UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020538 |
|---|---|
| Receipt number | R000023697 |
| Scientific Title | Enhanced recovery program emphasizing preoperative carbohydrate loading is safe and improves postoperative insulin resistance in gastrectomy patients: a randomized controlled trial |
| Date of disclosure of the study information | 2016/01/13 |
| Last modified on | 2018/06/02 14:42:38 |
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Basic information
Public title
Enhanced recovery program emphasizing preoperative carbohydrate loading is safe and improves postoperative insulin resistance in gastrectomy patients: a randomized controlled trial
Acronym
Enhanced recovery program emphasizing preoperative carbohydrate loading is safe and improves postoperative insulin resistance in gastrectomy patients: a randomized controlled trial
Scientific Title
Enhanced recovery program emphasizing preoperative carbohydrate loading is safe and improves postoperative insulin resistance in gastrectomy patients: a randomized controlled trial
Scientific Title:Acronym
Enhanced recovery program emphasizing preoperative carbohydrate loading is safe and improves postoperative insulin resistance in gastrectomy patients: a randomized controlled trial
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluated the clinical consequence of this protocol in gastric surgery, assessing not only safety but postoperative nutrition state, insulin-resistance, and quality of life (QOL).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We tested the noninferiority of ERAS with respect to the rate of achievement of discharge from the hospital within 12 days.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In the ERAS group, intravenous fluid was restricted to a minimal daily requirement during the first 3 postoperative days. Additional intravenous fluid was administered when patient showed poor oral intake of water or food.
Interventions/Control_2
The conventional group received intravenous fluid for 1 week postoperatively.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with radical surgery is scheduled.
2)ASA(American Society of Anesthesiology)class 1-3.
3)Written informed consent must be obtained from patients.
Key exclusion criteria
1)obstructin
2)Patients enrollment to the study is determined to be inappropriate.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ohdan Hideki |
Organization
Hiroshima University Hospital
Division name
department of gastro intestinal surgery
Zip code
Address
1-2-3 kasumi, minami-ku, Hiroshima city, Japan
TEL
082-257-5222
ktanabe2@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tanbe Kazuaki |
Organization
Hiroshima University Hospital
Division name
department of gastro intestinal surgery
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5222
Homepage URL
http://home.hiroshima-u.ac.jp/home2ge/
ktanabe2@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 12 | Day |
Last modified on
| 2018 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023697
