UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial for evaluation of Afternoon Colonoscopy
Title of the study (Brief title)	A randomized controlled trial for evaluation of Afternoon Colonoscopy
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to increase the acceptability of people in the working population to colonoscopies by verifying the usefulness of scheduling colonoscopy after intake in the morning (afternoon colonoscopy: ACS).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Verification that the efficacy of colon irrigation in the ACS group is not inferior to the control group (non-inferiority trial)
Key secondary outcomes	Evaluation of hunger and dizziness. Evaluation of whether or not they were able to work or do housework in the morning. Time taken from start of polyethylene glycol lavage intake until clear. Complications.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	ACS Group Day of exam, 8:00a.m. Jelly intake (Nonfiber Wieder in Jelly Energy Drink 2 packs=360kcal). 12:00, polyethylene glycol lavage 2000ml taken over a 2 hr period at the hospital.
Interventions/Control_2	Day of exam,no breakfast. 10:00a.m. polyethylene glycol lavage 2000ml taken over a 2 hr period at the hospital.
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	18 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Outpatients in the Dept. of Gastroenterology of Nikko Memorial Hospital in whom colonoscopy is deemed necessary
Key exclusion criteria	History of bowel resection. Patients with progressively worsening constipation. Patients with a palpable abdominal mass. Patients in whom CT or other imaging has shown colorectal cancer.
Target sample size	280

Research contact person
Name of lead principal investigator	Kazunori Yokoyama
Organization	Nikko Memorial Hospital
Division name	Department of Gastroenterology
Address	1-5-13,Shintomityo, Muroran-shi, Hokkaido
TEL	0143-24-1331
Email	yasuharumaeda610@hotmail.com

Public contact
Name of contact person	Yuichi Mori
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Address	35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi
TEL	045-949-7693
Homepage URL
Email	ibusiginjp@hotmail.com

Sponsor
Institute	Nikko Memorial Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	日鋼記念病院（北海道） Nikko Memorial Hospital

Other administrative information
Date of disclosure of the study information	2011 Year 02 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 01 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date	2011 Year 12 Month 01 Day
Date of closure to data entry	2012 Year 06 Month 01 Day
Date trial data considered complete	2012 Year 08 Month 01 Day
Date analysis concluded	2012 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 02 Month 03 Day
Last modified on	2018 Year 08 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005968