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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name