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

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 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


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

Value
https://center6.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