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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019730
Receipt No. 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

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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
Email 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
Email shiraishi@mcube.jp

Sponsor
Institute Yotsuya Medical Cube
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013511

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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