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Name
UMIN ID

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013416
Receipt No. 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

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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
Email 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
Email crc-yasuko.satou@ishinomaki.jrc.or.jp

Sponsor
Institute Ishinomaki Red Cross Hospital
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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