UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038013
Receipt number R000043330
Scientific Title Influence of meal on bowel preparation in colonoscopy:a pilot study
Date of disclosure of the study information 2019/09/13
Last modified on 2020/11/13 18:24:13

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Basic information

Public title

Influence of meal on bowel preparation in colonoscopy:a pilot study

Acronym

Influence of meal on bowel preparation in colonoscopy:a pilot study

Scientific Title

Influence of meal on bowel preparation in colonoscopy:a pilot study

Scientific Title:Acronym

Influence of meal on bowel preparation in colonoscopy:a pilot study

Region

Japan


Condition

Condition

Large intestine

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the outcome of lunch in colonoscopy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adenoma detection rate

Key secondary outcomes

Bowel preparation
Complication
Blood concentration
Polyp detection rate


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

control group (without lunch)

Interventions/Control_2

lunch group (with lunch)

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

18 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients over 18 years old, who are admitted in our hospital

Key exclusion criteria

the following patients
-to plan examination or treatment
-with gastrectomy
-with past surgical history of colon
-with inflammatory bowel disease
-with cognitive impairment
-whose chief doctor judge that te patient does not fit this study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name MASAMICHI
Middle name
Last name ARAO

Organization

Takayama red cross hospital

Division name

Internal medicine

Zip code

5008367

Address

4-6-13

TEL

08049857465

Email

aryao_poor_boy@yahoo.co.jp


Public contact

Name of contact person

1st name Masamichi
Middle name
Last name Arao

Organization

Takayama red cross hospital

Division name

Internal medicine

Zip code

5068550

Address

3-11, Tennmann cho, Takayama

TEL

0577-32-1111

Homepage URL


Email

aryao_poor_boy@yahoo.co.jp


Sponsor or person

Institute

Takayama red cross hospital

Institute

Department

Personal name



Funding Source

Organization

Takayam red cross hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Takayama red cross hospital

Address

3-11, tennmann , takayama, gifu

Tel

0577321111

Email

aryao_poor_boy@yahoo.co.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

2019 Year 09 Month 13 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

100

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

2019 Year 07 Month 14 Day

Date of IRB

2019 Year 07 Month 20 Day

Anticipated trial start date

2019 Year 08 Month 01 Day

Last follow-up date

2020 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 09 Month 13 Day

Last modified on

2020 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043330


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name