UMIN-CTR Clinical Trial

Basic information
Public title	Low-volume administration of polyethylene glycol laxative for bowel preparation
Acronym	Low-volume administration of polyethylene glycol laxative for bowel preparation
Scientific Title	Low-volume administration of polyethylene glycol laxative for bowel preparation
Scientific Title:Acronym	Low-volume administration of polyethylene glycol laxative for bowel preparation
Region	Japan

Condition
Condition	suspicious of colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Validation of small-volume polyethylene glycol laxative for bowel preparation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Duration time for bowel preparation on the examination day, the level of bowel preparation, and adenoma detection rate on the examination
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Conventional preparation group (Sennna 1g, 3 days)
Interventions/Control_2	Novel preparation group (Polyethylene glycol 13.7g, 3 days)
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	From August, 2019 to January, 2020. Outpatients who receive screening colonoscopy in the institution.
Key exclusion criteria	Patients who received surgical resection of the colon, suffered from inflammatory bowel disease and receive treatment for chronic constipation.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Fumiaki Middle name Last name Ishibashi
Organization	Koganei Tsurukame Clinic
Division name	Endoscopy center
Zip code	184-0004
Address	6-14-28, Honcho, Koganei-shi, Tokyo
TEL	042-386-3757
Email	ishibashi@tsurukamekai.jp

Public contact
Name of contact person	1st name Fumiaki Middle name Last name Ishibashi
Organization	Koganei Tsurukame Clinic
Division name	Endoscopy center
Zip code	184-0004
Address	6-14-28, Honcho, Koganei-shi, Tokyo
TEL	042-386-3757
Homepage URL
Email	ishibashi@tsurukamekai.jp

Sponsor
Institute	Shinjuku Tsurukame Clinic, Digestive Disease Center
Institute
Department

Funding Source
Organization	Shinjuku Tsurukame Clinic, Digestive Disease Center
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	Shinjuku Tsurukame Clinic
Address	2-11-15-3F, Yoyogi, Shibuya-ku, Tokyo
Tel	03-3299-0077
Email	ishibashi@tsurukamekai.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 08 Month 01 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	2019 Year 01 Month 15 Day
Date of IRB	2019 Year 01 Month 22 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date	2020 Year 02 Month 29 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 07 Month 06 Day
Last modified on	2020 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042520