UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006700 |
|---|---|
| Receipt number | R000007919 |
| Scientific Title | Efficacy of carbon dioxide-insufflating colonoscopy in patients with irritable bowel syndrome (IBS): a randomized double-blind study |
| Date of disclosure of the study information | 2011/11/11 |
| Last modified on | 2016/07/05 16:37:56 |
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Basic information
Public title
Efficacy of carbon dioxide-insufflating colonoscopy in patients with irritable bowel syndrome (IBS): a randomized double-blind study
Acronym
Carbon dioxide-insufflating colonoscopy for IBS
Scientific Title
Efficacy of carbon dioxide-insufflating colonoscopy in patients with irritable bowel syndrome (IBS): a randomized double-blind study
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Mototsugu Kato |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
North 14, West 5, Kita-ku, Sapporo, Hokkaido, JAPAN
TEL
0117161161
m-kato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mototsugu Kato |
Organization
Hokkaido University
Division name
Department of Gastroenterology
Zip code
Address
North 14, West 5, Kita-ku, Sapporo, Hokkaido, JAPAN
TEL
0117161161
Homepage URL
m-kato@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2008 | Year | 10 | Month | 16 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007919
