UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025714 |
|---|---|
| Receipt number | R000029542 |
| Scientific Title | The efficacy of transcranial motor-evoked potentials of laryngeal muscles for the recurrent laryngeal nerve palsy |
| Date of disclosure of the study information | 2017/01/17 |
| Last modified on | 2021/07/26 12:02:58 |
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Basic information
Public title
The efficacy of transcranial motor-evoked potentials of laryngeal muscles for the recurrent laryngeal nerve palsy
Acronym
Transcranial motor-evoked potentials for the recurrent laryngeal nerve palsy
Scientific Title
The efficacy of transcranial motor-evoked potentials of laryngeal muscles for the recurrent laryngeal nerve palsy
Scientific Title:Acronym
Transcranial motor-evoked potentials for the recurrent laryngeal nerve palsy
Region
| Japan |
Condition
Condition
Patients undergoing surgery for thyroid diseases
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluations of the transcranial motor-evoked potentials of laryngeal muscles. Comparisons between direct laryngeal recurrent nerve stimulated electric potentials and transcranial motor-evoked potentials. Postoperative laryngeal recurrent nerve palsy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparisons between direct laryngeal recurrent nerve stimulated electric potentials and transcranial motor-evoked potentials of laryngeal muscles.
Key secondary outcomes
Correlation of transcranial motor-evoked potentials of laryngeal muscles and incidence of the postoperative recurrent laryngeal nerve palsy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing operation for thyroid diseases
Key exclusion criteria
Patients with brain diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ichino |
Organization
Shinshu University of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2670
t_ichino@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ichino |
Organization
Shinshu University of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2670
Homepage URL
t_ichino@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology and Resuscitology, Shinshu University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Anesthesiology and Resuscitology, Shinshu University of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2670
t_ichino@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluations of the changes of transcranial motor-evoked potentials, reactions of direct laryngeal recurrent nerve electrical stimulation and postoperative laryngeal recurrent nerve palsy
Management information
Registered date
| 2017 | Year | 01 | Month | 17 | Day |
Last modified on
| 2021 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029542
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
