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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name