UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013416 |
|---|---|
| Receipt number | R000015665 |
| Scientific Title | Comparison between antral cross-sectional area (CSA) measured by ultrasonography and volume of stomach content measured by computed tomograhpy for the preoperative assessment of gastric content. |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2019/03/18 19:57:10 |
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Basic information
Public title
Comparison between antral cross-sectional area (CSA) measured by ultrasonography and volume of stomach content measured by computed tomograhpy for the preoperative assessment of gastric content.
Acronym
Assessment of gastric content.
Scientific Title
Comparison between antral cross-sectional area (CSA) measured by ultrasonography and volume of stomach content measured by computed tomograhpy for the preoperative assessment of gastric content.
Scientific Title:Acronym
Assessment of gastric content.
Region
| Japan |
Condition
Condition
Patients undergoing emergent surgery
Classification by specialty
| Radiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this trial is to improve the accuracy of preoperative assessment of gastric content by comparing antral cross-sectional area (CSA) measured by ultrasonography and volume of stomach content measured by computed tomography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
antral cross-sectional area (CSA)
volume of stomach content measured by computed tomography
Key secondary outcomes
Sex
Length
Weight
Body mass index
Disease and operation
Time from onset
Time from final oral intake
Time from CT scan
Mass of suctioned gastric content
American Society of Anesthesiologists physical status classification
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients who were taken abdominal CT just before emergent surgery
Key exclusion criteria
Patients who previously underwent stomach or upper abdominal surgery
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshikfumi |
| Middle name | |
| Last name | Okada |
Organization
Ishinomaki Red Cross Hospital
Division name
Division of Anesthesia
Zip code
986-8522
Address
Nishimicishita71 ,Hebita ,ishinomaki ,Miyagi
TEL
0225-21-7220
ZVS11433@nifty.com
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Hosokawa |
Organization
Ishinomaki Red Cross Hospital
Division name
CRC
Zip code
986-8522
Address
Nishimicishita71 ,Hebita ,ishinomaki ,Miyagi
TEL
0225-21-7220
Homepage URL
crc-yasuko.satou@ishinomaki.jrc.or.jp
Sponsor or person
Institute
Ishinomaki Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Tohoku University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Anesthesiology, Tohoku University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ishinomaki Red Cross Hospital CRC
Address
Nishimicishita71 ,Hebita ,ishinomaki ,Miyagi
Tel
0225-21-7220
crc-yasuko.satou@ishinomaki.jrc.or.jp
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
石巻赤十字病院（宮城県） Ishinomaki Red Cross Hospital(Miyagi)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Main results already published
Date of protocol fixation
| 2013 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
data analyzing
Management information
Registered date
| 2014 | Year | 03 | Month | 14 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015665
| Research Plan | |
|---|---|
| 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 |
