UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020538
Receipt number R000023697
Scientific Title Enhanced recovery program emphasizing preoperative carbohydrate loading is safe and improves postoperative insulin resistance in gastrectomy patients: a randomized controlled trial
Date of disclosure of the study information 2016/01/13
Last modified on 2018/06/02 14:42:38

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Basic information

Public title

Enhanced recovery program emphasizing preoperative carbohydrate loading is safe and improves postoperative insulin resistance in gastrectomy patients: a randomized controlled trial

Acronym

Enhanced recovery program emphasizing preoperative carbohydrate loading is safe and improves postoperative insulin resistance in gastrectomy patients: a randomized controlled trial

Scientific Title

Enhanced recovery program emphasizing preoperative carbohydrate loading is safe and improves postoperative insulin resistance in gastrectomy patients: a randomized controlled trial

Scientific Title:Acronym

Enhanced recovery program emphasizing preoperative carbohydrate loading is safe and improves postoperative insulin resistance in gastrectomy patients: a randomized controlled trial

Region

Japan


Condition

Condition

gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We evaluated the clinical consequence of this protocol in gastric surgery, assessing not only safety but postoperative nutrition state, insulin-resistance, and quality of life (QOL).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We tested the noninferiority of ERAS with respect to the rate of achievement of discharge from the hospital within 12 days.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

In the ERAS group, intravenous fluid was restricted to a minimal daily requirement during the first 3 postoperative days. Additional intravenous fluid was administered when patient showed poor oral intake of water or food.

Interventions/Control_2

The conventional group received intravenous fluid for 1 week postoperatively.

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)Patients with radical surgery is scheduled.
2)ASA(American Society of Anesthesiology)class 1-3.
3)Written informed consent must be obtained from patients.

Key exclusion criteria

1)obstructin
2)Patients enrollment to the study is determined to be inappropriate.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ohdan Hideki

Organization

Hiroshima University Hospital

Division name

department of gastro intestinal surgery

Zip code


Address

1-2-3 kasumi, minami-ku, Hiroshima city, Japan

TEL

082-257-5222

Email

ktanabe2@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tanbe Kazuaki

Organization

Hiroshima University Hospital

Division name

department of gastro intestinal surgery

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

082-257-5222

Homepage URL

http://home.hiroshima-u.ac.jp/home2ge/

Email

ktanabe2@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University Hospital

Institute

Department

Personal name



Funding Source

Organization

Hiroshima University Hospital

Organization

Division

Category of Funding Organization

Self funding

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

2016 Year 01 Month 13 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


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

2011 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date

2015 Year 02 Month 28 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2017 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 01 Month 12 Day

Last modified on

2018 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023697


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name