UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005019
Receipt number R000005968
Scientific Title A randomized controlled trial for evaluation of Afternoon Colonoscopy
Date of disclosure of the study information 2011/02/05
Last modified on 2018/08/14 23:50:00

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Basic information

Public title

A randomized controlled trial for evaluation of Afternoon Colonoscopy

Acronym

A randomized controlled trial for evaluation of Afternoon Colonoscopy

Scientific Title

A randomized controlled trial for evaluation of Afternoon Colonoscopy

Scientific Title:Acronym

A randomized controlled trial for evaluation of Afternoon Colonoscopy

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of the present study is to increase the acceptability of people in the working population to colonoscopies by verifying the usefulness of scheduling colonoscopy after intake in the morning (afternoon colonoscopy: ACS).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Verification that the efficacy of colon irrigation in the ACS group is not inferior to the control group (non-inferiority trial)

Key secondary outcomes

Evaluation of hunger and dizziness.
Evaluation of whether or not they were able to work or do housework in the morning.
Time taken from start of polyethylene glycol lavage intake until clear.
Complications.


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

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

ACS Group
Day of exam, 8:00a.m. Jelly intake (Nonfiber Wieder in Jelly Energy Drink 2 packs=360kcal).
12:00, polyethylene glycol lavage 2000ml taken over a 2 hr period at the hospital.

Interventions/Control_2

Day of exam,no breakfast. 10:00a.m. polyethylene glycol lavage 2000ml taken over a 2 hr period at the hospital.

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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Outpatients in the Dept. of Gastroenterology of Nikko Memorial Hospital in whom colonoscopy is deemed necessary

Key exclusion criteria

History of bowel resection.
Patients with progressively worsening constipation.
Patients with a palpable abdominal mass.
Patients in whom CT or other imaging has shown colorectal cancer.

Target sample size

280


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunori Yokoyama

Organization

Nikko Memorial Hospital

Division name

Department of Gastroenterology

Zip code


Address

1-5-13,Shintomityo, Muroran-shi, Hokkaido

TEL

0143-24-1331

Email

yasuharumaeda610@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Yuichi Mori

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code


Address

35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi

TEL

045-949-7693

Homepage URL


Email

ibusiginjp@hotmail.com


Sponsor or person

Institute

Nikko Memorial Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

日鋼記念病院(北海道) Nikko Memorial Hospital


Other administrative information

Date of disclosure of the study information

2011 Year 02 Month 05 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

2010 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date

2011 Year 12 Month 01 Day

Date of closure to data entry

2012 Year 06 Month 01 Day

Date trial data considered complete

2012 Year 08 Month 01 Day

Date analysis concluded

2012 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 02 Month 03 Day

Last modified on

2018 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005968


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name