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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name