UMIN-CTR Clinical Trial

Basic information
Public title	Randomized trial concerning the efficacy and safety of preoperative carbohydrate loading on postoperative bowel function
Acronym	Randomized trial concerning the efficacy and safety of preoperative carbohydrate loading on postoperative bowel function
Scientific Title	Randomized trial concerning the efficacy and safety of preoperative carbohydrate loading on postoperative bowel function
Scientific Title:Acronym	Randomized trial concerning the efficacy and safety of preoperative carbohydrate loading on postoperative bowel function
Region	Japan

Condition
Condition	stomach cancer, liver cancer, colon cancer
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of the degree of preoperative fasting and carbohydrate loading on postoperative bowel function
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	activity of DAO, insulin resistance
Key secondary outcomes	safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral rehydration solution is administered as a carbohydrate loading two hours before surgery.
Interventions/Control_2	In the control group, patients are not allowed to eat and drink for eight hours before surgery.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	adult patients aged 20 or over scheduled for major abdominal surgery under general anesthesia combined with epidural anesthesia
Key exclusion criteria	patients having gastrointestinal tract obstruction patients managed without epidural anesthesia patients having diabetes mellitus patients taking anticoagulants or antiplatelet agent
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroshi Hamada
Organization	Hiroshima University
Division name	Anesthesiology and Critical Care
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5267
Email

Public contact
1st name of contact person	1st name Middle name Last name Hiroshi Hamada
Organization	Hiroshima University
Division name	Anesthesiology and Critical Care
Zip code
Address
TEL	082-257-5267
Homepage URL
Email	hhamada@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Department of Anesthesiology and Critical Care
Institute
Department

Funding Source
Organization	Tsuchiya foundation
Organization
Division
Category of Funding Organization	Non profit foundation
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	広島大学病院

Other administrative information
Date of disclosure of the study information	2010 Year 04 Month 15 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	Terminated
Date of protocol fixation	2010 Year 04 Month 15 Day
Date of IRB	2010 Year 05 Month 28 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date	2011 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 03 Month 15 Day
Last modified on	2019 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004046