UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010802 |
|---|---|
| Receipt number | 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 13:29:30 |
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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
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
Sponsor or person
Institute
Department of anesthesiology, Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012167
