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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020132
Receipt No. R000023254
Scientific Title The effect of preoperative oral rehydration therapy on circulatory collapse during anesthetic induction.
Date of disclosure of the study information 2015/12/15
Last modified on 2017/12/15

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Basic information
Public title The effect of preoperative oral rehydration therapy on circulatory collapse during anesthetic induction.
Acronym Efficacy of preoperative oral rehydration therapy
Scientific Title The effect of preoperative oral rehydration therapy on circulatory collapse during anesthetic induction.
Scientific Title:Acronym Efficacy of preoperative oral rehydration therapy
Region
Japan

Condition
Condition The patients who plan to undergo resection of colorectal cancer.
Classification by specialty
Gastrointestinal surgery Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effect of preoperative oral rehydration therapy on circulatory collapse during anesthetic induction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Change of SVV, SVI after epidural administration of 2% lidocaine
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 taking rehydration solution at most 1000ml two hours prior to surgery
Interventions/Control_2 control
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 The patients who plan to undergo resection of colorectal cancer.
Key exclusion criteria Gastrointestinal dysfunction due to functional, non-mechanical inhibition of propulsive bowel activity
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makiko Komori
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Anesthesiology
Zip code
Address 2-1-10 Nishiogu, Arakawa-ku, Tokyo
TEL 81-3-3810-1111
Email komorim@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Junko Ichikawa
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Anesthesiology
Zip code
Address 2-1-10 Nishiogu, Arakawa-ku, Tokyo
TEL 81-3-3810-1111
Homepage URL
Email htwfx872@yahoo.co.jp

Sponsor
Institute Tokyo Women's Medical University Medical Center East
Institute
Department

Funding Source
Organization Budget for Anesthesiology department
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
2015 Year 12 Month 15 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
2015 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 15 Day
Last follow-up date
2017 Year 02 Month 10 Day
Date of closure to data entry
2017 Year 10 Month 31 Day
Date trial data considered complete
2017 Year 10 Month 31 Day
Date analysis concluded
2017 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 09 Day
Last modified on
2017 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023254

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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