UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017411 |
|---|---|
| Receipt number | R000019983 |
| Scientific Title | Efficacy of carbon dioxide-insufflating colonoscopy comparing use of air |
| Date of disclosure of the study information | 2015/05/04 |
| Last modified on | 2015/05/04 09:33:40 |
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Basic information
Public title
Efficacy of carbon dioxide-insufflating colonoscopy comparing use of air
Acronym
carbon dioxide-insufflating colonoscopy
Scientific Title
Efficacy of carbon dioxide-insufflating colonoscopy comparing use of air
Scientific Title:Acronym
carbon dioxide-insufflating colonoscopy
Region
| Japan |
Condition
Condition
patients with IBS and control
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of CO2 insufflation in colonoscopy of patients
with irritable bowel syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Patients' symptoms such as distension
and pain were compared using a 10-cm visual analog scale
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
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
carbon dioxide-insufflating colonoscopy
Interventions/Control_2
air-insufflating colonoscopy
Interventions/Control_3
IBS
Interventions/Control_4
non-IBS
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
patients who recieve colonoscopy
Key exclusion criteria
cases in which organic diseases caused abdominal symptoms, for
example, advanced colon cancer or colitis; cases in which one
designated endoscopist could not insert the endoscope to the
cecum; cases in which examinations were not performed by one
designated endoscopist or were not performed without sedatives or
analgesics; and cases for which the VAS scales questionnaire was
not returned.
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
Office: N-14, W-5, Kita-ku, Sapporo, 060-8468, Japan
TEL
011-716-1161
m-kato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mototsugu KATO |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
Office: N-14, W-5, Kita-ku, Sapporo, 060-8468, Japan
TEL
011-716-1161
Homepage URL
m-kato@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2015 | Year | 05 | Month | 04 | 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
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
Management information
Registered date
| 2015 | Year | 05 | Month | 04 | Day |
Last modified on
| 2015 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019983
