UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011572 |
|---|---|
| Receipt number | R000013534 |
| Scientific Title | Randomized clinical trial on the efficacy and safety of perioperative management using ERAS protocol in gastric cancer |
| Date of disclosure of the study information | 2013/08/24 |
| Last modified on | 2017/04/17 21:26:12 |
* 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 clinical trial on the efficacy and safety of perioperative management using ERAS protocol in gastric cancer
Acronym
Randomized clinical trial on perioperative management using ERAS(Enhanced recovery after surgery) protocol in gastric cancer
Scientific Title
Randomized clinical trial on the efficacy and safety of perioperative management using ERAS protocol in gastric cancer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Uchiyama |
Organization
Osaka medical college
Division name
General and Gastroenterological Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki city Osaka, Japan
TEL
072-684-6263
uchi@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Tanaka |
Organization
Osaka medical college
Division name
General and Gastroenterological Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki city Osaka, Japan
TEL
072-684-6263
Homepage URL
sur148@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka medical college,
General and Gastroenterological Surgery
Institute
Department
Personal name
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)
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
| 2013 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013534
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
