UMIN-CTR Clinical Trial

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
Condition	colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

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
Institute	Keio University School of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018914