UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000016693
Receipt number	R000018914
Scientific Title	Comparison of coloninc cleansing methods for patients undergoing surgery of colorectal cancer
Date of disclosure of the study information	2015/03/04
Last modified on	2020/03/03 19:52:10

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Basic information

Public title

Comparison of coloninc cleansing methods for patients undergoing surgery of colorectal cancer

Acronym

Comparison of coloninc cleansing methods

Scientific Title

Comparison of coloninc cleansing methods for patients undergoing surgery of colorectal cancer

Scientific Title:Acronym

Comparison of coloninc cleansing methods

Region

Japan

Condition

colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

The objective of this study is to clarify the safety and efficacy of two colonic cleansing methods (standard polyethylene glycol vs. low-volume polyethylene glycol).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Assessment

Primary outcomes

acceptability of colonic cleansing methods

Key secondary outcomes

frequency of bowel movement, dose of standard and low-volume polyethylene glycol, Time to first defecation, duration of taking medicine, Time to start examination

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

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who fills everything the
following
(1)Age of patients is above 20 years old
(2)Patients who were able to provide written informed consent for articipation in this study

Key exclusion criteria

(1) Patients who have or who are suspected to have gastrointestinal obstruction
(2) Patients who have or who are suspected to have gastrointestinal perforation
(3) Patients who have or who are suspected to have toxic megacolon
(4) Patients who have or who are suspected to have delayed gastric empty
(5) Patients who have glucose-6-phosphate dehydrogenase deficiency
(6) Patients who have renal dysfunction(blood urea nitrogen (BUN) >= 25 mg/dL, serum creatinine >= 2 mg/dL)
(7) Patients who have gastrointestinal stenosis
(8) Patients who have impaired vomiting reflex or risk of aspiration
(9) Patients who are dehydrated
(10) Patients who are under or need any treatments for severe cardiac disease (angina, cardiac infarction) or liver dysfunction (serum total bilirubin >= 3.0 mg/dL, ALT or AST >= 100 IU/L)
(11) Patients who have allergy of the drugs
(12) Patients who are pregnant or under lactation, or who would be expected to be pregnant during the study
(13) Patients who are not eligible due to physician's judgment
(14) Patients who are hospitalized for reasons other than taking colonoscopy
(15) Patients who receive intravenous hyperalimentation or enteral nutrition

Target sample size

200

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Hirotoshi Hasegawa

Organization

Keio University School of Medicine

Division name

Departement of Surgery

Zip code

Address

Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan

TEL

03-3353-1211

Email

hasegawa@z8.keio.jp

Public contact

Name of contact person

1st name

Middle name

Last name Koji Okabayashi

Organization

Keio University School of Medicine

Division name

Departement of Surgery

Zip code

Address

Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan

TEL

03-3353-1211

Homepage URL

Email

okabayashikoji@gmail.com

Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name

Funding Source

Organization

AJINOMOTO PHARMACEUTICALS CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2015 Year 03 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

Terminated

Date of protocol fixation

2014 Year 07 Month 07 Day

Date of IRB

Anticipated trial start date

2015 Year 02 Month 02 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

prospective observational study

Management information

Registered date

2015 Year 03 Month 03 Day

Last modified on

2020 Year 03 Month 03 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018914

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name