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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042000
Receipt No. R000047621
Scientific Title Retrospective study of unilateral cleft lip nose deformity after repair with a modified reverse U method
Date of disclosure of the study information 2020/10/05
Last modified on 2020/10/03

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Basic information
Public title Retrospective study of unilateral cleft lip nose deformity after repair with a modified reverse U method
Acronym Retrospective study of nasal repair unilateral cleft lip nose deformity
Scientific Title Retrospective study of unilateral cleft lip nose deformity after repair with a modified reverse U method
Scientific Title:Acronym Retrospective study of nasal repair unilateral cleft lip nose deformity
Region
Japan

Condition
Condition unilateral cleft lip
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacy of a series of cleft lip surgery via follow-up results from infancy to adulthood
Basic objectives2 Others
Basic objectives -Others Assessment of symmetry and deformities for each age, taking into account changes with growth. Evaluating the impact of primary surgery on rhinoplasty.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes On pre-surgery and 1 year, 5 years, 10 years, 18 years after primary surgery, assessment of morphology of the lip and nose via measuring set points
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 Example of cleft lip that has undergone initial cleft surgery
An example of external nose correction using modified Reverse U method
Examples of clinical data and clinical photographs meeting requirements
Key exclusion criteria An example of not being able to cooperate in data collection
Example of lack of clinical data and photographs
Target sample size 200

Research contact person
Name of lead principal investigator
1st name MARIKO
Middle name
Last name NOTO
Organization Osakacity General Hospital
Division name Plastic & Reconstructive Surgery
Zip code 5340021
Address 2-13-22, Miyakojimahondori, Miyakojima-ku
TEL 0669291221
Email m-noto@med.osakacity-hp.or.jp

Public contact
Name of contact person
1st name MARIKO
Middle name
Last name NOTO
Organization Osaka City General Hospital
Division name Plastic & Reconstructive Surgery
Zip code 5340021
Address 2-13-22, Miyakojimahondori, Miyakojima-ku
TEL 0669291221
Homepage URL
Email m-noto@med.osakacity-hp.or.jp

Sponsor
Institute Osakacity General 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 Clinical Research Ethics Committee, Osaka City General Hospital
Address Miyakojima center Bil. 2F, 5-15-21, Nakanocho, Miyakojima, Osaka
Tel 0669293269
Email xc0017@osakacity-hp.or.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
2020 Year 10 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 03 Day
Date of IRB
2018 Year 02 Month 26 Day
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective observational study

If meaningful results are obtained during this study, only the results may be reported at medical conferences and/or medical journals during the course of the study.

Management information
Registered date
2020 Year 10 Month 04 Day
Last modified on
2020 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047621

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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