UMIN-CTR Clinical Trial

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
Last 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
1st 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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015665