UMIN-CTR Clinical Trial

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	d-sakahara@med.osakacity-hp.or.jp

Public contact
Name of contact person	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
Homepage URL
Email	d-sakahara@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	2022 Year 09 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047617