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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033734
Receipt No. R000036807
Scientific Title Influence of lithotomy position under anesthesia on tissue blood volume and oxygenation in lower limbs
Date of disclosure of the study information 2018/08/13
Last modified on 2021/02/17

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Basic information
Public title Influence of lithotomy position under anesthesia on tissue blood volume and oxygenation in lower limbs
Acronym Circulation change in lower limbs in the lithotomy position
Scientific Title Influence of lithotomy position under anesthesia on tissue blood volume and oxygenation in lower limbs
Scientific Title:Acronym Circulation change in lower limbs in the lithotomy position
Region
Japan

Condition
Condition Indications for operation in the lithotomy position
Classification by specialty
Obsterics and gynecology Urology Anesthesiology
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We reveal the effect of lithotomy position under anesthesia on tissue circulation in the lower limmb
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes of lower limb blood volume measured by near infrared spectroscopy before and after the lithotomy position
Key secondary outcomes Changes in cardiorespiratory parameters before and after the lithotomy position

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Adult patients scheduled for surgery at the lithotomy position who have no systemic complications or mild complications.
Key exclusion criteria Patients with severe systemic complications.
Patients who are prone to tape rash in daily life
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Miho
Middle name
Last name Matsuda
Organization Nihon University School of Medicine
Division name Department of Anesthesiology
Zip code 1738610
Address 30-1, Ohyaguchi Kamichou, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email matsuda.miho@nihon-u.ac.jp

Public contact
Name of contact person
1st name Miho
Middle name
Last name Matsuda
Organization Nihon University School of Medicine
Division name Department of Anesthesiology
Zip code 1738610
Address 30-1, Ohyaguchi Kamichou, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email matsuda.miho@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine, Department of Anesthesiology
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 Nihon University School of Medicine
Address 30-1, Ohyaguchi Kamichou, Itabashi-ku, Tokyo, Japan
Tel 0339728111
Email matsuda.miho@nihon-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
2018 Year 08 Month 13 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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 21 Day
Date of IRB
2018 Year 05 Month 18 Day
Anticipated trial start date
2018 Year 08 Month 13 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information 1.Study design : observational study (case-control study)

2.Participants : Adult patients scheduled for surgery under anesthesia at the lithotomy position

3.Observational endpoint : changes in the tissue blood volume in the lower limb evaluated by NIRS before and after the lithotomy position

Management information
Registered date
2018 Year 08 Month 13 Day
Last modified on
2021 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036807

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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