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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014049
Receipt No. R000016357
Scientific Title An observation study of an effect of pneumoperitoneum on perfusion of extremities
Date of disclosure of the study information 2014/06/01
Last modified on 2016/05/31

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Basic information
Public title An observation study of an effect of pneumoperitoneum on perfusion of extremities
Acronym An observation study of an effect of pneumoperitoneum on perfusion of extremities
Scientific Title An observation study of an effect of pneumoperitoneum on perfusion of extremities
Scientific Title:Acronym An observation study of an effect of pneumoperitoneum on perfusion of extremities
Region
Japan

Condition
Condition Patients who recieced laparoscopic surgery with pneumoperitonium
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Pneumoperitonium is reported to influence cardiovascular system of the patients who underwent laparoscopic surgery. However, the effect of pneumoperitonium on perfusion of the extremities is not well-known. We observe the effect of pneumoperitonium on the perfusion of extremities.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure and regional saturation of oxygen of extremities at the time of pre and post pneumoperitonium.
Key secondary outcomes

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 Patients who underwent laparoscopic surgery with pneumoperitonium
Key exclusion criteria Patients with renal replacement therapy, Emergency surgery.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Iida
Organization Gifu University Graduate School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 1-1 Yanagido, Gifu, Gifu 501-1194, Japan
TEL +81-58-230-6404
Email iida@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kimito Minami
Organization Gifu University Graduate School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 1-1 Yanagido, Gifu, Gifu, Japan
TEL +81-58-230-6404
Homepage URL
Email nann_5115@ybb.ne.jp

Sponsor
Institute Gifu University Graduate School of Medicine, Department of Anesthesiology and Pain 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
2014 Year 06 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 Terminated
Date of protocol fixation
2014 Year 06 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information we observe blood pressure and regional saturation of oxygenation of extremities at the thme of pre and post pneumperitonium.

Management information
Registered date
2014 Year 05 Month 23 Day
Last modified on
2016 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016357

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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