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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020538
Receipt No. 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

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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
Email 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/
Email ktanabe2@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023697

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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