UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Enhanced recovery program emphasizing preoperative carbohydrate loading is safe and improves postoperative insulin resistance in gastrectomy patients: a randomized controlled trial
Title of the study (Brief title)	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	Ohdan Hideki
Organization	Hiroshima University Hospital
Division name	department of gastro intestinal surgery
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	Tanbe Kazuaki
Organization	Hiroshima University Hospital
Division name	department of gastro intestinal surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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