UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019730 |
|---|---|
| Receipt number | R000013511 |
| Scientific Title | Study on gastric emptying time after intake of oral rehydration solution in morbidly obese patients using MRI |
| Date of disclosure of the study information | 2015/11/10 |
| Last modified on | 2015/11/10 18:19:41 |
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Basic information
Public title
Study on gastric emptying time after intake of oral rehydration solution in morbidly obese patients using MRI
Acronym
Gastric emptying time after intake of oral rehydration solution in obese patients
Scientific Title
Study on gastric emptying time after intake of oral rehydration solution in morbidly obese patients using MRI
Scientific Title:Acronym
Gastric emptying time after intake of oral rehydration solution in obese patients
Region
| Japan |
Condition
Condition
Morbidly obesity
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of the gastric emptying time after intake of oral rehydration solution in obese patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preoperative fluid intake allowable time in morbidly obese patients
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Device,equipment | Maneuver |
Interventions/Control_1
ingestion of Oral Rehydration Solution
(OS-1) 500ml
Gastric Volume were measured before ingestion, just after the ingestion, 30min,60min,120min
Interventions/Control_2
Gastric Volume were measured with T2 weighted MRI.
Gastric emptying rate were measured.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Group OB: patient with BMI bigger than 35 who were scheduled to receive bariatric surgery in Yotsuya Medical Cube.
Group C: healthy volunteers with the BMI bigger than 18 and less than 25.
Key exclusion criteria
Dibetes Mellitus
Gastroesophageal Reflux
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshie Shiraishi |
Organization
Yotsuya Medical Cube
Minimally Invasive Surgery Center
Dirctor,
Division name
Dpt Anethesiology
Zip code
Address
Nibancho 7-7 Chiyoda-Ku
TEL
03-3261-0401
shiraishi@mcube.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshie Shiraishi |
Organization
Yotsuya Medical Cube Minimally Invasive Surgery Center
Division name
Dpt Anethesiology
Zip code
Address
Nibancho 7-7 Chiyoda-Ku
TEL
03-3261-0401
Homepage URL
shiraishi@mcube.jp
Sponsor or person
Institute
Yotsuya Medical Cube
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 11 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 10 | Day |
Last modified on
| 2015 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013511
| Research Plan | |
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| 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 |
