UMIN-CTR Clinical Trial

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