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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021855
Receipt No. R000025201
Scientific Title Evaluation of lower leg perfusion measured by regional oxygen saturation (rSO2) in lithotomy position
Date of disclosure of the study information 2016/05/01
Last modified on 2016/04/10

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Basic information
Public title Evaluation of lower leg perfusion measured by regional oxygen saturation (rSO2) in lithotomy position
Acronym Evaluation of lower leg perfusion measured by regional oxygen saturation (rSO2) in lithotomy position
Scientific Title Evaluation of lower leg perfusion measured by regional oxygen saturation (rSO2) in lithotomy position
Scientific Title:Acronym Evaluation of lower leg perfusion measured by regional oxygen saturation (rSO2) in lithotomy position
Region
Japan

Condition
Condition Well leg compartment syndrome (WLCS)
Classification by specialty
Surgery in general Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Acute lower leg compartment syndrome which caused by the position during surgical operation is called well leg compartment syndrome (WLCS). One of mechanism which develops to WLCS is considered perfusion reduction of lower leg. Especially, the frequency is high in the lithotomy position. We estimate the change of lower leg during operation by using rSO2 in the lithotomy position.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Regional oxygen saturation (rSO2)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 measurement of rSO2 value
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing laparoscopic low anterior resection on lithotomy position under general anesthesia.
ASA physical status 1 or 2.
Key exclusion criteria None
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Ushijima
Organization Kurume University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 67 Asahimachi, Kurume, Fukuoka, 830-0011, Japan
TEL 0942-31-7578
Email kimura_hiroko@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Kimura
Organization Kurume University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 67 Asahimachi, Kurume, Fukuoka, 830-0011, Japan
TEL 0942-31-7578
Homepage URL
Email kimura_hiroko@med.kurume-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Kurume University School of Medicine
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2016 Year 05 Month 01 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
2016 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 10 Day
Last modified on
2016 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025201

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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