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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036518
Receipt No. R000041605
Scientific Title end-to-side nerve graft for facial nerve reconstruction
Date of disclosure of the study information 2019/04/16
Last modified on 2019/04/15

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Basic information
Public title end-to-side nerve graft for facial nerve reconstruction
Acronym end-to-side nerve graft for facial nerve reconstruction
Scientific Title end-to-side nerve graft for facial nerve reconstruction
Scientific Title:Acronym end-to-side nerve graft for facial nerve reconstruction
Region
Japan

Condition
Condition facial nerve defect
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the efficacy of ten end-to-side nerve graft for facial nerve reconstruction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Yanagihara score, House-Blackmann score
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 end-to-side "loop" graft for facial nerve reconstruction
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
25 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria patients with more than 18 months follo-up
Key exclusion criteria other than above
Target sample size 32

Research contact person
Name of lead principal investigator
1st name KEN
Middle name
Last name MATSUDA
Organization Niigata University
Division name Graduate School of Medicine
Zip code 951-8510
Address 1-757, Asahimachi 1 Niigata Chuo-ku
TEL 0252272592
Email matsuken@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name KEN
Middle name
Last name MATSUDA
Organization Niigata University
Division name Graduate School of Medicine
Zip code 951-8510
Address 1-757, Asahimachi 1 Niigata Chuo-ku
TEL 0252272592
Homepage URL
Email matsuken@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Niigata University
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Niigata University
Address Niigata University
Tel 0252272592
Email matsuken@med.niigata-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

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 16 Day

Related information
URL releasing protocol http://dx.doi.org/10.1016/j.bjps.2015.04.005
Publication of results Published

Result
URL related to results and publications http://dx.doi.org/10.1016/j.bjps.2015.04.005
Number of participants that the trial has enrolled 32
Results
http://dx.doi.org/10.1016/j.bjps.2015.04.005
Results date posted
2019 Year 04 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2015 Year 04 Month 06 Day
Baseline Characteristics
patients with facial nerve reconstruction using end-to-side nerve graft
Participant flow
postoperative follow-up in outpatient clinics
Adverse events
none
Outcome measures
Yanagihara score
House-Blackmann scale
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2001 Year 04 Month 01 Day
Date of IRB
2014 Year 07 Month 28 Day
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2014 Year 08 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 15 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041605

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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