UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002777 |
|---|---|
| Receipt number | R000003377 |
| Scientific Title | Carbon dioxide insufflation for colonoscopy: a randomized, double-blind, controlled trial |
| Date of disclosure of the study information | 2009/11/21 |
| Last modified on | 2009/11/21 20:59:14 |
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Basic information
Public title
Carbon dioxide insufflation for colonoscopy: a randomized, double-blind, controlled trial
Acronym
Carbon dioxide insufflation for colonoscopy: a randomized, double-blind, controlled trial
Scientific Title
Carbon dioxide insufflation for colonoscopy: a randomized, double-blind, controlled trial
Scientific Title:Acronym
Carbon dioxide insufflation for colonoscopy: a randomized, double-blind, controlled trial
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare gas volume, abdominal pain, examination time and safety between CO2 and air insufflations during colonoscopy and to study effectiveness of Olympus UCR as a CO2 insufflator.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to reach cecum; total time of examination; abdominal pain immediately after, 30 after, 1 hour after, 6 hours after, 24 hours after examination by questionnaire; gas volume, examination time; transcutaneous partial CO2 before, during (peak value) and 30 minutes after examination; gas volume
Key secondary outcomes
Side effect
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
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Study group: carbon dioxide insufflation in colonoscopy
Interventions/Control_2
Control group: air insufflation in colonoscopy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing colonoscopy at Akita Red Cross Hospital, who submitted written informed consent. Patients must be at least 20 years old when submitting written informed consent. No criteria for gender.
Key exclusion criteria
Patients with a prior colonic resection or severe heart disease or lung disease and those undergoing treatment for a malignant disease are excluded from the present study. Patients with active gastrointestinal bleeding or intestinal obstruction requiring colonoscopic lavage during examination are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiro-o Yamano |
Organization
Akita Red Cross Hospital
Division name
Gastroenterology
Zip code
Address
222-1 Naeshirosawa-aza Saruta, Kamikitade Akita-city, Akita
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Akita Red Cross Hospital
Division name
Gastroenterology
Zip code
Address
222-1 Naeshirosawa-aza Saruta, Kamikitade Akita-city, Akita
TEL
Homepage URL
Sponsor or person
Institute
Akita Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2009 | Year | 11 | Month | 21 | 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
Completed
Date of protocol fixation
| 2008 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 18 | Day |
Last modified on
| 2009 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003377
