UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized clinical trial on the efficacy and safety of perioperative management using ERAS protocol in gastric cancer
Title of the study (Brief title)	Randomized clinical trial on perioperative management using ERAS(Enhanced recovery after surgery) protocol in gastric cancer
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of perioperative management using ERAS protocol in gastrectomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative lengths of stay
Key secondary outcomes	Postoperative complication rate Readmission rate Mortality rate Weight loss rate

Base
Study type

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Shortened fasting period Early oral intake Omission of bowel preparation Oral prophylactic analgesic
Interventions/Control_2	Conventional fasting period Conventional oral intake bowel preparation
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	85 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)T factor T1a-T4a. 4)Weight loss rate the month prior to surgery is within 10%. 5)Written informed consent must be obtained from patients.
Key exclusion criteria	1)Patients with severe complications. 2)Requiring resection the other organs except the gallbladder. 3)Patients with infection in progress. 4)Emergency surgery. 5)Patients with uncontrolled diabetes. 6)Patients enrollment to the study is determined to be inappropriate.
Target sample size	140

Research contact person
Name of lead principal investigator	Kazuhisa Uchiyama
Organization	Osaka medical college
Division name	General and Gastroenterological Surgery
Address	2-7 Daigaku-machi, Takatsuki city Osaka, Japan
TEL	072-684-6263
Email	uchi@poh.osaka-med.ac.jp

Public contact
Name of contact person	Ryo Tanaka
Organization	Osaka medical college
Division name	General and Gastroenterological Surgery
Address	2-7 Daigaku-machi, Takatsuki city Osaka, Japan
TEL	072-684-6263
Homepage URL
Email	sur148@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka medical college, General and Gastroenterological Surgery
Institute
Department

Funding Source
Organization	none
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	2013 Year 08 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2016 Year 06 Month 30 Day
Date of closure to data entry	2016 Year 06 Month 30 Day
Date trial data considered complete	2016 Year 06 Month 30 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 08 Month 24 Day
Last modified on	2017 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013534