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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026973
Receipt No. R000030930
Scientific Title Effects of postoperative supplementaion with amino acid enriched food on complications after lower gastrointestinal tract surgery in Japanese elderly patients.
Date of disclosure of the study information 2017/04/17
Last modified on 2019/03/30

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Basic information
Public title Effects of postoperative supplementaion with amino acid enriched food on complications after lower gastrointestinal tract surgery in Japanese elderly patients.
Acronym Effects of postoperative supplementaion with amino acid enriched food on complications after lower gastrointestinal tract surgery in Japanese elderly patients.
Scientific Title Effects of postoperative supplementaion with amino acid enriched food on complications after lower gastrointestinal tract surgery in Japanese elderly patients.
Scientific Title:Acronym Effects of postoperative supplementaion with amino acid enriched food on complications after lower gastrointestinal tract surgery in Japanese elderly patients.
Region
Japan

Condition
Condition Patients for operation to resect colon/rectum by laparotomy
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of amino acid supplementation on complications after laparotomy to resect colon/rectum
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assessment of Postoperative complications
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Supplementation:Test foods containing of amino acids
is administered by orally or gavage, twice daily (morning and evening)
Period:7 days of post operative period
Interventions/Control_2 Placebo is administered by orally or gavage, twice daily ( morning and evening)
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
65 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients (aged from 65 to 95 years old) for laparotomy to resect colon or rectum.
2)Patients with blood albumin revel before the study less than 3.8 g/dL
3)Patients with the judgment ability to understand the study enough, and from whom written informed consent is obtained
4)Patients who taking test food is possible
5) Patients deemed suitable by the principal investigator, investigators of the research project or investigators of the sub institution.
Key exclusion criteria 1)Patients for emergency surgery conducted within 72 hours from transport
2)Patients who receive blood transfusion ( include blood product) after surgery
3)Patients who have the severe complications (more than ASA classification grade 4)
4)Patients who have the history of severe hypersensitivity
5)Patients who have the history of aminoacidopathy
6)Patients included in other clinical studies within 3 months or in process
7)Patients with other conditions whom principal investigator, the investigator of this project and the investigator of sub institution consider inadequate such as routine users of similar food (e.g. amino acid supplement)
8)Patients who have renal dysfunction that creatinine clearance are less than 30 ml/min.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hiroyoshi
Middle name
Last name Matsuoka
Organization Kyorin University, School of Medicine
Division name Department of Surgery, Colorectal section
Zip code 181-8611
Address 6-20-2, Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL 0422-47-5511
Email hmatsu@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name Hideaki
Middle name
Last name Mizuno
Organization Mejiro Second General Hospital
Division name Department of Surgery
Zip code 197-0011
Address 1980 Hussa, Hussa, Tokyo, 197-0011, Japan
TEL 042-553-3511
Homepage URL
Email zbm05143@sky.zero.ad.jp

Sponsor
Institute KYOWA HAKKO BIO CO., LTD.
Institute
Department

Funding Source
Organization KYOWA HAKKO BIO CO., 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 Consider meeting about the ethics of a clinical study
Address 1-13-2 ichibanncho, Chiyoda, Tokyo, 102-0082, Japan
Tel 03-5213-0028
Email secretariat@hurecs.org

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 杏林大学医学部付属病院(東京都)、目白第二病院(東京都)、立正佼成会附属佼成病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 20
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
2016 Year 12 Month 02 Day
Date of IRB
2016 Year 03 Month 16 Day
Anticipated trial start date
2017 Year 04 Month 17 Day
Last follow-up date
2019 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 13 Day
Last modified on
2019 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030930

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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