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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041717
Receipt No. R000047617
Scientific Title Clinical study of Pre-and postoperative change of intracranial volume and craniofacial configuration for craniosynostosis
Date of disclosure of the study information 2020/09/14
Last modified on 2020/09/13

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Basic information
Public title Clinical study of Pre-and postoperative change of intracranial volume and craniofacial configuration for craniosynostosis
Acronym Clinical study of intracranial volume and craniofacial configuration for craniosynostosis
Scientific Title Clinical study of Pre-and postoperative change of intracranial volume and craniofacial configuration for craniosynostosis
Scientific Title:Acronym Clinical study of intracranial volume and craniofacial configuration for craniosynostosis
Region
Japan

Condition
Condition Craniosynostosis
Classification by specialty
Neurosurgery Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clinical effect and assessment of surgical procedu
Basic objectives2 Others
Basic objectives -Others The change of craniofacial definition with growth after surgery and efficacy and safety of surgical procedures
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of each craniofacial part on 3DCT cephalogram
Key secondary outcomes Intracranial volume, Analysis of cephalogram, measurement on clinical photos, Clinical findings (complication etc.)

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 1) patients performed craniofacial plasty
2) patients with complete medical records who have clinical photos, XP and CT perioperatively
Key exclusion criteria 1)Patients who are judged to be unsuitable as a subject by the research responsibility doctors

2)Patients with incomplete medical records and those who have not clinical photos, XP and CT enough perioperatively
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Sakahara
Organization Osaka City General Hospital
Division name Plastic & Reconstructive Surgery
Zip code 5340021
Address 2-13-22, Miyakojimahondori, miyakojima-ku, Osaka
TEL 0669291221
Email sakaharadprs@gmail.com

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

Sponsor
Institute Osaka City General Hospital
Plastic & Reconstructive Surgery
Institute
Department

Funding Source
Organization Self funding
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 0669291221
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 09 Month 14 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
2014 Year 02 Month 26 Day
Date of IRB
2014 Year 03 Month 19 Day
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2030 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective observational study

The subject is a cranial suture early fusion case undergoing cranioplasty (expansion, remodeling)and facial osteotomy performed at our hospital. The type of surgical procedures does not matter.

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 09 Month 07 Day
Last modified on
2020 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047617

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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