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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007560
Receipt No. 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

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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
Obsterics 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
Email 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
Email fuku-kaori@nms.ac.jp

Sponsor
Institute Nippon Medical School
Department of Anesthesiology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006768

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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