UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007560 |
|---|---|
| Receipt number | R000006768 |
| Scientific Title | Change in colloid oncotic pressure and osmolality following the operation using solbitol as irrigating solution |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2014/12/31 01:50:50 |
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Basic information
Public title
Change in colloid oncotic pressure and osmolality following the operation using solbitol as irrigating solution
Acronym
Change in colloid oncotic pressure and osmolality following the operation using solbitol as irrigating solution
Scientific Title
Change in colloid oncotic pressure and osmolality following the operation using solbitol as irrigating solution
Scientific Title:Acronym
Change in colloid oncotic pressure and osmolality following the operation using solbitol as irrigating solution
Region
| Japan |
Condition
Condition
Benign prostatic hypertrophy
Bladder tomurs
Uterus myoma
Classification by specialty
| Obstetrics and Gynecology | Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examin the perioperative change of colloid oncotic pressure and osmolality in the operation using irrigation fluid.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
colloid oncotic pressure
osmolality
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing trasurethral resection of prostate/ bladder tumors or transcervical resection of the endometrium
Key exclusion criteria
(1) patients have history of cardiovascular, pulmonary, or neurological disorders
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuhiro Sakamoto |
Organization
Nippon Medical School
Division name
Department of Anesthesiology
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
TEL
0338222131
fuku-kaori@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Yagi |
Organization
Nippon Medical School
Division name
Department of Anesthesiology
Zip code
Address
1-1-5, Sendagi, Bunkyou-ku, Tokyo 113-8602, Japan
TEL
0338222131
Homepage URL
fuku-kaori@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Department of Anesthesiology
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
| 2012 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 02 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 02 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 02 | Day |
Other
Other related information
monitoring each parameter to measure the blood volume change.
Management information
Registered date
| 2012 | Year | 03 | Month | 23 | Day |
Last modified on
| 2014 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006768
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
