surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | All participants |
Primary outcome
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.
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.
3 secondary outcomes
Comparison of stimulation with vs. without overlying fascia on nerve
Time frame: One week
Comparison of stimulation pre- vs. post-resection without overlying fascia on nerve
Time frame: One week
Comparison of stimulation of inferior vs. superior parts of recurrent nerve.
Time frame: One week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Diseases, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of amplitude values of bipolar vs. monopolar stimulation (time frame: One week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018; AzTrials last refreshed its copy on 26 Oct 2026.