UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014049 |
|---|---|
| Receipt number | 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 20:48:52 |
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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
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
nann_5115@ybb.ne.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine, Department of Anesthesiology and Pain 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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016357
