UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014042 |
|---|---|
| Receipt number | R000016350 |
| Scientific Title | Effect of early oral intake after gastric resection at multicenter randomized controlled trials. |
| Date of disclosure of the study information | 2014/05/22 |
| Last modified on | 2022/05/30 20:42:42 |
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Basic information
Public title
Effect of early oral intake after gastric resection at multicenter randomized controlled trials.
Acronym
Effect of early oral intake after gastric resection at multicenter randomized controlled trials.
Scientific Title
Effect of early oral intake after gastric resection at multicenter randomized controlled trials.
Scientific Title:Acronym
Effect of early oral intake after gastric resection at multicenter randomized controlled trials.
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examine the influence of early oral intake after gastric resection on safety, Hospital stay, QOL, medical economy and brain-gut interaction.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Postoperative hospital stay
Key secondary outcomes
Arrows day of discharge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of special diet i-Eat from noon of POD1 to POD 3.
Interventions/Control_2
Control group take normal nutritional care.
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) planned surgical procedure total or distal gastrectomy.
2) cStage:IA-IIIB
3) performance status:0-1
4) age:20-80 years
5) diagnosed as oral intake is possible within 1 post operative day.
6) written informed consent must be obtained from patients.
Key exclusion criteria
1) considered to be on a ventilator after surgery.
2) plan to chemotherapy or chemo-radiotherapy during hospitalization.
3) receiving neoadjuvant chemotherapy..
4) patient who have another active malignancy.
5) receiving combined resection (gall bladder is excepted).
6) past history of intestinal resection (resection of colon polyp and appendicitis are excepted).
7) severe complication such as heart disease ,respiratory disease, hepatic disorder, renal disorder.
8) drug administration influence of intestinal hormone such as KAMPO.
9) patients who plan to blood infusion during perioperative period.
10) past history of food allergy.
11) patients considered inappropriate by the study investigator.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Seto |
Organization
The University of Tokyo
Division name
Department of Gastrointestinal Sugery
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
seto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Shimizu |
Organization
SANNO HOSPITAL
Division name
Department of surgery
Zip code
1070052
Address
8-10-16, Akasaka, Minato-ku, Tokyo
TEL
03-3402-3151
Homepage URL
nshimizu@iuhw.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
EN Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
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
| 2014 | Year | 05 | Month | 22 | 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 | 09 | Month | 26 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 29 | Day |
Date analysis concluded
| 2017 | Year | 02 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 22 | Day |
Last modified on
| 2022 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016350
