UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019813 |
|---|---|
| Receipt number | 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 15:14:16 |
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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
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
uemuras@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022857
