UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041717 |
|---|---|
| Receipt number | 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 | 2022/09/27 09:19:24 |
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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
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
d-sakahara@med.osakacity-hp.or.jp
Sponsor or person
Institute
Osaka City General Hospital
Plastic & Reconstructive Surgery
Institute
Department
Personal name
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
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
Value
https://center6.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 |
