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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019813
Receipt No. R000022857
Scientific Title The effect of perioperative intravenous volume and intestinal edema by preoerative OS-1 administration in laparoscopic distal gastrectomy.
Date of disclosure of the study information 2015/11/17
Last modified on 2017/05/23

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Basic information
Public title The effect of perioperative intravenous volume and intestinal edema by preoerative OS-1 administration in laparoscopic distal gastrectomy.
Acronym Does preoperative OS-1 administration effect intestinal edema?
Scientific Title The effect of perioperative intravenous volume and intestinal edema by preoerative OS-1 administration in laparoscopic distal gastrectomy.
Scientific Title:Acronym Does preoperative OS-1 administration effect intestinal edema?
Region
Japan

Condition
Condition gastric cncer
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Perioperative effect of administration of oral rehydration solution
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes perioperative intravenous volume
presence of intestinal edema
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 administer 1000ml oral rehydration solution up to 2 hours before operation
Interventions/Control_2 starvation from 21:00 of the day before operation
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 elective distal gastrectomy
non starvation cure
Key exclusion criteria HbA1c over 8%
chronic heart failure
chronic kidney disease
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoko Uemura
Organization Saga University Hospital
Division name anesthesia and resuscitation
Zip code
Address Nabeshima 5-1-1 ,Sagashi
TEL 0952-34-3370
Email saco0421@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Satoko Uemura
Organization Saga University Hospital
Division name anesthesia and resustation
Zip code
Address Nabeshima 5-1-1 Sagashi
TEL 0952-34-3370
Homepage URL
Email uemuras@cc.saga-u.ac.jp

Sponsor
Institute Saga University Hospital
Institute
Department

Funding Source
Organization Saga University Hospital, anesthesia and resuscitation
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 佐賀大学医学部附属病院(佐賀県)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 17 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 Completed
Date of protocol fixation
2014 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 30 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
2016 Year 09 Month 30 Day
Date trial data considered complete
2016 Year 09 Month 30 Day
Date analysis concluded
2016 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 16 Day
Last modified on
2017 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022857

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/05/23 日麻2016.pptx [自動保存済み].pptx


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