UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled study evaluating the efficacy and acceptability of split-dose compared with morning-only dose reduced-volume polyethylene glycol electrolyte solution for afternoon colonoscopy
Acronym	Split-dose vs morning-only dose preparation for afternoon colonoscopy
Scientific Title	A randomized controlled study evaluating the efficacy and acceptability of split-dose compared with morning-only dose reduced-volume polyethylene glycol electrolyte solution for afternoon colonoscopy
Scientific Title:Acronym	Split-dose vs morning-only dose preparation for afternoon colonoscopy
Region	Japan

Condition
Condition	Inpatient who have a plan to be performed colonoscopy
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to compare the efficacy of the standard regimen compared to the alternate one; repeat to take 500 ml of PEG-ASC after 250 clear liquid three times.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint was successful bowel cleansing.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	The standard regimen of PEG-ASC for afternoon colonoscopy in Japan is to take the first liter of PEG-ASC (250ml every 15 min) after 500 ml of clear liquid, and to take 500 ml of PEG-ASC after 250 ml of clear water from 9 AM.
Interventions/Control_2	The split dose regimen; The day before colonoscopy; To take the one liter of PEG-ASC (250ml every 15 min) after 500 ml of clear liquid from 4 PM. The day of colonoscopy; To take one liter of PEG-ASC (250ml every 15 min) after 500 ml of clear liquid from 9:45 AM.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	All patients provided written, informed consent. All consecutive inpatients of both sexes aged 20 years and older who were scheduled for mainly therapeutic colonoscopy such as polypectomy, endoscopic mucosal resection, and endoscopic submucosal dissection at ACCH.
Key exclusion criteria	Patients with the following clinical features were excluded: significant cardiac, renal, hepatic, or metabolic co-morbidities, ascites, severe constipation (<2 bowel movements per week), known allergy to PEG-ELS, history of gastric stapling or bypass procedure, or history of prior colonic or rectal surgery. Patients were excluded if there was a suspected diagnosis of intestinal obstruction because of advanced colorectal cancer.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Tajika
Organization	Aichi Cancer Center Hospital
Division name	Endoscopy
Zip code	464-8681
Address	1-1 Kanokoden, Chikusa-ku, Nagoya City, Japan
TEL	052-762-6111
Email	mtajika@aichi-cc.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Tajika
Organization	Aichi Cancer Center Hospital
Division name	Endoscopy
Zip code	464-8681
Address	1-1 Kanokoden, Chikusa-ku, Nagoya City, Japan
TEL	052-762-6111
Homepage URL
Email	mtajika@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization	EA Pharma Co., Ltd., Tokyo, Japan
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	Aichi Cancer Center Hospital
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Japan
Tel	052-762-6111
Email	irb@aichi-cc.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	2016 Year 10 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	2016 Year 08 Month 26 Day
Date of IRB	2016 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2019 Year 01 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	2016 Year 09 Month 01 Day
Last modified on	2019 Year 03 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027412

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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