UMIN-CTR Clinical Trial

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
Last 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
1st 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