UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Surgical techniques for chronic subdural hematoma study
Title of the study (Brief title)	SSS
Region	Japan

Condition
Condition	Chronic subdural hematoma
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the difference of surgical complication and recurrence during surgical techniques for CSH by RCT
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Restlessness after surgery, Recurrence at 1M, Rate of mRS 0 and 1 at 1M
Key secondary outcomes	Surgical complication, Hospital Days

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Only drainage
Interventions/Control_2	Only irrigation
Interventions/Control_3	Irrigation and drainage
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	Symptomatic CSH
Key exclusion criteria	History of craniotomy within 6M History of shunt surgery Intracranial hypotension syndrome Those who investigator decide not compatible
Target sample size	90

Research contact person
Name of lead principal investigator	Takashi Inoue
Organization	Sendai Medical Center
Division name	Neurosurgery
Address	2-8-8, Miyagino, Miyaginoku, Sendai
TEL	022-293-1111
Email	tainoue@snh.go.jp

Public contact
Name of contact person	Takashi Inoue
Organization	Sendai Medical Center
Division name	Neurosurgery
Address	2-8-8, Miyagino, Miyaginoku, Sendai
TEL	022-293-1111
Homepage URL
Email	tainoue@snh.go.jp

Sponsor
Institute	Sendai Medical Center
Institute
Department

Funding Source
Organization	self
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	仙台医療センター

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 28 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 01 Month 23 Day
Anticipated trial start date	2018 Year 01 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 28 Day
Last modified on	2018 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035440