UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023833 |
|---|---|
| Receipt number | R000027458 |
| Scientific Title | Comparison of gastric transit time after ingestion of edible solid melts and glucose solution by ultrasound assessment of gastric volume. |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2017/08/31 19:09:42 |
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Basic information
Public title
Comparison of gastric transit time after ingestion of edible solid melts and glucose solution by ultrasound assessment of gastric volume.
Acronym
Comparison of gastric transit time after ingestion of edible solid melts and glucose solution by ultrasound assessment of gastric volume.
Scientific Title
Comparison of gastric transit time after ingestion of edible solid melts and glucose solution by ultrasound assessment of gastric volume.
Scientific Title:Acronym
Comparison of gastric transit time after ingestion of edible solid melts and glucose solution by ultrasound assessment of gastric volume.
Region
| Japan |
Condition
Condition
To evaluate the difference of gastric transit time after ingestion of edible solid melts and glucose solution.
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the difference of gastric transit time after ingestion of edible solid melts and glucose solution.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cross-sectional surface area of
the gastric antrum measured by ultrasound.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Food | Maneuver |
Interventions/Control_1
The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of 400ml of 12.5% glucose solution.
Interventions/Control_2
The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of 400ml of 6.25% glucose solution.
Interventions/Control_3
The change of the cross-sectional surface area of the gastric antrum with time after ingestion of one block of Calorie Mate Chocolate Flavor and 380ml of water.
Interventions/Control_4
The change of the cross-sectional surface area of the gastric antrum with time after ingestion of two block of Calorie Mate Chocolate Flavor and 360ml of water.
Interventions/Control_5
The change of the cross-sectional
surface area of the gastric antrum
with time after after ingestion of
500ml of water.
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
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
Persons who fills everything the following
1) a person of 20years or more
2) a person who gives written informed
consent
Key exclusion criteria
1. a person who have gastrointestinal lesion.
2. a person who are ineligible in the opinion of the investigator.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Okabe |
Organization
Hitachi, Ltd. Hitachinaka General Hospital
Division name
Department of Anesthesiology
Zip code
Address
20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN
TEL
029-354-5111
t-okabe@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Okabe |
Organization
Hitachi, Ltd. Hitachinaka General Hospital
Division name
Department of Anesthesiology
Zip code
Address
20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN
TEL
029-354-5111
Homepage URL
t-okabe@nms.ac.jp
Sponsor or person
Institute
Hitachi, Ltd. Hitachinaka General Hospital
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Hitachi, Ltd. Hitachinaka General Hospital
Department of Anesthesiology
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2016 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 02 | 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
| 2016 | Year | 08 | Month | 30 | Day |
Last modified on
| 2017 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027458
