UMIN-CTR Clinical Trial

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
Email	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
Email	sayakaito518@gmail.com

Sponsor
Institute	Kyoto Okamoto Memorial Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046265