UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014754
Receipt number R000017151
Scientific Title Oral intake and activities of the patients after pancreatoduodenectomy
Date of disclosure of the study information 2014/08/04
Last modified on 2016/08/05 07:53:03

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Basic information

Public title

Oral intake and activities of the patients after pancreatoduodenectomy

Acronym

Oral intake and activities of the patients after pancreatoduodenectomy

Scientific Title

Oral intake and activities of the patients after pancreatoduodenectomy

Scientific Title:Acronym

Oral intake and activities of the patients after pancreatoduodenectomy

Region

Japan


Condition

Condition

after pancreatoduodenectomy

Classification by specialty

Surgery in general Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

assessment of the correlation between the oral intake calorie and the number of steps after pancreatoduodenectomy

Basic objectives2

Others

Basic objectives -Others

observational study

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

correlation between the oral intake calorie and the number of steps

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

the patients of admission for pancreatoduodenectomy

Key exclusion criteria

the patients of cognition Disorder

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Etsuko Oyama

Organization

Tohoku university hospital

Division name

E8 ward

Zip code


Address

Seiryo cho 1-1, Aobaku, Sendai, Miyagi, Japan

TEL

022-717-7205

Email

kykudo@surg1.med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kudo Katsuyoshi

Organization

Tohoku university hospital

Division name

gastrointestinal surgery

Zip code


Address

Seiryo cho 1-1, Aobaku, Sendai, Miyagi, Japan

TEL

022-717-7205

Homepage URL


Email

kykudo@surg1.med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku university hospital gastrointestinal surgery

Institute

Department

Personal name



Funding Source

Organization

Tohoku university hospital gastrointestinal surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

2014 Year 08 Month 04 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

Main results already published

Date of protocol fixation

2014 Year 07 Month 10 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We measure the number of steps and walking distance of the patients by pedometer after removed ureteral catheter, after pancreatoduodenectomy. We record thier food intake and measure the intake calories.
We analyze the correlation between the oral intake calorie and the number of steps.


Management information

Registered date

2014 Year 08 Month 03 Day

Last modified on

2016 Year 08 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017151


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name