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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010802
Receipt No. R000012167
Scientific Title Safety of liberal preoperative fasting in gastrointestinal surgery
Date of disclosure of the study information 2013/05/31
Last modified on 2013/05/25

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Basic information
Public title Safety of liberal preoperative fasting in gastrointestinal surgery
Acronym Liberal fasting in GI surgery
Scientific Title Safety of liberal preoperative fasting in gastrointestinal surgery
Scientific Title:Acronym Liberal fasting in GI surgery
Region
Japan

Condition
Condition Disease that will be treated with surgery
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety of liberal fasting in gastrointestinal surgery
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Gastric fluid volume and pH that would be collected after induction of anesthesia.
Key secondary outcomes

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
15 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria Patients with elective surgery under general anesthesia
Key exclusion criteria Emergency surgery
Gastrointestinal obstruction
Cardiac surgery
Target sample size 67

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoi Sasuga
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of anesthesiology
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
TEL 042-323-5111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motoi Sasuga
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of anesthesiology
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of anesthesiology, Tokyo Metropolitan Tama Medical Center
Institute
Department

Funding Source
Organization none
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
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 東京都立多摩総合医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 31 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 Completed
Date of protocol fixation
2009 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 25 Day
Last follow-up date
2011 Year 04 Month 22 Day
Date of closure to data entry
2011 Year 05 Month 31 Day
Date trial data considered complete
2011 Year 05 Month 31 Day
Date analysis concluded
2013 Year 02 Month 28 Day

Other
Other related information Liberal fasting strategies were applied to patients undergoing elective surgery. Gastric fluids were collected after induction of general anesthesia via gastric tube. Patients were classified according to types of surgery into gastrointestinal surgery and non-gastrointestinal surgery. Gastric volume and pH were compared between both groups.

Management information
Registered date
2013 Year 05 Month 25 Day
Last modified on
2013 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012167

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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