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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040212
Receipt No. R000045854
Scientific Title Factors Associated with Late Admission to Facial Plastic Surgery among Patients with Long-Standing Facial Paralysis
Date of disclosure of the study information 2020/04/21
Last modified on 2020/10/27

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Basic information
Public title Factors Associated with Late Admission to Facial Plastic Surgery among Patients with Long-Standing Facial Paralysis
Acronym Factors Associated with Late Admission to Facial Plastic Surgery among Patients with Long-Standing Facial Paralysis
Scientific Title Factors Associated with Late Admission to Facial Plastic Surgery among Patients with Long-Standing Facial Paralysis
Scientific Title:Acronym Factors Associated with Late Admission to Facial Plastic Surgery among Patients with Long-Standing Facial Paralysis
Region
Japan

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

Objectives
Narrative objectives1 To elucidate the factors associated with late admission of patients with long-standing facial paralysis to the facial plastic surgery
Basic objectives2 Others
Basic objectives -Others epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The time interval between symptom onset and facial paralysis patients first admission to our facial paralysis clinic
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients newly admitted to our facial paralysis clinic from October 2017 to March 2020
Key exclusion criteria patients who have previously visited other facial plastic surgery, and those with facial deformities without any paralysis
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takeaki
Middle name
Last name Hidaka
Organization The University of Tokyo Hospital
Division name Plastic, Reconstructive and Aesthetic Surgery
Zip code 1138655
Address 7-3-1, Hongo, Bunkyo, Tokyo, Japan
TEL +81338155411
Email tahidaka1986@gmail.com

Public contact
Name of contact person
1st name Takeaki
Middle name
Last name Hidaka
Organization The University of Tokyo Hospital
Division name Plastic, Reconstructive and Aesthetic Surgery
Zip code 1138655
Address 7-3-1, Hongo, Bunkyo, Tokyo, Japan
TEL +81338155411
Homepage URL https://www.h.u-tokyo.ac.jp/plastic/
Email tahidaka1986@gmail.com

Sponsor
Institute Department of Plastic, Reconstructive and Aesthetic Surgery, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization None.
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 Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address Faculty of Medicine Bldg.2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel +813-5841-0818
Email tahidaka1986@gmail.com

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
2020 Year 04 Month 21 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 199
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
2017 Year 09 Month 30 Day
Date of IRB
2019 Year 11 Month 11 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The time interval between symptom onset and patients first admission to our facial paralysis clinic was retrospectively collected among the study group.

Management information
Registered date
2020 Year 04 Month 21 Day
Last modified on
2020 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045854

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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