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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002777
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Akita Red Cross Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003377

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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