UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021855 |
|---|---|
| Receipt number | 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 | 2023/10/18 12:05:12 |
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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 | Kazuo |
| Middle name | |
| Last name | Ushijima |
Organization
Kurume University School of Medicine
Division name
Department of Anesthesiology, Kurume University School of Medicine
Zip code
8300011
Address
67 Asahimachi, Kurume, Fukuoka, 830-0011, Japan
TEL
0942-31-7578
kimura_hiroko@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Hamada |
Organization
Kurume University School of Medicine
Division name
Department of Anesthesiology, Kurume University School of Medicine
Zip code
8300011
Address
67 Asahimachi, Kurume, Fukuoka, 830-0011, Japan
TEL
0942-31-7578
Homepage URL
kimura_hiroko@med.kurume-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Kurume University School of Medicine
Institute
Department
Personal name
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
Kurume University School of Medicine
Address
67 Asahimachi, Kurume, Fukuoka, 830-0011, Japan
Tel
0942-65-3749
i_rinri@kurume-u.ac.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
| 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
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025201
