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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026616
Receipt No. R000028967
Scientific Title Utility of CO2 insufflator for diagnosis of irritable bowel syndrome (IBS)
Date of disclosure of the study information 2017/04/01
Last modified on 2018/08/25

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Basic information
Public title Utility of CO2 insufflator for diagnosis of irritable bowel syndrome (IBS)
Acronym CO2 insufflator and diagnosis of IBS
Scientific Title Utility of CO2 insufflator for diagnosis of irritable bowel syndrome (IBS)
Scientific Title:Acronym CO2 insufflator and diagnosis of IBS
Region
Japan

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

Objectives
Narrative objectives1 We are aiming to evaluate the utility of CO2 insufflator for diagnosis of irritable bowel syndrome.
Basic objectives2 Others
Basic objectives -Others We are aiming to evaluate the utility of CO2 insufflator for diagnosis of severity of irritable bowel syndrome.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Differences in visual analog scale pain score induced by insufflation of CO2 between IBS group and non-IBS group.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Subjects who are underwent CT colonograhpy for screening colorectal neoplasms
Key exclusion criteria Subjects with gastrointestinal organic disease including colorectal cancer
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name EIJI KUBOTA
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of gastroenterology and metabolism
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL 052-853-8211
Email ekubota@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name TSUNEYA WADA
Organization Okazaki Medical Association Public Health Center
Division name Department of gastroenterology
Zip code
Address 1-9-1 Tatsumi nishi, Okazaki, Aichi
TEL 0564-52-1572
Homepage URL
Email t-wada@okazaki-med.or.jp

Sponsor
Institute Okazaki Medical Association Public Health Center
Institute
Department

Funding Source
Organization Department of gastroenterology and metabolism, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 岡崎市医師会公衆衛生センター

Other administrative information
Date of disclosure of the study information
2017 Year 04 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, we will investigate the utility of CO2 insufflators a tool for diagnosis and evaluation of IBS.

Management information
Registered date
2017 Year 03 Month 20 Day
Last modified on
2018 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028967

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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