UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003336 |
|---|---|
| Receipt number | R000004046 |
| Scientific Title | Randomized trial concerning the efficacy and safety of preoperative carbohydrate loading on postoperative bowel function |
| Date of disclosure of the study information | 2010/04/15 |
| Last modified on | 2019/04/23 00:01:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Public contact
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
hhamada@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Department of Anesthesiology and Critical Care
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004046
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
