UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040527 |
|---|---|
| Receipt number | R000046265 |
| Scientific Title | Assessment of burr hole craniectomies for chronic subdural hematomas |
| Date of disclosure of the study information | 2020/05/30 |
| Last modified on | 2020/05/26 17:01:07 |
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Basic information
Public title
Assessment of surgery for chronic subdural hematomas
Acronym
Assessment of surgery for chronic subdural hematomas
Scientific Title
Assessment of burr hole craniectomies for chronic subdural hematomas
Scientific Title:Acronym
Assessment of burr hole craniectomies for chronic subdural hematomas
Region
| Japan |
Condition
Condition
Chronic subdural hematoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is try to clarify whether simple drainage or irrigation and drainage significantly reduces recurrence of subdural hematomas
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence of chronic subdural hematomas
Key secondary outcomes
Complications after the surgeries
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
simple drainage
Interventions/Control_2
irrigation and drainage
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Pt. who agreed to perform this study
2)Pt. who is 20-years old or over
3)Pt. who is newly diagnosed as chronic subdural hematoma
4)Pt. who has not had a surgery for chronic subdural hematoma
Key exclusion criteria
1)Pt. who the principal investigator judged not eligible
2)Pt. who has had the interventional capsular embolization for the chronic subdural hematoma
3)Pt. who has V-P shunt, L-P shunt, or A-V shunt between the observational period
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Ito |
Organization
Kyoto Okamoto Memorial Hospital
Division name
Department of Neurosurgery
Zip code
613-0034
Address
Sayamanishinokuchi 100, Kumiyama, kuze, Kyoto, Japan
TEL
0774485500
sayakaito518@gmail.com
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Ito |
Organization
Kyoto Okamoto Memorial Hospital
Division name
Department of Neurosurgery
Zip code
613-0034
Address
Sayamanishinokuchi 100, Kumiyama, kuze, Kyoto, Japan
TEL
0774485500
Homepage URL
sayakaito518@gmail.com
Sponsor or person
Institute
Kyoto Okamoto Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Okamoto Memorial Hospital
Address
Sayamanishinokuchi100, Kumiyama, Kuze, Kyoto, Japan
Tel
0774485500
sayakaito518@gmail.com
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 | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Preinitiation
Date of protocol fixation
| 2020 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 26 | Day |
Last modified on
| 2020 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046265
