UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of algorithm-based active cleansing protocol for bowel preparation for colonoscopy
Acronym	The effectiveness of ABAC protocol for bowel preparation for colonoscopy
Scientific Title	The effectiveness of algorithm-based active cleansing protocol for bowel preparation for colonoscopy
Scientific Title:Acronym	The effectiveness of ABAC protocol for bowel preparation for colonoscopy
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we will prospectively examine whether the use of a predetermined algorithm-based active cleansing (ABAC) protocol results in faster and safer completion of the bowel preparation compared to conventional method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time spent on bowel preparation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	The bowel preparation method by using algorithm-based active cleansing: ABAC protocol
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Those who undergo colonoscopy for health checkup during the period
Key exclusion criteria	history of surgical colorectal resection, inflammatory bowel disease, familial adenomatous polypsis
Target sample size	325

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	6-14-28-3F, Honcho, Koganei-shi, Tokyo
TEL	042-386-3757
Email	ishibashi@tsurukamekai.jp

Public contact
Name of contact person	1st name Midori Middle name Last name Shinoki
Organization	Koganei Tsurukame Clinic
Division name	Secretariat of Center for Clinical Research
Zip code	184-0004
Address	6-14-28-3F, Honcho, Koganei-shi, Tokyo
TEL	042-386-3757
Homepage URL
Email	shinoki@tsurukamekai.jp

Sponsor
Institute	Koganei Tsurukame Clinic
Institute
Department

Funding Source
Organization	None
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	Shinjuku Tsurukame Clinic
Address	2-11-15-3F, Yoyogi, Shibuya-ku, Tokyo
Tel	03-3299-0077
Email	ando@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	2021 Year 05 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	362
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	2021 Year 03 Month 19 Day
Date of IRB	2021 Year 03 Month 23 Day
Anticipated trial start date	2021 Year 04 Month 10 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 09 Day
Last modified on	2022 Year 02 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050097