UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011027 |
|---|---|
| Receipt number | R000012912 |
| Scientific Title | safety and efficacy in early oral intake after gastrectomy |
| Date of disclosure of the study information | 2013/06/25 |
| Last modified on | 2013/11/12 18:12:01 |
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Basic information
Public title
safety and efficacy in early oral intake after gastrectomy
Acronym
feasibility study of early oral intake after gastrectomy
Scientific Title
safety and efficacy in early oral intake after gastrectomy
Scientific Title:Acronym
feasibility study of early oral intake after gastrectomy
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate both of the feasibility of early oral intake and patients' satisfaction using special diet treated particular enzymes, which is called "aito", after distal or total gastrectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility of early oral intake after gastrectomy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
oral intake of special diet "aito" from noon of POD1 to POD3
Interventions/Control_2
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.Age>20 and <85 years and both Men and Women
2.Elective distal gastrectomy or total gastrectomy
3.Oral intake without problems
4.Written informed consent
Key exclusion criteria
1.potential to be on a ventilator after surgery
2.history of inflammatory bowel disease
3.past history of intestinal resection
4.no function of intestine
5.serious complicatioon such as heart disease, liver disease, renal disorder, and diabetes
AST or ALT is over 2.5 times of upper limit
serum creatinine is over 2.0mg/dl
HbA1c is over 7.0%
6.past history of food allergy
7.judged as inappropriate by physician-in-charge
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita City Osaka
TEL
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Miyazaki,MD |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita City Osaka
TEL
06-6879-3251
Homepage URL
ymiyazaki02@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University School of Medicine Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
EN Otuka PharmaceuticalCo.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
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 | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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 | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 24 | Day |
Last modified on
| 2013 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012912
