UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of carbon dioxide-insufflating colonoscopy in patients with irritable bowel syndrome (IBS): a randomized double-blind study
Title of the study (Brief title)	Carbon dioxide-insufflating colonoscopy for IBS
Region	Japan

Condition
Condition	Irritable bowel syndrome
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the suffering from colonoscopy in patients with IBS and the efficacy of CO2 insufflation in colonoscopy for patients with IBS
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The two symptoms of distention and abdominal pain during colonoscopic examination were registered with a 10 cm visual analogue scale (VAS).
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Device,equipment Other
Interventions/Control_1	IBS(+), CO2
Interventions/Control_2	IBS(-), CO2
Interventions/Control_3	IBS(+), air
Interventions/Control_4	IBS(-), air
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	IBS was diagnosed by using the RomeIII criteria. Subjects who were receiving total colonoscopy as screening and didn't have a history of functional gastrointestinal disorders or significant gastrointestinal symptoms were studied as controls.
Key exclusion criteria	Patients with a previous history of intestinal resection, known severe adhesion, or severe heart or lung disease were excluded.
Target sample size	80

Research contact person
Name of lead principal investigator	Mototsugu Kato
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
Address	North 14, West 5, Kita-ku, Sapporo, Hokkaido, JAPAN
TEL	0117161161
Email	m-kato@med.hokudai.ac.jp

Public contact
Name of contact person	Mototsugu Kato
Organization	Hokkaido University
Division name	Department of Gastroenterology
Address	North 14, West 5, Kita-ku, Sapporo, Hokkaido, JAPAN
TEL	0117161161
Homepage URL
Email	m-kato@med.hokudai.ac.jp

Sponsor
Institute	Department of Gastroenterology, Hokkaido University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

Other administrative information
Date of disclosure of the study information	2011 Year 11 Month 11 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2008 Year 10 Month 16 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2011 Year 11 Month 11 Day
Last modified on	2016 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007919