UMIN-CTR Clinical Trial

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

Patients for operation to resect colon/rectum by laparotomy

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Assessment of Postoperative complications

Key secondary outcomes

Study type

Interventional

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

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

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

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

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

Institute

KYOWA HAKKO BIO CO., LTD.

Institute

Department

Personal name

Organization

KYOWA HAKKO BIO CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2017

Year

04

Month

17

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2017

Year

04

Month

13

Day

Last modified on

2019

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030930