UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036518
Receipt number 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 17:56:02

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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 or person

Institute

Niigata University

Institute

Department

Personal name



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

Value
https://center6.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